This blog summarized the Trust for America’s Health report, “Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services?” earlier.
More recently, Ricardo Carvajal published some insightful questions on the Blueprint and other proposals for a single Food Safety Administration (FSA). These proposal raise the “question of whether FDA’s dietary supplements and cosmetics programs should be housed in a new FSA or in the medical products agency that would remain once FDA’s food safety functions have been split off.”
Dietary supplements are defined as foods under the Food, Drug, and Cosmetic Act. Yet, the Blueprint appears to suggest that dietary supplements should be regulated by the medical products agency because they often are marketed for drug-like effects.
Ironically, the fear that FDA would regulate dietary supplement as drugs was a significant force behind passage of the Dietary Supplement and Health Education Act of 1994 (DSHEA). DSHEA was a significant rebuke to idea of treating dietary supplements like drugs.
Passing an statute to create a new Food Safety Administration is a monumental task. Hardly the time to exhume issues that Congress has already settled. This issue could kill the Blueprint’s chance of passage.
Mr. Carvajal notes,
It strikes us as curious that the decision of where to house the dietary supplement and cosmetics programs would be based to any degree on the fact that unlawful marketing claims might be made for those products (a problem that needs to be addressed through enforcement), or that some consumers might seek those products out for their “drug-like” effects (what is to become of coffee?). In any case, we thought that Congress had definitively settled the question as to how dietary supplements should be regulated – as food – and that nothing about the recent or current food safety crises suggests otherwise. As for cosmetics, their regulatory paradigm has long resembled the one for foods much more strongly than the one for drugs.
Read all of Ricardo Carvajal, “Would Dietary Supplements and Cosmetics Find a Home in a New Food Safety Administration?” here.