ISIS.GOLD
FDA issued a warning letter to ISIS.GOLD (Michelle Golde, Elmhurst, IL) on July 25, 2024, concerning two chemical peel products — 'TCA 100% Trichloroacetic Acid' and 'Whitening SA Peels' — sold on the company's website. The products were found to be unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act due to drug-intent claims such as removing warts, treating melasma, and anti-aging effects, without any FDA-approved application in effect. FDA flagged public health risks including burns, scarring, and injuries requiring emergency care. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (2)
REMOVES: o Thick Dead Skin o Fine Lines & Wrinkles o Deep Pock Marks o Tattoos o Warts o Genital Warts o Skin Tags o Acne Scars o Melasma & Hyperpigmentation
BENEFITS: o Peels Skin Like Saliclear o Whitens/Bleaches Skin o Anti-aging: Removes Wrinkles & Smooths Skin
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most longevity sites match 3-6 patterns.
Run my free site auditWant this watched for you? Free monthly monitoring re-scans your site against the Atlas ruleset and emails you when new flagged wording appears, and your site gets the "Compliance Monitored" seal. Start free monitoring.
Worried 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