BotableBook a call
FDA Warning Letter Explorer
FDA warning letter · Drugs

Aspen Aesthetics dba Fifty 410

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The compounded semaglutide and tirzepatide products displayed on your website identify “Fifty 410” on the pictured label, suggesting Fifty 410 is the compounder of those drugs when in fact it is not.

Passage 2

Compounded drug products are not FDA-approved. Your claim implies that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.1(h)(2)
  • 21 CFR 201.1(a)