News & Events
Implementation of the Dietary Supplement Health and Education Act (DSHEA) of 1994
Jane E. Henney, M.D.
Food and Drug Administration
Department of Health and Human Services
the House Committee on Government Reform
March 25, 1999
Mr. Chairman, and Members of the Committee, my name is Jane Henney. I am honored to address you as the Commissioner of Food and Drugs and pleased to be here today to discuss implementation of the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Since this is my first appearance before this Committee as the Commissioner, I would like to take this opportunity to share with you my priorities for the Food and Drug Administration (FDA or the Agency). They will give you context for our dialogue on specific matters today and in the future. My priorities are:
- Full and effective implementation of the FDA Modernization Act (FDAMA). I intend to build on this collaborative, constructive model by working closely with Congress, the regulated industry, patients, consumers, and health care professionals. This means not just implementing the letter of the law but the spirit of the law.
Enhancing the Agency's science base. It should be a concern to us all that, at the very time the public and private research enterprise in this country is flourishing, the FDA, an essential science-based regulatory Agency, may have difficulty recruiting and retaining strong scientists. If we are to meet our statutory obligations to regulate cutting-edge scientific discovery and development, we must have comparable cutting-edge expertise in our staff.
The remaining three priorities are not only priorities of the Agency but of the Administration:
- The safety of the Nation's food supply;
- The safety of the Nation's blood supply; and,
- Reducing young people's use of tobacco products.
These priorities are limited in number but encompass many activities. We need to allocate our finite resources wisely and when we undertake activities beyond these priorities we need to do so with deliberation and intention and in the areas of highest public health promotion and protection. This is the perspective from which we approach our implementation of DSHEA.
I understand that this statute was passed with bipartisan support and by the hard work of you and others in Congress in developing an appropriate regulatory scheme that would facilitate consumers' access to dietary supplements. It is important that the Agency's implementation of the statute be true to Congressional intent. As I stated during my confirmation process, I am aware that many Americans place great faith in dietary supplements to help them maintain and improve their health and that the scientific evidence documenting the benefits of a number of supplements is increasing. The challenge to FDA is to strike the right balance between preserving consumers' access to both products and information and assuring the safety and proper labeling of all of these products. It is clear, with the benefit of hindsight, that we still have a way to go both in achieving full implementation of DSHEA and in developing a workable regulatory framework. I want to take the opportunity to acknowledge our progress, shortcomings, remaining challenges, and commitment to fully implement the statute.
CHANGES SINCE DSHEA
There have been many changes in the size and scope of the industry and the consumers using dietary supplements, since 1994. Let me briefly outline some of these changes. The dietary supplement industry has grown exponentially since the passage of DSHEA. Surveys show that more than half of the U.S. adult population uses dietary supplement products. Annually, consumers spend approximately $12 billion on dietary supplements, according to Nutrition Business Journal in their 1998 Annual Industry Overview.
Just as the industry and consumption have grown, access also has changed. In the past, except for vitamin and mineral products, dietary supplements, particularly botanical products were available mainly in health food stores. These products were marketed principally to adults. Now such products are available in supermarkets and other retail stores, and even via the Internet. This makes dietary supplements readily available to children and adolescents, as well as to adults. While many of these changes would appear to be consistent with the expectations and intent of DSHEA, they nevertheless present new regulatory challenges.
DSHEA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to define the term "dietary supplement" and establish a regulatory framework for dietary supplements. In doing so, Congress made 15 significant findings that emphasize the importance of diet and nutrition, including dietary supplement use, in promoting health and reducing the risk of disease. FDA acknowledges these findings. DSHEA provides for broad access to dietary supplements for consumers and also recognizes that there is a need for a rational regulatory framework that provides FDA authority to remove from the market products that pose a "significant or unreasonable" risk to consumers or that are otherwise adulterated and to require that labeling for dietary supplements be accurate.
