Enforcement

“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.

Texas bill filed in advance of the state’s next legislative session starting in January while bills proposing prohibiting sales of supplements and OTC drugs for weight loss or bodybuilding to minors remain active in three states where current sessions continue, Massachusetts, Michigan and New Jersey.

GuruNanda appealing a National Advertising Division decision, following a review of a Procter & Gamble challenge, that it cease using a “natural teeth whitening” claim for its namesake brand pulling oil, mouthwash and gel pen.

Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.