Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The claims on your website establish that “Ariella Set” and “Ariella” are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).
Passage 2“FAST & EFFECTIVE: In most cases, skin tags and moles will fall off naturally within 7-10 days. We created this formula with the goal of helping people feel & look their best!”
Passage 3“EFFECTIVE SKIN TAG REMOVAL: Our Skin Tag removal pen attacks each Skin Tag. A Skin Tag will begin to die within 3-5 days of initial application of the liquid and with consistent treatment, most skin tags will be eliminated within several weeks without scars.”
Passage 4“SKIN TAG REMOVER: Skin tags on the face or body can be annoying, bothersome & even embarrassing, but with this unique product, you can get rid of them for good!”
Passage 5“Ariella Set” and “Ariella” are not generally recognized as safe and effective for their above referenced uses and therefore are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 6There are no FDA-approved applications in effect for your products. The introduction or delivery for introduction into interstate commerce of these products without an approved application violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).