Amazon warning over skin tag products puts online giant on notice for assuring regulatory compliance

In August the US Food and Drug Administration publicized three warning letters sent to companies marketing skin tag removal products.  The warning letters were sent to two manufacturers, Ariella Naturals and Justified Laboratories, and to Amazon directly.

The Amazon warning letter mentions two additional marketers, Desiana and Skincell, whose products are sold on the Amazon site.

No approved OTC treatments for skin tags

At time of the posting of the warning letters FDA put up a consumer facing website​​ in which it says: “Currently, there are no U.S. Food and Drug Administration approved prescription or over-the-counter (OTC) drugs for treating moles, seborrheic keratoses, or skin tags. But there are potentially dangerous products being sold that claim to help remove these lesions. The products are sold as ointments, gels, sticks, and liquids and may contain high concentrations of salicylic acid (a chemical) or other harmful ingredients.”​

Skin tags are benign tumors of the epidermis.  Dermatologists generally ignore tags unless patients want them removed for cosmetic reasons or if the tags have become infected or inflamed and are causing pain and irritation.

FDA’s concern in the matter, however, is that some of those growths may in fact be cancerous.  Many of these types of skin cancers can be dealt with more or less routinely with minor surgical procedures when diagnosed early, but can have serious or sometimes fatal consequences if treatment is delayed too long.

FDA: Amazon responsible for protecting consumers

The warning letter to Amazon seemed to put the firm on notice that it is responsible for making sure consumers aren’t exposed to these dangers, either from an OTC-type drug product or a dietary supplement making impermissible disease treatment claims.

“It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” ​the warning letter stated.

“This warning letter to Amazon is interesting in that I believe it would require Amazon to step up its policing of drug claims,” ​said attorney Marc Ullman, of counsel with the firm Rivkin Radler.

“I think you could say that is an intended consequence of this letter.  It wouldn’t be the first time that FDA would try to outsource its enforcement responsibilities,” ​he added.

“The bottom line is it does open a pathway for Amazon to institute some more policy,”​ said Jennifer Adams, an attorney with the firm  Amin Talati Wasserman.

Amazon: business as usual

In response to an inquiry from NutraIngredients-USA​, an Amazon spokesperson seemed to pour cold water on the idea that the recent warning letter represents a change of some sort.  The statement seemed to indicate that removal of the offending products was simply business as usual.

“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations. The products in question have been investigated and removed,” ​the statement said.

Hard to get online monolith to respond to specific concerns

Be that as it may, the online sales giant has been frequently been notified by supplement manufacturer NOW of test results it has done on a number of categories of supplements that show understrength or even fraudulent​​ products for sale on the site. It might appear that these efforts have had some effect in that Amazon has instituted new requirements​​ for the sale of supplements.  But NOW has never had a direct public response from Amazon on any of the questions it has raised.

Adams said her firm has had a similar experience on numerous occasions it has attempted on the behalf of clients to have counterfeit products that have shown up for sale on Amazon removed. While it’s possible to have sales sites shut down that are shown to be selling counterfeit goods, others can pop up almost immediately.  Adams said there appear to be insufficient checks and balances in place to make it less easy to sell counterfeit products.

“You can get the Amazon accounts shut down if you can find them.  But you chop off one head and another appears. You can raise alarms and questions with Amazon but you don’t get much response.  It’s kind of like radio silence,”​ Adams said.