Legislation

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.

Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.

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.

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.

Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.

The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”

Lawmakers in IL, MA and NJ as well as MI consider proposals as firms marketing weight loss and bodybuilding supplements in New York already are subject to first-ever state law limiting sales of products to consumers 18 and older.

Regardless of THC level and even though the US hemp product marketplace is growing, FDA regulations prohibit the botanical’s use as a dietary ingredient or food additive because it’s been studied or approved for use as a drug in the US.

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

Provision supported by Sen. Mitch McConnell, R-KY, along with House Appropriations Committee chair Andy Harris, R-MD, tightens definition of lawful hemp to exclude any THC derivative from cannabis at more than 0.3% concentration by dry weight and specifically exclude synthetics.

But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.