Beauty of Aztlan LLC
FDA issued a warning letter to Beauty of Aztlan LLC for selling unapproved and misbranded injectable botulinum toxin products ('Botulax 100units' and 'Innotox 50units') via their website without requiring a prescription. The products were marketed with drug-intent claims such as 'Correction of blepharospasm' and 'Hyperhidrosis (increased sweating),' triggering violations of the FD&C Act for introducing unapproved new drugs and misbranded prescription drugs into interstate commerce. FDA demanded cessation of sales, a written corrective action response within 15 working days, and warned that failure to comply could result in seizure or injunction.
Flagged claims (2)
Hyperhidrosis (increased sweating)
Correction of blepharospasm
Required actions (3)
FDA requests that www.beautyofaztlan.squarespace.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most medical spa / aesthetics sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker