September 2025 marked a major crackdown on the compounded GLP-1 industry. The FDA issued a coordinated batch of warning letters accusing dozens of telehealth platforms and compounding pharmacies of selling "unapproved and misbranded drugs." Here's what you need to know.
What Happened
On or around September 9, 2025, the FDA issued more than 50 warning letters targeting companies that sell compounded semaglutide and tirzepatide. This wasn't random enforcement—it was a coordinated campaign to address what the FDA called "false or misleading" marketing claims.
The timing wasn't coincidental. The FDA had declared the semaglutide shortage resolved in February 2025, meaning the legal basis for compounding "essential copies" had expired months earlier. Many companies continued selling compounded products while making claims that crossed regulatory lines.
Who Received Warning Letters
The FDA's enforcement targeted a range of companies, from major telehealth platforms to smaller online sellers:
Notable Companies That Received FDA Warning Letters
Hims & Hers Health, Inc.
The largest telehealth platform for GLP-1s. Cited for claims implying FDA approval of their compounded products.
Sprout Health Partners LLC
Cited for stating "GLP-1 medications are FDA-approved"—language that misrepresents compounded products.
DirectMeds
Cited for claiming products have "same active ingredient as Ozempic"—a comparison the FDA deemed misleading.
FWD Care (and others)
Various telehealth platforms and online sellers cited for similar violations.
What Claims Violated Regulations
The FDA identified specific language that constitutes "misbranding" under federal law. Companies using these claims were accused of misleading consumers about the nature of their products:
❌ Claims the FDA Called "False or Misleading"
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✗
"Same active ingredient as Ozempic/Wegovy"
Implies equivalence that hasn't been verified
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✗
"GLP-1 medications are FDA-approved"
Misleadingly implies compounded products are FDA-approved
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✗
"Generic Ozempic" or "Generic semaglutide"
No generic semaglutide exists; this is factually false
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✗
"Clinically proven ingredients"
Compounded formulations haven't been clinically proven
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"Safe and effective"
FDA hasn't determined this for compounded products
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✗
Using brand-name logos or product images
Creates confusion with FDA-approved products
The Legal Framework
The FDA's enforcement is based on specific sections of the Federal Food, Drug, and Cosmetic Act:
Unapproved Drug (21 U.S.C. § 355)
Compounded drugs are not FDA-approved. If the legal basis for compounding (drug shortage or patient-specific significant difference) doesn't apply, selling them violates federal law.
Misbranding (21 U.S.C. § 352)
A drug is "misbranded" if its labeling is false or misleading. Marketing claims that imply FDA approval or equivalence to brand-name drugs constitute misbranding.
What Warning Letters Actually Mean
An FDA warning letter is not the same as a fine, seizure, or injunction. It's the agency's way of saying "we've identified violations and expect you to fix them." Here's the typical process:
Warning Letter Issued
FDA notifies company of violations and requests corrective action within 15 business days.
Company Response
Company must respond explaining how they'll address violations or why they disagree.
Follow-Up
FDA may accept corrections, request more action, or escalate to enforcement.
Potential Escalation
If violations continue: product seizure, injunctions, or criminal prosecution.
Many companies that received warning letters have since updated their marketing language. Some continue operating with modified claims, while the FDA monitors compliance.
What This Means for Consumers
The Good News
- ✓ Compounded GLP-1s are still legally available when properly prescribed
- ✓ The FDA is actively protecting consumers from misleading claims
- ✓ Companies are being forced to be more honest in their marketing
The Concerns
- ⚠ Some providers may face supply disruptions as they adjust to regulations
- ⚠ The legal landscape remains uncertain for some formulations
- ⚠ Patients using providers that received warnings should monitor for changes
How to Use This Information
When evaluating compounded GLP-1 providers, the September 2025 warning letters provide useful data:
What to Look For in a Provider
- ✓ Clear disclaimers that compounded products are NOT FDA-approved
- ✓ No claims of being "the same as" or "equivalent to" brand-name drugs
- ✓ Honest language about what compounding means
- ✓ No use of brand-name logos or product images
- ✓ If they received a warning letter, evidence they've corrected violations
Red Flags to Avoid
- ✗ Still using "same as Ozempic" or "generic semaglutide" claims
- ✗ Implying FDA approval of their compounded products
- ✗ Using brand-name product photos or logos
- ✗ Received a warning letter and hasn't addressed the issues
The Bottom Line
The September 2025 FDA warning letters represent the most significant regulatory action against the compounded GLP-1 industry to date. They signal that the FDA is serious about enforcing marketing standards, even if they haven't shut down compounding entirely.
For consumers, this enforcement action is actually a good thing—it pushes providers toward more honest communication about what they're selling. Use the information from these warning letters as one factor in evaluating providers, along with pharmacy certifications, pricing transparency, and customer reviews.
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