The first half of 2026 has seen active U.S. Food and Drug Administration enforcement activity spanning multiple regulatory domains affecting businesses across sectors.
Legal experts are urging in-house counsel to closely monitor the FDA’s shifting enforcement priorities to maintain compliance and ensure audit readiness.
Megan Robertson, Member of the Firm at Epstein Becker and Green, P.C., has identified six key trends in the agency’s current regulatory approach that businesses must understand.
One of the most significant trends is the FDA’s active surveillance of websites, social media platforms, podcasts, and online storefronts for marketing claims that may be inappropriate based on a company’s regulatory status.
The most prominent enforcement trend this year has been continued regulatory action against online telehealth platforms offering compounded GLP-1 medications to patients.
Companies operating in this space must clearly distinguish between health care services and drugs being compounded and sold directly by pharmacies to avoid regulatory exposure.
The Center for Drug Evaluation and Research is actively enforcing current Good Manufacturing Practice compliance, with the agency setting a high bar for remediation.
Crucially, recalls alone do not satisfy the FDA’s remediation expectations, and companies must demonstrate comprehensive, root-cause corrections to close out enforcement matters satisfactorily.
Food facilities are also facing enforcement action for inadequate Foreign Supplier Verification Programs on imported products, including items such as produce, rice, matcha powder, and green tea.
Form 483 responses are receiving heightened FDA scrutiny, and medical device manufacturers should prepare for potential increased Quality Management System Regulation enforcement as the year progresses.
Robertson also notes that the warning letters underpinning many of these trends were issued under the former FDA commissioner, adding another layer of complexity for regulated businesses.
In-house counsel are advised to monitor carefully for potential shifts in enforcement priorities under new leadership as the regulatory landscape continues to evolve throughout 2026.