The report, titled Regulation of Dietary Supplements: Background and Issues for Congress, was issued by the Congressional Research Service yesterday. The report, written by health policy analyst Agata Bodie, is an update of an earlier report written former CRS analyst Amalia Corby-Edwards.
The report lays out for members of Congress and committee staffs how supplements are regulated and some of the issues surrounding the industry. The report covered how claims are regulated, FDA’s enforcement of GMP provisions and serious adverse event reporting.
Mention of current issues
The report also covered some issues of current concern. Those included FDA’s use of use of the drug exclusionary clause to find that CBD is not a legal dietary ingredient. Another current issue mentioned in the report is the desire by FDA to have a mandatory product listing. In addition, the report touches on the use of GRAS status as a workaround for a New Dietary Ingredient Notification, which some observers have characterized as a loophole in the regulations.
Why this update was issued at this particular time is still to be determined, said Daniel Fabricant, PhD, president and CEO of the Natural Products Association.
“These reports are usually issued at the discretion of a committee or a particular member of Congress. We are trying to figure out why this happened now,” Fabricant told NutraIngredients-USA.
Fabricant said in NPA’s view much of what’s in the report appeared to have come direct from FDA itself. For instance, the portion on the about the limitations fo current legislation, the report says,“Among these limitations is that under the current statutory framework, while entities that manufacture, process, pack, or hold supplements must register with FDA, the agency is not authorized to require listing of individual dietary supplement products. As a result, the agency is not aware of all the products currently on the market. “