Enforcement

During Trump’s second administration and with Republican majorities currently in both chambers of Congress, FDA may find even less support than it traditionally has for appeals for additional resources to improve compliance with the NDIN requirement. Likewise for FDA request mandatory product listing requirement for supplements available to US consumers.

“We've heard perhaps some kind of support for non-drug approaches to addressing a range of conditions,” says food and drug regulation attorney Jessica O’Connell. “For the first time in the nearly 80 years of HHS, we will have a secretary who actually sees our commodity is valuable and not just some nuisance they have to deal with,” says NPA CEO Daneil Fabricant.

NAD attorneys find Oral Essentials’ scanning electron microscopy study with extracted teeth “was not a good fit” as “enamel safe” claim “reasonably conveys a message that regular daily use of the product will have no negative impact on enamel at all or at any time.”

“We have made significant strides in finding new ways to return money to consumers, but a fix to our 13(b) authority is badly needed,” says Sam Levine.

Supplement and food product firms have until January 2027 and oral drug product firms have until a year later to stop using Red No. 3, FDA decides in approving 2022 petition filed by public health advocacy groups.

FTC seeks comment on three proposals to “strengthen the agency’s tools to curb deceptive earnings claims in industries where they are pervasive: multi-level marketing programs and money-making opportunities.” However, Republican members say they’ll reconsider the proposals as a majority after Trump takes office.

Final guidance on communicating scientific information on unapproved uses (SIUU) allows firm-generated presentations to be based on sources other than reprints, but says communications based on nonscientific content are not protected from enforcement.

National Advertising Division found multiple faults with Oral Essentials’ evidence for claim, including that an in vitro study the firm conducted on “mouse cells is not dispositive of whether the same product would have any adverse effects on humans under real world conditions.”

The compounding industry ties for Martin Makary, President-elect Trump’s candidate to lead the FDA, could mean less compounding enforcement, experts said, but government officials said their enforcement focus will remain nonpartisan.

Vitamin, mineral and supplement products “may bear nutrient content claims, including ‘healthy,’’ if they meet structure/function claim criteria “without being subject to the requirements of the ‘healthy nutrient content claim” stated in the final rule FDA published recently.