(Report to Congress)
Lester
M. Crawford, D.V.M., Ph.D.
Deputy Commissioner
This document responds to House Committee Report (House Rpt. 106-619) for the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 2001 Appropriations Bill. In that report, the Committee instructs the Food and Drug Administration (FDA or Agency) to report to the Committee, within six months of enactment of the bill, on the dollar cost to implement the Dietary Supplement Strategy 10-Year Plan.
Report Language -House Committee (Report No. 106-619)
The Committee instructs the Food and Drug Administration to report to the Committee within six months of enactment of the bill, on the dollar cost to implement the Dietary Supplement Strategy 10-Year Plan.
FDA's goal is to have a science-based regulatory program that will provide the Agency with the ability to successfully implement and carry out the regulatory responsibilities imposed by DSHEA within ten years, thereby providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.
In response to the additional regulatory responsibilities placed on FDA by the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA developed a plan for implementing those responsibilities. On January 3, 2000, the Agency published its Dietary Supplement Strategic Plan, hereinafter referred to as the Strategic Plan. The Strategic Plan presents a long-term implementation process to accomplish all of the dietary supplement activities that the Agency and/or its stakeholders identified. The Strategic Plan will be revised and modified, as necessary.
The Dietary Supplement Strategic Plan is designed to be implemented in stages, reaching an operational level by the fifth year and continuing at those levels to support the full implementation of DSHEA. The Agency's base funding for dietary supplements in FY 2001 is approximately $6.0 million and 46 FTEs. The Strategic Plan includes activities covered in the following categories: Safety, Labeling, Boundaries, Enforcement, Science-Base, and Outreach.
To respond to the Committee's request, the Agency has broken out the Strategic Plan's categories into three sections consistent with the activities addressed in the Strategic Plan: Safety and Regulatory, Field, and Science.
The FDA estimates the initial investment cost range to implement the goals in the Strategic Plan would be from $20 million to $40 million by Year 3, followed by an additional investment from $30 million to $55 million for Year 4, and a final investment from $40 million to $65 million for Year 5. These estimates are reported in FY 2002 current dollars.
* Please note that the cost figures contained in this report are estimates and that funding for these activities will be considered along with other high priority areas.
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994
Safety and Regulatory/Field/Science Breakdown
ILLUSTRATIONS:
Illustration 1: Dietary Supplement Sales for Years 1994 Through 2000 in Billions
Illustration 2: Dietary Supplement Establishments
Illustration 3: Year 2000 Estimated Sales Breakdown of $17.1 Billion Market
The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Federal Food, Drug and Cosmetic Act to define the term "dietary supplement" and to establish a regulatory framework for dietary supplements. DSHEA provides consumers' broad access to dietary supplements but provides FDA authority to protect consumers from products that pose a "significant or unreasonable" risk to consumers and that are otherwise adulterated and to require accurate labeling for dietary supplements.
In passing DSHEA, Congress defined "dietary supplement" to mean products that, among other requirements, are intended to supplement the diet and that contain one or more of certain dietary ingredients:
When passing DSHEA, Congress considered dietary ingredients already on the market to be generally safe. For those dietary supplements containing ingredients available prior to DSHEA, these products are permitted to be marketed without advance notification to FDA. Thus, DSHEA primarily requires postmarket Federal oversight. Under DSHEA, FDA is responsible for taking action against any dietary supplement product, after it reaches the market, that either presents an "unreasonable or significant risk of illness or injury," or has labeling that is "false or misleading."
FDA's postmarketing responsibilities include monitoring safety (e.g., voluntary dietary supplement adverse event reporting) and product information, such as labeling (including claims, package inserts, and accompanying literature). The Federal Trade Commission regulates dietary supplement advertising.
Postmarketing responsibilities also include ensuring product quality. As a preventive measure, DSHEA grants FDA explicit authority to establish good manufacturing practice (GMP) regulations for dietary supplements. Such regulations are intended to establish a mechanism to help assure potency, purity, and consistency in dietary supplement products.
If a supplement contains a new ingredient that was not marketed in the U.S. prior to 1994 and that has not been present in the food supply as articles used for food without chemical alteration, Congress requires the manufacturer to notify FDA at least 75 days before marketing and to include in the notification the manufacturer's basis for its conclusion that a dietary supplement containing the ingredient will reasonably be expected to be safe. However, there is no requirement that the firm wait for a safety determination from FDA before marketing the product.
