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Asked about the impact of FDA’s proposed reorganization of the human foods program on dietary supplements, FDA Commissioner Robert Califf responded, “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.”
January 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.”
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.
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.”
Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition
Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.
Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.
Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.
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