FDA Response to Pigment Approval Claims

Many members have called/emailed the SPCP office with reports of recorded phone messages by a permanent cosmetic pigment manufacturer. The recording stated their company was the first permanent cosmetics supply company to seek FDA approval for permanent cosmetics and that test results from the FDA research are in, and the news is exciting!

Below is the response received from the Society’s FDA contact person on October 4th:

“As required by law, a color additive must be shown to be safe and the subject of a listing by the FDA in the Code of Federal Regulations prior to its use in food, drugs, cosmetics, or medical devices. The appropriate process begins with a submission of a color additive petition to the FDA. A description of that process may be accessed at the following website: http://www.cfsan.fda.gov/~dms/col-toc.html.

Currently, no color additives are approved for use in tattooing and the FDA does not have a filed petition for the use of a color additive in permanent makeup tattooing. For future reference and to assist you in monitoring color additive petition activity, information on petitions currently under active review may be accessed at: http://www.cfsan.fda.gov/~dms/opa-expd.html. When a color additive petition is filed, the FDA publishes a filing notice in the Federal Register. The FR home page can be accessed online at: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm”

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