Consumer

Complaint filed Utah federal court says “Supreme Court explicitly rejected Chevron deference to agency interpretations” in the Loper decision, compelling rejection of “an agency’s statutory interpretation unless the court, ‘after applying all relevant interpretive tools, concludes’ the interpretatio

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

Health and wellness brands and retail chains providing access to prescriptions for compounded GLP-1 drugs, most also offering supplements curated to help meet dietary needs of GLP-1 patients, are offering formulations in oral form as well as injection.

Challenged advertising, which appeared in a TV commercial, in-store displays and advertising on social media, included express claims “It’s a better mouthwash. I guarantee it.” and “I guarantee it. – ‘Dr. Harold Katz.’”

In remarks at recent investor conference reflecting comments from across the US consumer health sector, Kenvue chief Thibaut Mongon says, “I'm going to state the obvious. The environment is very fluid.”

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

Along with two instructional videos, FDA provides fact sheet detailing common problems with NDINs while supplement industry awaits guidance on two hurdles for clearing the NDIN process, providing identity information and evidence of safety for ingredients.

Market growth and product innovations are continuing as FDA looks to Congress for authorization to establish regulatory pathway agency says it needs to determine whether to allow hemp-derived ingredients in food, dietary supplements and non-drug topicals including cosmetics.

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu