The short answer
In the U.S., tattoo inks and permanent makeup pigments are cosmetics under the Federal Food, Drug, and Cosmetic Act. Two FDA facts matter most for manufacturers:
- No color additive is approved for injection into the skin. FDA says that while many color additives are approved for cosmetics, none are approved for injection, and using an unapproved color additive makes the ink adulterated.
- Microbial contamination is FDA’s main enforcement focus. FDA’s final guidance of October 24, 2024 covers insanitary conditions and contamination risk in making tattoo inks. Firms carried out 18 voluntary tattoo ink recalls between 2003 and 2024.
The practice of tattooing — studios, artists, hygiene — is regulated by state and local authorities, not FDA.
What FDA expects from ink makers
- 1Control microbial contaminationTest inks and ink components for microorganisms, make sure the process does not introduce contamination, use appropriate sterilization methods where applicable, and do not release contaminated product.
- 2Use clean, high-purity pigmentsFDA notes that many tattoo pigments are not approved for skin contact and some are industrial-grade colors. Know your pigment sources and impurity profile.
- 3Keep good recordsBatch records, test results, sterilization validation and complaint files.
- 4Recall quicklyIf contamination is found, act before FDA has to.
MoCRA obligations
As cosmetics, tattoo inks fall under the Modernization of Cosmetics Regulation Act (MoCRA):
- Facility registration for the manufacturing site, with a U.S. Agent for foreign facilities, renewed every 2 years.
- Product listing of each ink by the responsible person, updated every year.
- Serious adverse event reporting to FDA within 15 business days, and records kept.
- Safety substantiation records for each product.
- A U.S. contact on the label for adverse event reports.
Labeling
- Identity, net quantity and an ingredient list (in descending order of predominance)
- Name and place of business of the manufacturer, packer or distributor, and the U.S. contact for adverse events
- A lot or batch number on every container (strongly recommended — essential for recalls)
- No drug claims (for example “heals”, “numbing”, “antibacterial”)
Temporary tattoos and henna
Temporary tattoos and henna products used on skin are also cosmetics. FDA Import Alert 53-19 allows detention without examination of henna-based skin color products. Products sold as “black henna”, which may contain hair-dye chemicals, are a known safety concern on skin.
Example: an ink maker in Italy
An Italian tattoo ink company that already meets EU rules on restricted substances plans to sell in the U.S. It registers its factory under MoCRA with a U.S. Agent, lists each color, adds a U.S. contact and lot number to every bottle, keeps sterilization validation and microbial test results for each batch, and sets up adverse event reporting. It also keeps pigment specifications on file, knowing FDA has not approved any color additive for injection.
Cosmetic facility registration with U.S. Agent from $300 (1 year) or $450 (2 years). Product listing $150 per product. Cosmetic label review $250.
Frequently asked questions
Are tattoo inks regulated by FDA?
Yes. Tattoo inks and permanent makeup pigments are cosmetics under federal law. Tattoo studios and artists are regulated by state and local authorities.
Has FDA approved any colors for tattoo ink?
No. FDA says no color additives are approved for injection into the skin.
Do tattoo ink makers need MoCRA registration?
Generally yes. Tattoo inks are cosmetics, and the MoCRA small business exemption does not apply to products that are injected.
What is FDA’s 2024 tattoo ink guidance about?
Insanitary conditions and microbial contamination in the preparation, packing and holding of tattoo inks — testing, process controls, sterilization and preventing release of contaminated product.
Sources
- FDA — Tattoos, temporary tattoos and permanent makeup
- FDA — FDA issues final guidance for tattoo inks (October 24, 2024)
- Crowell & Moring — FDA issues final guidance for tattoo industry
Requirements checked on November 11, 2026. This article is general information, not legal advice.