U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition

Opening Remarks

MR. LEVITT: Why don't we go ahead and get started. I am Joe Levitt. I am the Director of the Center for Food Safety and Applied Nutrition here at the FDA. I want to welcome you to day two of our priority-setting meeting, an opportunity for public input.

Since we have a few new people who were not here yesterday, I am going to take probably five minutes in trying to summarize what we heard yesterday, so we have the right context.

First, Dr. Friedman came and gave a broad FDA overview of the different areas of focus and the different areas we have given priority to, to get feedback on that, as part of our general obligations this year under Section 406 of the FDA Modernization Act to develop a plan by November for Congress on how we are going to meet all of our statutory responsibilities, and as part of that, to meet with all our different constituencies in this meeting as part of that overall process.

Second, I took a few minutes and outlined the purposes of the meeting which is to really especially being a new center director to really take a good look at, you know, where are the priorities recognizing we can't do everything. One of the speakers even said we need to accept what our limitations are and recognize that, too, and I used one of my favorite analogies that FDA too often has 100 pebbles moving up a mountain at one mile an hour, and at the end of 50 years, what do we have, 50 pebbles halfway up the mountain, and nothing to show for it, and I prefer the fewer boulder up and over the hill and something to show for yourself theory.

I also showed a couple of slides on resource history. I don't have the projector here today, but basically, what it showed for CFSAN, for the Center, and this was a surprise even to me, even though I have been here all this time, is that 20 years ago, in 1978, which was about the peak, the Center had roughly a thousand people, it was 995.

Within 10 years, during the eighties, a constant decline every year, and then about '88, '89, there started to be some increases that were dedicated to four specific purposes: imports, food safety, NLEA, and finally, the food safety initiative, and even with those increases, nevertheless, we began this fiscal year at a little under 800, or a 20 percent cut.

So, the first message is, whether anybody has noticed or not, we have a 20 percent cut from 20 years ago, and what I didn't say yesterday, but I usually do, and those cuts were all taken through attrition, so they were not planned cuts. Whenever people leave, that is who your reductions are.

The second slide I then showed is, of course, if you are somebody working in the Center in one of those programs that is not covered by those four areas--I am sorry, seafood is the second one--so if you are not in imports, you are not in seafood, if you weren't part of NLEA, or you are not part of the food safety initiative, and you take out and subtract those additive resources, then, the rest of the program is really down to about 660 or a full one-third reduction.

So, if you are in food and color additives, if you are in pesticides, if you are in dietary supplements, if you are in cosmetics, if you are in the milk programs or the other cooperative programs, this is what your world is at the FDA.

Then, the third slide I put up was during that same period of time, the additional laws that Congress has passed--and there are about six or eight of those including most recently the dietary supplement laws and the Modernization Act, and so we have a clear pattern.

We have sharply declining resources, sharply increasing responsibilities for the food safety initiative on top of that, and in my mind, it just means it is even more critical that we carefully look at where are our priorities, are we getting a return on our investment, which for me is the bottom-line question, where do we do the most good for consumers.

In the Federal Register notice we outline six questions which I won't repeat because you all have them, and a number of speakers have started speaking to them.

Yesterday's discussion was excellent, I look forward to continuing today. The format will continue to be the same as it was, which we will invite people up in a series of panels of people that have something in common in terms of background and interests.

We will let each speaker speak for seven or eight minutes. We have a timekeeper sitting right here in front, and she will flash you a sign when you have two minutes left, and a red sign that says you are out, and if you don't notice the red sign, I will remind you of it.

Then, at the completion of the speakers, we will have questions, and we have up here a panel in addition to myself, several senior members from the Center, and when the Q's and A's are done, we will proceed to the next. There also will be a written summary of this meeting, and we are holding the record open for 30 days for people to submit written comments, either supplementing what you have done or people who weren't able to speak, some written comments. We certainly encourage everybody to do that.

With that, we anticipate that we will be done certainly by 1 o'clock. If we need to take a short break later in the morning, we will. We kind of play that by ear.

With that, let me invite up first the FDA panel. We have Beth Yetley, our Director of our Office of Special Nutritionals; Ken Falci, our Director of the Office of Scientific Analysis and Support, Arnie Borsetti, who is the Director of Executive Operations Staff, and we have Juanita Wills' name up here, but I don't believe she is here because she usually needs to be in Parklawn on Thursday mornings.

I invite you to come up and join me, please, and we will also invite up the first set of speakers from the dietary supplement industry. We have representatives from the Council for Responsible Nutrition, the Nutrition Network, and the National Nutritional Foods Association. I have listed Annette Dickinson, Charlene Rainey, and Michael Ford.

I am having additional copies of the slides from yesterday made up, so for people who were not able to get a copy, they should be available before you leave today.

Finally, I would encourage, especially since it looks like we are only having a half-day today, to the extent it is possible for people to stay not only for their presentations, but for others, as well, because I think it is important, as far as the overall priority setting, for people to see what everybody else's priorities are, not just their own.

With that, let us begin with Council for Responsible Nutrition, Dr. Annette Dickinson.

Panel 3

Nutrition/Dietary Supplements

Council for Responsible Nutrition

DR. DICKINSON: Thank you, Mr. Levitt. We are very pleased to be here to participate in this priority-setting meeting.

The Council for Responsible Nutrition is a trade association representing the dietary supplement industry. We have about 100 member companies including suppliers of vitamin, mineral, and botanical ingredients, as well as finished product manufacturers whose products are sold in the mass market, health food stores, direct sales, as well as mail order.

We have a little trouble, Mr. Levitt, with your pebble and boulder comparison because, in one sense, the entire dietary supplement industry is only a pebble as compared to the food industry. We had sales estimated in 1997 of about $12 billion compared to over $450 billion for the entire food industry.

However, the interaction of FDA with dietary supplement issues has presented some boulders of issues over the years, and we serve a number of consumers, as well as members of the industry, who have a certain tendency to storm the barricades when they perceive that FDA is acting in what they do not believe is their interest.

CRN's proposition to FDA is that the industry is committed to be more proactive in the coming years in terms of self-regulation in order to relieve some of the burden that FDA currently suffers in terms of manpower and resources in dealing with dietary supplement issues. However, there are some basic FDA actions that need to be put into place in order for an industry self-regulatory system to thrive.

One of these is nutrition labeling, and that I am happy to say is something that has already been done. Your final rules were published in September of '97, we submitted some petitions for reconsideration which FDA granted earlier this month, and we appreciate FDA's receptiveness to those petitions. So, we are ready to move forward with nutrition labeling. You are already seeing those new labels on the shelf.

A second issue has to do with Good Manufacturing Practices. DSHEA authorizes FDA to establish GMPs for dietary supplements. The industry is committed to helping you do that, and has submitted a draft document which you published as an ANPR in 1997, and a group of the Food Advisory Committee is currently looking at this, CRN has members represented on that, and we are prepared to do anything else that you would suggest to us we can do to move that process along because we think it is one of the building blocks we need for action in the future.

Statements of nutritional support is another area of controversy. DSHEA's provisions on statements of nutritional support were self-implementing. Companies began using these statements immediately after the law passed. FDA has three and some-odd years now of experience with this, and, in general, our perception is that the fact that FDA has only needed to respond to about 7 percent of the notices indicates a fairly substantial degree of agreement between industry and FDA about what the permissible scope of these statements is.

In our view, this is not an area that required rulemaking. In other words, it is not an area that we believe has presented a problem of misunderstanding or of lack of compliance that really required rulemaking. Nevertheless, FDA has issued a proposed rule and we are deeply studying that rule and will be submitting extensive comments in October.

We do think that FDA made a couple of missteps in that rule. The first we believe was to enter the discussion by broadening the definition of disease, which we see as highly problematic and which we see as necessarily limiting the scope of statements of nutritional support.

We think the second problem area was to adopt what, in our view, is very much a medical model of disease as the basis of this presentation rather than the fully emergent model of health promotion and disease prevention. We think that it is true, as FDA observes in the notice, that almost any structure/function statement at some extension of its logical extension will have disease prevention implications.

We believe that DSHEA clearly anticipated that product labeling have this kind of information available to consumers specifically so that they could use these products for disease prevention and to help reduce health care costs, so we think that this needs some major reconsideration on the part of the agency and we will be submitting extensive comments to assist in that reconsideration.

As much as any industry may object to the existence of regulation, the fact is that an industry needs a strong regulatory agency and consumers need FDA in place and they need to be confident that if there are unexpected problems that come up, FDA can respond to those.

That means that there needs to be swift enforcement when unanticipated questions arise. For example, last year we had an issue involving plantain products which were contaminated with digitalis.

FDA notified the industry almost as soon as it learned about this case and also issued a public health alert. The industry and the agency were very productive in working together to rapidly locate the source of the problem, remove the contaminated material from the market, and correct the situation. We believe this is a good model for future cooperation between the industry and the agency in resolving these kinds of problems, which ideally should not occur, but which do occasionally happen.

An example of a safety issue that has come up that has not received that kind of swift response either from the agency or from the industry is the ephedra situation. This is a situation that has been dragging on for a number of years. CRN has repeatedly urged FDA to take action on this issue, but no final action has yet occurred despite two advisory committee meetings and a proposed rule.

There was at one time an industry coalition which largely supported FDA action on this, but it has largely dissipated. At this point, it seems that almost anything FDA does is likely to be subject to criticism from one side or the other, but since criticism is inevitable, and since this issue has been hanging a long time, CRN believes the best course is for FDA to just face up to that, finalize a rule with appropriate modifications based on comments, and let's all try to put this matter to rest.

On a larger issue, we would like to suggest that the agency improve its handling generally of adverse reaction reports in order to involve the industry in early response to problems that appear to be arising. We would like to have the opportunity to illustrate our ability and our willingness to respond to safety issues that may arise by quickly removing the product, identifying the product, working with FDA to identify whether indeed there is a problem in the interest of consumer protection.

There are some other areas where I would like to support some of the comments that were made yesterday about the importance of FDA's continued involvement, active involvement in the areas of risk assessment and in international activities.

There are currently international activities taking place within Codex Alimentarius and also in some individual nations where there are proposals on the table to place limits on vitamins and minerals that may be sold as dietary supplements generally based on small multiples and arbitrary multiples of the RDA.

CRN has been making the argument that if indeed there are to be any limits placed under any of these mechanisms on products, that they should be based on scientific risk assessment, and not on some arbitrary decisionmaking, and FDA has been supportive in making that argument in the Codex meetings.

We are also facing some of these issues at a state level where the State of California has had an initiative on lead and calcium. We have submitted a petition to the agency on this issue, and we encourage a response to that petition, again based on scientific risk assessment.

Finally, I would close by encouraging further cooperation between the dietary supplement industry and the agency, possibly facilitated by occasional meetings between the two groups, and in addition, we want to strongly encourage the agency to establish a dietary supplement advisory committee.

The Food Advisory Committee has spent three of its last six meetings dealing with dietary supplement issues. This distracts from its attention to conventional food issues, and more importantly, from our own immediate point of view, it fails to give FDA good guidance on dietary supplement issues because most of the members of that committee are not familiar with these products or with their regulations.

Thank you again for the opportunity to participate in this session.

MR. LEVITT: Thank you very much. Again, we will do questions after everybody has had their turn.

Let's move on to Ms. Charlene Rainey.

Nutrition Network, Inc.

MS. RAINEY: Thank you. Thank you for the opportunity to make these presentations today. I prepared a lovely slide presentation for you, but the slide projector is not working, so I am going to wing it.

