The letter, which was dated Dec. 12, 2017, was addressed to FDA Commissioner Scott Gottlieb, MD, seeking clarification on FDA’s enforcement priorities and projections. It specifically asks what that picture looks like now that the division within FDA responsible for dietary supplements has been elevated in status. The letter was signed by Rep. Andy Harris, MD (R-MD), Rep. Derek Kilmer (D-WA) and Rep. David Young (R-IA).
Office status meant to improve access to resources
In mid-December 2015 the then-Division of Dietary Supplements Programs was elevated to the status of an Office within the overall structure of FDA. To the layperson this might seem to be bureaucratic mumbo jumbo of little import, but when the action was taken almost exactly two years ago it was expected to have a real impact beyond the creation of a more impressive letterhead.
According to an FDA statement issued at that time, elevating the division was expected to raise the profile of dietary supplements within the agency, and was expected to enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources. The dietary supplement program was created more than 20 years ago, during which time the industry has grown from about $6 billion in sales to more than $35 billion.
The letter notes that FDA has reported that it conducts about 500 inspections of dietary supplement facilities a year and issues 70 to 80 warning letters. The representatives applauded FDA’s cooperations with the Department of Justice in removing illegal products from the market.
“To better understand FDA’s priorities in this area, we respectfully request you provide us with your assessment to the most significant threats to public health related to products marketed as dietary supplements and how you would deploy additional resources if Congress were to allocate increase funding to the Office of Dietary Supplement Programs (ODSP),” the representatives wrote. They also requested projections of how many GMP inspections FDA was planning to do in the coming year and how many employees (or Full Time Equivalents, also knowns as FTEs) would be devoted to this effort. They also requested a rundown of the number of adverse event reports FDA has received and a tally of the funds devoted to these efforts since the creation of the ODSP two years ago.
Committee members educated on funding needs
Mike Greene, senior vice president of regulatory affairs for CRN, said the letter is significant in that it is the first of its type that has specifically addressed what (if anything) has changed in the enforcement picture since the creation of ODSP.
“CRN has worked in partnership with the Pew Charitable Trust in meeting with members of the House and Senate Appropriations Committees to ask for more money for FDA enforcement. What we hope to do is to build a record for the need for more funding,” Greene told NutraIngredients-USA. (Reps. Harris, Kilmer and Young all sit on the House committee.)
“I think the letter is a great indication that Congress listened to what we had to say,” he said.
The industry has repeatedly called for more funding for FDA over the years so that the agency can fulfill all of its many missions. These calls have become more strident now that the agency has broad new responsibilities under the Food Safety Modernization Act. Whether the letter sent last week and FDA’s response to it will have much of an effect on that picture remains to be seen, Greene said.
“It’s a tough budget year, with cutbacks across the board. But FDA is mandated to respond to a letter like this, so we’ll see what they come back with within about two months,” Greene said.