The challenge to FDA is to strike the right balance between preserving consumers' access to both products and information and ensuring the safety and proper labeling of all of these products. In its initial efforts under DSHEA, the Agency concentrated on promulgating certain regulations mandated by DSHEA and began a number of other regulatory actions to establish the framework for implementation of the new statute. In 1999, FDA outlined the 25 Federal Register documents it had published since the passage of DSHEA and discussed specific regulatory actions it had taken with respect to dietary supplements. FDA acknowledged, however, that it had much more work to do to fully implement DSHEA. At a Congressional hearing in 1999, the Agency announced that it would lay out a framework of what needed to be done over the long term to fully implement the statute. Over a one-year period, FDA created a road map of the activities needed to fully implement DSHEA.
FDA's yearlong effort to develop its plan was a collaborative effort involving input from other government agencies, academia, health professionals, industry, and consumers. FDA held public meetings on June 8, 1999, and on July 20, 1999, to solicit comments on the development of the Strategic Plan. In addition, throughout the 1999 calendar year, FDA held several other public meetings on dietary supplement issues that are related to the Strategic Plan (e.g., GMP regulations for dietary supplements). Shortly after the June 8, 1999, public meeting, FDA developed five internal dietary supplement strategy teams to consider the ongoing stakeholder input, and to discuss the dietary supplement activities. The teams were organized as follows: Safety, Labeling, Boundaries, Enforcement, and Research. Except for the addition of a section on Outreach, and the broadening of the Research category to Science Base, these categories formed the organizational structure of the Strategic Plan.
The Dietary Supplement Strategic Plan is built on the "twin pillars" of law and science. As noted above, the Strategic Plan is divided into six sections, consistent with the stakeholder input that we received: Safety, Labeling, Boundaries, Enforcement, Science Base, and Outreach.
Taken as a whole, this Plan provides a comprehensive approach for FDA to fully implementing DSHEA. As noted above, the goal of the Strategic Plan, once implemented in a systematic, science-based manner, is to provide consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.
There have been many changes in the size and scope of the industry and in consumer use of dietary supplements since the 1994 enactment of DSHEA.
The dietary supplement industry is one of the fastest growing industries in the world consisting of 1,566 establishments, as referenced in Illustration 1 ("Survey of Manufacturing Practices in the Dietary Supplement Industry: Final Report," RTI Task Order No. 6, May 17, 2000). Dietary supplement sales reached $14.1 billion in 1998 and are estimated to reach $15.5 billion for 1999 and $17.1 billion for 2000, as referenced in Illustration 2 ("US 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). In 1999, consumers spent nearly double the amount spent in 1994, and sales continue to grow at more than 10% a year (Nutrition Business Journal, San Diego, 1998).
Illustration 1
Dietary Supplement Establishments
Total Establishments = 1,566
Illustration 2
Dietary Supplement Sales
Years 1994 through 2000
Surveys show that over 158 million consumers use dietary supplements (PREVENTION Magazine's Survey of Consumer Use of Dietary Supplements, 2000, page 4). An estimated 115.3 million consumers buy vitamins and minerals for themselves, and 55.8 million purchase them for other members of their family, including children (PREVENTION Magazine, page 5).
The basic reason cited for dietary supplement growth is the desire for self-care. Consumers use dietary supplement products to help them achieve their self-care goals, which arise out of a sense of alienation from the established health care system (PREVENTION Magazine, page 4). Results from a national survey conducted in 1999 by Men's Health magazine show that consumers use dietary supplements as a means of ensuring good health. They also use supplements for very specific, medicinal purposes such as treating and preventing serious illnesses, colds, and the flu; increasing mental sharpness; and alleviating depression (PREVENTION Magazine, pages 4-5).
Illustration 3
Year 2000 Dietary Supplement Estimated Sales
Breakdown of $17.1 Billion Market
The consumer's desire for self-care and the widespread use of dietary supplements may cause problems for public health. Many consumers put themselves at risk from misuse of dietary supplements and the possibility of interaction effects with prescription and over-the-counter (OTC) products. An estimated 22.8 million consumers use herbal remedies instead of prescription medicine, and an estimated 19.6 million use them with a prescription product (PREVENTION Magazine, page 5). Herbals and botanicals incorporate 32% of the estimated $17.1 billion dietary supplement market for the year 2000 with vitamins slightly higher at 38%, as referenced in Illustration 3 (National Business Journal, 2000, Dialog File No. 93, San Francisco: The Dialog Corporation, 2000).
