By Ricardo Carvajal –
Among the myriad proposals to overhaul the nation’s ailing food safety system, at least one calls for splitting off FDA’s food safety programs and incorporating them into a new Food Safety Administration ("FSA") within the U.S. Department of Health and Human Services. That’s the tack taken in a report issued by the non-profit Trust for America’s Health titled “Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services.” The report appears to have been strongly influenced by a paper included as an appendix titled “Restructuring Food Safety at HHS: Design and Implementation.” That paper caught our eye because it was authored in part by Michael Taylor, formerly Deputy Commissioner for Policy at FDA, and now on faculty at the George Washington University School of Public Health.
Mr. Taylor’s paper raises 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. The paper acknowledges that dietary supplements “are categorized legally as foods and housed in CFSAN.” However, the paper appears to suggest that perhaps the dietary supplement program should be housed in the medical products agency because:
the supplement category includes not only vitamins, minerals and other clearly nutritional substances but also herbal products and others that are marketed and sought after for their drug-like effects. In fact, the issue of whether supplement claims cross the line to become, legally, drug claims is a recurring issue.
Similarly, with respect to cosmetics, that paper notes that “one of the recurring issues in cosmetic regulation is whether marketing claims and intended uses for some cosmetic products render them legally drugs.”
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.
It’s not difficult to imagine how the fate of the dietary supplement and cosmetics industries could depend on whether they’re housed in a new FSA or a medical products agency. As the paper acknowledges in a masterful bit of understatement, “[t]he issue is of great interest to the regulated industries and other stakeholders and thus requires careful consideration.”