Enforcement

NAD reports the populations of six of seven RCTs Olly referenced as evidence were key in substantiating claims for Lovin’ Libido ashwagandha supplement challenged by Bayer. Supplement industry, though, is challenging the FTC’s RCT standard for claims support.

FTC decision, says Bureau of Competition director Daniel Guarnera, influenced by both companies marketing different lines in different countries, limiting the number of similar products in the same categories the combined firm would offer.

The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.

P&G provided sufficient support for all challenged claims, including the “Gum Detoxify” brand used on the product label and in advertising on the website and in magazine detail pages.

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.’”

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.

Some changes the administration has proposed are a “great example of regulating by press release,” says Duffy MacKay, CHPA’s dietary supplements chief. But “after 30 years, the Dietary Supplement Health and Education Act could be modernized to serve the consumer better.”

“We've made some progress and really hope to see some movement as we move forward this year,” says FDA Office of Dietary Supplement Programs director Cara Welch.

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.