International

Urban Retreat didn’t cooperate with Direct Selling Self-Regulatory Council’s review or “indicate any intent to comply with” recommendations to discontinue claims for its Balance Capsules. LoveBiome responded sufficiently to merit a DSSRC recommendation to pull three health claims.

Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.

FDA’s proposed order follows its review of OMOR DSM-Firmenich submitted showing bemotrizinol, at concentrations up to 6%, is generally recognized as safe and effective and can be added as an active ingredient to sunscreen monograph.

FDA looks to Congress for authority to require registration for all supplements available for sale in US for public-facing product listing but no authority can produce list of dietary ingredients available pre-DSHEA.

Decision on vitafusion and L’il Critters business planned by end of year, but Piping Rock Health provided incentive for C&D to opt for divestiture.

CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.

After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.

The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.

Enforcements at facilities in Missouri operated by Shaman Botanicals and Relax Relief Rejuvenate Trading were preceded by administrative detention orders, FDA’s first use of the authority since its reorganization in October 2024.

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.

CRN’s attorneys ask Second Circuit for en banc review of a three-judge panel’s denial of its appeal of 2024 decision in district court rejecting motion for preliminary injunction against enforcement of New York state law age-restricting sales of weight loss and muscle building supplements.