Ariella Naturals

Warning LetterOpen

Ariella Naturals 9200 Edmonston Rd Greenbelt , MD 20770 United States CS@ariellanaturals.comIssued Aug 4, 2022Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations0

Issue DateAug 4, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Ariella Naturals
Location: Ariella Naturals 9200 Edmonston Rd Greenbelt , MD 20770 United States CS@ariellanaturals.com
FEI Number: N/A
Country: United States
Issue Date: August 04, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Ariella Naturals was cited for marketing unapproved new drugs—specifically "Ariella Skin Tag Remover & Mole Corrector and Repair Lotion Set" and "Ariella Skin Tag Remover and Mole Remover"—in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made drug claims on its website (tryariella.com) establishing intended use for mole and skin tag removal without FDA approval. The FDA emphasized particular safety concerns, noting that no OTC drugs are legally permitted for mole or skin tag removal, and that such products could lead consumers to delay cancer diagnosis or forgo proven medical treatments.

Ariella Naturals FDA Warning Letter, August 4, 2022