As the World Cup has captured the attention of viewers around the globe, so has the Food and Drug Administration (FDA) when it comes to taking enforcement action against regulated companies around the globe.
We are at the midpoint of 2026, and several patterns are emerging based on FDA’s activity so far. Based on our own weekly tracking and analysis, we are sharing some of the key themes that have bubbled up as priorities for regulated industries and their stakeholders to watch as 2026 progresses.
Top Trend: Online GLP-1 Marketing
It should come as no surprise that we kick off this summary with FDA’s sustained crackdown on the marketing and compounding of GLP-1s, specifically semaglutide and tirzepatide, by telehealth companies and other online sellers. In September 2025, FDA announced the intent to target misleading direct-to-consumer (DTC) pharmaceutical advertisements and issued its first wave of letters to telehealth companies for unlawful sale of unapproved and misbranded drugs online. By early March 2026, FDA’s Center for Drug Evaluation and Research (CDER) had issued an additional 30 warning letters, and a third tranche of 25 letters followed in mid-June 2026. The agency states that these companies made false or misleading claims about compounded semaglutide and tirzepatide, including suggestions that the products were FDA-approved, clinically proven, or equivalent to branded reference products. Across all of these letters, common concerns included: implying FDA approval of a compounded product; claiming the product has the same active ingredient as branded FDA-approved drugs in a manner that suggests equivalence; and obscuring which entity is actually doing the compounding.
The bottom line here is that if your business touches compounded GLP-1s in any capacity, FDA is scrutinizing every channel for misleading claims, even telehealth platforms (which may have historically considered themselves to be outside of FDA’s scope as health care professionals). Importantly, the volume and breadth of these letters signal sustained enforcement, not a one-time sweep.
CDER: cGMP Violations, DTC Claims, and Inadequate 483 Responses
Setting aside the avalanche of GLP-1 letters, CDER has still been the most active FDA center of the year to date, and the one issuing the most variety with respect to subject matter. A few of the standout trends are as follows:
Focusing on Foreign Manufacturers
In 2026, CDER has issued numerous letters to drug manufacturers in India, China, South Korea, Greece, Canada, and elsewhere around the world for “significant violations” of cGMP for finished pharmaceuticals. Recurring issues include inadequate quality units, insufficient lab controls, failure to investigate out-of-specification results, data integrity concerns, and inadequate responses to FDA’s Form 483 observations. Products from multiple facilities were placed on import alert as a result of FDA’s concerns. The lab controls and quality issues extend to vendors as well, as a few letters went to contract testing laboratories, including one outside of the U.S. that FDA found had systematically destroyed analytical records, backdated documents, and failed to investigate out-of-specification results, which potentially causes problems for any product sponsor that relied on this lab for product release testing.
Talk About Talc
More recently, in mid-June 2026, CDER issued nine letters to manufacturers of products containing talc, citing significant cGMP violations based on responses to FDA records requests. FDA’s concern was tied to the risk of products containing talc being subject to potential asbestos contamination. These letters spanned facilities across India, China, Japan, Turkey, Canada, the Dominican Republic, and the U.S., and serve as a signal that FDA is actively scrutinizing the talc supply chain.
Opioids, Benzos, and Botox, Oh My!
Several firms received letters in connection with online sale of unapproved and misbranded opioids, benzodiazepines, and other Schedule II stimulants, as well as injectable Botox. We also saw FDA issue its first letter to a med spa specific to Drug Supply Chain Security Act compliance, identifying the company as a “dispenser” of drug products. Med spas and related wellness companies also saw FDA call out some “skin lightening” products due to a concern over high levels of mercury. FDA seems to be focusing on this wellness industry more as the line between cosmetic and therapeutic claims gets blurrier.
Sweeping Social Media for Claims
CDER has issued numerous letters in 2026 to companies it found to be marketing unapproved new drugs based on reviews of their websites and social media. In one notable case, FDA even cited a podcast interview in which a company’s chief scientific officer made statements on a nationally syndicated show that FDA viewed as promotional in nature. More recently, and perhaps most striking, FDA issued 12 letters to companies (including a major online marketplace) selling products online with claims related to prostate health, erectile dysfunction, and urinary health, including in several cases anti-cancer and anti-inflammatory claims. The breadth of these letters makes clear that FDA is reviewing product claims across an expanding range of therapeutic categories, and that major online platforms and social media accounts are not beyond the agency’s reach.
411 on the 483 Response Problem
Across the vast majority of CDER letters this year, FDA expressly found the companies’ Form 483 responses to be inadequate. FDA is not just noting this in passing. Rather, FDA is itemizing what was missing and what the company must now address in response to the warning letters as a result. While it is not always clear how much of a chance the agency gives companies to respond before warning letters are issued, this appears to constitute a reminder that in CDER’s view a vague commitment to fix the problem will not suffice.
cGMP Consultant Recommendation
FDA’s recommendation for companies to engage a cGMP consultant, as well as sometimes a data integrity remediation consultant specifically, now appears in letter after letter with such regularity that it reads like a standard clause and, as such, should be taken seriously.
Recalls Do Not End All
In several letters where FDA found products adulterated and/or misbranded, FDA acknowledged the firm had voluntarily recalled its products but still issued a warning letter because other aspects of the company’s response to the agency’s concerns (e.g., the corrective action plan, supporting documentation) were found to be lacking. We view this as FDA implying that a recall is a starting point, not a resolution.
