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On March 3, 2026, U.S. Food & Drug Administration (FDA) sent to telehealth companies that market compounded GLP‑1 products. These letters highlight ��ٴ�’s current enforcement priorities in the compounded GLP‑1 space and serve as a roadmap for telehealth, digital health, and pharmacy stakeholders. This is the second large batch of warning letters alleging that telehealth companies are engaged in misleading direct‑to‑consumer (DTC) pharmaceutical advertising, confirming that DTC telehealth marketing remains a top enforcement priority for FDA.

��ٴ�’s primarily allege unlawful marketing of compounded GLP‑1 products, resulting in the introduction or delivery for introduction of misbranded drugs into interstate commerce in violation of the . Under the FDCA [], a drug is misbranded if its labeling is false or misleading, and a compounded drug is misbranded if its advertising or promotion is false or misleading.

Key Themes in the Warning Letters

FDA alleges the compounded GLP-1 products are misbranded because:

1. Telehealth companies placed their own brand name on labels in a way that suggests they compound the drugs when they do not, which FDA considers false or misleading;
2. The compounding and marketing practices do not qualify for the exemptions under FDCA (traditional pharmacies) or (outsourcing facilities), such as exemptions from new drug approval; and
3. Promotional materials make new drug claims and imply that FDA has approved, or otherwise evaluated, the compounded products for safety and effectiveness. 

The letters emphasize that compounded drugs are not FDA‑approved. ��ٴ�’s allegations highlight that FDA is concerned that the telehealth companies’ advertising and promotional materials appear to blur the line between FDA‑approved products (such as Ozempic®, Wegovy®, and Mounjaro®) and compounded versions. 

Many companies receiving the letters used brand names, “generic” terminology, or brand‑adjacent claims for their compounded products. According to the letters, FDA views comparisons to brand‑name products and use of “generic” terminology as implying FDA approval or equivalence, rendering such products misbranded under the FDCA.

Examples of alleged misleading claims from the FDA warning letters:

• Treatment and weight loss claims:
  • “Clinically studied and shown to deliver powerful results when combined with healthy habits.”
  • “This FDA-approved treatment promotes safe, effective weight loss.”
• Brand-adjacent marketing:
  • “Contains the active pharmaceutical ingredient in Wegovy”
  • “Generic Zepbound”
  • “FDA approved active pharmaceutical ingredients”

Compliance Responsibilities and Corrective Actions

FDA states in the letters that introducing or delivering misbranded drugs into interstate commerce violates the FDCA and that the cited issues are not an exhaustive list of potential violations. According to the letters, companies are responsible for full compliance with federal law and must take immediate corrective action. Failure to correct violations may result in enforcement action, including seizure or injunction without further notice. For foreign companies, FDA may also detain or refuse products at the border and notify foreign regulators that products appear to be misbranded for the U.S. market.

Why This Matters for Telehealth and Digital Health Models

The letters underscore several important trends:

• GLP‑1s remain a top enforcement priority. High demand, supply constraints, and high prices have driven a robust market for compounded alternatives. FDA is signaling aggressive oversight where it sees safety concerns or statutory compliance risks.
• Telehealth is not exempt from traditional FDA rules. Fully virtual care models are still subject to the FDCA. Online prescribing and fulfillment can trigger the same “manufacturer,” “distributor,” and “introducer into interstate commerce” concepts that apply to brick‑and‑mortar operations.

Practical Compliance Takeaways

Telehealth, digital health, and pharmacy companies offering GLP‑1 products or related services should consider the following:

1. Catalog GLP‑1 offerings. Catalog all GLP‑1 products and identify any compounded products that emulate approved drugs currently available on the market and differentiate those from FDA-approved products.
2. Reassess compounding eligibility:
   • Confirm that active ingredients upon which the compounded product will be based match those in FDA‑approved products (not merely related salts) and are included on applicable bulk substance lists, which includes those bulk substances that are approved for compounding, or otherwise compliant with § 503A or 503B.
   • Evaluate whether the “shortage” rationale for compounding remains valid based on current FDA drug shortage determinations, and whether compounding is limited to prescriptions for identified individual patients (as required under § 503A) or otherwise meets § 503B conditions.
3. Tighten marketing and content.
   • Avoid implying that compounded GLP-1 products are equivalent, interchangeable with, or approved in the same manner as FDA-approved products.
   • Refrain from using FDA‑approved brand names or trademarks to describe compounded GLP-1 products and avoid phrases such as “Ozempic‑like” or “generic Wegovy.”
   • Scrub promotional materials for unsubstantiated weight‑loss claims, superlatives, and before‑and‑after imagery that could be viewed as misleading or as evidence of intended use beyond a legitimate medical context.
4. Strengthen prescribing practices.
   • Review telehealth workflows to ensure appropriate clinical evaluation, documentation, and follow‑up, especially for off‑label GLP‑1 uses.
   • Confirm that prescribers, not marketing or sales teams, drive treatment decisions, and that automation does not circumvent individualized medical judgment.
5. Clarify roles and contracts.
   • Update contracts among telehealth platforms, affiliated or partner pharmacies, and 503B outsourcing facilities to clearly allocate compliance responsibilities and address FDA scrutiny of compounded GLP‑1s.
   • Build in rights to audit, receive notice of regulatory inquiries or actions, and terminate relationships where compounding practices or sourcing raise FDCA risk.
6. Prepare for broader enforcement.
   • Anticipate potential follow‑on actions, including FDA/FTC joint scrutiny of advertising, state board attention to telehealth prescribing and pharmacy operations, private litigation, and payor audits or coverage challenges.
   • Develop an internal response plan (including media and patient communications) in the event of an FDA inquiry or public enforcement action.

Companies operating in this space should promptly reassess their GLP‑1 strategies, including product portfolios, marketing, telehealth protocols, and supplier relationships, to align with ��ٴ�’s evolving guidance and enforcement posture around compounded GLP‑1 products and DTC telehealth models. 

�鶹ֱ�� is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your �鶹ֱ�� relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.