CRN decries Califf’s anti-supplement comments

The Council for Responsible Nutrition (CRN) decried derogatory comments made by U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf during a recent meeting on Capitol Hill.

Califf: Supplements have little data backing benefits

In a webinar recording of the live and virtual National Institutes of Health (NIH)-FDA Nutrition Regulatory Science Workshop, Califf made the following statement:

“I hope this workshop will clarify in terms of what the research enterprise needs to deliver beyond ultra processed food, we also need a much more robust research agenda related to contaminants and nutrients in food and on the impact of different regulatory actions. It seems highly likely that dietary supplements, for example, will be a hot topic in the coming years, with over 100,000 supplements on the market and over $160 billion per year in sales. We have had a lot [KB1] of advertising and marketing, but very little evidence about what's beneficial, what's detrimental and what has no effect, except on the wallet. The premarket requirement for drugs and devices forces the industry's research engines to answer crucial questions. But no such authority exists for dietary supplements or for food. We need the public research engine to pick up steam and take these issues on.”

Related:NPA lawsuit, amended FDA petition could shape future of NMN in supplements

CRN: Califf mischaracterized regulatory and scientific underpinnings of industry

In a statement to the media, CRN said that Califf’s remarks represent “a fundamental misunderstanding of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the extensive scientific investment made by the industry. These remarks undermine billions of dollars spent on rigorous scientific research, clinical trials, and peer-reviewed studies that demonstrate the safety and efficacy of dietary supplements.

“DSHEA already provides the FDA with comprehensive regulatory oversight, including safety reviews of new ingredients, labeling requirements, good manufacturing practices [GMPs], adverse event reporting, and facility registration. Unlike pharmaceuticals, dietary supplements are not intended to treat or cure diseases and have decades of safe consumer use that highlight their exceptional safety profile. Drawing misguided comparisons between supplements and pharmaceuticals ignores their inherent differences and the balanced regulatory framework established by Congress,” the CRN statement added.

The organization asserted that Califf chose to ignore the significant body of research on dietary supplement effects which already exists.

Related:Uncovering DOJ’s ‘capacity’ in dietary supplement prosecutions: Gov’t transparency

Califf has revealed anti-supplement bent before

This is not the first time that Califf, a medical doctor with professional ties to Duke University, has voiced his skepticism of the dietary supplement industry. He was an invited speaker at CRN’s annual members gathering that took place this in early October at Dana Point, California. Califf laid out some context for his remarks on the dietary supplement industry by observing that many drugs — even though they are backed by multimillion-dollar research efforts — fail to demonstrate enough of an effect (or have too many side effects) to make it to market.

Recognizing the difficulty of establishing suitable biochemical pathways in the body for preventing or treating disease and finding substances to affect those pathways, Califf then went on to voice his deep-seated skepticism of what the labels on dietary supplements claim to offer.

“So, when I walk down the aisle, I see a lot of these structure/function claims, and I have no idea what they mean,” Califf said. “Maybe you understand it. You’ll have to explain it to me one day.”

CRN noted that it is anticipated that Califf will leave FDA after the new Trump administration takes office. The trade group said it hopes the new leadership will “embrace a balanced and informed approach to dietary supplement regulation.”

Related:Q4 2024 warning letter roundup with Asa Waldstein

The CRN statement added, “The industry calls on incoming leadership to recognize the scientific contributions of responsible companies, restore consumer confidence, and align with Congress’s vision of a robust and innovative marketplace that prioritizes safety and transparency.”