FDA Warning Letters Issued

An organization the SPCP belongs to, the Association of Food and Drug Officials (Body Art Committee) sent the following to committee members that they…became aware that on October 1, 2019 the FDA sent out warning letters to Intenze Product Inc,, Color Art, Inc. DBA Solid Ink, and Dynamic Color regarding adulterated and misbranded cosmetics due to:

  • Microbial contamination in tattoo inks that are on the market.
  • Tattoo inks that are on the market being prepared, packed, or held under insanitary conditions.
  • Labeling of the tattoo inks on the market being false or misleading because the products are labeled as “sterile” but were found to contain microorganisms.

Tattoo inks contaminated with microorganisms can cause infections and lead to serious health injuries when injected into the skin during a tattooing procedure, since there is an increased risk of infection any time the skin barrier is broken.

The inks referred to in the warning letters are:

  • Intenze Advanced Tattoo Ink – True Black
  • Intenze – Raw Umber Light
  • Solid Ink – Super Red
  • Solid Ink – Matte Black
  • Solid Ink – White
  • Solid Ink – Yellow
  • Solid Ink – Orange
  • Solid Ink – Olive
  • Solid Ink – Deep Red
  • Solid Ink – Diablo
  • Dynamic Color WD1 White
  • Dynamic Color BLK Black

https://tinyurl.com/IntenzeProducts-Warning-Letter
https://tinyurl.com/ColorArt-SolidInk-WarnLetter
https://tinyurl.com/Dynamix-Color-Warning-Letter

These investigations were from November and December of 2018 and the letters were issued September 18, 2019 by the FDA. The SPCP does not investigate these matters and provides the links for information confirmation and further research purposes by interested parties.

October 15, 2019