Intenze Products Inc. – FDA Warning Letter, Nov 28, 2018

On November 28, 2018, the FDA collected samples of tattoo ink products, including Intenze Advanced Tattoo Ink-True Black and Intenze – Raw Umber Light, from customers of the firm in Anaheim, CA, and Beloit, WI. These products are classified as cosmetic products under section 201(i) of the Federal Food, Drug, and Cosmetic Act (the Act).

FDA analysis revealed serious violations. The Intenze Advanced Tattoo Ink-True Black product (Lot (b)(4), FDA Sample #1092208) was found to have significant microbial contamination, exceeding (b)(4) colony forming units/gram (cfu/g), and containing Pseudomonas andersonii, Oligella ureolytica, and unidentified Methylobacterium. This renders the product adulterated under section 601(a) of the Act, as it contains a poisonous or deleterious substance that may render it injurious to users. The Intenze – Raw Umber Light product (Lot (b)(4), FDA Sample # 1039248) also showed low levels of microorganisms, including Bacillus circulans and unidentifiable gram-negative, oxidase-positive bacteria.

Both products were deemed misbranded under section 602(a) of the Act because their labeling falsely claimed they were "sterile" despite the presence of microorganisms. Introducing or delivering adulterated or misbranded cosmetics into interstate commerce violates