Senators Durbin and Blumenthal request information on FDA’s proposed changes to ODSP

• By: AHPA
• On: 08/29/2023 14:40:03
• In: Regulation / Legislation

FDA's proposed reorganization to create a unified Human Foods Program includes relocating the Office of Dietary Supplement Programs and a new model for the Office for Regulatory Affairs

August 29, 2023

Last week, U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Richard Blumenthal (D-CT) sent a letter to the U.S. Food and Drug Administration (FDA) expressing concerns about proposed changes to the Office of Dietary Supplement Programs (ODSP) as part of the agency's proposed reorganization to create a unified Human Foods Program. The proposal includes relocating ODSP and a new model for the Office of Regulatory Affairs (ORA) in response to the Reagan-Udall Foundation's evaluation of and December 2022 report on FDA's Human Foods Program.

“ODSP is the lead office at FDA responsible for oversight of the $50 billion supplement market in the United States. With a little more than $13 million in funding, it sets strategic priorities, and ensures that limited resources are used in the best manner possible to protect the health and well-being of consumers. According to the June 27, 2023, announcement, ODSP will be merged into the ‘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,” wrote the senators.

In the letter, Senators Durbin and Blumenthal also posed several questions about the proposed changes to ODSP -- including how the proposed changes would lead to greater oversight and enforcement of dietary supplement regulations, what metrics would be used to evaluate the effectiveness of the new office in regulating dietary supplements, and if FDA would request dedicated funding for the regulation of dietary supplements or general funding for the Office of Food Chemical Safety, Dietary Supplements, and Innovation. The senators requested that FDA respond to their questions by Sept. 8, 2023.

“AHPA shares the concerns expressed by Senators Durbin and Blumenthal about the potential impact on the regulation of dietary supplements of placing ODSP within a larger office,” said American Herbal Products Association (AHPA) President Michael McGuffin. “We too have expressed our concerns to FDA directly, and we await with interest the agency's answers to the senators' discerning questions.”

The letter follows FDA's recent announcement of the selection of James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. In the new executive position, Jones would lead a unified Human Foods Program as part of the agency's proposed reorganization.

Last year, AHPA endorsed the Food Safety Administration Act of 2022 as introduced by Senator Durbin and Representative Rosa DeLauro (D-CT) in the 117^th Congress. The legislation sought to separate food from drugs, medical devices, and other products regulated by FDA, rename FDA as the Federal Drug Administration, and establish the Food Safety Administration as a new federal agency responsible for ensuring the safety of food, including dietary supplements, on the U.S. market.