In September 2019, the FDA sent warning letters to three tattoo ink manufacturers about microbial contamination in the products. The agency conducted microbial analysis of tattoo ink samples collected from customers around the country.

The warning letters noted that the tattoo inks contained pathogens and microorganisms that rendered them adulterated under the Federal Food Drug & Cosmetic Act (FFDCA). The agency regulates tattoo inks as “cosmetics” under the FFDCA because the inks are introduced into the body to “promot[e] attractiveness” or “alter[] the appearance.” See 21 U.S.C. § 321(i).
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Takeaways:

  • The intended uses of products are relevant to their classification as a cosmetic and/or a drug.
  • Products can be regulated concurrently as both a drug and a cosmetic depending on intended uses.
  • Companies should be aware of claims of intended uses of products to ensure these products are properly classified under federal law.


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Takeaways:

  • Recent detection of cosmetic products containing asbestos has led to voluntary recalls of five products so far this year.
  • At present, the FDA does not have mandatory recall authority over cosmetic products.
  • The FDA and Congress are contemplating proposals concerning the cosmetics industry that may lead to further enforcement activity in this sector.


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