Questions and Answers:
Strategy for Dietary Supplements

Q: What are the goals of FDA's strategy?

A: FDA is announcing a strategy that describes FDA's planned actions to continue implementing and enforcing the Dietary Supplement Health and Education Act of 1994 (DSHEA). The strategy has three goals

1. monitoring and evaluating product and ingredient safety;
2. assuring product quality (current good manufacturing practice regulations); and
3. monitoring and evaluating product labeling.

Q: How will FDA implement the strategy?

A: The strategy sets forth a series of specific, integrated research and regulatory measures, including guidance, regulations, and science-based compliance and enforcement mechanisms.

Q: Does FDA have resources to implement this strategy?

A: The funding to implement this strategy will come from funds allocated to FDA and will bring the agency closer to achieving many of its longer-term goals for DSHEA implementation and enforcement.

Q: What effect will these initiatives have on dietary supplements stakeholders, such as manufacturers, distributors and consumers?

A: With this strategy, FDA hopes to improve the transparency, predictability, and consistency both of the agency's scientific evaluations of dietary supplement product and ingredient safety, and of its regulatory actions to protect consumers against unsafe dietary supplements and dietary supplements making unauthorized, false, or misleading claims, including unsubstantiated claims. FDA expects that this improved transparency will help engage stakeholders in the development of further measures to implement DSHEA. The agency also believes that it will give consumers a higher level of assurance about the safety of dietary supplements and their labeling.

Q: How will FDA monitor and evaluate dietary supplements?

FDA will work collaboratively with federal and other partners to develop the evidentiary base the agency needs to make science-based safety and enforcement decisions. FDA will pursue a transparent, predictable and consistent strategy, fully described in the Strategy document.

Q: What is a "new dietary ingredient?"

A: A "new dietary ingredient" is a dietary ingredient that was not marketed in the United States before October 15, 1994. The act requires dietary supplement manufacturers to submit a premarket safety notification for certain new dietary ingredients (specifically, any new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered). One of today's announced initiatives, the public meeting on new dietary ingredient issues, is intended to result in clarification of when an ingredient in a dietary supplement is a "new dietary ingredient" that requires a pre-market notification to FDA and what information should be included in the notification.

Q: When must a manufacturer notify FDA about an NDI?

A: If a dietary ingredient is a new dietary ingredient for which a notification is required, the firm must make the submission 75 days before marketing its product.

Q: Has FDA received a new dietary ingredient safety notification for all dietary supplements that require such a notification before marketing? What will FDA do about dietary supplements already on the market that don't meet this requirement?

A: FDA believes that there are some dietary supplements that have been marketed without complying with the new dietary ingredient safety notification requirement. FDA will continue to take enforcement action against dietary supplements that do not meet the requirements of the Federal Food, Drug, and Cosmetic Act. With respect to dietary supplements that contain new dietary ingredients, the agency intends to focus on those new dietary ingredients that present significant safety concerns.

Q: What current steps is FDA taking to fully implement the "new dietary ingredient" provision of DSHEA?

A: FDA is taking three steps to help ensure that dietary supplements that contain new dietary ingredients are not adulterated:

1. convene a public meeting to obtain comment on issues pertaining to new dietary ingredients, including what information should be included in new dietary ingredient notifications;
2. bring enforcement actions against marketed dietary supplements that contain new dietary ingredients for which a required notification has not been submitted; and
3. bring enforcement actions against marketed dietary supplements that contain a new dietary ingredient and are adulterated because there is no history of use or other evidence of safety establishing that the dietary ingredient will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement.

Q: Has FDA taken any enforcement actions before this strategy was announced?

A: As part of its routine surveillance and investigative activities, FDA has taken a number of enforcement actions. For example: after determining that androstenedione-containing products sold as dietary supplements posed significant health risks and lacked new dietary ingredient notifications, FDA sent warning letters to 23 companies in March 2004 asking them to cease distributing these products and warning them that they could face further enforcement actions if they did not take appropriate measures.

Q: What about those dietary supplements that don't contain a "new dietary ingredient?" Can I assume those products are safe?

A: As part of the strategy, FDA is taking five steps to help ensure that dietary ingredients marketed before October 15, 1994 do not pose a significant or unreasonable risk to consumers:

1. improve the evidentiary base for safety and enforcement decision-making;
2. implement a transparent and systematic process for evaluating safety concerns about dietary ingredients and dietary supplements;
3. use the FDA website as an information resource for consumers and conduct other outreach efforts to give consumers access to reliable scientific information about the safety of specific dietary ingredients and dietary supplements;
4. educate consumers and health care providers on how to report to FDA adverse events or other product complaints; and
5. encourage manufacturers, marketers, and distributors of dietary supplements to report adverse events associated with use of their products.

Q: How does FDA learn of unsafe dietary supplements?

A: FDA receives information about the safety of dietary supplements from a variety of sources, including the agency‘s federal, state and local counterparts; adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts.

Q: What does FDA do when concerns about the safety of dietary supplements are brought to its attention?

A: The process begins with "signal detection" or identifying an issue of concern. FDA will determine when the quality or quantity of these signals raises a reasonable concern that health problems may result from ingestion of a dietary ingredient or dietary supplement. FDA may then seek an independent expert third party review and evaluation of the risks and benefits of the ingredient or supplement. FDA intends to consider any independent report and other evidence, as appropriate, to determine whether there exists an adequate basis for a finding of significant or unreasonable risk, or whether additional research, labeling or outreach efforts are needed.