Congress defined "dietary supplement" to mean products that are intended to supplement the diet that contain one or more of certain dietary ingredients, such as:
- a vitamin or a mineral,
- an herb or other botanical,
- an amino acid,
- a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or
- a concentrate, metabolite, constituent, extract, or
- combination of the preceding ingredients,and, that meet other criteria specified in Section 201(ff)(2)-(3).
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). If a supplement contains a new dietary ingredient that has not been in the food supply, however, Congress required 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. There is no requirement that the firm wait for a safety determination from FDA before marketing the product.
Should safety problems arise after marketing, DSHEA makes "adulterated" any dietary supplement that creates a "significant or unreasonable" risk to consumers, thereby subjecting it to FDA enforcement action. Further, in particularly compelling cases, DSHEA allows the Secretary to ban a dietary supplement if she finds it to be an "imminent hazard."
Finally, as a preventive measure, DSHEA grants FDA explicit authority to establish good manufacturing practice (GMP) regulations for dietary supplements. Such regulations would be intended to establish a mechanism to help assure purity and consistency in dietary supplement products.
Regarding labeling, DSHEA seeks to provide consumers with information to help guide personal choice. This includes specially tailored requirements for ingredient labeling and nutrition labeling.
DSHEA also 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, must be substantiated, and must be 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."
Finally, DSHEA contains ground rules for publications used in connection with the sale of dietary supplements.
FDA's ROLE IN THE IMPLEMENTATION OF DSHEA
In its initial efforts under DSHEA, the Agency concentrated on promulgating the many regulations mandated by DSHEA and began a number of other regulatory actions to establish the framework for implementation of the new statute. Since passage of DSHEA, FDA has published 25 Federal Register notices regarding dietary supplements (see Appendix). Let me briefly discuss a few specific DSHEA regulatory actions we have taken.
- Supplement Facts: On September 23, 1997, FDA published a final rule in the Federal Register implementing the nutrition labeling provisions of DSHEA. As of March 23, 1999, the effective date of the regulation, all dietary supplements must bear nutrition information entitled "Supplement Facts." This labeling is similar to nutrition content labeling for conventional foods but is tailored to the special characteristics of dietary supplements.
- Good Manufacturing Practice: On February 6, 1997, FDA published in the Federal Register an Advance Notice of Proposed Rulemaking requesting comment on whether FDA should institute rulemaking to develop current GMP regulations for dietary supplements and dietary ingredients. In February 1998, we asked our Food Advisory Committee to establish a working group to assist us in defining GMP for dietary supplements. While we have not moved as rapidly on this rulemaking as we might have, the Agency is committed to accelerating the development and implementation of GMP regulations. I have made it one of my priorities. The general view we have received is that GMP regulations would be a useful tool for both the industry and the Agency. By including GMP regulations in the overall priority-setting strategy, we recognize the importance of such regulations as an effective mechanism for consumer protection. As noted earlier, such regulations would help assure the purity and consistency of dietary supplement products.
- Structure/Function: On April 29, 1998, FDA published in the Federal Register, and sought public comment on, a proposed rule defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body. This action is intended to implement the provisions of DSHEA that permit structure/function claims but prohibit claims to treat or prevent disease. The comment period closed on September 28, 1998, and the Agency received over 100,000 comments, many of which addressed the proposed definition of disease. The Agency currently is reviewing each of the comments, and we will re-evaluate each of the elements of the proposed rule in light of these comments.
- Authoritative Statement Health Claims: On January 21, 1999, FDA published a proposed rule in the Federal Register to permit the use of health claims based on authoritative statements for dietary supplements under the notification procedures established in FDAMA. This proposal tracks the language of Section 303 of FDAMA and would place dietary supplements on an equal footing with conventional foods with respect to health claims based on authoritative statements. On May 11, 1999, a public meeting is planned to gather stakeholder input on the proposal and other issues relating to the Agency's implementation of Sections 303 and 304 of FDAMA.
Many of the proposals referenced in the Appendix, or above, are open rulemakings that are still in progress.
Mr. Chairman, notwithstanding our actions to date, I want to acknowledge that FDA still has a long way to go to achieve full implementation of DSHEA. I assure you that as the new Commissioner of Food and Drugs, I am focusing attention on dietary supplements, an issue that is currently a priority for FDA's Center for Food Safety and Applied Nutrition (CFSAN).
Last month, CFSAN published a 1999 program priorities document which includes on its "A" list completion of an overall dietary supplement strategy by the end of the year. The Agency is committed to developing an overall strategy for achieving effective regulation of dietary supplements under DSHEA, and in doing so, to provide ample opportunity for stakeholder input. In developing its strategy for implementing DSHEA, the Agency will be guided not only by the basic tenets of DSHEA, but also by the priorities I articulated earlier that include commitment to the Agency's mission for promoting and protecting the public health and basing our regulatory decisions on sound science.
The dietary supplement strategy will address all elements of the dietary supplement program, including:
- definitional boundaries between dietary supplements and conventional foods, between dietary supplements and drugs, and between dietary supplements and cosmetics;
- good manufacturing practice regulations;
- adverse event reporting, review, and follow-up;
- laboratory capability;
- research needs;
- enforcement; and
- resource needs.
CFSAN also is committed to enhancing outreach efforts to stakeholders to assure effective communication as we move forward with the development and implementation of this strategy.
Mr. Chairman, I think important progress has been made towards achieving the central objective of DSHEA: that of assuring consumer access to safe dietary supplements. At the same time, none of us could have foreseen the great increase in products claiming to be dietary supplements promoted on the Internet and elsewhere. A small but disturbing number of these products have a potential for harm or bear unsupported claims. In this context, a rapidly expanding industry and a changing demographic of consumers eager to manage their own health care needs provide a significant regulatory challenge.
Just as the Agency is committed to implementing DSHEA fully and ensuring consumers have access to dietary supplements, FDA also is committed to quickly removing unsafe products from the market or taking other timely actions to protect consumers. FDA has tools at its disposal to take enforcement actions against dietary supplements found to have safety, labeling, or other violations of the FD&C Act, as amended by DSHEA. The Agency has used a variety of regulatory tools from enforcement actions to rulemaking, when it has found dietary supplements that cause safety concerns. A good example is digitalis-contaminated plantain.
After being notified of a young woman with life-threatening abnormal heart function who required hospitalization for six days, FDA conducted an investigation. The Agency detected the botanical Digitalis lanata in samples of raw material labeled "plantain" that was an ingredient in one of the dietary supplement products used by this young woman. Digitalis is a powerful heart stimulant whose effects may include nausea, vomiting, dizziness, headache, confusion, hypotension (low blood pressure), vision disturbances, and abnormal heart rate and rhythm.
FDA then traced all uses of the contaminated ingredient and asked manufacturers and retailers to recall these products from the market. FDA issued several press releases in May and June 1997 warning consumers not to purchase or ingest certain dietary supplement products labeled as containing plantain because these products might contain Digitalis lanata, a plant that can cause life-threatening heart reactions, including cardiac arrest, if ingested. In the press releases, FDA listed the names of distributors, manufacturers, and retailers, as well as the products involved, and urged consumers to obtain updates from FDA's Consumer Hotline and FDA's "Foods" website. Fast and effective actions by FDA prevented serious adverse effects, which would likely have occurred if these contaminated products had remained in the marketplace.
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 the ingredients used in such dietary supplements were subject to the food additive provisions of the FD&C Act, which require the safety of an ingredient to be demonstrated before it can be marketed. The supplement was subject to regulation as a drug if therapeutic claims were made, i.e., claims to treat or prevent disease; if claims were made to affect the structure or function of the body through a non-nutritive mechanism; or if there was other evidence that the intended use of the product was as a drug. The supplement, with such claims, would have to meet the rigorous drug safety and efficacy requirements of the FD&C Act, including, in the great majority of cases, premarket approval.
