What has FDA objected to?
Foley’s review of the March 2026 letters and Sheppard Mullin’s review of the June round point to the same patterns. You can read a June 2026 letter directly on FDA’s site. These are FDA’s allegations in warning letters, not court findings, but they show what draws attention:
| Pattern | Why FDA objects | A more careful direction |
|---|---|---|
| “Generic” of a brand-name drug | Compounded drugs are not FDA-approved generics | Call it a compounded medication |
| “Contains the active ingredient in” a brand-name drug | Implies sameness to an approved product | Describe the preparation without borrowing the brand |
| “FDA-approved treatment” near a compounded product | Implies FDA evaluated the compounded drug | State that compounded drugs are not FDA-approved |
| “Clinically proven” with a brand’s trial results | Those trials studied the approved drug | Make only claims you can substantiate for this product |
| Your brand name on the label, unqualified | Suggests you compound a drug you do not | Say who prepares it, for example “prepared by a licensed compounding pharmacy” |
What must every compounded product page say?
At minimum, say plainly that compounded drugs are not FDA-approved, in the language of FDA’s own statement, and that a licensed prescriber decides whether the medication is right for the patient. Put both near the claim they qualify. Footer text alone is easy to miss, which is the problem regulators look for.
Do FTC rules apply as well?
Yes. The FTC’s Health Products Compliance Guidance expects competent and reliable scientific evidence behind health claims, and it covers testimonials, before-and-after images and influencer posts. Ask for the evidence behind a claim before it goes into an ad.
Do ad platforms have separate rules?
Yes. Google uses LegitScript certification in its telemedicine policy, and a certified business can still have ads disapproved. Rules differ by platform and country and change often, so read the current policy for each one before you commit a budget.
Who reviews your copy on SourceRX?
You do, with your own counsel. SourceRX runs the prescribing, pharmacy and checkout infrastructure, and a partner’s advertising is the partner’s responsibility. Storefront legal documents on a 503A shop state that the shop does not compound or hold the stock and that a compounding pharmacy prepares each order.
Is this legal advice?
No. Enforcement priorities shift, and the wording that is safe depends on your product, your claims and your states. Have healthcare counsel review your copy before it runs.
Sources
- Foley & Lardner, FDA Targets Telehealth Marketing in 30 New Warning Letters (March 2026)
- Sheppard Mullin, FDA’s Focus Returns to Compounding and Telehealth: Another Wave of Warning Letters
- FDA warning letter to Altru Telehealth LLC, June 8, 2026
- FDA, Compounding and the FDA: Questions and Answers
- FTC, Health Products Compliance Guidance
- LegitScript, Certified but still getting disapproved: telehealth advertising takeaways
General information, not legal or medical advice. Rules vary by state and change over time, so have healthcare counsel review your plans.