March 20, 2001
Introduction
Mr. Chairman and Members of the Committee, my name is Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA or Agency). I am joined by Dr. Elizabeth A. Yetley, Lead Scientist for Nutrition, at CFSAN. I am pleased to be here today to update you on FDA's progress in the area of dietary supplements since I testified before this committee on May 27, 1999.
We would like to share with you today what we have accomplished in this program over the last two years, the Agency's priorities for the next year, and the program challenges as we see them.
Background
The dietary supplement industry has grown exponentially since the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Today's multi-billion dollar dietary supplement industry is now one of the world's fastest growing industries. Moreover, in the past, dietary supplements were mainly sold to adults in health food stores. These products are now purchased in supermarkets, retail stores, and even through the Internet, making them available to a much wider range of consumers of all ages.
There are an estimated 1566 establishments1 that claim to manufacture dietary supplements. Many large pharmaceutical companies have entered the dietary supplement business. Dietary supplement sales are reported to have reached $17.1 billion in 2000.2 Between 1994 and 2000, consumer spending on dietary supplements nearly doubled, and sales continue to grow at better than 10 percent a year.3
Surveys show that over 158 million consumers use dietary supplements.4 An estimated 115.3 million Americans buy vitamins and mineral for themselves, and 55.8 million purchase them for family members, including children.5 According to a Prevention Magazine survey published in 2000, consumers use dietary supplements to help them achieve their self-care goals and as a means of ensuring good health. They also use them for "medicinal" purposes such as treating and preventing various illnesses, colds, flu, increasing mental sharpness, and alleviating depression.6
The consumer's desire for self-care and the widespread use of dietary supplements raises a number of issues. This includes the possibility of harmful interactions between dietary supplements and prescription or over-the-counter (OTC) pharmaceutical products. Indeed, an estimated 19.6 million consumers use them with a prescription product.7 Herbals and botanicals constituted 32 percent of the estimated $17.1 billion dietary supplement market in 2000 compared to vitamins that account for 38 percent of the market.8 Finally, as the overall use of these products increases, so does the potential for adverse effects.
A different type of FDA program
When Congress passed DSHEA, it created a unique regulatory framework for dietary supplements. Its purpose was to strike the right balance between providing consumers access to dietary supplements and truthful information about them, while preserving regulatory authority for FDA to take action against supplements that present safety problems or false or misleading labeling.
As you know, the regulation of dietary supplements is, for the most part, a postmarketing program. Since Congress considered dietary ingredients marketed prior to the passage of DSHEA to be safe, dietary supplements containing these ingredients are permitted to be freely marketed, just like regular foods (e.g., fresh fruits and vegetables, processed foods and beverages, and seafood). Should safety problems arise after marketing, the adulteration provisions of the statute come into play. Under DSHEA, a dietary supplement is adulterated if it or one of its ingredients presents "a significant or unreasonable risk of illness or injury" when used as directed on the label, or under normal conditions of use (if there are no directions). The burden of proof is on FDA to show that a product or ingredient presents such a risk. In addition, the Secretary of Health and Human Services may also declare that a dietary supplement or dietary ingredient poses an imminent hazard to public health or safety.
With such a "post-marketing" emphasis, DSHEA's statutory framework requires FDA to utilize such tools as good manufacturing practices (GMPs), labeling rules and adverse event reporting to identify and address potential health risks to consumers associated with the use of dietary supplements. As a preventive measure, DSHEA grants FDA explicit authority to establish GMP regulations for dietary supplements. Such regulations would provide a mechanism to help assure quality, purity and consistency in dietary supplement products. Recognizing the utility of GMPs in helping to ensure the safety of dietary supplement products, FDA has made the publication of a GMP proposed rule and stakeholder outreach a high priority in Fiscal Year (FY) 2001.
The only "premarket" provision of DSHEA requires dietary supplement manufacturers that wish to market certain new dietary ingredients (specifically, new dietary ingredients that were not marketed in the United States (U.S.) before 1994 and that have not been in the food supply as articles used for food without chemical alteration) to submit to FDA, at least 75 days before the product is expected to go on to the market, information that supports the conclusion that a supplement containing the ingredient will reasonably be expected to be safe. There is no requirement that the manufacturer receive FDA approval or clearance before marketing the product after the 75-day period has expired. This makes it essential for public health protection that FDA have the resources to review the notifications in a timely manner. So far we have been able to keep up. But the further we get from 1994, the more the industry will likely seek to market to new dietary ingredients.
Dietary Supplement Strategic Plan
In January 2000, CFSAN published its overall dietary supplement strategy. It represents the work of an expert team from across the Agency that worked collaboratively to establish a road map to fully implement DSHEA. Built on law and science, the strategy sets out clear program goals to be accomplished by the year 2010. It is a science-based regulatory program, which will fully implement DSHEA to provide consumers with a high level of confidence in the safety, composition, and labeling of dietary supplements.
There are five major points from this strategy that I would like to highlight:
1. FDA held public meetings on June 8, 1999, in Washington, D.C. and on July 20, 1999, in Oakland, California, which I chaired personally, to solicit comments on the development of its overall dietary supplement strategy. Also, throughout 1999, FDA held several other public meetings on other dietary supplement issues that were incorporated into the strategy. These included meetings on current GMPs and structure/function claims.
2. After the June 8, 1999 meeting, FDA developed five internal dietary supplement strategy teams to consider the addition of stakeholder input, and to discuss dietary supplement activities. Teams were established to examine safety, labeling, boundary issues, enforcement and research issues.
3. This strategy is built on the "twin pillars" of law and science. Clear, science-based program goals have been established that will fully implement DSHEA by the year 2010.
4. As with other new legislative mandates, there needs to be a long-term implementation process to accomplish all of the dietary supplement activities the Agency and/or its stakeholders identified. FDA will develop, on an annual basis, specific items that are to be accomplished that year by the Agency.
5. FDA recognizes that the success of the strategy will depend on new and continued partnerships with other government agencies, academia, health professionals, industry and consumers. FDA will continue its outreach to stakeholders. FDA is committed to establishing stronger working relationships with our stakeholders as well as leveraging resources, and communicating accurate dietary supplement information.
The Plan is divided into six sections, consistent with the stakeholder input that we received: Safety, Labeling, Boundaries, Enforcement, Science-Base, and Outreach.
Safety
Virtually every stakeholder has urged us to address "safety first." FDA's Adverse Event Report Monitoring System for dietary supplements provides an essential tool for signaling potential safety problems that may be associated with the use of a particular product or type of products already in the marketplace that need to be investigated and critically evaluated. As noted earlier, DSHEA grants FDA the authority to establish GMP regulations governing the preparation, packaging, and holding of dietary supplements under conditions that help ensure their safety, and CFSAN has listed publishing the dietary supplement GMP proposed rule and conducting outreach as a high Agency priority for FY 2001. There is broad public support, including from industry, that dietary supplements GMPs are needed to ensure that the public has confidence in using these products. Instituting a credible GMP system will require resources to hire new FDA investigators to inspect manufacturers to ensure that they are manufacturing products in accordance with the GMPs.
Product Labels
DSHEA allows the use of certain claims (often called structure/function claims) of general well-being from consumption of a dietary ingredient, and claims of benefits related to classical nutrient deficiency diseases. These claims require notification to FDA within 30 days of marketing. Manufacturers must have substantiation that the claims are truthful and not misleading, and the product label must bear the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." FDA published a final "structure/function" regulation in January 2000.
FDA reviews proposed health claims for dietary supplements under the provisions of the Nutrition Labeling and Education Act of 1990 (NLEA), implementing regulations and relevant case law. A number of dietary supplement health claims are authorized by regulation, including claims for calcium and reduced risk of osteoporosis and for psyllium and reduced risk of heart disease. Claims that a dietary supplement treats or mitigates a disease may not be made unless the supplement is approved for that use under the new drug provisions of the Federal Food, Drug and Cosmetic Act.
Boundaries
The Boundaries section highlights one of the profound challenges of DSHEA - determining the regulatory category of a product. It is important to draw boundaries between dietary supplements, drugs, and conventional foods and to give manufacturers notice of the regulatory regime that applies to their products. FDA's "structure/function" rule, referenced above, began to address the drug/supplement boundary issues.
Enforcement
The plan also outlines FDA's enforcement priorities, with safety issues at the top. This section also includes activities devoted to improving FDA's internal capacity in the enforcement area.
