Compliance preferred to crackdowns, FDA’s dietary supplement chief Welch says

Helping to bring dietary supplement firms into compliance with FDA regulations is “a win for everyone,” and only when that option is unavailable or has been “exhausted” does the agency pivot to enforcement, a government official said last week at a two-day event hosted by the American Conference Institute (ACI) and Council for Responsible Nutrition (CRN).

Cara Welch, Ph.D., who oversees FDA’s Office of Dietary Supplement Programs (ODSP), said her agency’s enforcement priorities are focused on protecting public health. She also suggested FDA considers indirect impacts on her program, including the effects on other companies if FDA does not enforce against a firm violating the law.

She offered those comments in response to a question from CRN President and CEO Steve Mister, who asked her about the idea that FDA enforcement is too lax.

“FDA’s role ideally is to help firms come into compliance,” Welch said during the 12th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements. “That’s always going to be the better option. It’s cheaper. It is more efficient. If we can explain the rules, help folks come into compliance, that’s a win for everyone.”

But when FDA does see the need to enforce against firms violating the law, what is Welch’s role in that process? Using the example of products containing the erectile dysfunction drug sildenafil (Viagra) and being labeled as dietary supplements, Mister asked her whether she can pick up the phone and request that FDA’s Center for Drug Evaluation and Research initiate action and pressure the U.S. Department of Justice to get involved.

Related:DOJ faces ‘capacity’ litigating dietary supplement cases

“Do you have that kind of interaction with the agency or are you all siloed off from one another?” Mister asked.

Welch responded, “I am a squeaky wheel because that’s my job. I am the director of Dietary Supplement Programs and that is my focus, so if I am not constantly nagging at people and annoying people, then I’m not doing my job.”

On the other hand, Welch pointed out her office does not have authority to issue FDA warning letters and the agency faces limited resources. FDA enforcement actions involve collaboration between various parts of the agency, such as the Office of Regulatory Affairs, Office of Compliance and Office of Chief Counsel, as well as intervention from DOJ.

“I do nag folks about problematic products [and] problematic firms,” Welch said.

During the ACI-CRN conference, Justice Department trial lawyer Patrick Runkle noted his agency is “litigating supplement cases every day of the week, and so we are at capacity in terms of the amount of cases we can take.”

Runkle emphasized that bringing cases in the dietary supplement sphere is challenging and often involves “deep science,” underscoring the need for clarity.

Welch said her staff prepares memos in support of DOJ cases on such issues as: whether a substance meets the definition of a dietary supplement; is a new dietary ingredient (NDI); whether FDA has received a premarket notification for the NDI; and whether the ingredient is safe.

“Nothing goes forward without our absolute support,” she explained.

She also discussed recent approval of FDA's unified Human Foods Program under a sweeping reorganization, which will see her office fall under a larger super office known as the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI). The reorganization is expected to be implemented on Oct. 1, 2024, which coincides with a new fiscal year for the federal government.

Welch said her office’s “structure will look exactly the same” with no decrease in personnel. ODSP has 40 full-time employees, plus a few contractors or fellows, she reported.

She also addressed concerns from some industry stakeholders that FDA under the reorganization would improperly treat dietary supplements as food additives, in contravention of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

“We’re not looking to treat dietary ingredients in dietary supplements as food additives in foods,” she said, adding her office is “very aware” of its authorities.