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Aug 18, 2023

FDA chief mum on impact of human foods reorg on dietary supplements

Josh Long | Jan 31, 2023 FDA on Tuesday announced a plan to transform

Josh Long | Jan 31, 2023

FDA on Tuesday announced a plan to transform organization of its human foods program, following the review of findings and recommendations from an external evaluation and a separate internal assessment of FDA's response to the infant formula crisis.

FDA Commissioner Robert Califf also revealed plans to transform the Office of Regulatory Affairs (ORA)—which oversees inspections of various commodities including food—to enable ORA "to be singularly focused on excellence in its core mission—inspections, laboratory testing, import and investigative operations."

Related: FDA top brass meet with dietary supplement trade groups to discuss human foods program

The sweeping proposal, which includes plans to appoint a single leader to oversee the "Human Foods Program," was announced in the wake of criticism from media, U.S. lawmakers and others over FDA's handling of the infant formula crisis and its responses to outbreaks of foodborne illness.

"The proposed structures for both groups will have clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment," Califf said in a Jan. 31 news release.

Related: Trade groups raise drug-spiked 'supplement' products in FDA meeting

FDA has envisioned unifying into a new group—called the Humans Foods Program—the functions of the Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR), as well as certain functions of ORA. A Deputy Commissioner for Human Foods, who will report directly to Califf and who FDA plans to hire through a national search, will oversee the human foods program.

"Creating a Human Foods Program under a single leader who reports directly to the commissioner unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way," Califf said.

How the reorganization will affect the cosmetics industry and roughly $60 billion-a-year market for dietary supplements remains to be seen. Asked about the issue during a call with media, Califf responded FDA is "really working on that now and we don't have anything new to say today."

However, he pointed out FDA recently secured new authorities for cosmetics that it had requested "for a long time to help that industry produce the highest quality products."

A bill signed late last year by President Joe Biden overhauls the regulatory framework for cosmetic products, including establishing requirements related to facility registration, safety substantiation, good manufacturing practices (GMPs) and adverse event reporting.

"And so now we have to figure out exactly where in the system [cosmetics] will fit," Califf said during the media call.

Referencing a quote by one of his colleagues—Principal Deputy Commissioner Janet Woodcock—Califf said, "I think 100% of people do agree that cosmetics are not food. We need to find the right home and we’re working on it under the guidance of" FDA Chief Science Officer Namandjé Bumpus.

"Dietary supplements [are] a whole different kettle [of] fish that we can discuss at a later time, but I assure you we’ll be working on that," the commissioner added.

Woodcock suggested during the call that cosmetics and dietary supplements weren't within FDA's requested scope of the Reagan-Udall Foundation report, which examined FDA's human foods program, "because obviously that was a very broad scope, but it isn't that we do not consider these issues. We do."

As Natural Products Insider previously reported, dietary supplement industry stakeholders met on Jan. 3 with Califf and Woodcock to discuss the Reagan-Udall Foundation report. Stakeholders also raised issues of concern to the industry, including the marketing of "tainted" or drug-spiked products, the CBD quandary facing the industry and inconsistencies in FDA inspections.

"The purpose or understanding [of the meeting] was basically to grease the skids on, ‘Hey, we’re just going to fold ODSP [FDA Office of Dietary Supplement Programs] into this reorg and you guys should be OK with that,’" Natural Products Association (NPA) President and CEO Dan Fabricant, who oversaw FDA's Division of Dietary Supplement Programs during part of the Obama administration, said in an interview earlier this month. "That was the purpose of the call. Make no mistake."

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