Compounded GLP-1 Advertising: What Compounders Need To Know NOW

The regulatory tone surrounding compounded GLP-1 products shifted decisively. What had been an aggressive but largely tolerated advertising environment is now under direct scrutiny from regulators, self-regulatory bodies and brand manufacturers. The National Advertising Division (NAD) recently issued a high-profile recommendation involving a telehealth company marketing compounded semaglutide, and the implications for compounding pharmacies are significant. The message is clear, i.e., advertising compounded GLP-1 products as if they are equivalent to FDA-approved drugs, or implying proven safety and efficacy, is no longer flying under the radar.

The NAD matter arose from a challenge brought by a branded manufacturer against a telehealth provider that marketed compounded semaglutide for weight loss. The challenger argued that the advertising conveyed express and implied claims about clinical effectiveness, safety and equivalence to FDA-approved products without adequate substantiation. NAD agreed, concluding that the company's advertising created a misleading impression and lacked the evidentiary support required for such claims. When the company declined to confirm compliance with NAD's recommendations, the matter was referred to federal and state regulators.

For compounders, this development is more than an isolated advertising dispute. NAD decisions, while technically voluntary, often serve as a gateway to broader enforcement. Federal and state regulators, including the FDA and state attorneys general, routinely rely on NAD findings when assessing whether advertising violates consumer protection laws. Once a matter is referred, the conversation shifts quickly from marketing edits to warning letters, investigations and potential enforcement actions.

Why GLP-1 Advertising Is Under a Microscope

The compounded GLP-1 market grew rapidly during the nationwide shortages of semaglutide and tirzepatide. During that time, compounding pharmacies stepped in to meet patient demand where FDA-approved products were unavailable. Under long-standing FDA policy, compounding during a bona fide shortage was permissible, and many pharmacies lawfully prepared compounded versions to address individual patient needs.

That environment has since changed. Both semaglutide and tirzepatide have been removed from the FDA's drug shortage list. Once a drug is no longer in shortage, compounders lose the broad ability to prepare "essentially copies" of commercially available products. Compounding may still occur in limited circumstances, but only when a prescriber determines that a patient has a specific medical need that cannot be met by an FDA-approved drug.

At the same time, regulators have turned their attention to how compounded GLP-1 products are marketed. The FDA has made clear that compounded drugs are not FDA-approved, have not undergone premarket review for safety or efficacy and cannot be promoted in ways that suggest otherwise. This applies regardless of whether advertising is directed to consumers, prescribers or intermediaries such as telehealth platforms.

The FDA's recent enforcement posture reflects a broader regulatory philosophy. Prescription drug advertising, whether for approved products or compounded preparations, must be truthful, non-misleading and supported by adequate substantiation. Claims that might have gone unnoticed during the height of the shortages are now being examined closely, particularly where marketing leverages the popularity and clinical reputation of branded GLP-1 drugs.

The Most Common Advertising Mistakes

Many of the advertising practices drawing scrutiny share common themes. One of the most problematic is the use of brand-adjacent language. Statements suggesting that a compounded product contains "the same active ingredient" as a branded drug, or that it functions as a "generic" alternative, create an implied claim of equivalence. Regulators view this as misleading because compounded drugs are not approved generics, are not interchangeable and are not subject to the same manufacturing and review standards as FDA-approved medications.

Another recurring issue is the use of clinical outcome claims. References to weight loss results, cardiovascular benefits or metabolic improvements that mirror claims made for branded GLP-1 products are especially risky. Those claims are typically based on large-scale clinical trials conducted by manufacturers of FDA-approved drugs. Compounders cannot simply borrow that data to support advertising for compounded formulations, particularly when differences in formulation, excipients, dosing or administration may exist.

Equally concerning to regulators is the failure to clearly disclose that a product is compounded. Advertising that omits this fact, or buries it in fine print, can be considered misleading by omission. Patients are entitled to know whether they are receiving an FDA-approved medication or a compounded preparation. When advertising creates ambiguity on that point, it undermines informed decision-making and raises consumer protection concerns.

Some marketing materials also imply regulatory endorsement by referencing FDA oversight in a vague or misleading way. While compounding pharmacies are regulated entities, that does not mean their compounded products are reviewed or approved by the FDA. Any suggestion that the FDA has evaluated or endorsed a compounded GLP-1 product is inaccurate and invites enforcement.

Telehealth Partnerships Add Another Layer of Risk

For compounders working with telehealth providers, advertising risk is magnified. Telehealth platforms often control the consumer-facing messaging, intake process and promotional strategy. However, compounding pharmacies are not insulated from liability simply because a third party drafted the copy. Regulators and plaintiffs' attorneys routinely look at the entire ecosystem, including pharmacies that dispense the compounded drugs being promoted.

If a telehealth partner makes aggressive claims about compounded GLP-1 products, pharmacies supplying those products may be drawn into investigations or litigation. Advertising scrutiny often expands into questions about prescribing practices, patient evaluations and whether compounded drugs are being dispensed in compliance with federal and state law. A marketing issue can quickly evolve into a broader compliance problem.

What Regulators Expect Going Forward

The direction regulators are heading is not subtle. They expect compounded GLP-1 advertising to be restrained, accurate and transparent. Claims should focus on the nature of compounding and the role it plays in individualized patient care, not on comparisons to branded products or promises of outcomes.

Disclaimers alone are not enough if the overall impression of the advertising is misleading. Regulators evaluate advertising holistically. A statement buried at the bottom of a webpage that a product is "not FDA-approved" will not cure prominent claims that imply clinical equivalence or proven results. The headline, imagery and tone all matter.

Substantiation is another key expectation. Any express or implied claim about what a compounded GLP-1 product does must be supported by reliable evidence appropriate to the claim being made. In practice, this means avoiding claims that go beyond the basic description of the compounded preparation and its intended use as determined by a prescriber.

Practical Steps for Compounders

Given the current enforcement environment, compounding pharmacies should take proactive steps to reduce risk. A comprehensive review of all advertising and promotional materials is essential. This includes websites, social media content, email campaigns, intake forms and any materials provided to telehealth partners or prescribers.

Language that references branded drugs, clinical outcomes or regulatory approval should be carefully scrutinized and, in many cases, removed or revised. Transparency should be front and center. Advertising should clearly state that products are compounded and explain, in plain terms, what that means.

Legal review is no longer optional in this space. Marketing teams, whether internal or external, should not be operating without oversight from counsel familiar with FDA advertising standards, compounding law, and consumer protection statutes. The cost of preventive review is minimal compared to the expense of responding to a warning letter, investigation or enforcement action.

Compounders should also revisit their relationships with telehealth partners. Contracts should address advertising responsibilities, compliance expectations and indemnification. Pharmacies should have the ability to review and approve promotional content that references their compounded products.

Conclusion: A Tighter Line, But a Navigable One

Compounding pharmacies continue to play an important role in patient care, including in the GLP-1 space. But the era of aggressive, brand-adjacent advertising is ending. Regulators have drawn a firmer line between lawful compounding and misleading promotion, and they are actively enforcing it.

The path forward is not to abandon GLP-1 compounding altogether, but to approach advertising with discipline and respect for regulatory boundaries. Honest descriptions, clear disclosures and avoidance of implied equivalence are not just legal necessities— they are good business practices that build trust with patients and prescribers alike.

Compounders who adapt now, before enforcement finds them, will be far better positioned to continue operating in this evolving landscape. Those who ignore the warning signs may find that what once felt like ordinary marketing is now the basis for regulatory action.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.