FDA budget request includes call for mandatory premarket product registration

More funding to deal with FSMA

The FDA portion of the budget request was detailed in a press release​​ on Tuesday from Commissioner Scott Gottlieb, MD. Gottlieb led the release with an emphasis on increasing funding for food safety programs to coincide with the agency’s new responsibilities under the Food Safety Modernization Act (FSMA).  Gottlieb said new technology, such as the use of Whole Genome Sequencing, could revolutionize how the agency responds to crises within the supply chain.

FSMA was implemented in part to deal with the increasingly globalized nature of the US food supply. That is true of the supply of dietary ingredients for dietary supplements, too.

“When the lack of transparency in supply chains delays the identification of contamination sources and the root causes of product problems, the economic and public health costs can be considerable. An enhanced ability to trace foods to source during an outbreak will also allow us to conduct better and more real-time root cause analysis to prevent similar reoccurrences,” ​Gottlieb wrote.

Request for mandatory product listing

Senior political advisors Tricia Knight and Peter Reinecke did a quick analysis of the budget request for United Natural Products Alliance members and supplied some of that to NutraIngredients-USA. Tops on their list of notable items in the request was FDA’s desire to have the authority to require companies to supply a list of the products they have on the market or are intending to bring to market.

“Under current law, FDA is not clearly authorized to require listing of individual dietary supplement products on the market, and the Agency has no convenient mechanism for compiling basic information about those products. This proposal would require all products marketed as ‘dietary supplements’ to be listed with FDA and give FDA authority to act against non-compliant products and the manufacturers and/or distributors of such products. This would allow FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, and improve transparency and promote risk-based regulation,” ​the FDA budget request reads.

Knight and Reinecke noted that FDA would need new statutory authority to require the product listing. But now that this proposal has moved from trial balloon to formal proposal, a new law is one step closer to reality.

“The request for language to support a new listing program makes it much more likely that action could occur on Capitol Hill.  As you recall, Commissioner Gottlieb mentioned it recently, but that was thought to be a trial balloon.  It is now an official Administration request,” the pair wrote in the member memo.

The UNPA analysis also notes that federal funding for dietary supplement research would decline by $500,000 in the coming fiscal year if Congress agrees to the cut.