The U.S. Food and Drug Administration (FDA) has issued a draft guidance to help manufacturers and distributors prevent microbial contamination in tattoo inks. With approximately 30 percent of people in the U.S. having a tattoo, it is important to ensure that tattoo inks are free of contamination to prevent infections and serious injuries. The FDA has received reports of illness caused by infected tattoo inks and has found many sealed tattoo inks in the U.S. to be contaminated with microorganisms.
Tattoo inks are injected into the dermal layer of the skin, which means they have the potential to introduce harmful pathogens directly into the body. Therefore, it is crucial for tattoo inks to be manufactured using methods that ensure their safety. The draft recommendations provided by the FDA include testing ink and ink components for microbial contamination, ensuring the manufacturing process does not introduce contamination, validating sterilization methods, making sure cleaning and sterilization methods do not adulterate the finished product, and taking corrective measures to prevent the release of contaminated tattoo inks.
The FDA encourages consumers and healthcare providers to report any adverse reactions from tattoos. Adverse reactions can be reported to MedWatch, the FDA’s problem-reporting program. Under the Modernization of Cosmetics Regulation Act of 2022, manufacturers, packers, or distributors of cosmetic products, including tattoo inks, are required to report serious adverse events associated with the use of the product to the FDA.
The FDA is accepting comments on the draft guidance for 90 days from the date of publication in the Federal Register on Regulations.gov.
The FDA is an agency within the U.S. Department of Health and Human Services that is responsible for ensuring the safety, effectiveness, and security of drugs, vaccines, medical devices, food supply, cosmetics, dietary supplements, products that emit electronic radiation, and regulation of tobacco products.
In conclusion, the FDA has issued draft guidance to help prevent microbial contamination in tattoo inks, given the significant number of people with tattoos in the U.S. Tattoo inks have the potential to introduce harmful pathogens into the body, so it is crucial to manufacture them using methods that ensure their safety. The FDA encourages reporting of adverse reactions from tattoos and requires manufacturers, packers, or distributors of cosmetic products, including tattoo inks, to report serious adverse events to the FDA. The agency is accepting comments on the draft guidance for 90 days.
