FDA Announces Crackdown on Compounded GLP-1 Drugs and Misleading Marketing

On February 6, 2026, the US Food and Drug Administration announced its intent to take action against compounded GLP-1 medications. The statement noted that FDA intends to take decisive steps to restrict the GLP-1 active pharmaceutical ingredients intended for use in non-FDA-approved compounded drugs and to combat misleading direct-to-consumer advertising and marketing.

Just a day before FDA's most recent announcement, the Trump administration launched a new government website for TrumpRx, through which patients can access partnered pharmaceutical manufacturer direct-to-consumer programs for eligible drug products, including brand-name GLP-1 products. The same day, telehealth company Hims & Hers announced the addition of a compounded pill version of GLP-1 medications to its product line. The launch of the compounded pill was met with a renewed lawsuit against Hims & Hers by the brand manufacturer for allegations of intellectual property infringement, and a notice from the HHS Office of General Counsel that it had referred the matter to the US Department of Justice for investigation. Shortly thereafter, Hims & Hers announced it would remove its compounded GLP-1 pill from the market.

FDA has increasingly focused on escalating its enforcement activity against compounded GLP-1 drugs following US President Donald Trump's September 9, 2025, memorandum on prescription drug advertisements, which called on the FDA commissioner and the secretary of the US Department of Health and Human Services to take actions to enforce prescription drug advertising laws and regulations. That same day, FDA announced its intent to take aggressive steps to "rein in misleading direct-to-consumer pharmaceutical advertisements." Throughout the remainder of the quarter, FDA issued more than 40 warning letters and more than 100 cease-and-desist letters to compounding pharmacies and related entities for deceptive advertising.

FDA's statement was not limited to Hims & Hers; the agency noted it would take decisive steps to restrict the GLP-1 APIs themselves. In 2025, FDA launched an import alert to block potentially unsafe GLP-1 APIs from entering the US market. The import alert established a "green list" of FDA-vetted foreign manufacturers whose GLP-1 APIs meet safety and quality standards. Pursuant to the import alert, APIs imported from non-green-list sources are subject to detention without physical examination at the border. That move targeted foreign-sourced APIs used in compounding, especially those from manufacturers not meeting FDA standards. Additionally, on February 18, 2026, the FDA commissioner stated in an interview that FDA will focus on importation of unapproved APIs. Accordingly, FDA likely intends to increase its focus on API sources through increased inspection activity, border restrictions, or both.

FDA also emphasized that it intends to take enforcement actions against misleading direct-to-consumer advertising and marketing, referring back to the warning letters FDA issued in fall 2025. These warning letters flagged four general categories of inappropriate advertising claims related to the compounded drugs: claims stating that compounded drug products have the same active ingredients as FDA-approved drugs; claims implying that compounded drugs are the equivalent of their FDA-approved counterparts; claims suggesting that compounded drugs are "clinically proven" or otherwise efficacious; and claims implying that the compounded drugs are FDA approved.

Drug pricing deals struck with the makers of blockbuster weight loss drugs last November were hailed by President Donald Trump as a game changer for Americans seeking more affordable access to medicines that have shown benefits for conditions ranging from sleep apnea to cardiovascular disease. But seniors seeking the drugs have faced a complicated set of financial trade-offs since the start of the year, leaving many uncertain about the most affordable way to obtain them.

For some who can obtain the drugs through Medicare Part D for indications other than weight loss, they have three options: purchase the medication and pay toward their deductible, turn to the newly launched TrumpRx cash-pay option or wait for an anticipated government program that would allow beneficiaries to obtain the drugs for a $50 co-payment.

Officials at the Centers for Medicare and Medicaid Services acknowledged the rollout of pathways for seniors to obtain weight-loss drugs does not cleanly align with the calendar year used by insurance companies. But the effort to lower GLP-1 prices will result in more competition and lower prices over time, they said. Initially, the Trump administration is planning to use a so-called 402 demonstration project outside of Medicare's Part D drug benefit program to expand access to the weight-loss drugs for many seniors in mid-2026. Starting in 2027, the program is expected to transition to a voluntary CMS Innovation Center model that will contain "strong incentives" for Medicare Part D plan participation.

However, a CMS document released in December says the agency is considering requiring a "minimum threshold of participation" for the model to be launched — meaning there is a risk that some seniors may temporarily gain access to affordable weight-loss drugs in 2026 before losing access next year.

States have also implemented their own regulatory requirements that adopt and, in some cases, expand on FDA's compounding regulations. For example, in June 2025, California updated its compounding regulations to require pharmacists to verify and document that compounded products produce a clinically significant difference, although pharmacists are not required to make independent clinical determinations. As the focus on compounding practices continues to grow, it is possible that states will implement increasingly more rigorous compounding regulations.

At the federal level, members of Congress have introduced two prominent pieces of legislation that attempt to address some of these issues. Representatives Diana Harshbarger (R-TN) and Buddy Carter (R-GA) introduced the Drug Shortage Compounding Patient Access Act (H.R. 5316) in September 2025. This legislation would allow state-licensed 503A pharmacies to compound shortage drugs for urgent hospital or clinical use with physician certification, with a 60-day transition period after a drug leaves the FDA shortage list.