The Nutrition Network is a network of 650 dieticians across the United States and Canada. We monitor the food supply by going out into the marketplace and collecting samples and sending them into laboratories for chemical analysis.

Our work is sponsored in whole by the food industry, by mostly agricultural commodity boards, food trade associations, food manufacturers, food industry ingredient suppliers, and our reports are submitted to government agencies.

Our reports to FDA are in the form of approval for nutrient databases and petitions to change serving sizes. We also send the same data into the USDA for inclusion in agricultural handbook 8 for food composition and in to FTC for substantiation on food claims and to EPA for re-registration of chemicals and chemical residues.

Our goal here today is twofold, and that is, one, to continue to encourage the FDA to hold approval and review of nutrient databases in high priority and to convey the economic importance to the food industry of having nutrient databases.

Now, in my lovely slide presentation, you would see excerpts from a short course that I received a scientific lectureship from IFT, and the databases began shortly after the implementation of nutrition labeling in 1973, so the food industry has been depending for over 20 years on nutrient databases.

The first was submitted on milk by the Dairy Board, and I was involved in the second database that was put together on potatoes for the National Potato Board. The National Potato Board model was used as a model for now over 100 commodities and products from fresh produce commodities to processed commodities, frozen, canned. There is a lot of dependency on nutrient databases.

The three steps in creating nutrient databases are dynamic. They are sample collection, laboratory analysis, and the math used to summarize the results.

Sample collection is dynamic because it has to be constantly changing to include the new variables of the food. As new foods get imported, as foods change in the fresh produce section, we have fresh cut and processed carrots that did not exist 10 years ago, and as the products change, as they are imported from new countries, the sample collection has to be a monitoring process that keeps up with these changes.

The laboratory analysis methodologies change. They are constantly being updated and improved through the AOAC process, and sometimes the data gets old and the laboratory data becomes outdated.

One example of an outdated laboratory analysis is a product like papayas. We used to think there were 60 percent of vitamin A in papayas, but this was a gross old colorimetric method where we counted every bit of the color as vitamin A and beta carotene, but with new beta carotene and carotenoid analysis, this vitamin A is found to be very, very low in papayas, less than 8 percent.

Another change that is found in this dynamic process, raisins are a good example. If you look up in handbook 8, you will find that raisins have 28 percent of daily requirement for iron, but the raisin industry changed their processing equipment and they no longer use iron vats for the processing of raisins, and they changed to stainless steel. Now raisins have practically no iron.

So, as things like this come up as we are monitoring, we find changes where we would least expect them, which makes the constant ongoing process of continuing to look at the nutrients in the food supply an important step.

Now, the nutrient database approval program is the math, and unfortunately, the math keeps changing, as well. Since we started in 1973, the math of this process, that is, how we summarize the results, the math was put into place because some nutrients in some foods have a very wide variation naturally occurring.

Milk has a 200 percent variation in calcium, and this is beyond the 20 percent variation allowed, so we have to have some math to take into account the wide variation of some nutrients that are naturally occurring.

Potatoes at the early season might have 100 percent vitamin C, but by the very late season, have zero vitamin C. Which number do we select to go on the nutrition label? This is the importance of the math.

The math has changed only a few times since 1973, and it has changed for good reasons. It has changed because there was a new policy or there was an improvement to the method, and I would encourage FDA, in their review process, to not change math if it is not broken.

The changing of math has a lot of economic implication. There are several food manufacturers that use our software to create their own nutrient databases beyond those which are submitted to you for review, and they are all based on your guidelines and using your math.

You should understand that every time you change math, if it is policy and if it is for a good reason and if it is improving the process, then, we encourage it, but if it is merely a careless mistake or something that does not warrant the economic impact of having everyone reprogram their computers and by updates to change all their nutrition labeling, then, we would encourage you to make sure you have thought about the economic impact to the food industry.

But as you can see, it helps a lot to have a nutrient database rather than have every dairy in the country provide their own analytical analysis.

Thank you very much.

MR. LEVITT: Thank you very much. May I compliment you on recovering from not having the slides available. I sympathize. I gave a talk earlier in the week down in Atlanta. It was a luncheon talk, and the time got shift around, so I had to speak with slides just as the meal was being served, so half of the people, because of the round tables, they had to have their backs to the slides, so I said when it is important, I will tell you to stop and turn around. So, a very nice job. Thank you very much.

Our third presenter is Mr. Michael Ford from the National Nutritional Foods Association.

National Nutritional Foods Association

MR. FORD: Thank you.

The NNFA is a trade association founded in 1936. We represent about 2,500 health food stores throughout the country and about 800 manufacturers, distributors, and suppliers of dietary supplements, health foods, and natural ingredient cosmetics. I, like the others, very much appreciate the opportunity to have input to your priority-setting process. I am going to address five of the areas mentioned in the letter I received.

First, in the area of consumer safety, we hear protestations frequently that the FDA does not have the regulatory might that it needs and the power to appropriately regulate dietary supplements, and we feel this is not really the case. Instead of enforcing DSHEA, the Dietary Supplement Health and Education Act of 1994, many times we hear FDA officials saying that their hands are tied and that the agency is powerless to regulate.

We don't believe this is true, and need to stress that the industry did not pass DSHEA, Congress did, and the industry was not making the outcry for the passage of DSHEA. That was from consumers.

As a result, the law sets labeling and potency standards, the violations of which are crimes, and no one likes to be read to, but I am going to recite the sections in DSHEA which I believe underscore the point I am trying to make.

FDA is empowered to do the following: to refer for criminal action a company selling a toxic or unsanitary dietary supplement. That is Section 402(a). To obtain an injunction against the sale of dietary supplement with false or unsubstantiated claims. That is under Section 403(a)(r)(6). To seize dietary supplements posing an unreasonable or significant risk of illness or injury. That is Section 402(f).

To sue a company claiming a dietary supplement cures or treats a disease. That is Section 201(g). To halt the sale of a new dietary supplement with insufficient advance safety data. That is Section 413. To stop the sale of an entire class of dietary supplements posing an imminent hazard to the public health, that is Section 402(f), and to require dietary supplement manufacturers to meet strict GMPs. That is Section 402(g).

Incidently, our association this fall will begin inspecting the dietary supplement plants that are members against the GMPs. That will be a prerequisite for membership and a requirement for continuing membership in our association.

In the area of international activities, we want to commend U.S. Codex delegate Betty Campbell for her efforts to keep the issue of health claims alive within Codex. We believe countries should be devising their own policies with respect to the regulation of dietary supplements, but we also believe the United States has something unique to offer with the utilization of structure/function statements.

We would suggest this morning that you consider issuing a regular invitation to the Codex briefings to the U.S. Trade Representative Office which has a great deal of interest in the export of American dietary supplements.

In the area of authoritative statements, you know that the Modernization Act authorizes claims for conventional foods based on authoritative statements from governmental research agencies of the National Academy of Sciences.

In your June 11th guidance statement, you say that you intend to extend that to dietary supplements, and I want to say on behalf of the association we appreciate that very much and would be pleased to work with you toward that end and hope that ultimately, the authoritative statement rules for conventional foods and dietary supplements will be the same.

In the area of adverse reaction monitoring, we would like to see improvements in the system, and I think you would too. We would like to see the data be more useful in alerting the industry when there are problems with its ingredients and products.

We have proposed in the past, and I propose again this morning, I echo Dr. Dickinson's remarks, that there be a partnership between CFSAN and the dietary supplement industry in post-market product surveillance, as well as the tracking of injury and adverse reaction reports.

We believe that if the data were more consistent, more readily available, more complete and more relevant, it would likely eradicate the current problem that we have of subjective interpretations which seem to forestall action.

Finally, in the area of safety of herbs, as I said earlier, I believe that FDA currently has adequate regulatory authority to ensure the safety of herbal and botanical products under DSHEA, but we also support the recommendation of the President's Commission on Dietary Supplement Labels, that an additional option be made available for dietary supplements to make a more direct health claim through the OTC designation.

We would urge, though, as you consider this, that you create an additional and discrete herbal review panel comprising pharmacognosists and herbalists and other herbal specialists, so that you can ensure a learned and specific review process leading to the OTC approval.

That concludes my statement. Thank you very much for having me here.

MR. LEVITT: Thank you and thank all of you.

I think just one thing that I would mention at the outset, that I was educated, too, in terms of, you know, I understand the feeling. You feel like you are a pebble in the world of boulders, all of us feel that, but the law did in a way set out some of our priorities for us, for example, the notification process does take a fair amount of resources because it goes into effect if we don't do anything, so we are very careful to try and look at those letters within I guess it's 75 days--is that what it is--

DR. YETLEY: It depends on what it is.

MR. LEVITT: --whatever the different time frames are--and so in a way, some of our priorities have been, you know, set forth by the law and we do our best to accommodate that.

I think the one question I would have, if you can expand at all in the area of adverse event reporting, do you have specific things, specifics you would like to see specifically, or just, you know, it is an area we need to start working on more together?

DR. DICKINSON: I think we do have some specific things that we would like to see. For example, when FDA first becomes aware of a serious adverse reaction, we would like to be notified of that fairly promptly, and not find out about it literally months or sometimes many months later, when it becomes available in an adverse reaction report.

We would like to have the opportunity to help FDA with methods to help FDA determine what products were being used, what other products are available with those same ingredients, and if necessary, take some industry actions to either remove the product or correct the situation.

The situation in the past has been that FDA has been forthcoming at times in letting us know that some problems seem to be emerging, but when we sought more specific information, it was not available until there was a Freedom of Information request and that sometimes took a very long time.

There also is a significant lag between the time that a report is generally received at the field and the time it makes it to the official adverse reaction report, so we are looking for some more flexibility in the ability of FDA to notify the industry when a problem exists.

I understand from discussions with Beth and with others that there are other industries who get involved in the adverse reaction responses where maybe there is a more efficient system for dealing with this, and we would like to follow those models.

MR. LEVITT: Thank you. Let me just follow up on that. There are a lot of other industries and a lot of other models. Some of them are mandatory reporting by the industry. Is that a model that you would be interested in?

DR. DICKINSON: No, we are not looking at mandatory reporting. We are looking at the response mechanism more than the reporting mechanism, and in particular, I believe the infant formula industry has been cited to us in the past as a group that is highly responsive to any initial reports, but I think that begins with their being notified at an early date of those reports.

MR. LEVITT: Thank you.

In the area of nutrition databases, are there specific areas that we should be paying more attention to than we are?

MS. RAINEY: Yes. I think one area is the harmonization with Codex rules and with the international scientific community. We have one technical amendment that we have been waiting quite some time for, and that is the changing of international units in vitamin A. The word "international units," we are the only country left in the world using "international units." Everyone else has switched to retinol equivalence because of the obvious technical error of using international units.

So, when I am giving you a database on carrots, I know that I am stating on that database twice the vitamin A that are in those carrots, twice the vitamin A that are in those tomatoes, and this just isn't fresh produce, this is every plant food labeled in the United States.

So, we have this Canadian retinol equivalence. When my tomatoes are sitting in Canada, they have 8 percent vitamin A. When they are sitting in the U.S., they have 16 percent vitamin A. It is a technical error. We would really like this corrected.

MR. LEVITT: For my educational benefit, is that something that requires that we change the regulation or what would need to be done in order to correct that?

MS. RAINEY: Dr. Yetley told me it was a technical error.

DR. YETLEY: We would have to amend the regulations.

