Lean Rx, Inc. dba SkinnyRx
FDA issued a warning letter to Lean Rx, Inc. dba SkinnyRx (Sacramento, CA) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The letter cites two categories of violations: (1) the website's product images display the 'SkinnyRx' label, falsely implying SkinnyRx is the compounder of the drugs, and (2) marketing claims imply FDA approval or equivalence to FDA-approved medications, which is false for compounded products. FDA found these practices constitute misbranding under FDCA sections 502(a) and 502(bb) and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.
Flagged claims (3)
Get access to the same active ingredient as name-brand GLP-1 medications
It contains the same active ingredient as FDA-approved medications
from the same family as GLP-1 treatments like Mounjaro® and Zepbound®
Required actions (5)
Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.
Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].
Identifying the entities that produce the compounded products offered on your website;
Providing a representative sample of labeling for such products;
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your site against every entry in this Atlas. Most glp-1 / weight loss sites match 3-6 patterns.
Run my free site audit