FDA Warning Letters 2021

FDA signage

I’ve been receiving a lot notices of FDA warning letters, so I reviewed the last 106 warning letters (60 days) to see what sort of warnings they have been sending out lately.

Here’s the breakdown of the types of products cited (in descending order).

  • Family Smoking Prevention & Tobacco Control – 46
  • Unapproved new drug – 19
  • Corona Virus 2019 “cures” – 11
  • Foreign Supplier Verification Program – 9
  • Pharmaceutical Ingredients – 5
  • Compounding Pharmacies – 4
  • Pharmaceutical Products – 4
  • Biotech Monitoring – 1
  • Animal Products – 1
  • Devices – 1
  • Human Cells, Tissues & Cellular Products – 1
  • Seafood – 1

Unapproved New Drugs

Warning letters concerning cosmetics are usually found under the “unapproved new drug” category, since that’s the most likely problem facing cosmetic manufacturers. They make claims that the product will treat, mitigate, prevent, or diagnose a disease, or that it will alter the function or structure of the body and—whammo!—they have created an unapproved new drug.

In the 19 warning letters covering unapproved new drugs, 17 were for ingested substances claiming to be “nutritional supplements.” Mostly the drug claims were to treat diabetes, improve blood sugar levels, and/or promote weight loss. Several contained prescription weight loss drugs and/or unapproved food additives (ingredients that aren’t nutritional supplements and aren’t otherwise approved for use in food).

The two remaining unapproved drug warning letters were for products that are applied to the human body.

The first was a “Black Salve.” In that case the company was promoting the product to treat “various types of abnormal growths both external and internal.” Definitely a drug! In addition to warning about the claims for treatment, the FDA also cited the fact that two of the ingredients were known to be corrosive and were capable of indiscriminately damaging both healthy and diseased tissue.

The second was a “pain relief roll-on” containing CBD.


Data Reviewed by the FDA

One interesting point I noted was that in all of the unapproved new drug warning letters, the FDA stated they had reviewed one or more of:

  • Company website(s),
  • Amazon storefront
  • Amazon seller profile
  • Facebook
  • Instagram
  • Twitter

In most cases it was also mentioned that the website(s) and social media pages were ALSO reviewed by the FTC.

In other words, if you use social media to make drug-type claims about your product and then to link back to your website from your social media, the FDA can use that information in determining whether or not the product is an unapproved new drug.

Dollar Tree

Another interesting tidbit is that Greenbrier International, Inc. (dba Dollar Tree) was cited for the lack of good manufacturing practices at the foreign facilities which manufacture Dollar Tree’s Assured Brand drugs. The three foreign facilities listed (all located in China) had already been cited by the FDA, but the Dollar Tree was still bringing in and selling the products. Dollar Tree said that they were having the drugs tested, but when the FDA checked with the company Dollar Tree used, they said they weren’t qualified to test drugs.

No wonder Dollar Tree Assured Brand is so cheap!

Navigating the Rules and Regs book by Marie Gale

Besides labeling, there are many other laws and regulations that apply to handcrafters. To find out which ones apply to you and how to comply with them, buy my book and keep it handy!


5 responses to “FDA Warning Letters 2021”

  1. Thank you for being such a great resource.


    Thank you for this article. Your posts are so informative. I appreciate all you do.

  3. I have signed up to receive these notifications also. I especially remember the Black Salve! It amazes me how many companies make claims and think it’s ok. The FDA does not mess around and I never want to be on their radar! I have not opened a website yet but plan to and seeing these letters helps keep me in check when writing my descriptions! Also-I can’t find your article on what’s acceptable wording when describing items. Can you send me the link?

    1. It’s not really “acceptable wording.” It’s the intended use of the product. So long as it is to make more attractive, beautify, or cleanse, then it’s a cosmetic. If the intended use is to do anything “under the hood” (treat, cure, mitigate, prevent disease or alter the function or structure of the body) then it is an unapproved new drug. It’s what the consumer thinks is the intended use that is the determining factor.

      1. Thank you Marie, you provide an valuable service.

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