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 products and truthful information about the products while retaining authority for FDA to take action against products that present safety problems or are improperly labeled. We are now engaged in the difficult task of delineating boundaries between drugs, dietary supplements, and conventional foods. This is a task 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.
For example, Congress has permitted dietary supplements to be intended to affect the structure or function of the body, but it has not permitted dietary supplements to be intended to treat, prevent, mitigate, cure, or diagnose disease, except that dietary supplements may bear authorized health claims. DSHEA required FDA to draw a line between two types of intended use that the Agency never needed to distinguish previously. Congress also drew a line between conventional foods and dietary supplements by saying that a dietary supplement may not be represented for use as a conventional food. This boundary, too, raises many complex issues that the Agency is responsible for clarifying.
Aspects of DSHEA's dietary supplement definition that have proven especially problematic to implement are the statute's limitation of dietary supplements to products that are intended to supplement the diet and its inclusion of dietary substance[s] for use by man to supplement the diet as dietary ingredients that may be used in dietary supplements. It is clear that the dietary ingredients specifically listed in DSHEA (vitamins, minerals, herbs or other botanicals, and amino acids) were intended by Congress to be broadly available under DSHEA, and many of these have a long history of safe use. Products are now being positioned as dietary supplements, however, by purporting to fall within the "dietary substance" language. The terms "dietary substance" and "intended to supplement the diet" are broad, but they must not allow the inclusion of ingredients never intended to fit within the universe of dietary supplements. Now, products that contain substances similar to those found in prescription drugs are marketed for children as dietary supplements. Likewise, products with ingredients that simulate illicit street drugs are marketed as dietary supplements to adolescents via the Internet and shops specializing in drug paraphernalia. FDA is working toward a solution that will be consistent with the intent of DSHEA.
DSHEA also amended the FD&C Act to permit certain types of claims for dietary supplements that formerly would have made them drugs, including claims to affect the structure or function of the body through a non-nutritive mechanism. Congress recognized that if foods and dietary supplements were permitted to make disease treatment and prevention claims without premarket review, the burden would have been on consumers to evaluate the validity of a myriad of claims about products marketed for serious and life-threatening conditions. In addition, dietary supplements would be given an unfair advantage over prescription and over-the-counter drugs in the marketplace.
Thus, as I have noted above, the Agency issued a proposed rule intended to provide direction to the industry as to the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body and to clarify the line between disease and structure/function claims. This is important because disease claims for drugs as well as for conventional foods and dietary supplements continue to require pre-market authorization by FDA.
For foods, including dietary supplements, disease claims are "health claims." These claims describe the relationship between a food substance and a disease. The claim is usually in the context of risk reduction of the disease. Any person or firm may petition FDA to authorize a health claim. FDA then reviews the scientific evidence for or against the claim. If the Agency finds that the claim is supported by significant scientific agreement among qualified experts, it will issue a regulation authorizing the claim. Recently, FDAMA authorized a second method for streamlined review of health claims. This involves the use of authoritative statements made by certain federal scientific bodies and the National Academy of Sciences in their publications. With this latter method, an interested party notifies FDA of its intent to make a health claim based on an authoritative statement and provides information as to the source of the statement.
With the passage of DSHEA, dietary supplements are deemed to be foods, except for purposes of the drug definition. In addition, Congress specifically excluded "dietary ingredients" in dietary supplements from the definition of "food additive." As a result, dietary ingredients used in dietary supplements no longer require premarket documentation of safety for submission to FDA unless they are new dietary ingredients subject to the notification requirement in Section 413(a)(2) of the FD&C Act. The notification requirement stipulates that the manufacturer or distributor of the dietary supplement submit to FDA information which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe at least 75 days before marketing.
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 evidence adequate to support a regulatory action has to be gathered and assembled. 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. This process is often complex and warrants being thoughtful but timely.
Mr. Chairman, I share the goal of making safe products available to consumers who want to make informed personal choices about using dietary supplements to improve their health. DSHEA was enacted to ensure access to those products. I also believe DSHEA provides FDA with the necessary legal authority to protect the public health. We will do our best to marshal the scientific information and expertise necessary to exercise that authority when the public health is threatened.
