This week, the FDA and other federal health agencies have come under increased public and political attention following several key developments. From expert panel controversies to a push for a national definition of ultra-processed foods, recent headlines reflect the shifting landscape of U.S. regulatory policy.
Concerns Over FDA Expert Panel Transparency
A series of recent expert panel meetings hosted by the FDA has drawn criticism from media outlets and policy experts. Unlike traditional advisory committees, these panels are not subject to the same transparency requirements regarding member selection, briefing documentation, or opportunities for public input.
STAT News and Medpage Today highlighted that several recent panels, including those examining the use of antidepressants during pregnancy and fluoride safety, lacked representation from opposing viewpoints. Some experts alleged that panelists were selectively chosen, raising concerns about scientific bias and procedural fairness.
During the July 23 panel on oral fluoride supplements, discussion echoed Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.’s public stance against water fluoridation. Kennedy has previously stated that fluoride exposure may lower intelligence, a position not widely supported by mainstream scientific evidence.
Legislation to Increase Committee Transparency
In response to growing concerns, Senators Gary Peters (D-MI) and Bill Cassidy (R-LA) have reintroduced legislation aimed at increasing transparency around federal advisory committees. The proposed bill would codify the General Services Administration’s collection of committee data and require it to be published online for public review.
HHS and USDA Request Feedback on Ultra-Processed Foods
HHS, FDA, and the U.S. Department of Agriculture (USDA) jointly issued a request for information (RFI) seeking public input on how to define “ultra-processed foods.” A standardized definition would support more consistent research and policy development in nutrition and labeling. The agencies emphasize the importance of collaboration with industry and the scientific community in creating a practical and evidence-based definition.
Staff Reinstatements and New Approaches to Policy
FDA Commissioner Marty Makary stated in a Politico interview that approximately one-quarter of staff laid off during the Trump administration’s reduction-in-force initiative have now been reinstated. He confirmed there are no current plans for further staff reductions and expressed confidence in the agency’s ability to maintain operations.
Makary, along with CDC Director Mehmet Oz, also authored an op-ed in The Wall Street Journal defending their approach of working with industry to voluntarily adopt public health measures rather than relying solely on formal rulemaking.
Technology, Drug, and Device Updates
Artificial Intelligence:
CNN reported that the FDA’s AI assistant, Elsa, is currently limited in function. It can help draft meeting notes and emails but is not capable of performing regulatory review tasks or accessing premarket submission data. The tool has also shown a tendency to generate inaccurate or misleading information.
Digital Health:
Sonja Fulmer, acting director of the FDA’s Digital Health Center of Excellence, is stepping down. Fulmer has been with the agency for over a decade and had been serving in the role since January.
Drug Developments:
- Bayer’s menopause drug, elinzanetant (Lynkuet), is facing a 90-day review extension by the FDA.
- Sarepta Therapeutics must conduct a new s afety study for its Duchenne muscular dystrophy treatment Elevidys following reports of patient deaths.
Medical Device Recalls:
- Maquet Critical Care issued a Class I recall for Servo Ventilator Systems due to incorrect tidal volume delivery in neonatal patients.
- Ethicon Endo-Surgery recalled certain Endopath Echelon staplers that may lock during surgery.
- FDA rescheduled its General and Plastic Surgery Devices Panel meeting for August 13 to evaluate new indications for dermal fillers.
At EMMA International, we help clients stay current on regulatory developments, whether navigating complex FDA processes, managing product recalls, or adapting to new food and drug policy shifts. Our team offers strategic guidance and compliance support tailored to your organization’s needs.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
Al-Faruque, F. (2025, July 25). This Week at FDA: Expert panels draw criticism, HHS seeks to define ultra-processed foods. Regulatory News.
