This May, the food and drug law community gathered at an annual conference hosted by the Food and Drug Law Institute (“FDLI”) in Washington DC. The agenda featured speakers across the agency, including former Commissioner Makary, current Acting FDA Commissioner Kyle Diamantas, Grace Graham, Sara Brenner, FDA Chief Counsel Sean R. Keveney and leaders from across the private sector. These speakers shared important insights into agency enforcement priorities and policies, which are summarized below.
Human Foods
The topic on the human foods program was led by Kyle Diamantas, who was then FDA’s Director of Human Foods. During the session, he highlighted the success of the transition to splitting animal and human food into two different specialized categories to allow more targeted support. Another success included the agency’s recent testing of infant formula in the US, which found the United States supply to be safe.
The Make America Healthy Again (“MAHA”) movement has also led, from the agency’s perspective, companies to increasingly review data of customer demands, removing more additives from major brands, and overall increasing awareness and customer transparency. The session did acknowledge that such changes affect supply chains, and such risks will have to be managed moving forward. Other priorities noted include continued efforts to introduce front of package labeling, working toward microbiological food safety, and coordinating with other countries to more effectively test food prior to entering the country.
The agency at the time was unable to provide substantive details on the pending GRAS and ultra-processed food rulemakings but generally acknowledged the difficulties involved in defining exactly what constitutes an ultra-processed food in light of dietary guidelines. There was another breakout session dedicated to GRAS compliance as a whole, where speakers from law firms, industry, and consultant groups walked through the current requirements, landscape of industry self-GRAS, the GRAS loophole, and thoughts on the forthcoming GRAS rulemaking.
The lively discussion highlighted the passion behind GRAS reform, both from proponents of the stability of the existing system for industry and from proponents seeking more dynamic change with public input and more constraints on self-GRAS. Speakers expressed concern that, without a clear federal directive, states are seeking to fill the void with GRAS-like legislation tracking elements in food. The example noted was New York’s pending “Food Safety and Chemical Disclosure Act,” which most recently passed the Senate and Assembly and is heading to the Governor’s desk Another clear theme that emerged was a need for more post-market review/assessment of food ingredients and the need for the resulting rulemaking to encourage innovation.
Medical Devices
A key topic that attracted a large group of attendees was a session on wearables and how far to push the limits on a “wellness” device before it risks being classified as a medical device. See our previous blog post on this topic that delves into the detail of the guidance. The speakers, including general counsel from industry, walked through the most recent guidance including FDA’s “General Wellness: Policy for Low Risk Devices” and “Clinical Decision Support Software” (both published in 2026). The general wellness guidance aligns with the Secretary of the Department of Health and Human Services advocation for wearable health devices. General themes of the General Wellness guidance include if devices are non-invasive, intended to support general wellness, do not provide a diagnosis or direct health outcomes (i.e., fall within the definition of a medical device), and include limited alerts (such as suggesting one consult with their doctor or increase activity), then the product will be regulated as wellness versus a medical device. On the Clinical Decision Support end, if devices meet all of four criteria and do not affect the clinician’s ultimate judgment, then such clinical decision support will not be regulated as a medical device. From the speakers’ perspective, there may be opportunities for guidance to become more refined as artificial intelligence and device capability expands.
Enforcement Trends
FDA Chief Counsel Sean Keveny spoke on multiple topics across the various FDA centers. Some key highlights include the following:
- Agency successes include rapid responses to the screwworm parasite threatening livestock (resulting in first Emergency Use Authorization for an animal drug); warning letters to retailers for failure to adequately remove infant formula during the recent botulism outbreak; and the quick response to radioactive shrimp due to the identification of cesium-137 (representing a novel use of the Import Certification Authority).
- Recent FDA warning letters have targeted unsafe compounded drugs, 7-OH, and misbranded medical devices such as illegally modified CPAP machines.
- Industry needs to be prepared in advance with recall plans and clear resources in place prior to a recall happening. The speakers on the panel see too often scenarios where the plans are being improved after a recall happens. Mock recalls are an effective tool to improve your preparedness ahead of time.
- FDA quality management system regulations for medical devices are now harmonized with ISO 13485. Industry must be prepared and accountable to develop procedures appropriately. If not, you are at risk of the agency and plaintiffs lawyers reviewing to determine if you implemented changes, how, and when. FDA has also developed a new inspection process.
Inspection Trends
FDA is currently exploring ways to utilize artificial intelligence to speed time for inspections, particularly for low-risk facilities. Specifically, the agency is launching a pilot across FDA to identify low-risk sites for one-day inspections. The risk factors under consideration include “product type, prior inspection outcomes, and operational characteristics.” The agency will reserve the right to conduct more in-depth inspections if warranted, but the action is seen as a move to reduce burden on both the agency and industry.
Clinical Research
Former Commissioner Makary highlighted challenges FDA faces in maintaining the quality and rigor of clinical trials in the United States while also keeping pace with international efforts not subject to the same level of requirements. A key example noted during the conference was China, which has up to four times the amount of clinical trials ongoing compared to the United States. The agency is exploring ways to streamline the process without sacrificing quality, such as streamlining the IND/Phase 1 process, encouraging Institutional Review Boards (“IRBs”) to be more efficient, and evaluating if any requirements that do not relate specifically to safety are causing bottlenecks. One step in the near future will be to publish a list of information that is explicitly not required when submitting INDs, as the agency indicated it often receives more information and data than is actually required under law.
Grace Graham later described this as a process with two priorities: (1) Making sure foreign clinical trials are following Good Clinical Practices with human protection in place and (2) Modernizing the United States’ own system of clinical trials in a post-pandemic landscape. Additional considerations may include pursuing additional inspections for foreign trials, conducting remote regulatory assessments, and/or expanding mutual recognition agreements or entering into new ones.
Artificial Intelligence
The use of artificial intelligence is spreading across the agency, and not only for the low-risk inspections mentioned above. Using its own internal AI platform, leaders from the agency mentioned it is being used to lead efficiency in administrative work, review and summarize comments received during the rulemaking process, facilitate more rapid peer-reviewed publications, and more. AI regulations are in a very early stage of development, and the Center for Devices and Radiological Health is the regulator behind those efforts.
If you have any questions, please feel free to reach out to the authors of this post. We would be glad to discuss the conference and learn more about how to customize these updates to your specific products and needs. Continue to watch this space for more updates as the agency continues to be in a period of dynamic change.