Enforcement

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.

NAD says Amazentis didn’t substantiate cellular performance and muscle function claims for its supplements containing proprietary ingredient Mitropure but provided “a sufficiently reliable and reasonable basis” for “clinically proven to revitalize mitochondria.”

After National Advertising Division attorneys, in a review prompted by a challenge by Band-Aid line marketer Kenvue, recommended ASO LLV cease use of its “up to 2x faster healing” claim, they determined the firm had not fully complied.

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.