As use of these products increases, so does the potential for adverse effects. For example, FDA issued a public warning on January 21, 1999, alerting consumers of the potential hazards from consumption of GBL-containing products, which were marketed as dietary supplements. Firms known to produce or distribute GBL were contacted beginning on January 19, 1999. Beginning on January 27, 1999, warning letters were delivered to firms not voluntarily recalling their products. Another example of a growing problem is that the dietary supplement Ephedra, also known as ma huang, and its derivatives are producing consumer complaints from many states, including Georgia, Kentucky, Minnesota, Nebraska, Ohio, Pennsylvania, and Texas. FDA is actively involved in assessing the nature and degree of public health risks associated with the use of dietary supplements containing ephedrine alkaloids. On April 3, 2000, FDA announced the availability of certain new adverse event reports associated with dietary supplement products that were known or suspected to contain ephedrine alkaloids and participated in a public meeting held on August 8-9, 2000, to discuss these adverse event reports and related information. In addition, poison control centers in various states are reporting adverse reactions to a range of dietary supplements.
In the past, except for vitamin and mineral products, dietary supplements, particularly botanical products, were mainly sold to adults in health food stores. In contrast, now such products are available in supermarkets, other retail stores, and on the Internet, making these products readily accessible to children and other vulnerable populations. The Nutrition Business Journal estimated that in 1999 U.S. consumer sales of supplements over the Internet amounted to $142 million, almost three times the previous year's total of $48 million ("E-Commerce in the Nutrition Industry," Nutrition Business Journal, Volume No. 4, April 2000).
Before Congress passed DSHEA, dietary supplements (including vitamins and minerals) were regulated either as foods or as drugs, depending on their intended use. If a product was used primarily for its taste, aroma, or nutritive value, it was regulated as a food. This meant that ingredients used in dietary supplements were subject to the food additive provisions of the Federal Food, Drug and Cosmetic Act, which require the safety of an ingredient to be demonstrated before it can be marketed. When Congress passed DSHEA, it created a regulatory framework for dietary supplements that previously did not exist. The purpose of creating this new framework was to strike the right balance between providing consumers access to both dietary supplements and truthful information about them while retaining authority for FDA to take action against supplements that present safety or labeling problems. FDA is now engaged in the difficult task of delineating boundaries between dietary supplements, drugs, and conventional foods. This task is one that requires great care if the Agency is to fulfill Congressional intent with regard to the availability of dietary supplements while preserving the established food additive and drug regulatory frameworks for products that fall outside the dietary supplement boundaries.
As previously stated, FDA's regulation of dietary supplements is for the most part a postmarketing program. Since Congress considered dietary ingredients marketed prior to passage of DSHEA to be generally 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). A dietary supplement that contains a new dietary ingredient (i.e., an ingredient not marketed for dietary supplement use in the U.S. prior to October 15, 1994) is adulterated when there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury. 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. However, as with any other food, it is a manufacturer's responsibility to ensure that its products are safe and properly labeled prior to marketing. Except with certain new dietary ingredients, supplement manufacturers do not have to provide information to FDA to get a product on the market, unlike the food additive process often required of new food ingredients. In addition, FDA does not have the authority to approve dietary supplements as a prerequisite to entering the marketplace. This shifts the regulatory emphasis to postmarketing surveillance and enforcement and sound, science-based research to evaluate the safety of these products.
Because of DSHEA's statutory framework, FDA must look to other safety tools to identify and address potential health risks to consumers associated with the use of dietary supplements: GMP regulations, labeling requirements, and adverse event reporting. As a preventive measure, DSHEA grants FDA explicit authority to establish GMP regulations for dietary supplements. Such regulations would be intended to establish a mechanism to help assure purity and consistency in dietary supplement products.
In regard to labeling, manufacturers must make sure that product label information is truthful and not misleading. DSHEA provides for use of claims to affect the structure or function of the body, claims of general well-being from consumption of a nutrient or dietary ingredient, and claims of benefits related to classical nutrient deficiency diseases. These claims require notification to FDA within 30 days after marketing; they must be substantiated, and accompanied by the disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." Authorized health claims may be made in dietary supplement labeling, as permitted by the NLEA. Such claims show a relationship between a nutrient or other substances in a food and a disease or health-related condition. Finally, DSHEA contains ground rules for publications used in connection with the sale of dietary supplements.
Because in most cases dietary supplement manufacturers are not required to provide safety information to FDA before marketing a product, FDA has the responsibility for gathering information before the Agency can take action to restrict the sale of a dietary supplement product for safety reasons. This means that the Agency must rely on adverse event reports, product sampling, information in the scientific literature, and other sources of evidence. The Agency's scientists have to determine whether a safety problem exists, and adequate evidence has to be gathered and assembled to support a regulatory action. As is the case whenever the Agency considers regulatory action against a product, it must take care to ensure that statutory requirements for an action against a dietary supplement are met, and that the action has adequate scientific support. This process is often complex and warrants being thoughtful but timely.
FDA has authority for premarket review for safety and efficacy for many of the products it regulates. For example, drugs undergo the required clinical studies to determine their safety, effectiveness, possible interactions with other substances, and appropriate dosages before they are marketed. Similarly, food additives (substances added to food that are not generally recognized as safe or prior sanctioned) must undergo FDA's premarket approval process for new food ingredients. This process requires manufacturers to conduct extensive safety studies and to submit the results to FDA for review before the ingredient can be used in marketed products.
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 before 1994 and that have not been in the food supply as articles used for food without chemical alteration) submit to FDA, at least 75 days before the product is expected to go on the market, information that supports the conclusion that a supplement containing the new ingredient can reasonably be expected to be safe. However, there is no requirement that the manufacturer receive FDA approval or clearance before marketing the product after the 75-day period. This means it's essential for public health protection that FDA has the resources to review these on time.
In January 2000, the Center for Food Safety and Applied Nutrition (CFSAN) published its Dietary Supplement Strategic Plan. As noted earlier in this report, FDA's primary program goal is to have a science-based regulatory program that fully implements the Dietary Supplement Health and Education Act of 1994, thereby providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.
The total base funding for FY 2001 is about $6.0 million. In FY 2000, FDA expended approximately $6.7 million on dietary supplement activities. An estimated $4.8 million of this amount was operational and payroll dollars. The remaining amount of $1.9 million was one-time funding that was received in FY 2000 as a result of tobacco and Agency reprogramming. However, these one-time fundings did not carry over into the next fiscal year. Thus, the base funding for FY 2000 is at $4.8 million. In FY 2001, the Agency received appropriated increases in the dietary supplement program of $1.2 million. These increases were dedicated to the Agency's activities involving collaborative research on dietary supplements with the University of Mississippi's National Center for Natural Products Research and premarket activities related to dietary supplements.
In implementation, a phased-in approach may be prudent given the breadth of the Strategic Plan and the estimated resources that will be needed to support the dietary supplement program. The Agency estimates that its dietary supplement program could be implemented within five years which could require an operating base of between $40 million and $65 million and an estimated FTE range between 133 and 244 (includes both Headquarters and field personnel). During this five-year ramp up, the Agency would devote its resources to building and establishing the program's infrastructure (i.e., equipment, hiring, training, etc.) to successfully meet the regulatory expectations, as outlined in DSHEA, as well as the corresponding tasks and goals contained in the Strategic Plan.
|
Category |
By Year 3 |
In Year 4 |
In Year 5 |
|||
|---|---|---|---|---|---|---|
|
% |
Dollar Range |
% |
Dollar Range |
% |
Dollar Range |
|
Safety/Regulatory |
57% |
$14.25-$22.80 |
33% |
$ 9.90-$18.15 |
25% |
$10.00-$16.25 |
Field |
25% |
$ 6.25-$10.00 |
44% |
$13.20-$24.20 |
48% |
$19.20-$31.2 |
Science |
18% |
$ 4.50-$ 7.20 |
23% |
$ 6.90-$12.65 |
27% |
$10.80-$17.55 |
|
Total |
100% |
$25.00-$40.00 |
100% |
$30.00-$55.00 |
100% |
$40.00-$65.00 |
The chart on the previous page represents the potential ramp-up years by Year 3 and in Years 4 and 5. The activities contained in the Strategic Plan's six categories (Safety, Labeling, Boundaries, Enforcement, Science-Base and Outreach) have been reorganized into the following three categories: Science, Field, and Safety and Regulatory. The Safety and Regulatory category consists of those activities contained in the Strategic Plan that were devoted to Safety, Labeling, Boundaries, and Outreach. The Field category consists of those activities in the Strategic Plan pertaining to GMP inspection and to Enforcement, and the Science category consists of Research/Science-Base activities.
In addition to the previous chart, the table, identified below, reflects the FTE levels that are associated with the three categories during the ramp-up years – by Year 3 and in Years 4 and 5. There is a total base of 46 FTEs for FY 2000. The Safety and Regulatory category consists of 15.5 FTEs. The Field category consists of 22.5 FTEs, and the Science category consists of 8.0 FTEs.
|
Category |
By Year 3 |
In Year 4 |
In Year 5 |
|||
|---|---|---|---|---|---|---|
|
% |
FTE Range |
% |
FTE Range |
% |
FTE Range |
|
Safety/Regulatory |
54% |
27- 61 |
33% |
42- 77 |
33% |
44- 81 |
Field |
34% |
17- 39 |
51% |
64-118 |
49% |
65-119 |
Science |
12% |
6- 14 |
16% |
20- 37 |
18% |
24- 44 |
|
Total |
100% |
50-114 |
100% |
126-232 |
100% |
133-244 |
During a ramp-up between Years 1 and 3, the Agency anticipates that approximately 57 percent of estimated funds would be devoted to building/developing a framework for regulating dietary supplements. This could be primarily related to the Adverse Event Report Monitoring System; drafting new regulations, including the final GMP regulations; and in overseeing product labeling. Thus, an estimated 54 percent of the projected FTEs during this same time period would be dedicated to the Safety and Regulatory activities. Further, an estimated 25 percent of the funds estimated would be spent on field-related activities that would concentrate on enhancing routine compliance efforts and improving the Agency's compliance procedures. Approximately 34 percent of the total FTEs during the first three years would be devoted to the Field activity. Science activities would be modest but would begin to develop research capabilities to support regulations and enforcement efforts and would consume about 18 percent during this same time. Approximately 12 percent of the total FTEs would be targeted towards this activity.
Assuming that a foundation for a regulatory structure could be underway by the third year, the fourth and fifth ramp-up years would see a shift in emphasis from building a regulatory framework to strengthening significantly the Agency's field and science activities. This shift is based on the expected publication of the final GMP regulations and the need to begin inspecting the over 1,500 dietary supplement firms.
The shift is reflected in the total dollars estimated as well as the associated FTE levels for these years. It is estimated that 44 percent of the estimated funds would be devoted to enhancing the field activities in Year 4 and 48 percent of funds would be devoted to this activity in Year 5. Accordingly, 51 percent of the total FTEs during Year 4 would be concentrated on the field activity while 49 percent would be devoted to this activity in Year 5. The science activities in Year 4 would receive approximately 23 percent of the total estimated funds and by Year 5 they would comprise 27 percent of the total. Science activities are defined in this way because they represent longer-term efforts, and because the number of premarket submissions is expected to increase in the later years. FTE levels for the science activity would reach its highest level in the final ramp-up year consuming an estimated 18 percent of the total. The lower FTE percentage represents a greater need to "leverage" with outside organizations to effectively build the science base.
It is FDA's desire to continue to work collaboratively with other governmental agencies, academia, health professionals, industry, and the Congress so that we all can be assured that we are doing what is best for the American consumer with regard to the safety of dietary supplements. In support of that effort, the Agency firmly believes that its Dietary Supplement Strategic Plan (supported with adequate funding) will provide the necessary guidance, using a phased-in approach, for a comprehensive program that will implement the additional regulatory responsibilities imposed on FDA by DSHEA.
FDA fully understands that it operates in a world of limited resources and competing priorities and is sensitive to the amount of resources that will be required to fully implement its Dietary Supplement Strategic Plan. It should be noted that all cost estimates provided for in the Strategic Plan were prepared and reviewed by program experts who are well versed in the requirements of implementing each of the respective goals and their associated activities. Further, the Agency also understands the discipline required to manage and utilize these resources in the most effective and economical way possible, while at the same time achieving maximum results for the taxpayer. The Agency is committed to utilizing all resources in a manner consistent with the goals and activities delineated in the Strategic Plan in order to achieve success.
Finally, FDA takes seriously the new and expanded responsibilities that the Congress has entrusted to it through DSHEA. The Agency believes that through full implementation of its Strategic Plan, an opportunity exists to make a meaningful difference in the effort to ensure the safety of one of the world's fastest growing industries. FDA is proud to be in the forefront to lead this effort.
Hypertext updated by kwg/dms 2002-JUN-07