Supply Chain

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.

FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”

Preliminary registration data released by FDA offers a first glimpse of the Modernization of Cosmetics Regulation Act’s impact on information the agency has at hand.

FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.

FDA testing of 95 benzoyl peroxide products due to concerns about elevated benzene detected by third-party testers found 90% with undetectable or extremely low benzene levels.

CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.

A week after announcing 2024 full-year and fourth-quarter results, the firm says its corporate name will be Niagen Bioscience Inc. starting 19 March. It stated in its latest results that during 2024 it launched Niagen Plus line of pharmaceutical-grade Niagen.

Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”

Indian CDMOs could consider collaborating with allies in Europe amid a focused effort via a new industry body to counter existing challenges like China’s manufacturing, regulatory and policy advantages and a shortage of funding and talent in the country even as talk of US tariffs throws a new spoke in the wheel