For years, the commercial compounding and telehealth industry blossomed, buoyed by exploding consumer interest in GLP-1s and other compounded drugs. But things are changing. We recently blogged more generally about the telehealth and “direct to consumer” market, but the government is taking a close look at commercial compounding. The regulatory landscape for compounding, particularly in the GLP-1 and peptide space, is transitioning from a period of limited oversight to one of heightened and highly visible enforcement activity. The events of the last six months signal a fundamental shift in how the Department of Health and Human Services (“HHS”) and the U.S. Food and Drug Administration (“FDA” or the “Agency”), led by Commissioner Makary, intends to exercise its enforcement. According to FDA’s press release, “[c]ompounded drugs are not FDA-approved[,]” and “compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”
Gone are the days of FDA overlooking both consumer and industry concerns over mass-marketed, unapproved new compounded drugs. This week, FDA further exemplified its intent to put a thumb on consumer compounding operations through aggressive application of its misbranding and advertising standards. The message is clear—regardless of whether these products are legitimate under the law, advertising and promoting them incorrectly (i.e., in a way that is more likely to grab consumer attention) is no longer permitted .
The Trajectory of Enforcement: From September to Now
The initial salvo in September 2025 was unprecedented in scale. By issuing myriad warning and untitled letters simultaneously, the Agency and HHS signaled a departure from its previously passive regulatory posture in favor of a “shock and awe” campaign targeting today’s digital-first consumer compounded drug marketplace. Much has occurred since with some big name companies, legislative and executive proposals to combat shady imports, and other regulatory measures. However, the focus back in September, as is FDA’s now, was primarily on illegal marketing of compounded GLP-1 medications and deceiving consumers into thinking these products were similar to their blockbuster counterparts developed by innovator drug manufacturers subject to the full panoply of clinical testing and quality regulations, nearly all of which compounders are not.
This week’s wave of 30 warning letters to telehealth companies is thus unsurprising in context and represents the next logical step in this escalation against an industry the Agency views as presenting significant regulatory and safety concerns. While the September actions were a broad brushstroke against misleading direct-to-consumer ads, this most recent move drills down into the structural ambiguity of the telehealth model . The FDA is taking aim at the “unqualified” use of brand names or trademarks by telehealth firms that imply they are the actual compounders or that their products have undergone the rigorous safety and efficacy review via New Drug Application.
The Agency’s Core Contentions
The FDA’s press release and the accompanying letters highlight three primary violations:
- The Agency is aggressively challenging claims that compounded versions contain the “same active ingredient” as the innovator drug—or any other number of ways of saying, expressly or impliedly, that their unapproved compounded product is the same as or similar to those of the innovator manufacturers. This is a clear misbranding violation under Section 502 of the FD&C Act.
- One of the more pointed critiques from Commissioner Marty Makary and other officials is the marketing of compounded drugs as “generic” equivalents. Under the FD&C Act, a generic drug must be approved via an Abbreviated New Drug Application. By conflating compounding with the generic approval process, the Agency argues that telehealth firms are systematically deceiving the public about the level of federal oversight involved.
- Through the lens of the recently established “Green List” and Import Alert 66-80, the FDA is narrowing the funnel for API sourcing. They are signaling that “research use only” (RUO) labeling for peptides is no longer a viable shield when the intended use—human consumption—is obvious from the surrounding marketing.
Subtext and Structural Shifts: What This Signals
There is a clear subtext here that goes beyond simple consumer protection. The FDA is clearly under immense internal and industry pressure to address what innovator manufacturers see as an erosion of industry and public trust in the Agency’s devotion to protect the American public from harmful unapproved drugs and unscrupulous opportunists. The publicization of these enforcement actions—the press releases, the mainstream media news interviews, the active social media presence—signals the Agency’s intent to use the current obesity drug zeitgeist to re-establish its primacy over the medication supply chain and to reinforce public confidence in its regulatory oversight.
But the deeper question is whether the current statutory framework for compounded drugs—specifically FD&C Act Sections 503A and 503B—is sufficient to meet the Agency’s goals. Changing the approach from a rules perspective, especially in the post-Loper era, will prove a tall task, and compounding falls at best to page two or three of what Congress is most concerned about these days. So, barring some emergent health and human safety issue that would otherwise likely spur immediate legislative corrective action, what comes next?
Commissioner Makary’s recent CNBC comments about seeing the end of unlawful mass compounding in 2026 suggest that the Agency may find its current “guidance-and-warning-letter” approach too cumbersome. The Agency still has a number of tools at its disposal. We expect to see FDA publicly engage in something more serious like a full-scale investigation, litigation, or other dispute-oriented engagement with the consumer compounding and telehealth industry. Ultimately, whether the future of the current 503A/503B consumer compounding and telehealth business model remains commercially tenable and worthwhile will depend the scope and intensity of the Agency’s enforcement efforts under its existing statutory authority.