MR. LEVITT: We have to amend the regulations to do that. Okay. Very good.

Dr. Yetley.

DR. YETLEY: I wanted to pick up also on the adverse event reporting system. I think certainly we would welcome cooperation with the industry. There are some areas that from our perspective become rate limiting that I think the industry could particularly help with, and I wondered what your reaction would be.

One is the difficulty in getting information on products, if we have only a product name and no other information, we don't know the manufacturer and address or ingredients necessarily, and I wondered if the industry would be interested or had some mechanism for having information on products that was more readily accessible.

DR. DICKINSON: We don't have a product database that is immediately accessible. I think NNFA may have one through true label to some extent, but we don't have one that would cover all the products in the marketplace, however, we have a very good network, and if we were notified of a product name, we could certainly send out a request for information on whose product that is and what it contains.

DR. YETLEY: The other big area--and I think Michael referred to it--is the methods development area, and I wonder if you have any suggestions on how there could be better collaboration and coordination between FDA and the industry in terms of methods development, not only for bulk products which are more generic, but also for finished product.

MR. FORD: Are you talking about for testing methodology?

DR. YETLEY: Methods of analysis to identify what is in there and the quantitative amounts.

MR. FORD: We would be delighted to collaborate with the agency in any way we could on that. As you know, through our true label program, every product manufacturer who are members submits the labels of all of their products to us, and we take off of those labels the various ingredients and have them organized in a database, so when we find out that there is a problem, for example, with the plantain, we can pull up immediately on our screen all of our members who have a plantain product, and we were able in that instance to notify them very quickly, which was terrific.

We would be very open, in fact, our Science Committee will be meeting in about two weeks, and we would be very open to cooperating on methodology on testing.

MR. LEVITT: Dr. Falci.

DR. FALCI: Dr. Dickinson, you mentioned a very interesting term, self-regulation in the industry, and Mr. Ford also mentioned a little bit about maybe what I would term internal audits on GMP, for instance, in the industry, and I was wondering, Dr. Dickinson, if you would maybe expand on what you might mean, what the industry might do as far as self-regulation was concerned.

DR. DICKINSON: For example, in the area of GMPs and of product identity, we are considering at this time an industry educational effort which would help to bring all manufacturers in the industry up to at least the GMP proposals that we have submitted to the agency and that were submitted as a ANPR.

We think that this is one area where we could take some action to both assure product identify because some of the adverse reactions that occur are due to errors in identifying the product, and we think that through training programs and through cooperation with the agency, we can bring the products up to a higher quality standard.

We think most of the products are already at a fairly high quality standard, but there is always a segment that isn't quite up to speed with the rest of the industry, and so we think that education and internal industry activities to improve processing methods, to improve record-keeping. We know that in the plantain/digitalis issue, record-keeping was a barrier to some of the efforts to trace the product to its origin, and those are the kinds of problems that we think must, as a priority matter, be corrected within the industry.

DR. FALCI: This focuses basically on the manufacturers and producers, not necessarily on the public per se?

DR. DICKINSON: Yes. Our membership is manufacturers and producers, so what we have in mind is primarily activities that would go to them. They then, in turn, deal directly with consumers, however.

DR. YETLEY: I have a follow-up to that question. Does self-regulation work best when FDA has policies and guidelines out there, and regulations, or does it work best when there is nothing out there?

DR. DICKINSON: There certainly needs something out there. As we discussed, we need GMPs to go by. Everybody in the industry isn't necessarily going to take our word for what the GMPs ought to be, so we need some superstructure to base that self-regulation on, but once that is in place, we would offer the resources of the associations, I am sure all of the associations, in helping to improve compliance and assure compliance with those underpinnings.

MR. FORD: I agree. DSHEA and the guidelines that you have been putting out, and some of the rules that we agree with and some we don't, nonetheless, do create an important benchmark I think for the industry and allow the trade associations to educate their members.

In our case, we have both suppliers and retailers, so we are able to educate our manufacturers about how to comply and exceed some of the standards, and as well, make sure that our retailers are aware of how they have to perform with respect to the availability of literature and what they say to their customers.

We are also able to provide information to the public through the health food stores, through to the customers of health food stores, and I think that has been very positive for us, as well.

I want to just also, Dr. Falci, just quickly mention that with our true label program, not only do we gather the ingredients off of the label for the database, but we also have a random testing program where we will go to a health food store and buy product off the shelf and test it.

Sometimes it is because of a complaint or a concern that has been expressed, and sometimes it is just to test like multiple vitamins to make sure they have what they say they do. If we find there is a problem, we privately contact the manufacturer and tell them that either the label or the product has to change within a certain time frame or they will not be able to remain members of the association, and since we have a large and successful trade show, that has been a pretty good hammer for us.

DR. FALCI: Thank you. One more question. Ms. Rainey, you had mentioned that you wanted us to keep the nutrition database reviews basically in a high priority. I know that we get literally hundreds of them and have reviewed hundreds of them, and I am sort of opening FDA up now for potential criticism here, but as far as our reviews are concerned, and the information that you got back that the reviews were complete, how did you rate us as far as that kind of service?

MS. RAINEY: Well, there has been a large turnover of personnel. I have been submitting databases for review for 18 years to the agency, and there is a little bit of a training process that has to go on every time I get a new person working on this project.

So, I have in my company, from my end, created a checklist of what things need to be approved before samples go into the laboratory and what things need to be approved after you get the results from the laboratory, and I think that if we sat down in some sort of a partnership way--and I know that requires trust on both ends, you know, more trust of industry on your part--but if we could go down and share this checklist with you of what we need to know, because if you disapprove of the way we are collecting our samples and try to identify one variable or another, and we have already spent money on laboratory analysis, that is not the time to find out--submission of the plan ahead of time.

We would like to have the process not be a moving target. We send in for preapproval and then after they have had a chance to look at the results, then, there is new criteria that are added on, and the new criteria, you know, this is a dynamic process. We can make it better for upcoming and future samples, but we need to have this understanding that it needs to stabilize a little bit, and not feel like a moving target that we can't possibly hit.

DR. FALCI: You want to go to completion at least on one issue, and then improve it later on as the time goes on.

MS. RAINEY: For the future, constantly improving for the future, and the data is merely place card holders in time of what we learned today.

DR. FALCI: I would agree with that. We should meet more of that.

MR. LEVITT: Dr. Borsetti.

DR. BORSETTI: This is to pick up a little bit on the famous phrase, "ask not what your country can do for you, but what you can do for your country." Ask not what FDA can do for you, but how you can work with us to help us to get an enormous job done, especially in this very complicated area where there is not enough research, which is what my question is coming to, to satisfy the needs in order to develop the rules and the health claims, and the other types of statements that we need to assure that products are safe.

To the panel in general, would you please reflect on how you might be able to work with us given the fact that we now have a new joint institute for food safety and applied nutrition, which I think is one mechanism where you might be able to work with us to help divide the labor in the area of research for dietary supplements. I think, Mr. Ford, you alluded to some of these a few moments ago about this development area.

MR. FORD: Yes. I think we could be very helpful by providing some of the research to you, at least that which would not be considered overly proprietary that is going on with many of our companies despite the fact that the way DSHEA is structured, the claims are not patentable, nevertheless, there is a great deal of research going on in our major companies, and a lot of it is quite good, and I think that is something that I would be glad to talk to my Science Committee and the Board of Directors, and the membership broadly about being able to provide.

I also would suggest that you not overlook a couple of resources available to you within government that the National Institutes of Health, and that would be the Office of Dietary Supplements and the Office of Alternative Medicine, which have lot of resources--more resources than they used to at least--and I know we would be very interested in collaborating with the FDA and providing other kinds of information you would need.

DR. DICKINSON: We have some collaborative methods currently underway for method development with an organization that is being established within the industry under the industrial laboratories, which is a service laboratory in Colorado, in which the effort is to establish agreed-upon methods of analysis for a number of botanical products and certain other ingredients, and get those into at least peer-reviewed approved mechanism for AOAC, so that these are publicly available methods.

We currently find that many of our companies have developed proprietary methods which are probably very good, but which are not generally available to the industry, so this is an effort to break out of that kind of restricted model and get to the point of publicly available methods, and I know that many of our members have been working with people at FDA in the analytical area to share information and to facilitate that process.

MR. LEVITT: I have just one final question. One of the issues dealing with the whole dietary supplements area is that the law is still relatively new and a lot of the basic framework is not yet in place, and so the number of regulations we have in the dietary supplement areas is clearly disproportionately high compared to what we would have in other areas of larger impact.

The order we are doing them in I would describe in terms of state of readiness is ephedra first, there has already been a proposal out, the structure/function claim proposal, which is out but more recently, the authoritative statement, promise of a proposal which was made recently, and the GMP, which is at advisory committee working group for work.

Is that the right order, putting aside it will take longer than you would like, but at least is that the right order of importance?

DR. DICKINSON: I would bump the GMP up higher because I think we do have some identity and quality issues that have come up which do have implications for public health. The labeling issues also obviously have some implications for health, but to a large extent, as I mentioned, DSHEA is pretty much self-implementing on the subject of the claims side, whereas, on the GMP side it really is not. We really need an FDA model for GMPs for this industry in order to improve the processes across the board.

MR. LEVITT: Thank you very much. I thank all of you.

[Applause.]

We can proceed I think straight away to the second group. The second group is a group of three food trade associations: the National Food Processors Association, John Cady; the Society of Plastics Industries is Jerry Heckman and Tom Brown; and the Apple Processors Association.

Mr. Cady, why don't you lead off, please.

National Food Processors Association

MR. CADY: Thank you very much. Good morning. I am John Cady, President and CEO of the National Food Processors Association, and we appreciate this opportunity to provide input on the priority-setting process for the Center for Food Safety and Applied Nutrition.

As most of you know, NFPA serves as a scientific and technical trade association for the $430 billion U.S. food processing industry. Our primary focus is on issues related to food science and food safety, so it is highly appropriate that we provide input on behalf of our broad-based food industry at this meeting.

My comments today will briefly address the administration's food safety initiative, as well as making recommendations for priorities related to other food safety issues and additional CFSAN activities. Our written comments go into very specific detail on these points.

On the subject of the food safety initiative, let me say at the outset that NFPA salutes the administration's interest in food safety issues. We stand willing to work with CFSAN on its endeavors related to the initiative, especially those activities on which we believe the highest priority should be placed, which is research, risk assessment, and education, but NFPA remains concerned that other equally important food-related programs, such as the review process for new food and color additives or new uses for approved ingredients or international trade issues may not receive adequate agency attention or an adequate level of funding from general revenues.

CFSAN and the administration must not divert funding or attention from other important Center activities to pay for food safety initiative related projects. I would like now to address our views as to what a few of CFSAN's top priorities should be outside of the food safety initiatives in general.

It is our strong belief that FDA should take action to require that all fruit and vegetable juices be pasteurized to ensure their safety. FDA must mandate pasteurization on an equivalent process for all juices or an equivalent process for all juices, not just most juices as the agency has proposed, or, we believe, juice safety regulations will not be successful in advancing food safety in this country, and E. coli will still be a major concern for consumers of certain products.

Another priority for CFSAN should be the proper implementation of HCCIP regulations for a variety of foods. HCCIP is best used where there is evidence that rigorous oversight is needed to control the food safety hazard and where technology and processes exist to control that hazard, however, the application of HCCIP where these considerations do not apply will likely result in undue costs for processors and higher food costs for consumers without meaningful improvement in safety.

