> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Amazon Distributing Unapproved New Drugs: FDA
- URL: https://www.fdaweb.com/amazon-distributing-unapproved-new-drugs-fda/
- Published: 2022-08-09T12:00:00.000Z
- Updated: 2026-09-14T17:55:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152463

An 8/4 FDA [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-629452-08042022?ref=fdaweb.com) notifies Amazon.com that two mole and skin tag remover products it is marketing through its Web site and distributing through Amazon fulfillment services are unapproved new drugs and are not generally recognized as safe and effective for their intended uses. The letter references the over-the-counter (OTC) drugs Deisana Skin Tag Remover, Mole Remover and Repair Gel Set, and Skincell Mole Skin Tag Corrector Serum.

“There are no OTC drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for their uses,” the letter says. “…FDA has issued a consumer warning that products marketed for removing moles and other skin lesions can cause injuries and scarring.”

The letter includes examples of claims for each product that establishes that they are legally considered to be drugs.

Amazon was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with copies of related documentation.

Similar Warning Letters were also issued to [Ariella Naturals](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ariella-naturals-632509-08042022?ref=fdaweb.com) and [Justified Laboratories](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jb-exchange-incjustified-laboratories-631521-08042022?ref=fdaweb.com).