June 16, 2001
Board Position on Dietary Supplements
The Association of Food and Drug Officials (AFDO) Board of Directors (hereinafter referred to as the Board) does not condone the sale of dietary supplements that are unsafe or deceptively advertised or labeled. The Board recommends that the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) consult with the industry to explain and clarify dietary supplement use, advertising, and labeling requirements and concerns. The Board further recommends that, after allowing a reasonable period for voluntary correction, fair, firm, and rapid regulatory action should be taken against unsafe or deceptively advertised or labeled dietary supplements. The operational objectives of this regulatory action would be to remove from the market unsafe or deceptively advertised or labeled dietary supplements and to deter future similar violations The ultimate goal of these enforcement actions would be to safeguard public health and consumer protection.
Dietary supplements can be dangerous if formulated with unsafe ingredients, if substituted for prescribed medications without medical consultation, or if taken in dosages so high that the effect of the pharmacologically active ingredients are toxic or cause undesirable side effects. In addition, the labeling or advertising for some dietary supplements ranges from deceptive to fraudulent because they claim uses or effects that are unsubstantiated or insufficiently supported by science.
In addition, there are many fraudulent practices used to market dietary supplements, and such practices, as well as many supplements themselves, pose significant concerns with respect to public health and safety. The Board also recognizes that the use of dietary supplements is a choice that many consumers want and should continue to have. Therefore, the Board believes that only through cooperative national and international action, involving both the regulatory community and regulated industry, can the problems associated with unsafe products and fraudulent practices used to market many supplements be controlled. Actions to identify and eliminate the use of fraudulent ads in the marketing of supplements and the sale of supplements which pose health and safety risks must be a high priority for the entire regulatory community and the industry alike.
The Board believes that uniform and rigorous enforcement of current laws and regulations to end unsafe and fraudulent practices associated with some dietary supplements would be beneficial to the U.S. consumer. AFDO urges its member state regulatory agencies to work closely with the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC) to target unsafe dietary supplement products and any dietary supplements that attract customers with unfounded claims. The Board also urges consumers to avoid dietary supplements that have ingredients that are not shown by scientific studies to be safe or dietary supplements that are represented to treat diseases and other serious health problems.
The Board also considers labeling a critical component to the safety and safe use of dietary supplements. AFDO has testified at numerous hearings about the importance of disclosing to consumers adequate information for safe use, especially the nature and effects of the pharmacologically active herbal products and ingredients. Therefore, the Board supports the mandatory label disclosure of: 1) the quantity of each pharmacologically active ingredient; 2) information regarding any side effects or adverse reactions; 3) contraindications to warn those consumers who may be adversely affected because of their age, existing health problems and risks posed if pregnant or nursing; 4) if there is a risk of adverse drug and dietary supplement interaction; and 5) cautionary language directing the consumer to seek health practitioner guidance if there are any health concerns present.
The Board has identified the following practices as the highest priority for regulatory agency action:
* Dietary supplements that contain ingredients that pose a health hazard when used as labeled or advertised.
* Products that are marketed as dietary supplements but represent that the products have the same effects as prescription drugs, are to be used instead of prescription drugs, or have no safety concerns because they are not drugs. The Board believes these products should be considered drugs that have not been shown to be safe and effective and pose a serious health threat if used in place of approved medical intervention.
* Formulating and marketing conventional foods utilizing herbs and other ingredients of unknown safety by claiming the products are dietary supplements; formulating and marketing conventional foods utilizing herbs and other ingredients which are not GRAS or approved food additives, by incorrectly marketing the products as dietary supplements in violation of FDA regulations.
* Marketing various concoctions as dietary supplements via the Internet, printed ads and "infomercials" that make unsubstantiated claims about their miraculous benefits such as diet-less weight loss, non-exercise muscle building and body toning, improved and heightened sexual function and rejuvenation and life extension that cannot be substantiated by scientific studies.
AFDO has formed a Dietary Supplement Workgroup with FDA and FTC to develop solutions to address the unsafe and fraudulent practices associated with some dietary supplements. AFDO, through its participation in the Workgroup, intends to promote dietary supplement industry cooperation and compliance by providing uniform information and enforcement guidance. AFDO in cooperation with FDA and FTC intends to provide dietary supplement information to consumers through various outreach programs. AFDO will provide direction to its members via comprehensive training and guidance documents that provide: 1) the scientific and legal support for the uniform application of dietary supplement laws and regulations; 2) a public health-based plan for enforcement priority; 3) information regarding laboratory resources available to analyze dietary supplements; and 4) a focus point for regulatory agency communication and information exchange. AFDO will also help coordinate member enforcement actions with FDA and FTC to reduce to a minimum any duplication of effort.
The Board recognizes that some dietary supplements pose public safety and fraud concerns that are not limited to domestic manufacturers. The U.S. public has direct access to dietary supplements and their claims via the mail and the Internet. The Board also recognizes that dietary supplements made with unsafe ingredients and/or utilizing unsupported claims are being exported from the U.S. The Board advocates international cooperation and changes in current regulatory enforcement policy to eliminate the illegal and unethical practices posed by some imported and exported dietary supplements.