CFSAN should also place a high priority on reforming of the food additive review process. It is no secret that FDA regularly fails to act within its statutory review periods for various applications and petitions. Despite the fact that FDA is required to approve or deny food additive petitions within six months, the average petition lingers close to four years before FDA acts on it.

Timely action on food additive petitions is necessary and we urge FDA to reform its review process, so that the agency can comply with its statutory obligations.

International activities are becoming increasingly important to the United States. Consequently, CFSAN should place a much higher priority on efforts to improve international food safety standards through cooperation in Codex Alimentarious. Since 1962, the Codex process has developed many guidance documents on food safety and wholesomeness.

We urge CFSAN's continued strong participation in the Codex process and other activities which strengthen international food safety, and we emphasize the problems that exist between the United States and Canada where products have to be reformulated and labels have to be redone because we can't ship them between on a uniform basis, and I think we need to look at Canada specifically as a good starting point.

National uniformity and harmonization among federal and state agencies should also be a priority for CFSAN. The efficiency of the food industry is greatly impeded when it must deal with different regulations established by federal and state agencies. This also contributes to inefficient regulation and inspection.

Inspectors, be they state or FDA, should be able to evaluate a plan's performance and the safety of a product with respect to a single set of standards. Additional programs which should also receive higher priority within CFSAN include the continued maintenance and administration of the food standards program, as well as ensuring consumer confidence in the food supply through prevention of economic fraud. Both are extremely important needs for the food industry and for consumers.

CFSAN has a mandate to carry out a range of food-related activities, however, to reiterate, the Center must not rob Peter to pay Paul, nor can it continually cite lack of resources and personnel to justify delay in important activities. That answer does not pass muster.

Like industry, CFSAN will continue to be called upon to do more with less, which is why we applaud this effort to set priorities in order for the Center to meet its obligations. We suggest a bold approach to establishing Center priorities and an even bolder approach for addressing an organizational structure that will reflect the public health needs of the new century.

In closing, I would urge the administration and HHS to make CFSAN funding a priority and to act much more aggressively in obtaining the annual funding necessary for CFSAN's mission to be properly accomplished. This funding support by the administration at the highest levels cannot be overemphasized.

Again, we appreciate the opportunity to present these program priorities for consideration by the Center and, as I said, our written extended documentation goes into detail on each one of these subjects.

Thank you.

MR. LEVITT: Thank you very much.

Next, we will hear from The Society of Plastics Industries. I am not sure who is going to be speaking. Mr. Heckman?

The Society of Plastics Industries, Inc.

MR. HECKMAN: I am going to introduce Tom if I may. On behalf of the Society of Plastics Industries, Inc., Tom Brown and I very much appreciate this opportunity to tell you why we feel strongly that the Food and Drug Administration should implement the notification system for food contact substances created by the Food and Drug Modernization Act of 1997.

This is a case, using your analogy, where we feel that you can get rid of a number of pebbles by just pushing one boulder up the hill and avoiding the sisyphus effect that we have been suffering under for many years. In a way what we are saying is that we think we can help you to maybe conserve or reorient the use of some resources, so that you will have more to do with, with regard to the food safety initiative or whatever the other priorities are.

We recognize that the amount of additional funding FDA will receive to carry out this program is uncertain at this time. As I hope you will recall, the packaging industry was, and remains, willing to pay reasonable fees to help cover the cost of processing the notifications. Congress, however, decided that the program should be funded from FDA's budget and authorized the additional funding in FDAMA. That is different than appropriating it and authorized.

As you know, the appropriation of the funding authorized in FDAMA presently is being considered by Congress, and the packaging industry continues to work diligently to obtain this appropriation. Here, we hope to highlight the advantages of the food contact notification system over the current indirect food additive petition process, focusing on ways in which the new system will we believe actually reduce the resources required from FDA.

We believe that the agency will be able to implement the notification system without devoting significant additional resources to the task. In fact, there are efficiencies in the notification system that may allow the redeployment of resources currently allocated to the regulation of food contact materials to other FDA responsibilities more critical to public health and safety.

The one thing we would like to help bring about, to borrow a phrase that caught my attention and kept it, used by Dr. Cheesman last week, is that we would like to help you not continue spending a kilogram of energy on a phenogram of risk. That seems to me to characterize our problem completely and has for 40 years.

So that you will receive a very informed analysis of why we believe moving to the food contact notification model for substances now dealt with in the same way as direct food additives can result in important pluses for a more efficient operation of the Center, I have asked Tom, who is experienced in the Office of Premarket Approval, and before its existence, the Division of Food and Color Additives, is well known, and he will make our presentation in chief to you, I hope with some specifics that you might find challenging and interesting.

MR. BROWN: I would like to thank you very much for permitting me a few minutes during this unique opportunity to comment on the CFSAN priorities and explain why we urge CFSAN to include food contact premarket notifications as a priority item in the upcoming plans for Fiscal Year 1999 and beyond.

We believe that implementation of the notification program will not require significant additional resources from FDA. It could well permit current resources devoted to petition reviews to be transferred to the food safety initiative.

As you know, the Food and Drug Administration Modernization Act of 1997 sets forth a new procedure for food contact items that would permit the use of notification procedures in lieu of the current food additive petition process now in use at FDA.

Under this procedure, the person wishing to use the food contact material that is either new or not currently regulated for such uses would submit a notification to FDA containing the same quantity and quality of data that would be submitted to the food additive petition.

FDA would have 120 days to review the data and determine if, in its opinion, the use has not been shown to be safe. If FDA does not raise the safety issue, the notification would be effective in 120 days with no further action by the agency.

One of the unique features of the FDA Modernization Act of 1997 is that the start-up of the notification program is dependent upon FDA receiving a special appropriation from Congress to fund the program. In FDAMA, Congress authorized funding for the program of $1.5 million for Fiscal Year 1999 and $3 million beginning in FY 2000.

The packaging industry is exerting great efforts to have Congress appropriate the authorized funding which Congress substituted for the reasonable filing fees that the industry is willing to pay, but I hope to show in this presentation that the notification system will not demand significant resources and may allow resources to be allocated to more critical tasks.

Because I spent 29 years with FDA, 22 of which were in the regulation of indirect additives, my aim here is to offer some insight into the implementation of the notification procedure and why we believe it will work for the benefit of all, so the implementation of the program should be prioritized.

Also, for many years I spent time developing budgets for the entire food additive program and had reason to pay special attention to how much time was actually being spent working on petitions.

My main objective is to share with you my thoughts on resource allocation where food contact substances are concerned and thereby to persuade you that the new premarket notification program will not require long-term additional funding as compared to what is now being spent on dealing with petitions for food contact applications.

To provide this analysis as coherently as possible, I will first give you my analysis of how FDA resources are now being expended on petition process and indirect additives and how much of this expenditure can be avoided with no adverse public health implications under the premarket notification concept.

I will indicate to you how I feel FDA may best implement the new premarket notification program to assure that it is conducted in a way that will least strain the resources of the agency and those who deal with them.

If you look at the current petition process, it is understood that 85 percent of all the petitions, food additive petitions that FDA receives are for what we call indirect additives, but should probably better be called food contact substances since there is really no food additive effect for a great majority of these substances, and realizing that when the notification program is implemented, perhaps 90 percent or more of these petitions will no longer be necessary.

It would appear worthwhile to analyze resource utilization differences between the two systems, in other words, assuming as is intended, that the scientific reviews under both systems will not differ substantially since the same data will be submitted and same conclusions as to safety assurance will be essential, what differences might there be, what reduced demands on agency resources might be anticipated, because the need for writing, reviewing, and publishing complex regulations must be understood by all and will govern all, will no longer exist, we see this as a definite area where there is a savings of time, not only at OPA, but in other parts of the agency, CFSAN, Parklawn, too.

As I see it, the elimination of the burden of issuing regulations is sufficiently significant, so that even though we continue to believe that the food contact notification program would best and most fairly be funded by the sort of cost recovery fees Congress has thus far refused to authorize, it is our basic belief that the program, once launched and in place, may free some of the resources for further agency activities, such as other programs with greater potential for public health benefits like the food safety initiative.

In passing we should note that we believe that the commencement of the program will help provide data that would enable us to try once again to make the system self-sustaining on a cost recovery charge per notification basis.

We realize that the Congress has thus far rejected the plan we proposed, and which FDA endorsed, but we think that a demonstration of the effectiveness of the system and an effort to further educate Congress and other industries on its value and proprietary nature could affect the turnaround at this point.

One good way of actually measuring the impact of the notification program on the agency's resources would be to conduct a pilot study. This is the procedure that we used--I say "we," my time at FDA--on setting up the threshold of regulation and the special project team, both of which were proved to be quite successful and very time saving.

This could easily be done by taking several petitions or threshold of regulation requests from the current backlog and processing them through the review portions of the food contact notification program.

It would seem that this could be done with no real disruption of the current petition review process and the review times and subsequent administrative times. That is the time involved with actually getting the regulation out, which can easily surpass the--

MR. LEVITT: If you could just try to wrap up quickly.

MR. BROWN: Okay. To summarize--it will be in written testimony--but I have made a list of things that don't happen, and people do not have to look at filing notices and petition regulations.

Filing notices, that is not really all that great, but there is about 15 people above the actual level of OPA that will not have to be involved in this, and it is probably a savings of 15 to 20 hours per petition, and in the actual regulation area, I calculate is--again, this is all detailed in the testimony--that 46 people handle each petition on its way after it has been written by the CSO before it is published.

MR. LEVITT: Thank you very much. Don't worry, we will read the entire set of written comments. Thank you very much.

Let us move to our third presenter, Mr. Paul Weller, from the Apple Processors Association, a different element of the food industry.

Apple Processors Association

MR. WELLER: Thank you, Mr. Levitt.

Let me preface my remarks by saying we very much appreciate the opportunity to be here. We appreciate you all putting this forum together, and we appreciate over the years the opportunity to work with the Food and Drug Administration.

I am Paul Weller. I am President of the Apple Processors Association. We are a national association of firms that manufacture quality apple products mainly from the whole apple. Our member companies operate as apple grower cooperatives or they grow a portion of the apples processed in their plants. They produce the majority of the nation's applesauce and much of the apple juice and especially apple products in the nation.

Our member firms stress quality and safety in their food processing operations. All of our member firms pasteurize their juice products to ensure consumer safety and with hot filter food containers as an added precaution, and we are proud of our adherence to the strictest safety standards.

We appreciate this opportunity for several reasons. One is that several of the regulations that are pending before the Food and Drug Administration and your Center at this point give us great concern.

We are recommending today that FDA place its priorities in three areas, three areas for regulation and enforcement: Number one, that you focus on valid--and I say "valid"--food safety problems; number two, that you assure that consumers know what they are buying; and, number three, that you adopt a science-based policy to define health claims in labeling, and I would like to very quickly elaborate on each of those three.

Number one, focus on valid food safety problems. In cases of illness and death associated with microbial contamination of food, we think that FDA should: one, target the problem; two, find the most effective remedy; and, three, act quickly to implement that remedy.

The current proposed HCCIP procedures for the safe and sanitary processing in importing of juice is an excellent example of FDA's failure to target the industry that poses the greatest risk, this industry being the fresh fruit juice processors that do not pasteurize their products.

FDA should take immediate action to significantly curtail hazards. Instead, FDA proposes a HCCIP proposal that would require additional costly procedures and record-keeping for the segment of the industry that already spends significant resources to make juices safe through pasteurization, while FDA proposes to exempt those processors that arguably pose the greatest risk to consumers, the small processors that make and sell less than 40,000 gallons of juice per year to consumers.