The dietary supplement industry sells products on which millions of Americans rely. I am aware that in the past the relationship between FDA and some in the dietary supplement industry has been at times antagonistic and counterproductive. FDA is committed to developing a positive working relationship with the industry so we may together meet our goals of providing safe products to the American public.
The statute is still in the early stages of implementation, and I look forward to working with Congress and other interested parties to ensure that resource constraints or other issues do not impede FDA's ability to use this statutory authority most effectively.
I would be happy to respond to any questions the Committee may have.
- October 6, 1994, Proposed Rule, "Iron-Containing Supplements and Drugs; Label Warning Statements and Unit-Dose Packaging Requirements" (59 FR 51030)
- December 6, 1994, Advance Notice of Proposed Rulemaking; Withdrawal, "Regulation of Dietary Supplements; Withdrawal of Advance Notice of Proposed Rulemaking" (59 FR 62551)
- February 9, 1995, Notice of Intent, "Food Labeling; General Requirements for Nutrition Labeling of Dietary Supplements; General Requirements for Nutrient Content Claims for Dietary Supplements" (60 FR 7711)
- April 19, 1995, Notice, "Dietary Supplements: Notice of Withdrawal of Regulatory Guidance" (60 FR 19597)
- December 28, 1995
Final Rule, "Food Labeling: Reference Daily Intakes" (60 FR 67164)
- Proposed Rule, "Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements" (60 FR 67176)
- Proposed Rule, "Nutrient Content Claims: Definition for High Potency Claim for Dietary Supplements and Definition of Antioxidant for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods" (60 FR 67184)
- Proposed Rule, "Food Labeling; Statement of Identity, Nutrition Labeling, and Ingredient Labeling of Dietary Supplements" (60 FR 67194)
- April 22, 1996, Notice, "Inapplicability of the Dietary Supplement Health and Education Act to Animal Products" (61 FR 17706)
- September 27, 1996
- Proposed Rule, "Food Labeling; Dietary Supplement; Nutritional Support Statement; Notification Procedure" (61 FR 50771)
- Proposed Rule, "Premarket Notification for New Dietary Ingredient" (61 FR 50774)
- January 15, 1997, Final Rule, "Iron-Containing Supplements and Drugs; Label Warning Statements and Unit-Dose Packaging Requirements" (62 FR 2218)
- February 6, 1997, Advance Notice of Proposed Rulemaking, "Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Supplements" (62 FR 24619)
- June 4, 1997, Proposed Rule, "Dietary Supplements Containing Ephedrine Alkaloids" (62 FR 30678)
- September 23, 1997
- Final Rule, "Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide, Revocation" (62 FR 49826)
- Final Rule, "Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements" (62 FR 49859)
- Final Rule, "Food Labeling; Nutrient Content Claims: Definition for 'High Potency' and Definition of 'antioxidant' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods" (62 FR 49868)
- Final Rule, "Food Labeling; Notification Procedures for Statements on Dietary Supplements" (62 FR 49883)
- Final Rule, "Premarket Notification for New Dietary Ingredient" (62 FR 49886)
- April 29, 1998
- Notice, "Comments on Report of the Commission on Dietary Supplement Labels" (63 FR 23633)
- Proposed Rule, "Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body" (63 FR 23624)
- June 5, 1998, Revised Final Rule, "Food Labeling; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide, Revocation" for volume measure on liquid extracts (63 FR 30615)
- June 11, 1998, "Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on Authoritative Statement of a Scientific Body" (pursuant to FDAMA)
- January 12, 1999, Proposed Rule, "Food Labeling: Nutrition Labeling of Dietary Supplements on a 'Per Day' Basis" (64 FR 1765)
- January 21, 1999, Proposed Rule, "Food Labeling: Use on Dietary Supplements of Health Claims Based on Authoritative Statements" (pursuant to FDAMA) (64 FR 3250).