Last month, the FDA’s Office of Cosmetics and Colors issued a Draft Guidance encouraging tattoo ink manufacturers and distributors to recognize situations in which these products may become contaminated with microorganisms, and thus, be potentially injurious to health. Under the Federal Food, Drug, and Cosmetics Act (Act) a cosmetic is considered adulterated in violation of the Act if: it contains a substance that “may” make the product harmful to consumers under customary conditions of use; if it contains a filthy, putrid, or decomposed substance; or if it is manufactured or held under insanitary conditions that could be harmful to consumers.

The Guidance provides recommendations specific to tattoo inks regarding certain steps that manufacturers and distributors should take to help prevent the occurrence which could cause the ink to be adulterated. These recommendations, and the Guidance itself, are only focused on specific practices at the manufacturer and/or distributor level. The practice of tattooing (which may include storing and handling tattoo ink after distribution) is regulated at the state and local level -- think licensing and certifications for tattoo artists and shops -- and therefore not addressed in the Guidance.

The FDA was motivated to issue this Guidance, having received multiple reports over the past 20 years of illness caused by the injection of infected tattoo inks. Subsequent testing by the agency found that many sealed tattoo inks in the U.S. were contaminated with microbes. Because, unlike most cosmetics, tattoo inks are injected deep into the skin’s dermal layer, they have greater potential to introduce harmful pathogens. Therefore, the FDA recommends several steps manufacturers should consider taking to help ensure tattoo inks are not contaminated, including:

1. Testing ink and ink components for microbial contamination or purchasing these products from companies that test for contamination;
2. Ensuring the manufacturing process itself does not introduce microbial contamination;
3. Ensuring that any sterilization method used is validated;
4. Ensuring that any cleaning or sterilization method used does not adulterate the finished product; and
5. Taking corrective measures to prevent the release of any tattoo inks that microbiological testing shows contain any type of level of microorganisms.

This, however, is just the tip of the proverbial tattooing needle. The FDA is also messaging that mandatory regulation of cosmetic manufacturers is on the horizon as required by federal law. More specifically, through this draft Guidance, the FDA has said, “We note that we intend to conduct rulemaking to establish good manufacturing practice regulations as part of the implementation of the Modernization of Cosmetics Regulation Act of 2022, which requires FDA to establish good manufacturing practice regulations that, to the extent practicable and appropriate, are consistent with national and international standards.” We expect the FDA to include mandatory reporting of adverse events, product listing and recalls. There will come a time when cosmetic companies can no longer simply choose to voluntarily abide by good manufacturing practices. It is worth noting that although this topic does not appear on the FDA’s recently released unified agenda, it is a topic the cosmetic industry should begin planning to address.

The FDA is accepting comments on the draft guidance until September 11, 2023.