These small processors produce the bulk portion of the 2 percent of juice products that are not pasteurized for consumer safety. We understand that this issue was addressed yesterday, and I think Mr. Cady addressed it briefly this morning, as well. We urge that FDA carefully reconsider its proposed regulations in this regard.

FDA should require fresh juice processors to use full pasteurization or its equivalent in processing juices for consumer use. Moreover, FDA should define the temperature range and duration of effective pasteurization or similarly effective technologies. Labeling of unpasteurized juices should only be an interim fix until all juice manufacturers adopt effective technologies to kill microbes.

FDA has not acted quickly enough to implement a strategy to effectively address the problem. It has been a year and a half since the severe illnesses and death from E. coli 0157:H7-contaminated juice occurred in the Northwest. It will be another two years before HCCIP will be implemented. Even the interim labeling requirements will not go into effect until the end of this summer, nearly two years since the outbreak.

We understand FDA's political pressures. We were part of the initial testimony a year and a half or so ago when the pressures came from the small and from the politicians. We think FDA should act now regardless of these political pressures or concerns. No one--no one should be exempt from sensible food safety measures that are effective in protecting consumers.

Number two, assure that consumers know what they are buying. It is FDA's mandate under the Food, Drug, and Cosmetic Act to protect consumers from being misled on food products. FDA should maintain a strict interpretation of this law vis-a-vis food labels. FDA should also take the necessary steps to enforce compliance with this law.

When a consumer issue is raised, labels need to be modified and regulated accordingly. FDA's action several years ago to require labeling a percentage of juice in blended juice products is an excellent example of FDA protecting the consumer's interests, and we appreciate that very much.

We also commend FDA's actions to ensure that adulterating substances, as in the case of sugar water, in imported juice products, are clearly declared on ingredient labels When adulterating substances have not been properly declared on labels, FDA has acted properly to remove those products from the marketplace. Again, we appreciate that action very much.

When FDA acts quickly and decisively in the public interest, both FDA and private industry gain through increased consumer confidence.

Finally, we think FDA should adopt a science-based policy to define health claims in labeling. APA is concerned that not all agency decisions are based on sound science. Health claims must be based on sound science and supported by statements made by federal agencies.

FDA should continue to enforce and follow the rules contained in the Nutrition Labeling Education Act, and FDA should be also responsive to scientific consensus and findings of your Dietary Guidelines Committee.

In summary, the Apple Processors Association is pleased to work closely with the FDA and pledges its resources and cooperation in establishing and enforcing sound food safety rules and regulations.

Thank you.

MR. LEVITT: Thank you very much. May I just say with respect to your first set of comments on the juice HCCIP proposal, I trust that you will be submitting separate comments to the docket on that, as I am sure others will.

MR. WELLER: We do indeed by the July 8th date.

MR. LEVITT: Let me start with a couple of questions. I will start with Mr. Cady since he was the first speaker.

HCCIP. A question was asked yesterday, so I will give you a chance to reflect on it also, that in some other countries, I think Europe, that they are adopting more what was called a universal HCCIP.

Should we be thinking more in terms of a universal HCCIP, does it help on trade, what are your thoughts on what should be the right scope and applicability of the HCCIP model?

MR. CADY: I think that even on the international level, I think HCCIP has to be looked at from a food safety risk perspective, and I think arbitrarily putting HCCIP mandatorily or universally across the board for all food products is not going to utilize the system, the HCCIP system the way it should be, and doesn't allow it to focus on where the risk is.

I think it is easy for people to say universal HCCIP or mandatory or across-the-board HCCIP, but the fact of the matter is, is that HCCIP is there in order to look at risk and to identify it and to control it, and there are just plenty of food products where that does not apply.

MR. LEVITT: Thank you. Let me ask you a more specific question, having nothing to do with HCCIP, and this is as much for my education as anything. You referenced international, specifically, some issues dealing with Canada. Could you just give a couple of specifics there?

MR. CADY: Well, the same product going into Canada, the ingredients have to be changed, the formulation of the product has to be changed, and that of course, obviously, then, we get into the uniformity of labeling between Canada and the United States.

It is interesting, as I go around and talk to our member companies, the amount of people who bring up problems that they are having with Canada versus the rest of the world that they ship to when they are so close.

The detail that we have in our written testimony I think goes into that, and if you want us to provide more information and examples, we have plenty of them that we can give you.

MR. LEVITT: Those are general labeling issues, not really safety issues?

MR. CADY: No, they are general labeling issues and product formulation ingredient issues.

MR. LEVITT: Thank you very much.

If I could move down the table a little bit, to Mr. Heckman and Mr. Brown, on food contact substances, one of the concerns I have heard within staff at the agency is while the concepts and the model developed is a very good one, there is a concern that it will be such a good one, that a lot of companies will try to utilize it.

Do you have any good estimates of what the volume of usage might be with that in place?

MR. HECKMAN: The best model we have, the closest thing to it that we know of is the way they do it in Canada, and our experience of course in Canada is better than it is in this country.

The Canadians are handling roughly 1,200--well, I was told last week--1,267 requests in 1997. You have got to remember a lot of these will be duplicative. The people have looked at a lot of the things in the total, and will know that they have passed on them recently and they are all okay.

They handle 1,267 clearances and responded to them with four and a half--the same as about four and a half full-time equivalents. Now, what they don't have to do, that we do have to do--and that is the biggest part of the problem in our opinion, this is where the kilogram of energy is used--is write regulations, have them reviewed by everybody from here to Parklawn and back two or three times, et cetera, et cetera.

They do this by giving it the same kind of scientific review, chemistry, toxicology, and then out, and when you are dealing with proprietary notifications, so that you have all the facts in front of you including the precise intended use, that should make it a lot easier to deal with that issue, and you don't have to write a rule of general application. That can save a lot of time.

We know that many of those petitions are held up, the current food additive petitions are held up. I think Dr. Cheesman spoke at a meeting we had last week, and if I understood him correctly--if I am mischaracterizing him, I will find out and apologize--I think he indicated that a threshold of regulation requests might require 150 days to get out currently, but that doesn't include the time to log it in and to write the letter, and things like that, and that ends up taking eights months to a year.

So, we are spending a lot of time writing complicated regulations and threshold responses that probably don't have to be written.

Of course, we have been saying that--our problem is that the original sin was committed in 1958, and that original sin needs to be looked at and changed. It was never a good idea to treat both direct and indirect additives in the same way. That was the original sin. It is time for us to rid us of it.

MR. LEVITT: A follow-up really, a more food additive question. One thing, as we are talking about priorities, what happens is certain activities do drive our priorities whether we want them to or not. You know, that is going to drive our priorities.

Yesterday, we heard a presentation on a coalition of food industry on a user fee program for direct food additives, which NFPA I believe is a part of. If that is enacted, but not this, that will drive priorities.

We also heard testimony about GRAS affirmation and how some GRAS affirmation issues, that ought to really be where the priority is.

I tried yesterday to get people to rank these different things and hopelessly failed. I will try to learn from that experience. But do you see from an industry perspective a way to pull all these together somehow, because if it is becoming a race and one beats the other, it will pull from the other whether it is intended to or not just by the nature of our process and our limitations.

So, are there efforts to kind of link all these together, food additives, GRAS affirmations, indirects, in terms of wrap it up in one bow?

MR. HECKMAN: I can start if you want. We are aware of the fact that people in the food industry are attempting to find methodology to improve the processing of direct food additive petitions, and we certainly are much in favor of that, like we are in favor of uniformity as they are and many other things.

By and large, we are together. I guess the only place we have come apart in the past is on this matter of fees for the service. We favor reasonable fees. We don't favor fees for food additive petitions and probably never will unless you make food additive petitions as simple as indirect food additive notifications, but basically, I think we are in the same place.

MR. LEVITT: And the reason for that is just out of curiosity?

MR. HECKMAN: On why we don't? Well, we are against food additive petitions per se as far as indirect additives are concerned. As I said, I consider that original sin, so we are certainly not in favor of it. On the other hand, if they want food additive petitions, you know, that is fine. If that is what the people who make direct food additives want, we will not in any way oppose that idea as long as we are not included in it.

Now, let me try to weave in the GRAS notification concept. GRAS notification, GRAS affirmation petitions were all extra-statutory. When the law was enacted, there wasn't any provision for GRAS affirmation petitions. That was put in, in 1973 or '74, if I recall correctly, and was an initiative by the General Counsel's Office.

The fact that there is no priority put on it means that I have got a couple of them that have been pending for 13 years, and there are probably more that maybe have been pending longer.

If you put in the GRAS notification procedure, and it works in some effective way, that is just another alternative. There is no reason why, for example, indirect additives could not be the subject of a GRAS notification petition.

I don't think that is the right way to go for us, but if you put in the GRAS notification procedure, or you are trying to choose between GRAS notification and food contact substance notification, we can do either one.

So, if you are going to prioritize, you might as well, in my opinion, you might as well prioritize and get rid of the 85 percent by putting in the food contact notification. That should help make the GRAS notification procedure work without as much difficulty, and if there is also progress made on the food additive petition concept that at least that alliance has, in due course, maybe there will come a time when we are able to fund on a self-funding basis anything that amounts to safety assurance as distinguished from safety per se. These issues are safety assurance issues.

The reason industry wants to have something that shows that the substances it uses are okay is because that increases public confidence or customer confidence. That is a big part of the function they play.

MR. CADY: We just want to make a differentiation. I guess I always try to do that between "user fees" for public health inspections which we obviously are against and can't see the benefit of that to the public or industry, but in this particular case, where specific companies are benefiting from this specific process, we firmly believe that there is a way in which we can come up with some type of fee arrangement in order to speed along the process, and we intend to work with the legislature here in Washington to try and figure out how to make that happen.

We realize the dollar limitations that are placed on the Center. It is unfortunate how the pie is distributed, so to speak, once the FDA budget is approved regardless of what the total number is. We believe that the Center needs more, a bigger part of the pie, and we are going to continue to try to get that to happen, whether it is through food additive petition fees or whatever.

MR. LEVITT: Thank you. I don't want our friend from the Apple Processors Association to feel left out, so I have on question for you, and then we will move down the table.

Your second point was to the effect of ensure consumers know what they are buying, and you gave a couple of examples of things that you thought had gone well. Are there specific medium-sized boulders that you think, if you could look ahead a year from now, and say if FDA had done this in that area, I would be really pleased? Are there any specifics, or is that more on general principle?

MR. WELLER: Are you talking about labeling?

MR. LEVITT: Labeling.

MR. WELLER: For many years, Mr. Levitt, we have tried to monitor the food shelves, and have brought to your Center examples of food labeling of food products whose labels do not meet your regulations, and find that FDA has not been able to enforce those particular regulations. It is always that we don't have the staff or we don't have the budget.

So, to answer your question, I hope specifically, what we would like to see is that the labeling standards that are there now be enforced, because we think they are good standards. We think that the percent of juice on the front, we think that the nutritional labeling that we helped put together, these are all good points, but we have to monitor and enforce that labeling regulations.

If you can do that or come to us and say we need more money from the Hill to do that, maybe we could help you. That is what we would like to see, because we are all for the consumer's right to know.

MR. LEVITT: Thank you. Let me move down the table. Dr. Yetley.

