| Resolution Year 2001 Resolution Number 10: Safety and Marketing of Dietary Supplements
Whereas, the utilization of dietary supplements is a choice that many consumers want and should continue to have, and
Whereas, dietary supplements can be very unsafe if formulated with unsafe ingredients, and
Whereas, some dietary supplements are advertised to be taken in place of prescribed medications or in dosages where the effect of the pharmacologically active ingredients are toxic or cause undesirable side affects, and
Whereas, some dietary supplements are marketed by the use of unsubstantiated and unscientific claims or by the use of fraudulent practices which pose significant concerns with respect to public health and safety, and
Whereas, the concerns regarding fraudulent practices and public health and safety are not limited to domestic manufacturers and marketers, and
Whereas, 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 dietary supplements be controlled, and
Whereas, uniform and rigorous enforcement of current laws and regulations to end unsafe and fraudulent practices associated with some dietary supplements is very beneficial to the U.S. Consumer, therefore be it
Resolved, that the Association of Food and Drug Officials (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 and fraudulent practices, and be it further
Resolved, that consumers are urged to refrain from buying and using dietary supplements that have ingredients that are not shown by scientific studies to be safe or are represented to treat disease and other serious health problems, and be it further
Resolved, that AFDO supports the mandatory dietary supplement 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) any risk of adverse drug and dietary supplement interaction; and 5) cautionary language to seek health practitioner guidance if there are health concerns present, and be it further
Resolved, that AFDO identifies the following dietary supplement ingredient formulation and sales practices necessitating the highest priority for regulatory agency action:
*Dietary supplements containing ingredients that pose a health hazard when used as labeled or advertised. *Products that are marketed as dietary supplements but are represented to have the same effects as prescription drugs or are to be used instead of prescription drugs and have no safety concerns because they are not drugs. *Formulation and marketing of 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, and be it further
Resolved, that AFDO will work with FDA and FTC to develop solutions to address the unsafe and fraudulent practices associated with some dietary supplements by:
*Promoting dietary supplement industry cooperation and compliance by providing uniform information and enforcement guidance. *Providing dietary supplement information to consumers through various outreach programs. *Providing direction to its members with 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. *Coordinating member enforcement actions with FDA and FTC to reduce to a minimum any duplication of effort.
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