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Recent Warning Letters - regarding adulterated and misbranded cosmetics

October 04, 2019 8:55 AM | Amy Bonsell (Administrator)

We became aware that on October 1, 2019 the FDA sent out warning letter to Intenze Product Inc. and Color Art, Inc. DBA Solid Ink 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

Intenze Product Inc. Warning Letter

Color Art, Inc. DBA Solid Ink Warning Letter

The inks referred to in this warning letter are:

  • Dynamic Color WD1 (White)
  • Dynamic Color BLK (Black)

Dynamic Color Inc. Warning Letter

We are working to get this information out to our committee members as it comes up in order to support the artists, manufacturers, and distributors in protecting themselves and their clientele. We are here to help in anyway that we can. If you have any questions please feel free to contact Laurel or KC.

Laurel Arrigona: larrigona@ceuticallabs.com

KC Stevenson: kcstevenson@ceuticallabs.com


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