DR. YETLEY: Thank you. I want to address a question to both John Cady and Paul Weller. Both of you gave us a number of issues in which you would like to see the agency place higher priority or higher emphasis. If we do that, we obviously then have to cut something else out. What would you like us to drop that we are doing now?

MR. CADY: I know that we have tried to come up, as Joe did, with numbers 1 to 10. It is always a good way for that to work if it works that way. Unfortunately, my experience in the government prior to coming into this part of the world doesn't allow that to happen because it is a public health center, it is a public health function. You have a tremendous amount of requirements placed on you.

I do believe that the efficiency within house, within the organization of this center has not been fully reached yet in terms of not only people, but also in process, and we talked a little bit about that here this morning I think amongst us here.

I can't tell you go to give up indirects, I can't tell you to give up whatever somebody else may feel is their major thing in the world, but I can say that if the food center is to be truly the food center, then, there are groups of things that I think can be done on a quicker, faster basis.

I think we take too much time. I think once the science is established, I think the process ought to move faster, and I think the whole notice and comment process, as an example, needs to be totally revisited and totally recalled as to who may, who should, and how long a comment can be in order to move this process along.

I think we err too much in gathering data and then mulling over the decision. I realize that, as good people who run the center, you work in a Civil Service organization that ultimately is directed, as in any administration, by political appointees, and I think there has been an awful lot of politics that have entered into a tremendous amount of food center decisions, and I think that obviously extends any decision process that is made by people who are trained in science, et cetera, to come up with the right answer based on their experience.

MR. WELLER: Dr. Yetley, you have gone in the right direction by setting priorities and targeting your resources to those priorities, and we certainly commend you for that.

We think that you can reduce some of your superfluous techniques, for example, if a company processes at 180 or 190 degrees Fahrenheit for three to four minutes, and it kills the microbes, why do we have to follow HCCIP? You are requiring that, and yet all the paperwork that has to go with that HCCIP comes back to you all. So, it seems to us to be superfluous.

I think if you look at these priorities and say how can we protect the consumer, how can we protect the public health, let's do one or the other. So, I think you are going in the right direction. Let's just keep it slim and trim.

MR. CADY: I think the choices have to be made within the Center as to the definition of safety, and there is a risk basis associated with this. That has to go into your decision process and where you put your emphasis. I think in most cases, we have tried to be so sure in your job to protect the public that that just takes up too much time and too much energy on the part of the limited staff.

DR. YETLEY: I just had one other question for Paul Weller. You indicated that the agency should base its labeling decisions on sound science and consult with other federal agencies. Do you have specific examples on where that has failed or has not been the case?

MR. WELLER: Where they have not used sound science? There is a lot of politics that have entered into, and I don't know if you want to go back to the whole alar situation, but we in the apple industry have been hit time and time again with some of this unsound science, and found that our best ally, the people sitting across from me, the Food and Drug Administration, have not come up to our defense. It took you 17 days to come to our defense on alar, until our industry was decimated.

There is examples of unsound science that are in the media literally every day, if FDA could help us build that case, in other words, use your public information capabilities a little bit better, and let us knock down this unsound science that is out there. There are groups in this town that make a very good living just trying to destroy parts of our industry here on this side of the table, and you are our allies and we need your help.

MR. LEVITT: Dr. Falci.

DR. FALCI: Two things for Mr. Cady, one, a clarification, and the second, a question. The clarification, you mentioned organizational structure that should be changed, and you mentioned people and process, and I supposed you meant in CFSAN.

Were you also talking about organizational structural change in CFSAN, the way the offices are set up?

MR. CADY: Yes, I was. I think that that needs to be really looked at in depth. Under the current procedures where you are not filling people who retire, et cetera, I think that keeps pecking away at different things, and I think there should be a way to put people together in teams and to address specific general areas.

I also think that the Center needs to come up with what I would call a food safety scheme, food safety management system that encompasses a new way of looking at a lot of different things that I think would help you from a resource perspective and be able to do things on a more efficient and still effective and protective basis.

DR. FALCI: And this is outlined in your comments, as well?

MR. CADY: It is mentioned in there, but we can detail it more if it is not. There is some direction in there.

DR. FALCI: Then, we talked a little bit about HCCIP, and it didn't sound like you were in favor of general HCCIP, you were more in favor of a risk-based HCCIP approach. You can imagine that the agency has taken, and will take in the future, some actions on HCCIP. We have looked at seafood, we are looking at juice. We are probably going to look at other things.

Would you like to suggest some commodities where the agency should go and maybe correct our movement in looking at future HCCIP?

MR. CADY: I think the industry has commented on that before when we were doing HCCIP, and we have done the HCCIP pilot plants, and we went into great depth on trying to define areas, levels of risks. I am not going to get into products or commodities at this point here, but I would say that the seafood HCCIP program, as an example, is in being now. Nobody ever realized the cost impact on the seafood processor that the HCCIP system has placed on them, which is going to be seen in price rises in the seafood industry.

While somebody may define risk in the seafood industry, maybe there is portions of the seafood industry that need to be prioritized versus across the board, and I think that that applies to normal packaged food products.

There is hundred of thousands of products in packaged foods that should never even be looked at by this agency because they do not carry any type of a food safety risk. There are some where, for purposes of the consumer, and in your mission they probably need to be looked at, but I don't believe that you can say HCCIP is the silver bullet and it should be applied across the venue of all food products, because that is going to hurt industry, it is going to hurt the FDA someday, and I think it is a total waste of resources that you don't have.

DR. FALCI: Thank you.

DR. BORSETTI: A topic that has come up, and it has come up over the past two days, yesterday and today, and I guess it was a bit of a surprise to me and I think some of us sitting here on panels that were up here yesterday, and that is the issue of economic adulteration.

What I am coming at is the question of priority and how we address this, which in many cases is not a real safety problem, but an economic problem. So, my question I guess to John would be, across the industry, if you have any idea, first, what percentage of the industry might be affected by this? I know that is a very difficult question.

MR. CADY: You have to look at the product in some cases. I mean Paul is a juice guy, as an example, there is an awful lot of adulteration that goes on in that particular area. His members are a lot of my members, and we talk on these issues jointly, but when you say that it is the consumer's right to get what they are paying for, and it is the industry's right, who puts up with the processes and the regulations and the labeling requirements, to get their due in terms of their competitive position in the marketplace versus somebody who wants to put something out and says it is high in vitamin C, and you find out there is no vitamin C in it, or whatever the case may happen to be, and that exists out there.

I would say that 98 percent of the food industry is abiding by the regulations and putting out quality product and identifying it properly on the labels, but there are people out there who do not do that, and they don't do it in juice, is predominate as I said, and there is other product areas, packaged areas, and people know it is not enforced.

That makes consumers nervous when they find out about it obviously. It creates animosity from the consumer groups who try to protect the consumer, and it makes industry look bad when 98 percent of the industry is in total compliance.

So, I think that is a big area that needs to be looked at also.

MR. WELLER: There is a lot of reconstituting of apple juice from concentrate in garages, literally, in garages, in backyards, in our industry, which those of us who crush apples and to make a pure juice, 100 percent juice product, take the brunt of the consequences of that.

We find that some of this goes into the private school systems, a lot of these juices right in this area--I won't mention any names--but right in this area that go into the archdiocese of Catholic schools, that are real problems, and so there is a lot of adulteration, especially in the juice area.

DR. BORSETTI: For us, it is a tradeoff, because the amount of resources we have got, how do we allocate those resources, but the message is fairly clear, and it keeps coming through to us, and I am trying to understand.

MR. CADY: I think this resource issue, if I could just comment on this because I know the constraints that you are under, we don't like it, and I know you like it even less, but it all comes down from the top, and I am going to just say if HHS can't go to bat for the Center, then, you are never going to fix this dilemma that you are talking about in terms of resources.

It is one thing to continue to put out political statements about food safety, about things that are needed for the consumer, but if you don't fund it correctly, that is all it is, is hollow statements, and you are where the rubber meets the road, and you can't implement it unless you have the proper people and the proper funding to do it.

So, I share your concern, I am not asking for a response because I know that is not your business, but I will tell you that I do not believe that FDA has properly given the Center the resources that it needs to do its job, and it hasn't done so in a long time because they have decided to use it for other priorities.

So, our goal from my industry is try to help fix that.

MR. LEVITT: Thank you. Let me ask John just one last question. In a way I have already asked the other two this question, which is looking shorter term, if you could look a year from now, and we really got together next year, in July 25th, whatever the date is today, and said a year from now I would like to see these two or three things done, what would they be?

MR. CADY: I would like the food additive process fixed, and I would like to have the juice pasteurization issue settled with mandatory pasteurization. Do you want two?

MR. LEVITT: That is good. Jerry, I think I know what yours is.

MR. HECKMAN: Well, I just wanted to comment on that. We have already submitted proposed regulations for you to consider. We would like you to go forward with that process, and if at the end of the year, we have got new regulations pretty much agreed upon for food contact notification, I think that would be a pretty major achievement and one that would be worthwhile.

MR. LEVITT: Thank you for that suggestion. As you know, the system built into it a prerequisite of funding, and one theme I take away from all of this is, while everybody wants their priorities, nobody wants to take it away from anything, and so at some point we need to balance that out.

MR. HECKMAN: We think with that system we will be putting back, not taking out, so I hope that will be taken into account.

MR. LEVITT: If you get the food additive guys to line up and say I can take away time from their work to do that, then, I will. If I were to have one global kind of reaction, which is at some point--I mean we are talking about funding over years and years, and that's fine and that is important obviously--but at some point, life is a zero sum game, and yes, we will look for efficiencies, but we struggle with the problem of everybody wanting their pebble pushed, everybody wanting their pebble pushed at the requisite speed, and what we are hoping to try to get a sense of is, you know, there is different kinds of priorities. Sometimes they are based on readiness, is it ready to be done, is it almost done already. Yesterday, people were talking about things that were old.

Sometimes it is risk because it is just so urgent as opposed to readiness or just kind of global impact, and so forth, but what people say to me in my center is give me focus, we are spread so thin we know we are not getting the job done we need, we need to get clear direction on this, that, and the other.

This meeting I think is giving us some very good input into that.

MR. CADY: In conclusion, maybe the agency and the Center need to look at the yard in which all the pebbles lie and decide how big the yard has to be, and maybe the growth that has been put into the Center year after year of requirement and et cetera, maybe it has got to be revisited and maybe you have to look at it.

If you want to call it a zero sum game, and you want the focus, maybe in the end it requires a judgment and final decision by the Center and by the agency, and the rest of us are going to have to live with whatever that answer happens to be.

I can't give you the 10 top priorities because he has got 10 more, so maybe it is time that the agency and the Center have to make some decisions as to what they think they are capable of doing and what their priorities are in terms of carrying out their mission, and the rest of us then have to fall in line.

MR. LEVITT: Thank you, and thank you for everybody's participation today.

[Applause.]

MR. LEVITT: We have taken a quick poll up here on whether we need a short break, and our consensus is, no, we are having a good time, so I think we will just proceed straight to our next panel.

We have two health professional organizations, the American Heart Association, the American Dietetic Association, Carole McGeehan Johnson and Tracey Fox.

Before we get going, I have been given a note on a couple of questions, common questions people are asking. One is when will the executive summary be available on the web. That is a good question. I think we have talked in terms of a couple of weeks. Let me agree to by July 15th we will have a summary available on the web for that.

Second, just to let you know that additional copies of the slides are available at the registration desk on your way out, and I think there is enough that people don't have to rush out to get them now.

