On September 9, 2025, President Trump issued a memorandum on prescription drug advertisements that 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, the FDA announced its intent to take aggressive steps to “rein in misleading direct-to-consumer pharmaceutical advertisements.” In its announcement, the FDA expressed  concerns that such advertisements often fail to present a “fair balance” of benefit and risk information as required by federal standards, and instead emphasize benefits while minimizing potentially serious side effects.

In addition to the warning letters, the FDA sent thousands of letters to pharmaceutical companies and issued approximately 100 additional cease-and-desist letters for deceptive advertising.

Background

In recent years, compounding pharmacies operating under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA), along with outsourcing facilities operating under Section 503B of the FDCA, began to compound, market, and distribute compounded versions of weight loss medications – a development we’ve explored in previous client alerts. This practice was particularly widespread during periods when branded products were listed on the FDA’s drug shortage list, as the FDA relaxed many of the restrictions concerning compounding branded medications because of the shortage. However, even after FDA declared an end to the shortage, many compounders continued to market and sell compounded weight loss medications through alternative pathways.

While brand manufacturers pursued private litigation against these facilities with mixed results, the FDA had largely remained quiet – until now. On September 9, 2025, the agency significantly increased its enforcement activity by issuing more than 40 warning letters to telehealth-based compounding pharmacies. These letters raised concerns about advertising practices related to the pharmacies’ compounded drug products.

Advertising practices flagged by FDA

Although each letter emphasized the importance of maintaining a fair balance in promotional materials, the FDA focused primarily on claims that implied compounded drugs were equivalent to their FDA-approved counterparts. In total, the agency scrutinized five different compounded drugs in the warning letters: tirzepatide, semaglutide, tadalafil, sildenafil, and retatrutide.

Outside of issues related to companies’ retatrutide products, which centered on the compound’s ineligibility for relevant compounding exemptions under the FDCA, the FDA’s 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
• Claims implying that the compounded drugs are FDA approved

The overarching focus of the FDA’s crackdown appears to be on claims that compared the compounded products to their branded counterparts, whether directly through the inclusion of brand names or indirectly through references to clinical studies.

Next steps

FDA scrutiny of compounding pharmacies is likely to increase, so stakeholders should remain vigilant and closely monitor the agency’s evolving position on advertising and promotional compliance. For all prescription drug products, marketing materials must present a fair balance between benefits and risks. For compounded drug products specifically, marketing materials should:

• Avoid referencing FDA-approved products
• Refrain from suggesting that the advertised compounds are “clinically proven”
• Omit any statements implying that the FDA has approved the drug or otherwise played a role in reviewing the product or its components for safety or efficacy

We will continue to monitor the FDA’s oversight of compounding pharmacies and broader efforts to address deceptive prescription drug advertising. If you have questions about how these developments may affect your business, please contact a member of McDermott Will & Schulte’s Food, Drug & Medical Device Group.