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Enforcement
Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.
Sales of Bioventra’s probiotic put inventory at “a critical low” as “parallel rise in unverified listings on third-party marketplaces prompted concern among” customers. DoJ and food and drug industry attorney say counterfeiting remains a problem in supplement sector.
It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.
National Advertising Division finds Magni Group didn’t support claims made on MagniLife Gel packaging, in direct-mail advertisements and online and in social media “Rapid Pain Relief.”
Kyle Diamantas was a partner with the Jones Day firm when he was tabbed as acting deputy commissioner to lead the FDA’s Human Foods Program, established in the agency’s reorganization which became effective in October.
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.