Let's turn to our next group. Let's start with the American Heart Association.

American Heart Association

MS. JOHNSON: Good morning or I guess it is early afternoon by now, right?

MR. LEVITT: You still get the good morning. Your colleague will get to say good afternoon.

MS. JOHNSON: I am Carole Johnson, legislative representative for the American Heart Association. I am joining today with Tracey Fox of the American Dietetic Association to present a brief overview of some key issues of interest to our organizations as CFSAN works to set priorities.

I support the comments Tracey will offer highlighting dietary supplement issues. My comments will focus particularly on the implementation of the FDA Modernization Act.

Over 4.2 million American Heart Association volunteers work each day in communities throughout America to fight America's leading cause of death - cardiovascular disease. Essential to our mission is the dissemination of scientifically sound nutritional advice to the public. Poor nutrition is among the major modifiable risk factors for heart disease and stroke, as identified by American Heart Association's scientific authorities.

We are therefore grateful that the Center has convened this meeting to solicit our views and those of our colleagues in the nutrition community in the priority-setting process for CFSAN.

We believe that CFSAN plays a vital role in influencing public understanding and perceptions of a healthful diet. We continue to encourage the agency to make public understanding of the value of a total overall healthy diet rather than a diet of magic bullet foods a priority.

The AHA urges Americans to enjoy a diet consisting of a variety of foods, low in fat, low in saturated fatty acids, and low in cholesterol, balanced with regular physical activity. CFSAN public leadership when nutrition is used can help advance this message.

While we recognize the breadth of issues on CFSAN's agenda, including important work in food safety, we want to ensure that proper attention is given to implementing the FDA Modernization Act sections related to health and nutrient content claims.

There are many issues on CFSAN's plate that are of interest to the American Heart Association's Nutrition Committee, and we will attempt to address those in more detail in written comments. However, today, we simply want to emphasize the importance of getting it right with regard to health and nutrient content claims.

We applaud the agency's recently issued guidance on this issue. We are among many in the nutrition community who encourage the agency to move quickly in response to the Modernization Act to ensure that the consensus developed in the implementation of the NLEA was not endangered.

Clearly, we think the agency is correct in its conclusion that authoritative statements used to support health claims must reflect significant scientific agreement. The final regulation ought to continue to reflect this conclusion.

However, among the best means of determining when an authoritative statement meets the significant scientific agreement standard is to allow scientists, like those who sit on the AHA Nutrition Committee, and the respective membership of the American Dietetic Association, the opportunity to even be aware that the FDA is even considering a proposed health claim.

The FDA must place notifications for health claims in a public docket. The ability of interested parties like us to review the docket and comment to the agency on the scientific validity of the claim may, in fact, help alleviate some of the resource burdens CFSAN is sure to feel as a result of the expedited approval process established by the Act.

In fact, in setting priorities, CFSAN must take into account the resources needed to review notifications in the limited time frame defined by the Act. Minus appropriate resources to properly review notifications, FDA may very well be overwhelmed with requests that cannot be properly met.

It will then become the task of the American Heart Association, the American Dietetic Association, the American Cancer Society, and other prominent health information sources to discern for the public the growing number of claims, some of which may, in fact, be conflicting, that begin to flood their supermarket shelves.

This was not Congress' intention and from the interim guidance you have issued, it certainly does not seem to be the agency's intention, and we in the public health community would rather be on the front end of these decisions than on the back end.

Therefore, it is of the utmost importance that FDA put their resources in place to protect the integrity of the review process; first, by publicly disclosing the notification filings, and second, by ensuring adequate staffing for thorough review.

As I mentioned, we will look more fully at priority areas and attempting to craft written comments. We wanted to be here today, however, to point out the importance of the Nutrition Labeling and Education Act to the American Heart Association's mission of fighting heart disease and stroke, and to emphasize our strong concern that the agency include among its priorities a careful focus on balancing the requirement to expedite health claims review with the importance of ensuring that the public receive accurate and scientifically reliable information about food products.

Thank you again for the opportunity to be here.

MR. LEVITT: Thank you very much. Please.

American Dietetic Association

MS. FOX: Good afternoon now, and also I am very glad to hear you are having such a good time up here.

Hello. My name is Tracey Fox. I am a registered dietician and a senior federal regulatory manager with the American Dietetic Association's government affairs office here in Washington.

Like AHA and others who have talked before me, we really appreciate having the opportunity to share with FDA our ideas and concerns about areas under the jurisdiction of the Center for Food Safety and Applied Nutrition, and thanks the agency for soliciting our input.

ADA is the world's largest organization of food and nutrition professionals with nearly 70,000 members who are dedicated to improving the nutritional health and well-being of Americans.

We support the comments made by the Carole Johnson of the American Heart Association, which highlighted health and nutrient content claim issues. My comments today here will be focusing on dietary supplements, but our written comments will address a number of areas.

Consumer safety should continue to be the top priority at the Center. Direct consumer safety, such as activities related to the President's food safety initiative, clearly deserve and are receiving significant attention at this Center and other federal agencies, however, consumer safety is also a factor in other FDA-related activities.

ADA urges FDA to continue and strengthen efforts surrounding dietary supplements. Areas needing specific attention include regulations addressing Good Manufacturing Practices for dietary supplements, as well as critically important labeling issues. Consumers deserve scientifically based information in order to make appropriate and safe choices regarding dietary supplements.

Health care professionals need accessible and balanced information about supplements. Over the past several years, we have seen shifts in the health care setting, and consumers are seeking medical advice, not from their physicians, but from other health care providers.

Registered dieticians, experts in the area of nutrition-related sciences are seeing a major significant increase in clients seeking nutritional advice and expertise on the use of dietary supplements.

In order for trained professionals, such as R.D.'s, to provide sound information about the appropriate use of supplements, they must have access to both current and emerging sciences, and there is no efficient and effective system in place today to provide such information.

ADA urges FDA to optimize its limited resources and work with others, such as NIH's Office of Dietary Supplements and other NIH entities, to supplement industry and organizations like ADA, American Heart, American Cancer, other professional organizations and associations to develop an effective communication strategy about dietary supplements.

Such a strategy must include the need for accessible scientifically-based information for health care professionals and consumers. Only then can we hope to reach a balance among all those parties truly concerned about the health of this nation.

FDA specifically asked for information on future research directions. While ADA recognizes the limitations in resources the agency faces, there is a great and growing need for more research in the consumer arena. Specifically, more data is needed regarding consumer perception of labeling information on foods and on dietary supplements.

With more and more products in the marketplace, and limited control on what information is placed on the label, good consumer data is essential. Without such data, FDA's limited resources will be even less targeted and potentially wasteful.

There has been some interesting research conducted by FDA regarding consumer perception of health and nutrient content claims on the food label. This research clearly points to the need for a more consistent mechanism to gather similar data across the board including consumer perception of nutritional support statements and dietary supplements.

ADA recognizes that it should not be the total responsibility of FDA to continually gather data on consumer attitudes and understanding. We therefore recommend that consumer research be a shared responsibility with several entities including FDA, the food and dietary supplement industry, and other organizations.

Such efforts must be continuous and results should form the basis for policy enhancements. ADA also urges FDA to look at the issue of consumer research being a required component of substantiation files for dietary supplements. While health care professionals, federal regulators, and industry experts can debate the merits of a structure/function claim or a health or nutrient content claim, the real decision regarding such claims rests with the consumer, and until we know how consumers interpret and understanding information, an effective solution cannot really be reached.

Again, ADA's written comments will address a number of the priority areas outlined in the Federal Register notice. Thanks for the opportunity to provide comments today.

MR. LEVITT: Thank you. Let me begin with the American Heart Association.

In terms of the new health claim notification process and your desire to have input, part of the question, of course, is how much time there is. We know we will find it a struggle to do out work in the 120 days provided. If we get comments from you after 118 days, that is not something that will be useful, and a lot of work for you, that will not be productive either.

How much time do you need to provide such input because we have to start figuring out--the system wasn't set up with that in mind, but if that is what you want to do--you don't have to answer now, but roughly what is your capacity for turnaround?

MS. JOHNSON: Time is always beneficial to us because our members are volunteers and have full-time jobs, and so we try to get the benefit of their knowledge when we can and when we can convene them, but we can move quickly when we need to.

You issued an interim document on the 10th, and we have comments from our Nutrition Committee ready to submit this week on that. So, when we need to, and that is the circumstance, and that is the congressional intention is to move the process more quickly, we will have to adapt, but we would rather adapt at the front end than have the information out there later and try to sort it out for the public.

MR. LEVITT: Thank you. A question on dietary supplements. Are there current safety issues out there that you are worried about?

MS. FOX: I think there are probably a lot of potential safety concerns that won't be highlighted given the current structure and system until there is a major concern. In terms of specific supplements, I think FDA certainly has moved to address the ephedra issue.

We would like to see some more movement on that in terms of finalizing regulations, but in terms of specific nutrient supplements, no, I am not aware of a particular safety issue, but I think the overriding concern is just the multitude of supplements and new products being developed every day.

Eventually, there is going to be a problem, and if there isn't a good system in place, like good manufacturing practices that are standard across the board, then, the potential for a problem down the road is huge.

MR. LEVITT: Thank you. Dr. Yetley.

DR. YETLEY: You mentioned that health professionals want to be more involved, but they sometimes need more heads-up or more information from the agency.

Certainly, I think in terms of your associations, you do provide comments on most of the major rules, and we appreciate those, but oftentimes we would like to have more individual comments from individual members of your associations, particularly when they have particular scientific expertise in the topic that is of interest at the time.

Do you have any suggestions on how you can or we can work with you to mobilize health professional communities or health professionals as individuals to be more involved in the rulemaking process?

MS. FOX: I think certainly from ADA's standpoint, we certainly heartily agree. We clearly comment as an association, but also encourage our members to, on their own comment, because we know numbers do sometimes speak volumes, as well as just finding that particular issue that might be addressed by an expert, so we will continue to do everything we can to try to encourage our members to get involved in the important regulatory process, which eventually will result in a decision that will impact consumers.

I think also just continuing to get information from your office. I have noticed an increase in the amount of information I am getting from your office regarding different issues that are happening regarding food safety or dietary supplements, and I think to continue that flow and to give us as much of a heads-up on those issues will then allow us to notify our members, so they have the time element to be able to provide useful comments to you, but we will continue to work in that area and we will make sure we try to get those who are experts in that area to not only help us in developing our comments, but to individually provide comments, as well.

MS. JOHNSON: I may take that back to our scientists your interest in that because what we try to do is develop some consensus, bring the experts to the table ourselves and develop some consensus among them to offer a unified AHA position. So, if you would like individualized comments in addition rather than something like that, we need to look at that.

DR. YETLEY: Certainly, I don't want to suggest rather than, but certainly where your members have scientific expertise, it is also useful to hear from them.

My second question has to do with a comment I think Tracey made, that health professionals want more reliable information in dietary supplements and other label issues, and also you were interested in having more consumer research.

This is a common request or these are common requests that we give, and they really do exceed what we have resources to do, but is there some mechanism that we could implement that would facilitate meeting those goals, whether it is a partnership or whatever, so that we could get more reliable information packets available, and could get more consumer research, well-done consumer research?

MS. FOX: I think one of the recommendations or at least an area to look at would be to have some consumer research be part of substantiation for dietary supplements when it comes to structure/function claims because I think that is a very potentially confusing area for consumers, and if there is a way to establish certain criteria, just as perhaps there might be some unwritten guidance or guidance, not regulations, regarding health claims and consumer perception, that might be one area to look at.

