The Council for Responsible Nutrition, (CRN) Washington, D.C., reaffirmed its support of potential legislation that would mandate reporting of serious adverse events (AEs) for dietary supplements and over-the-counter (OTC) drugs to FDA in a position statement it released March 6th. Although many responsible dietary supplement manufacturers already voluntarily report any serious AEs associated with their products, CRN believes all companies should be required by law to report these events to the FDA.

CRN says than 150 million Americans take supplements and they deserve to choose from a wide variety of high quality, safe and effective products. For these reasons, the organization wants consumers to be reassured that if they call or write to a manufacturer about a serious health event they believe is associated with use of a dietary supplement, the company would notify FDA.

In actual fact, dietary supplement companies receive very few serious adverse event reports (AERs), which demonstrates the wide margins of safety for these products. But requiring manufacturers to report these relatively few incidents will demonstrate to FDA, the medical community and to consumers the safety of this class of FDA-regulated products. And while AEs only serve as a signal to FDA, rather than proof of causation between a product and the actual AE, they can be an important indicator that something may not be right.

By providing these early warning signals to a single source—the FDA—manufacturers increase the likelihood that trends indicating a problem will be identified more quickly, and fewer consumers will be affected. This is why CRN strongly supports the bipartisan efforts of Senators Orrin Hatch (R-UT), Tom Harkin (D-IA), Richard Durbin (D-IL), Mike Enzi (R-WY) and Ted Kennedy (D-MA) in the development of legislation that would mandate the reporting to FDA of serious AEs for dietary supplements and OTC products.

CRN also issued a position statement in support of the Food Stamp Vitamin and Mineral Improvement Act—S. 1546 in early March. This act is one that would amend the Food Stamp Act of 1977 to permit the recipients of food stamps the choice of using their benefits to purchase nutritional supplements in the same way they are free to make other dietary choices. Currently, food stamp recipients can use their benefits to purchase “any food or food product intended for human consumption,” regardless of nutritional value (i.e. junk food, sodas and candy), yet United States Department of Agriculture (USDA) policy prohibits the use of food stamps to purchase vitamin and mineral supplements whose specific function is to improve nutritional status.

Vitamin and mineral supplements are especially relevant and important to low-income individuals as a means to enhance nutrition, improve health, prevent disease, enhance quality of life, increase individual productivity and slow the increase in our nation’s rising healthcare costs. CRN feels the Food Stamp policy should facilitate and not impede the efforts of the nation’s poor to obtain all these valued health benefits. Repeated studies have shown that the poor and elderly are more likely than others to have insufficient and nutritionally inadequate diets. In fact, studies done by the USDA show that a very high proportion of women and children in lower income households fail to consume the recommended daily allowances of vitamins and minerals. CRN feels dietary supplements are a component of smart lifestyle choices, playing a key role in preventative healthcare and overall good health.