The FDA just sent warning letters to three companies that introducing unapproved new drugs into interstate commerce. What’s interesting is that one of them is Amazon.com. Read the press release.
The products in question were mole or skin tag removers that were not approved by the FDA. There are no approved over-the-counter products that can be legally sold for that purpose – so the products in question fall into the category of unapproved new drugs.
Directly from the Statutes:
No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application … is effective with respect to such drug.
21 USC 355(a)
The FDA normally issues warning letters to the manufacturers or sellers of unapproved new drugs, citing the website, social media, or other promotional material as evidence that the product is an unapproved new drug. For example, they cited Young Living for their essential oils and a multitude of companies for claims made for CBD products.
Two of the warning letters issued by the FDA last week did go directly to the companies, Justified Laboratories and Ariella Naturals. Each company was cited for products sold under their own brand name.
Fulfillment by Amazon
The warning letter to Amazon was different. In that warning letter, the FDA referenced Amazon’s distribution of two unapproved new drugs which were introduced into interstate commerce by Amazon via their Fullfillment by Amazon service.
According to the information about Fulfillment by Amazon, it is the Amazon seller that sets up the product listing and adds it to the Amazon catalog. So, in the case of these products, it was most likely the seller that made the claims, but Amazon was cited because they are the ones that actually distributed the product(s).
This could have some interesting repercussions for both Amazon and the companies that want to have their products fulfilled by Amazon.
Other Questionable Products at Amazon
I checked for other mole and skin tag removers listed at Amazon. There are still many listed. I didn’t check EVERY listing, but I didn’t see any that were set for “Fulfillment by Amazon.” What I did notice that there is a disclaimer down at the very, very bottom of each of them. I don’t know if it was there before (I never noticed and couldn’t find an archived page to compare). The disclaimer states:
Disclaimer: While we work to ensure that product information is correct, on occasion manufacturers may alter their ingredient lists. Actual product packaging and materials may contain more and/or different information than that shown on our Web site. We recommend that you do not solely rely on the information presented and that you always read labels, warnings, and directions before using or consuming a product. For additional information about a product, please contact the manufacturer. Content on this site is for reference purposes and is not intended to substitute for advice given by a physician, pharmacist, or other licensed health-care professional. You should not use this information as self-diagnosis or for treating a health problem or disease. Contact your health-care provider immediately if you suspect that you have a medical problem. Information and statements regarding dietary supplements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease or health condition. Amazon.com assumes no liability for inaccuracies or misstatements about products.
No doubt Amazon attorneys were involved in the wording of this disclaimer!
What does it mean to you?
If you are selling your products on Amazon, check to make sure your descriptions, claims, and products are legal and correct. Keep in mind that Amazon is probably going to be more watchful and/or restrictive on products allowed in the “Fulfillment by Amazon” program.
Don’t sell products that claim to be mole or skin tag removers.
As always, keep your products legal, which means that you cannot promote or sell (“introduce into interstate commerce”) unapproved new drugs. And you can’t manufacture drugs (even if they are approved) unless you have an approved and registered drug manufacturing facility.
Directly from the Statutes
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals;
21 ISC 321(g)(1)
Keep your products within the definitions of soap or cosmetics!