There are also a lot of surveys that go on, on a regular basis, and it might be worthwhile to enter into some kind of discussion about some elements to capture on existing surveys that wouldn't require your resources other than some recommendations and guidance on data elements to capture, whether it be--ADA does a survey every two years, I know FMI does a survey, as well--there are existing mechanisms to capture data, which might be beneficial, they happen on a regular basis, and they are consistent and fairly worthwhile in terms of getting consumer perception.

DR. FALCI: This is for Ms. Tracey. I was taken a little bit by your comment about trying to get information to the health care professionals and the registered dieticians who are dispensing nutrition information throughout the nation.

One of the things we are doing in the food safety initiative is to develop a food safety.gov. It is a way of developing a list server, if you like, or an education net is also part of that system, and it is an interactive way of getting information out to, for instance, what I would think could be registered dieticians and have it back and forth.

I would like to get your thoughts on that. Do you think by doing something like that, it would reach all of the people and you wouldn't have a problem anymore?

MS. FOX: I wish the solution were that simple. That is an excellent first step in terms of communicating. ADA has a list serve that I think has close to 1,000 members. Of course, we have 70,000 members, so in terms of that being a large percentage of our association, it is not, but there are a number of mechanisms that I think we could use, that being one of them.

I think the Office of Dietary Supplements really needs to be active in this area. They are trying to get some information now and building a database of information that is out there on dietary supplements, but I think between the resources that are being spent now in a number of different areas, that if those resources were pooled with some recommendations from outside organizations on ways that we can help to get the message out, then, I think there might be a fairly cost effective solution, but I think a list serve or some kind of a web page, like the Fightback Campaign, or other food safety areas, might be a very resource-smart mechanism for getting information out, and then it would be up to our offices, in the association role, to make sure our members know of that information, but right now there is really not one place or even just a few places to look.

There is a whole lot of information out there, and some of it is good, and some of it isn't.

DR. BORSETTI: A couple of questions. In terms of getting information out, the FDA puts out a Medical Bulletin. It goes to health professionals. I assume that you are both aware of that.

My question here is do you have any thoughts on how effective that bulletin has been in reaching the health professionals, or is it something that is not working very well? That is my first question.

MS. FOX: I think perhaps for some of the health care professionals who are in the clinical arena, it is probably fairly effective. For a lot of the other dieticians out there who are either hospital-based or long-term care-based dieticians in nursing homes, dieticians who are in private practice and consulting, it is not. That information is certainly not getting to them at all.

Should it all? I am not sure it needs to, but I think there is probably a lot of information that does come out of FDA that a lot more people would be interested in knowing about.

DR. BORSETTI: My second question related to a topic that has come up over the past days of accident reporting, and injury reporting I think as Dr. Friedman referred to it yesterday. My question is how could your associations be able to work better with us in this arena if we were to centralize such a system at the agency level?

MS. FOX: That is a good question that at this time I am not prepared to answer, but I would certainly be glad to take that back to others and get their ideas on adverse event reporting. We certainly had a lot of discussion with it when we were dealing with the medical foods regulation, so I know there are some people out there with some very specific thoughts on this issue, and I would be glad to provide that to you in writing.

MR. LEVITT: There being no further questions, I would like to thank both of you very much. Again, we are happy to have written submissions for the record.

[Applause.]

MR. LEVITT: Let us now welcome our final presenter from the Viskase Corporation, Mr. Tom Higgins. If I didn't say that correctly, please correct me.

Mr. Higgins, as you are coming up, let me also thank you for your patience. Somebody has to go last. I suppose with a V in your name, maybe you are used to it, but nevertheless, we thank you very much for your patience and sorry you had to wait until the end.

Viskase Corporation

MR. HIGGINS: Thank you. You did get it correct, it is Viskase Corporation.

My name is Tom Higgins, and I am Manager of Regulatory Affairs for Viskase Corporation with headquarters in Chicago. Viskase appreciates and thanks you for the opportunity to comment on program priorities. Viskase will submit written comments.

I want to thank you also for your openness, this open meeting and the openness of your staff. Just an example of the openness of your staff, which I hope would continue, is that three weeks ago, Ed Machuga returned a Viskase call within 30 minutes. He took the time to answer a technical question completely including his reasoning. It all made sense to us, and we are still running with his answer. He made us more responsive and more efficient.

The phone call had nothing to do with the President's food safety initiative. In fact, when was the last time that food packaging was the cause of food-borne illness or death? I don't think there was a last time, and I think we are still waiting for the first time.

Viskase is regulated by the USDA and by the FDA. It follows, then, that there are program areas and activities that are extremely important to Viskase that are outside the President's food safety initiative.

In the area of programs, there are two that are important to Viskase - threshold of regulation determinations for food packaging, under the current system can mean millions to our company. Certificates of free sale, 35 percent of Viskase's sales revenue is outside of the United States, comes from outside the United States. Certificates of free sale are essential often for this export business.

In the area of activities, I would class activities in three types that are crucial to us, and these may seem trivial to you, but the opinion letters that you supply, that currently take 12 months, we would like to see 4 months.

You have meetings, both these open meetings, and you will have short, face-to-face focused meetings on technical issues with us, and we can get answers to your questions in one to two days to maybe three weeks in that setting.

With phone calls, sometimes we can get an answer immediately. Sometimes it is 30 minutes, and sometimes it is a day or two. We appreciate having the choice of these three, what I will call activities to decide what we need from you to answer the questions that we have, and we would encourage you to cut the time for opinion letters.

Why is it important that these areas be given attention in your priority settings? Well, Viskase Corporation is a packaging company. We are the world's leading producer of cellulosic food casings. We also make specialty films for meat, poultry, and cheese. Our sales are 1 percent of the total U.S. food packaging sales.

To give you one example, Viskase's largest product line is a sausage casing for the hot dog. Sausage casing is about 10 percent of the cost of making a package of hot dogs. In fact, speaking of hot dogs, I would like to show you this ad. This ad, to me, is unbelievable.

It appeared in the Chicago suburbs last week, and I call your attention to the upper righthand corner. The price of hot dogs. Hot dogs for 39 cents. Is that 39 cents each? No. This is 39 cents for 12 ounces of franks. That to me is simply incredible.

You can't buy 12 ounces of anything for 39 cents, but it is a fact that U.S. hot dog makers are efficient. They produce hot dogs in the U.S., they ship them to China and to Russia where they are sold at a lower price than if they were made by the Chinese and the Russians.

Viskase is proud to contribute to the hot dog makers productivity, and you, as regulators, are part of this story, as well. You have, and you must continue to regulate efficiently and well.

In your regulation, you have a responsibility to do no gratuitous harm to those that you regulate. By providing rapid answers, by cutting response times, by keeping resources where they must be kept in critical areas, not just for food safety, but for the economic well-being of the United States and for providing customers a choice, a choice to buy 12 ounces of franks for 39 cents is something that you really must consider, and if you do your work wisely, the result will continue to be the safest, most abundant, and varied meat and poultry products in the world.

Consumers will have more choices, and exports will continue.

Thank you.

MR. LEVITT: Thank you. What kinds of products does your company make, or what product line to you sell?

MR. HIGGINS: We sell cellulosic sausage casings for the meat and poultry industry, the sausage casing that hot dogs are made in is one of those products, the sausage casings for baloney and larger products that you see in the deli case, and these casings are all stripped off before the product is eaten.

Those are our products. We make specialty films for the meat and poultry industry primarily, that are used, most of our products, before retail sale, packaging primal cuts of meat, cook-in bags for cooked roast beef. We also make and sell pouches for the retail display of cheese, and the bags that frozen turkeys are in is one of our products.

MR. LEVITT: Thank you. Certificates of free sale, what is your experience in turnaround time?

MR. HIGGINS: We get them within a month.

MR. LEVITT: Is that an okay time for you?

MR. HIGGINS: That is an okay time for us, and we would encourage you not to lengthen that time in your allocation of resources, but you will always hear that from someone like me.

MR. LEVITT: I think I will ask the others if they questions. Dr. Yetley.

DR. YETLEY: I just discovered that I can buy hot dogs for less than I can buy bottled water, so I guess I know where the bargain is now.

I appreciate your point about FDA responsiveness, particularly when industry has questions. Certainly in the office that I am in, we have numerous, numerous telephone questions on a daily basis, 50 to 100 a day probably. This becomes a very critical use of staff resources.

My question to you is, number one, is there a way to make this more efficient in terms of having information available in other forms, or if not, what should we cut out to take care of the telephone inquiries?

MR. HIGGINS: Well, I would submit to you that responding to these telephone requests, although it seems like a drag to you, it avoids problems down the way. It is very similar to consultations that people who might be involved in submitting petitions do up-front.

It is not important that we speak to a particular person, but that a person has authority to answer for the agency. For example, Ed Machuga says he gets 60 telephone calls a day, and that to me is overwhelming, I can't imagine being able to respond to that many, so that I could see that you have a problem there, but I would submit that it is also responding to these telephone calls that can avoid additional problems, or not problems, but telephone calls or meetings in the future.

DR. YETLEY: How useful would be a section on the web page that would have commonly asked questions and answers to those commonly asked questions?

MR. HIGGINS: I think the more and varied types of communication that you can use, the better, and I don't think any particular one is the answer any more than I think responding to telephone calls is the answer. I think that would be useful, yes.

DR. FALCI: Mr. Higgins, I think you just answered my question, but you had mentioned telephone calls, opinion letters, open meetings, and technical meetings, and I was wondering how they rank in priority with you. It sounded like they are all about the same. Was there one that was more valuable than the other?

MR. HIGGINS: From an immediate standpoint, telephone calls have to be up there on the top. Open meetings, I know require a lot of your resources to conduct those. I find them to be very educational, and I did attend every session, although sometimes when there wasn't a break, I had to take a few minutes, but I attended the entire sessions and found them to be very informative and very educational.

The face-to-face meetings we have used less. So, I would guess I would rank them in that order.

DR. BORSETTI: As complimentary as you have been, I think I am ready to take the rest of the day off. I am used to standing up here and receiving some form of criticism. I appreciate, we all do, your kind comments.

Is there anything that we are not doing right that maybe we could do better?

MR. HIGGINS: I haven't had a lot of experience with getting caught up in your web of threshold of regulation. We had a submission that we thought was a simple opinion letter, that turned out to be threshold of reg, maybe because the product was so much different than--it was different in the area of what this packaging product had in it in the way of contaminants that it was in the range of threshold of regulation, and we were almost shocked to discover that it was in the threshold of regulation committee, it wouldn't be quite as simple a subject as we thought, and that the time would be extended.

I would say the length of time that it takes to get these deliberations done is a shock to me--I shouldn't say a shock--but I am amazed that it requires that much deliberation. If a petition is deficient in some way, we would prefer that you toss it back to us, explaining to use how it is deficient, so that the ball is in our court and we must provide you with something.

Maybe it needs a system that allows much more give and take would be able to cut down that total time.

MR. LEVITT: With that, let me thank you very much for coming and again for your patience.

Let me thank everybody in the audience that has been here with us listening.

This will conclude our day and a half of priority-setting meeting. Again, let me think everybody for participating. Let me thank the staff again who worked hard for putting it together, and we will look forward to seeing additional comments in the public record.

(Whereupon, at 12:35 p.m., the meeting was adjourned.)

Summary of Proceedings | Panel A | Panel B