CHICAGO--How do dietary supplements differ from drugs, food additives, and food ingredients in classification and regulation? Are the safety and efficacy of supplements ensured? What are the differences between drug claims and health claims on supplement labels? What is required on the new "Supplement Facts" panel? What are the potential benefits and adverse effects of supplements? What do scientists know about drug-supplement interactions? The Institute of Food Technologists' (IFT's) Scientific Status Summary "Dietary Supplements: Nutritional and Legal Considerations" addresses these and other key questions, summarizing information to date on vitamins, minerals, amino acids, botanicals, and dietary hormones.
The Dietary Supplement Health and Education Act (DSHEA) of 1994 provides the regulatory framework for supplements. According to IFT's summary, published in the July 1999 issue of Food Technology, this act broadened the definition of supplements to include ingredients not recognized as traditional nutrients, such as botanicals and hormones.
"Prior to DSHEA, these ingredients could have been challenged by the FDA as unapproved food additives, [but they are now] exempt from additive regulations applicable to conventional foods," note summary authors Mary Ellen Camire, Ph.D., University of Maine, and Mark A. Kantor, Ph.D., University of Maryland.
Unlike drugs and additives, which must undergo rigorous scientific testing for safety and efficacy and FDA pre-market approval, supplements have no formal regulatory requirements prior to being marketed and sold. Although supplement manufacturers should ensure that their products are safe and be able to provide information to support any labeling claims, the FDA bears the burden of showing that a supplement is unsafe or mislabeled before it can restrict or ban the product's use, say Camire and Kantor.