FDA’s 2026 Enforcement Priorities: What In-House Counsel Must Know

The first half of 2026 has seen active U.S. Food and Drug Administration (FDA) enforcement across multiple regulatory domains.

For regulated companies, monitoring the FDA’s enforcement priorities is critical to compliance and audit readiness.

Megan Robertson, Member of the Firm, examines the FDA’s recent enforcement actions, identifies six trends in the agency’s regulatory approach, and offers practical guidance for in-house counsel.

Key Takeaways

• The FDA is monitoring websites, social media, podcasts, and online storefronts for marketing claims that may be inappropriate based on a company’s regulatory status.
• The most prominent trend is continued enforcement against online telehealth platforms offering compounded GLP-1s. Companies must clearly distinguish health care services from drugs being compounded and sold by pharmacies.
• The Center for Drug Evaluation and Research is actively enforcing current Good Manufacturing Practice compliance. Recalls alone do not satisfy the FDA’s remediation expectations; companies must demonstrate comprehensive, root-cause corrections.
• Food facilities face enforcement action for inadequate Foreign Supplier Verification Programs on imported products, including produce, rice, matcha powder, and green tea.
• Form 483 responses are receiving heightened FDA scrutiny. Medical device manufacturers should prepare for potential increased Quality Management System Regulation enforcement as the year progresses.
• These warning letters were issued under the former FDA commissioner. In-house counsel should monitor for potential shifts in enforcement priorities under new leadership as the year progresses.

For more information, contact Epstein Becker Green’s FDA Inspections and Enforcement group.

Transcript

[00:00:06] Megan Robertson: The most prominent trend coming from FDA's 2026 warning letters so far is the continued steady enforcement against online telehealth platforms that are holding themselves out as offering compounded GLP-1s. FDA's push here is for these companies to clean up their websites and marketing materials to make sure that the delineation of services provided by them as health care professionals is distinct from the drugs being compounded and sold by pharmacies. CDER has certainly been the most active center to date, not only with its GLP-1 letters to telehealth companies, but also with several letters to manufacturers, both domestic and foreign, citing CGMP concerns in a variety of contexts.

[00:00:57] Megan Robertson: We observed FDA cracking down on the adequacy of the firm's responses to the Form 483’s that were issued post-inspection. In particular, we note there are several instances where FDA acknowledges that the company has made efforts to recall their product or product lines, but that recalls alone are not the end of the remediation expectations by the agency.

[00:01:20] Megan Robertson: In addition, there continues to be a growing trend of FDA scouring the internet, including not only websites, but also social media posts, podcasts, and online storefronts to find different areas where companies may be making claims that in FDA's view are inappropriate based on the company's regulatory status.

[00:01:41] Megan Robertson: This includes, in particular, dietary supplements and the wellness industry, specifically as to where their claims cross the line into drug territory. Another fairly consistent issue cited by FDA so far this year is aimed at food facilities that fail to comply with the agency's expectations for maintaining a foreign supplier verification program with respect to imported foods.

[00:02:02] Megan Robertson: Everything from various fruits and veggies, rice, matcha powder to green tea, all sorts of products have been identified as being imported without proper adherence to the FSVP expectations. And last but not least, we thought we would have seen a lot more from CDRH this year given the newly effective QMSR that companies are expected to comply with as of earlier this year.

[00:02:28] Megan Robertson: But not much has come out so far. This, of course, might be due to how new the requirements are. So medical device manufacturers should still, of course, make sure that they have their ducks in a row when it comes to QMSR, but we didn't see as many warning letters coming out of CDRH as we would have thought.

[00:02:44] Megan Robertson: Based on what's publicly available, in 2026, the main takeaways from my perspective are, first, FDA is reading your digital footprint as a core enforcement method. Second, responding to Form 483s is always important, but details and thoroughness seem to be mattering more than ever right now. And number three, most of these warning letters were issued under the former FDA commissioner, so it'd be wise to keep an eye on how the trends may shift for the remainder of the year under new oversight.

About Thought Leaders in Health Law

The Thought Leaders in Health Law^® video series tracks the latest trends in multiple areas of the health care and life sciences industries, featuring attorneys and advisors from Epstein Becker Green and EBG Advisors. Part of the Epstein Becker Green Insights Network.

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