Under DSHEA, FDA will take appropriate action against unsafe products, inaccurate and misleading labeling and consumer fraud. FDA will also conduct marketplace surveillance and monitoring activities. Consumer groups and many in the industry have called for stronger FDA enforcement in order to create a "level playing field" and ensure that all companies adhere to the same rules. FDA will establish partnerships with Federal, State, and local agencies to enhance enforcement efforts by sharing data, heightening communication, and utilizing resources.
Science-Base
The Science-Base section is the most important component of the plan because, like all FDA-regulated products, public credibility comes with knowing there is an adequate scientific foundation to the products and their claims. However, it is also the least well-developed section of the plan. For example, unlike conventional foods, FDA has limited experience and expertise with dietary supplement ingredients. Leveraging and partnerships will be needed to forge a strong scientific underpinning for dietary supplements. For example, we are working closely with the Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health. FDA has already begun leveraging with outside organizations as well.
Outreach
Finally, the Outreach section of the plan reflects FDA's continued commitment to a two-way dialogue with the dietary supplement community. Communication with the general public, FDA field offices, health care professionals, and industry in an appropriate and timely manner, is critical, including information about potential adverse effects associated with dietary supplements. FDA will continue its commitment to establish a stronger working relationship with organizations interested in promoting two-way communication and cooperation. As a result of input from FDA's stakeholders and the increasing scope of the scientific questions concerning dietary supplements, a standing Dietary Supplement Subcommittee was officially added to FDA's restructured Food Advisory Committee on June 26, 2000.
CFSAN Dietary Supplement Accomplishments
Mr. Chairman, let me assure you that fully implementing DSHEA is a priority at CFSAN. Within our current resource allocation, however, we can only expect to make incremental progress. At the ends of FY 1999 and 2000, CFSAN published documents titled: CFSAN Program Priorities 1999 Report Card and CFSAN Program Priorities 2000 Report Card.(Appendix) The publication lists the Agency's accomplishments for FY 2000, including those in the area of dietary supplements. Let me highlight several areas.
Institute of Medicine (IOM)/National Academy of Sciences (NAS) Study
Last year FDA entered into a contract with the IOM at the NAS entitled, "Framework for Evaluating the Role of Dietary Supplements in Health." The IOM will develop a protocol for the Agency to use in reviewing the safety of dietary supplements. The contract is for two years and covers the time period September 30, 2000 through September 29, 2002.
Because this project is critical to the responsible and timely implementation of the DSHEA, the Agency believes it should be an open process driven by well-grounded scientific rationale. The contract requires that the IOM constitute a committee that will:
1. Develop a proposed framework for categorizing and prioritizing dietary supplement ingredients based on safety issues;
2. Describe a process for developing a review system with specifications for evaluating the safety and role in health of dietary supplement ingredients; and
3. Develop at least six prototypes as examples of using the proposed framework.
The framework will include a methodology to examine the available peer-reviewed literature with regard to the role of dietary supplement ingredients in health. Methods that other expert bodies have used to categorize and review issues related to safety and the possible roles of dietary supplements and their ingredients in health will also be taken into consideration.
The IOM process includes opportunities for public input. The Agency expects that a proposed framework will be developed during the first year (FY 2001) of the project and released for comment and review prior to being finalized by the end of the second year (FY 2002).
Pearson v. Shalala policy
The U.S. Court of Appeals for the District of Columbia, in the matter of Pearson v. Shalala, ordered FDA to clarify its significant scientific agreement (SSA) standard, reevaluate four claims the Agency had previously denied, and permit health claims that do not meet the SSA standard if a disclaimer can ensure that the claim will not mislead consumers.
The Agency is committed to fully implementing the Federal court order. FDA published a revised strategy for implementation of the Pearson court decision in an October 6, 2000, Federal Register (FR) Notice (65 FR 59855 - 59857). FDA noted that it had completed three steps of its original implementation strategy (published December 1, 1999, 64 FR 67289-67291). These steps were:
a literature review and public request for scientific data to retrieve relevant scientific information that had become available on the four claims in dispute since FDA's initial 1991 and 1993 review;
publication of a guidance clarifying the SSA standard; and
convening of a public meeting (on April 4, 2000) to solicit input on changes to the general health claims regulations for dietary supplements, in light of the Pearson decision.
Under its revised strategy, FDA announced that we intend to respond in one of three ways to the four health claims at issue in Pearson and, pending rulemaking to amend its regulations in response to Pearson, to new health claim petitions that are filed for comprehensive review. As are outlined in the revised strategy, the three possible responses include:
1. If the SSA standard is met, the Agency will propose to authorize the health claim, and will consider using its interim final rule authority which would allow use of the health claim immediately upon publication of the proposal.