BIMO Busts
Clinical investigator letters from Bioresearch Monitoring Program (BIMO) inspections were a consistent theme, with FDA citing principal investigators in both the U.S. and abroad for protocol deviations, failure to obtain informed consent, and inadequate oversight of clinical trials. Notably, multiple letters in the spring arose from bioequivalence studies at different sites connected to the same sponsor, suggesting that when FDA identifies compliance problems at one site, it appears to look carefully at other sites under the same sponsor umbrella.
CBER: Stem Cells and Exosomes Remain on FDA’s Radar
FDA’s Center for Biologics Evaluation and Research (CBER) has issued fewer letters than CDER overall so far this year but continues its focus on unapproved stem cell therapies and regenerative medicine products. Multiple letters issued in 2026 have targeted companies marketing allogeneic stem cell products, particularly those derived from umbilical cord blood or Wharton’s Jelly, based on therapeutic claims on company websites. Several letters included specific warnings about exosome marketing, consistent with FDA’s longstanding public safety notice on this topic.
CDRH: Quality System Failures and a High-Profile Bassinet
FDA’s Center for Devices and Radiological Health (CDRH) was quieter than CDER in terms of volume in the first half of the year, which is a little surprising given the newly effective Quality Management System Regulation (QMSR) requirements, but CDRH still produced several letters worth noting:
Sleeping on Submissions
Arguably one of the most media-attention-grabbing device letters of the year so far goes to the manufacturer of a well-known smart bassinet and accompanying infant sleep sacks. FDA found the products adulterated and misbranded because the company had introduced two new sleep sack sizes, one for very small infants and one for larger infants, without authorization, constituting a change in intended use from the original De Novo approval. FDA also found the company’s “hospital bundle” to be a major modification because it extended the product’s use from a home-use device to a clinical setting, again without clearance. Putting the media hype aside, the letter serves as a practical reminder that even seemingly incremental product changes require regulatory evaluation before launch. APAP and CPAP ventilator devices, and accompanying software, also got FDA’s attention.
Quality System Violations
Other CDRH letters continued the familiar pattern of quality system violations, including failures in corrective and preventive action (CAPA) systems, complaint handling, medical device reporting (MDR), and corrections and removals. As companies operationalize QMSR requirements, the specificity in these letters about why 483 responses were found inadequate is useful reference material for inspection readiness planning.
Center for Veterinary Medicine: Cattle Deaths and a Fish Protection Campaign
FDA’s Center for Veterinary Medicine (CVM) appeared on the warning letter docket more frequently than usual this spring. One letter addressed a self-reported drug mix-up at a licensed medicated feed manufacturer that resulted in at least 16 cattle deaths. FDA also issued letters to multiple companies selling, via their websites, unapproved veterinary products for use in aquarium fish and pet birds, in what seems a concerted effort to assert regulatory authority over this corner of the online marketplace. FDA also found too much ampicillin in a dairy cow slaughtered to be used as food, with the company also holding animals in unsanitary conditions.
Human Foods Program and Office of Inspections and Investigations: FSVP, Seafood, and Supplements
Fumbling FSVP
The Foreign Supplier Verification Program (FSVP) continued to generate a steady stream of enforcement letters throughout the first half of 2026, with FDA’s Office of Inspections and Investigations (OII) issuing violations to importers of an eclectic range of products, from fresh produce to hoisin sauce, to basmati rice to matcha powder, with green tea on the side. The pattern is consistent, in that companies that fail to respond to 483s, or that provide responses lacking supporting documentation, are currently appearing to proceed directly to warning letter territory. One recent case involved a company whose 483 response consisted of a blank Excel template rather than actual data, a filing error that apparently still resulted in a warning letter, which raises its own questions, but underscores the point that a substantive, documented response is non-negotiable.
Dietary Supplement Subtleties
A significant number of HFP letters targeted dietary supplement companies for drug claims identified on websites and social media, ranging from neurological and cardiovascular claims to anti-viral and blood sugar regulation. In several cases, FDA found both drug claim violations and cGMP failures at the same facility, resulting in FDA deeming the company’s entire product line adulterated, not just the products with the most problematic claims. The examples cited in these letters are useful reference points for understanding exactly where FDA draws the line between a structure/function claim and a drug claim.
Seafood and Food Facility Sanitation
Seafood Hazard Analysis and Critical Control Point violations appeared regularly throughout the spring, and several food establishment letters cited Listeria or Salmonella Notably, FDA issued a letter to a national airline catering company for widespread Listeria contamination in ready-to-eat products and on food-contact surfaces, serving as a reminder that enforcement extends to non-traditional food service contexts.
Center for Tobacco Products: Same Old, Same Old
Nicotine pouch and electronic nicotine delivery systems (ENDS) product letters appeared in virtually every weekly posting throughout the first half of 2026. The message has not changed in FDA’s view, and selling these products online without marketing authorization will result in a warning letter.
The Bigger Picture
Based on FDA’s performance at this stage of the year, a few themes are worth carrying into the second half of 2026:
FDA Is Reading Your Digital Footprint
Websites, social media accounts, online shops and storefronts, and podcasts have all served as the evidentiary basis for warning letters this year. This is now a core enforcement methodology, not an exception.
How You Respond to a 483 Matters Enormously
The companies receiving warning letters in 2026 are largely the ones that responded to 483s with vague commitments, thin documentation, or extension requests. FDA has been explicit in the warning letters that it expects specificity, supporting documentation, and a credible corrective action plan. Above all, don’t ignore the FDA.
Watch the Leadership Transition
Commissioner Makary departed earlier this spring and has been succeeded, at least temporarily, by a regulatory attorney from private practice. Whether the intensity and priorities we have seen in the first half of the year continue, evolve, or shift under new leadership is an open question, and one worth monitoring as we continue through the year.