Q: What factors lead FDA to conclude that a dietary supplement may be unsafe?

A: FDA makes its safety evaluations based on the totality of the scientific evidence available, including the pharmacology of the substance, scientific literature, adverse event reports, and evidence-based reviews.

Q: What assurances does FDA have that dietary supplement manufacturers produce quality products?

A: DSHEA gives FDA the authority to issue current good manufacturing practice (cGMP) regulations for dietary supplements. These regulations will help ensure that dietary supplements (and dietary ingredients) are of high quality, do not contain contaminants or impurities, and are labeled to accurately reflect the ingredients in the product.

On March 13, 2003, FDA published a proposed rule on cGMP for dietary supplements. This proposed rule would help prevent superpotent and subpotent products, wrong ingredients in dietary supplements, the presence of contaminants (e.g., bacteria, pesticide, glass, and lead), under-filled containers, foreign material in a dietary supplement container, improper packaging, and mislabeling.

Q: What is the status of the proposed rule?

A: FDA staff are currently reviewing and evaluating the more than 1,600 pages of comments on the proposed rule. Publication of a cGMP final rule is one of the agency's highest priorities.

Q: Why is FDA concerned about the labeling of dietary supplements?

A: Consumers purchase dietary supplements to improve their appearance, promote general health, or help them maintain a healthier lifestyle. If dietary supplement labeling contains false or misleading information, consumers can fall victim to products that cheat them out of their money or persuade them to make unhealthy or even unsafe choices.

Q: Aren't dietary supplements allowed to make some claims?

A: Yes. DSHEA provides for the use of claims about the effects of a dietary supplement on the structure or function of the body (e.g., fiber maintains bowel regularity), claims of general well-being from consumption of a dietary ingredient (e.g., product X promotes health and wellness), and claims of benefits related to classical nutrient deficiency diseases (e.g., a claim about vitamin C and scurvy). These kinds of claims may be made without premarket review or authorization from FDA, although a postmarket notification is required.

Authorized nutrient content claims and health claims may be made in dietary supplement labeling if the product qualifies to bear the claim. Nutrient content claims characterize the level of a nutrient in a food (e.g., "high in fiber"). Health claims describe the role of a food substance in reducing the risk of a disease (e.g., "Adequate folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord birth defect. ").

Claims that a dietary supplement is useful in diagnosing, mitigating, treating or curing a specific disease or class of diseases are drug claims, not health claims. Products sold as dietary supplements that bear such disease claims are subject to regulation as drugs.

Q: Why is FDA concerned about structure/function claims?

A: FDA is concerned about unsubstantiated structure/function claims because such claims are not only unlawful but can lead consumers to buy dietary supplements that do not do what they claim to do.

Q: What steps is FDA planning to take regarding unsubstantiated dietary supplement labels?

A: FDA intends to undertake five actions to help ensure that dietary supplement labeling is truthful and non-misleading:

1. FDA will continue to identify and take action against dietary supplements making claims that are not supported by scientific evidence.
2. FDA intends to develop and publish a draft guidance addressing what constitutes adequate scientific substantiation for structure/function claims and claims of a benefit related to a nutrient deficiency disease. This draft guidance document is intended to describe the amount, type, and quality of evidence a manufacturer should have to substantiate claims of these types.
3. FDA plans to identify and take enforcement action against products whose labeling fails to reveal material facts, targeting those products that pose the greatest risks to consumers.
4. FDA intends to obtain and analyze samples of dietary supplements in the marketplace to verify that the contents are consistent with the labeling.
5. As a routine part of FDA's surveillance, investigative and other regulatory activities, FDA will review Supplement Facts panels on dietary supplement labels to determine whether the substances listed as dietary ingredients can be lawfully marketed in dietary supplements.

Q: What is the purpose of the meeting?

A: FDA will hold a public meeting on FDA's premarket notification program for new dietary ingredients. The agency is soliciting comments concerning the type, quantity, and quality of information that a firm should provide in notifications.

Q: When will FDA hold this meeting?

A: The public meeting will be held on November 15, 2004, from 9:00 a.m. to 5:00 p.m. at FDA's Center for Food Safety and Applied Nutrition, Harvey W. Wiley Building.

Q: Does FDA believe the current regulations are not sufficient?

A: No, but FDA has identified a number of omissions and other problems in previous new dietary ingredient notifications. These problems suggest that it may be helpful for FDA to consider ways to assist firms that submit new dietary ingredient notifications to ensure that these notifications contain the information the agency needs to evaluate them.

There is also recognition by the regulated industry that the quality of new dietary ingredient notifications could benefit from FDA clarification of the statutory requirements.

Q: What kind of problems is FDA seeing in the notifications?

A: Omissions include a failure to:

• adequately describe the identity and composition of the new dietary ingredient;
• provide information that states the basis for a conclusion that the substance is a new dietary ingredient;
• provide adequate safety information about the new dietary ingredient; or
• provide other necessary information.

Q: What information is FDA seeking at this meeting?

A: At this public meeting, FDA is posing a number of questions in order to get information and views on new dietary ingredient notifications. These questions are discussed in the meeting notice.

Q: What will FDA do with the information it gathers from this meeting?

A: FDA intends to give careful and thoughtful consideration to the comments and recommendations made at the meeting, as well as to comments made to the docket. The agency will use the information in determining what next steps are appropriate.