Congress concerned about FDA oversight of supplements under reorg

Congressional critics and supporters of the dietary supplements industry have now expressed concerns regarding proposed “tone deaf” changes to the Food and Drug Administration’s Office of Dietary Supplement Programs (ODSP), following an FDA’s announcement earlier this summer to reorganize its food programs, according to the CEO of an industry trade group.

In an Aug. 24 letter to the commissioner of FDA, Sen. Majority Whip Dick Durbin (D-Ill.) and Sen. Richard Blumenthal (D-Conn.) asked several questions to determine how the proposed changes will affect oversight and enforcement of the dietary supplement market.

In an update in late June on its proposal to create a unified Human Foods Program, FDA released an organization chart that proposed creating an Office of Food Chemical Safety, Dietary Supplements and Innovation.

“We are concerned that these changes could divert resources, funding and attention from the supplement market at a time when it is needed more than ever,” Durbin and Blumenthal wrote to FDA Commissioner Robert Califf. M.D.

The senators’ letter was addressed to Califf just days after Rep. Jeff Duncan (R-S.C.) raised similar concerns in a letter to the commissioner. Duncan described FDA’s reorganization as a “shortsighted” decision that could “lesson the agency’s focus on the dietary supplement industry.”

Related:Rep. Duncan says proposed reorg ‘could lessen’ FDA focus on supplements

An FDA spokesperson said the agency has received the letter from Durbin and Blumenthal and will respond directly to the senators.

FDA principally oversees the market for vitamins, minerals, probiotics and other natural products under the Dietary Supplement Health and Education Act of 1994 (DSHEA). However, FDA’s enforcement and oversight “has not kept pace, while the market has seen significant growth over the past 29 years,” according to Durbin and Blumenthal. They pointed out ODSP has a budget of about $13 million.

“In 1994, there were 4,000 dietary supplements marketed in the United States, compared to today where there are more than 95,000 supplements taken by adults and children,” Durbin and Blumenthal wrote to Califf. “FDA has documented instances in which some of these supplements have included illegal ingredients in violation of DSHEA.”

The senators requested FDA answer several questions about the impact of the proposed reorganization on supplements. Some of their inquiries asked about the number of full-time equivalents (FTEs) in the Office of Food Chemical Safety, Dietary Supplements and Innovation that will support the regulation of the supplement market; who will set the budget, goals and priorities for FDA’s dietary supplement activities; and whether FTEs in the office will be devoted to the supplement market or split their time between supplements and other markets, specifically food chemical safety and innovation.

Both congressional critics and supporters of industry have now both indicated that FDA’s proposed reorganization is not the right decision, according to Dan Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), who oversaw FDA’s supplement programs from 2011 until 2014.

He considers Duncan a champion of industry and Durbin and Blumenthal critics. Durbin and Sen. Mike Braun (R-Ind.) introduced the Dietary Supplement Listing Act of 2022, which proposed requiring manufacturers to list their dietary supplement products with FDA. (A comprehensive 2023 industry survey commissioned by Natural Products Insider and SupplySide found slightly more people favor mandatory product listing (MPL) than oppose it, with 21% of survey respondents undecided.)

Fabricant expressed hope that the letters to Califf from members of Congress would persuade FDA to retain ODSP as a standalone office and perhaps recognize that some of its “race to reorganize has been done in a tone-deaf manner, and better engagement with stakeholders is needed to ensure accountability going forward.”