2. If the SSA standard is not met but the scientific evidence in support of the health claim outweighs the evidence against the claim, and if certain other general criteria enumerated in the October 6 Notice are met, FDA will consider exercising enforcement discretion for dietary supplements that bear an appropriately qualified health claim. The petitioner will be notified by letter about the basis for FDA's decision and the criteria for the Agency's exercise of its enforcement discretion.
3. If the evidence against the claim outweighs the evidence for the claim, the substance that is the subject of the claim poses a threat health, or if other conditions of the implementation plan are not met, the claim will be denied and the petitioner will be notified by letter.
FDA has announced decisions, under its implementation plan, on three of the claims at issue in Pearson (two on October 11, 2000, and another on October 31, 2000). In addition, FDA has reconsidered two additional petitions, submitted in 1999, that were initially denied. Decisions under the implementation plan on those petitions were issued on November 28, 2000, and February 9, 2001. Of these five claims, qualified claims were allow for two instances (omega-3 fatty acids and heart disease, B vitamins and heart disease), two were denied in two instances on the basis that the evidence against the claims outweighed the evidence for the claims (fiber and cancer, vitamin E and heart disease), and one claim was denied per se but alternative qualified language was offered (relating intake levels and sources to effectiveness of folic acid in reducing risk for neural tube defects in infants). The Agency is in the final stages of review for the last Pearson health claim, the relationship between antioxidant vitamins and reduction of risk of some cancers.Priorities for Dietary Supplements
In addition to CFSAN's Dietary Supplement Strategic Plan, in January 2001 CFSAN published its FY 2001 overall program priorities. These priorities are broken down into A and B lists, with A items being given top priority and B items being completed when Agency resources allow. The CFSAN "A" list goals for dietary supplements for the next year include:
Regulations/Guidance
In the area of regulations, FDA is committed to seeing that the dietary supplement GMP proposed rule is published. This will include conducting an outreach program after the publication of the proposed rule. FDA is working to complete health claim evaluations for antioxidants and cancer begun in FY 2000. CFSAN will continue to review premarket (75-day) notifications for new dietary ingredients within the statutory timeframe.
Enforcement/Outreach
The Center will continue to identify high priority safety issues and initiate appropriate enforcement actions against unsafe, adulterated, or misbranded dietary supplement products and ingredients. CFSAN is looking into ways for making adverse event reports (AERs) promptly available to manufacturers that complies with Freedom of Information regulations and patient privacy issues. We are continuing to study the scientific evidence related to dietary supplements that contain ephedrine alkaloids, based on the March 2000 release of AERs and related material and the August 2000 public meeting/public comments. Finally, we also plan to create and publish a Dietary Supplement Labeling Guide.
Research/Science-Base
As previously mentioned, CFSAN is working with NAS and IOM, to establish a framework to review dietary supplement safety. The Center will develop mechanisms to expedite dietary supplement adverse event investigations and enhance timely clinical assessment of dietary supplement AERs. The Center plans to review analytical methods for isoflavones in soy.
Finally, we will also complete and disseminate the dietary supplement research plan.
Reports to Congress
The Agency plans to submit three reports to Congress including:
(1) A report summarizing the total funding spent in FY 2000 to assess the safety of dietary supplements, including related costs required to meet the statutory burden of proving adulteration under DSHEA.
(2) A report on the cost for implementing our Dietary Supplement Strategic Plan.
(3) A report on implementation of the U.S. Court of Appeals for the District of Columbia Circuit decision in Pearson v. Shalala regarding dietary supplement health claims.
Challenges
Recognizing that no new funds were authorized or appropriated in DSHEA, the Strategic Plan announced that a long-term implementation process to achieve all the goals that were identified to ensure the safety of dietary supplements. We have outlined a flexible ten-year implementation plan, that could be accelerated or decelerated, depending on resources available and safety concerns.
Resources: What FDA needs to fully implement DSHEA
As noted earlier, the 2001 Agriculture, Rural Development, the Food and Drug Administration, and Related Agencies Appropriations Bill directed FDA to issue a report on the dollar cost to implement the Dietary Supplement Strategic Plan.
