In a bold move to protect its proprietary medications, Eli Lilly has filed lawsuits against two medical spas, Thrive Health and Wellness LLC in Colorado and Valhalla Vitality LLC in New York, for selling unapproved products claiming to contain tirzepatide. Tirzepatide is the active ingredient in Zepbound, Lilly’s popular weight-loss drug, and Mounjaro, approved for type 2 diabetes. This legal action is a wake-up call for medspa owners still offering compounded versions of tirzepatide.
Why the Lawsuits?
The FDA resolved the shortage of tirzepatide in December 2024, meaning compounding pharmacies and medspas must now cease production and distribution of off-brand tirzepatide products. Despite the FDA allowing compounders to finish using existing stock until February 2025, medspas selling these products are at significant legal and regulatory risk.
Eli Lilly alleges that these spas marketed compounded tirzepatide with false claims about efficacy, safety, and purity.
This marks Lilly’s broader crackdown on over two dozen spas, wellness centers, and compounding pharmacies engaged in similar practices.
Can Medspas Sell Existing Stock?
While the FDA’s grace period applies to compounders, medspas selling compounded tirzepatide must ensure their suppliers complied with FDA guidance. Selling or administering compounded tirzepatide now carries significant risks, including:
Legal Action: Lilly’s aggressive legal stance could target non-compliant medspas.
Regulatory Penalties: The FDA’s position is clear—compounded tirzepatide is no longer permitted.
Reputation Damage: Offering unapproved products can harm your business’s credibility and client trust.
What Should Medspas Do Now?
Stop Offering Compounded Tirzepatide: Discontinue these products to avoid legal and regulatory trouble.
Verify Compliance: Check with your suppliers to ensure they’ve ceased production in line with FDA rules.
Communicate with Clients: Be transparent about why you’re removing these offerings and prioritize patient safety.
Explore Alternatives: Shift your focus to FDA-approved weight-loss treatments or other services.
Why Compliance Matters
The weight-loss market is booming, but cutting corners with unapproved products is not worth the risk. Prioritizing compliance and client safety ensures your business remains trustworthy and legally protected.
Conclusion
Eli Lilly’s lawsuits highlight the risks of selling compounded tirzepatide post-shortage. Medspa owners should act immediately to stop offering these products and stay ahead of regulatory changes. Protect your business, prioritize safety, and maintain your reputation by aligning with FDA-approved solutions.
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