Implementing DSHEA—Progress Made, but Much Remains to be Done

The Scientific Status Summary on Dietary Supplements by Mary Ellen Camire and Mark A. Kantor that appears on pages 87-96 of this issue provides an overview of this topic by describing the history of vitamin/mineral supplements, the regulatory framework, physiologic functions (including benefits and safety), and the types of monitoring data for assessing public health needs and consumer uses. The Summary, prepared for IFT’s Expert Panel on Food Safety and Nutrition, provides a concise overview of a complex topic that so often invokes polar perspectives and misperceptions.

The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, amendED the Food, Drug and Cosmetic Act to create a regulatory and scientific framework for dietary supplements. In doing so, Congress stated 15 findings that describe the basis for this legislation. These findings include statements on the: (a) importance of dietary supplements in promoting health and reducing the risk of disease, (b) need for broad access to dietary supplements by consumers, and (c) need for the availability of accurate information to allow consumers to make choices. The findings also state that “dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare.” In addition, DSHEA recognizes a need for research by creating the Office of Dietary Supplements (ODS) at the National Institutes of Health.

Under DSHEA, dietary supplements are regulated as foods. In establishing the regulatory framework for dietary supplements, Congress blended aspects of the “old” and the “new” to create a unique regulatory approach for these products. That is, Congress extended some provisions in place for conventional foods or drugs to dietary supplements; in other cases, Congress created unique requirements and standards for supplements. For example, DSHEA exempted dietary supplement ingredients from food additive provisions, created a unique safety standard of a “significant or unreasonable risk” under label conditions of use, and then retained other adulteration provisions of food law (e.g., pesticides, filth, and food additive requirements for color additives) for these products.

Under DSHEA, labeling requirements also exhibit a blend of “old” and “new.” Some aspects of nutrition labeling, including declaration of nutrients, nutrient content claims, and health claims are generally similar for both conventional foods and dietary supplements. At the same time, DSHEA specifically allowed nutrition support (e.g., structure–function) claims for non-nutrient ingredients and required that, unlike conventional foods, dietary supplements bearing these types of claims use disclaimers indicating that these claims have not been reviewed or approved by the FDA and that these products are not intended for therapeutic uses.

From a scientific perspective, implementation of DSHEA requires effective collaboration among disciplines not used to working together, e.g., clinicians and food scientists, pharmacognocists, and nutritionists. Definitions and characterization of “test” substances create particularly difficult scientific challenges.

From a regulatory perspective, DSHEA created a framework that previously did not exist. New definitions need clarification and new boundaries need to be drawn. For example, what does “to supplement the diet by increasing the total dietary intake” mean? What types of ingredients did Congress intend for this definition to include? How do we make sure that this definition does not allow the inclusion of ingredients never intended to fit within the universe of dietary supplements? Given quite different regulatory requirements for “disease” vs. “structure–function” claims, how do we draw the boundary between these two categories—a boundary that was not previously defined in the regulatory framework and is even more difficult to differentiate scientifically? Since DSHEA allows certain types of claims that are similar to drug claims, how do we preserve the “bright line” between dietary supplements and drugs? Given somewhat different requirements for claims and safety of dietary supplements and conventional foods, how do we distinguish between these two regulatory categories? For the regulator, the challenge is to strike the right balance between preserving consumers’ access to both products and information while ensuring the safety and proper labeling of all these products. What is the best approach for achieving this? FDA is currently soliciting input on how best to develop an overall strategy for effective regulation of dietary supplements.

To date, considerable progress has been made in implementing DSHEA. FDA has published several regulatory documents specific to dietary supplements. The Federal Trade Commission has issued substantiation guidelines for claims on dietary supplements. The White House Commission on Dietary Supplement Labeling has published its report. ODS has published a strategic plan, funded research projects, and set up information databases to facilitate access to scientific information on dietary supplements.

Yet much remains to be done. Scientific organizations such as IFT can play a key role in providing expert advice to the regulators and scientific community as we work to achieve full and effective implementation of DSHEA. Background papers, such as the IFT Scientific Status Summary presented in this issue, that objectively and effectively lay out the frameworks and issues help to pave the way for this new collaboration.

by ELIZABETH A. YETLEY, PH.D.
Director, Office of Special Nutritionals’
Ctr. for Food Safety & Nutrition, FDA
Washington, D.C.