The Dietary Supplement Strategic Plan is designed to be implemented in stages, becoming fully functional after several years. To be successful, the program must continue at these levels over a sustained period of time. As a starting point, the Agency's current base for dietary supplements in FY 2001 is approximately $6 million and 46 Full-Time Employees.
The Report to Congress will set forth the resources needed for headquarters safety and regulatory activities (e.g., AER reporting and regulations development), for field activities, and science-based activities, both intramural and extramural.
Leveraging: University of Mississippi Research
In FY 2001, Congress appropriated $1 million in FDA's budget for collaborative research between FDA and the National Center for Natural Products Research (NCNPR) at the University of Mississippi. NCNPR is nationally and internationally recognized for its expertise and research experience in botanicals used for health purposes. The NCNPR mandate is to bring government, academia, industry, consumers, health professionals and industry together to solve scientific problems in this area. We are enthusiastic about this new partnership and hope to be able to expand it in future years.
Bovine spongiform encephalopathy (BSE) in dietary supplements
As you may know, much has been written about the BSE crisis in Europe. With concerns over the disease in Europe, Americans are asking perfectly reasonable questions about whether there are gaps in the U.S. systems that could allow BSE to enter this country. The FDA, U.S. Department of Agriculture (USDA) and other government agencies have been vigilant in making sure that BSE is kept out of this country. There has been much media attention to the fact that there are dietary supplements being sold in health food stores that contain animal tissues, including tissues and organs from cattle. Some of these dietary supplements contain central nervous system tissues such as brain or spinal cord tissue. However, these types of products do not constitute a large part of the market. In fact, information provided to us by one trade association, the National Nutritional Foods Association, indicates that such products likely make up less than 1.0 percent of the marketplace. Nonetheless, even though the market share for these products is small, FDA has taken seriously the threat that they might pose to public health if they were to be contaminated with the infectious agent that causes BSE. Both FDA and USDA have taken steps to minimize the possibility that cow tissues from a BSE country might find its way into a dietary supplement.
In 1991, the USDA banned the importation of cattle tissues and organs from countries infected with mad cow disease. Amid concerns that USDA's restrictions might not capture all FDA-regulated products, we imposed an import bulletin in 1992 (later upgraded to an import alert in 1995) to halt imports of high-risk bulk dietary ingredients, as well as to provide guidance to FDA inspectors to examine other bulk and finished dietary supplements to ensure that they did not originate from BSE countries. Additionally, in 1992 FDA issued a letter to the dietary supplement industry laying out our concerns about the use of cow derived ingredients in dietary supplements and advising them that they should take immediate steps to ensure that no cow derived ingredients originated from animals in a BSE country. FDA has periodically re-issued the letter over the years to keep the industry focused on this issue, the last letter being issued in November 2000. We remain concerned about this issue and are actively reviewing our current regulatory controls to ensure that they are as effective as they can be to ensure the safety of consumers who choose to use products that contain cow derived ingredients. But, at this time, the information we have from the industry and from our own import and domestic inspectional programs, while limited, provides no evidence that cow derived ingredients from BSE countries are being used in dietary supplements.
We are addressing these issues within the Agency's overall strategy of BSE containment.
Conclusion
Mr. Chairman, we are committed to making safe products available to consumers who choose to use dietary supplements to improve their health. DSHEA was enacted to ensure access to these products and the Agency is committed to fully implementing DSHEA over the next ten years. As I stated in my testimony, we will accelerate or decelerate our program priorities depending on resources and safety issues. It is our goal to make sure these products are safe and accessible to all American consumers.
I would be happy to respond to any questions the Committee may have.
1 Survey of Manufacturing Practices in the Dietary Supplement Industry: Final Report, RTI Task Order No. 6, May 17, 2000
2 "U.S. Dietary Supplements Market Size Expressed as Dollar Sales by Top Six Product Categories for 1994 to 1998 and Forecast for 1999 and 2000", National Business Journal, 2000, Dialog file No. 93, San Francisco: The Dialog Corporation, 2000
3 Nutrition Business Journal, San Diego, 1998
4 PREVENTION Magazine's Survey of Consumer Use of Dietary Supplement, 2000, p. 4
5 PREVENTION Magazine, p.5
6 PREVENTION Magazine, P. 4-5
7 PREVENTION Magazine p. 5
8 National Business Journal, 2000, Dialog File No. 93, San Francisco: the Dialog Corporation, 2000.
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