FDA's Office of Color & Cosmetics says it has successfully accomplished all four of its priority objectives for fiscal year 2006, ended Sept. 30.

Firstly, OCC has fulfilled its plan to distribute information about the health hazards associated with tattoo inks and permanent makeup in particular, an official from the Center for Food Safety & Applied Nutrition (CFSAN) told "The Rose Sheet" Dec. 13.

OCC presented its findings in April at the FDA Science Forum in Washington, D.C. It also has helped FDA's Office of Women's Health bring its related information up to date, the CFSAN rep said.

According to updated information posted to CFSAN's Web site in July, the permanent makeup route can represent "a time saver" or an option for those who have physical difficulty applying regular, temporary makeup.

It can also serve "as an adjunct to reconstructive surgery - particularly of the face or breast - to simulate natural pigmentation," the division adds.

While FDA considers tattooing inks to be cosmetics and the pigments used in them to be color additives requiring premarket approval, the substances were not "traditionally" regulated prior to the relatively recent emergence of safety concerns, according to the agency.

OCC says it has received more than 150 adverse event reports related to permanent makeup shades; most involved rashes, whiles others cited "permanent disfigurement."

The office's investigation has identified infection, allergic reactions, granulomas - nodules that may form around material the body perceives as foreign - and the formation of keloids, or excessive scarring, as primary complications that can result from tattooing.

CFSAN's online materials also note that individuals with permanent makeup can experience complications when undergoing magnetic resonance imaging (MRI) and that tattoo removal entails its own set of problems.

A forthcoming final report from the Centers for Disease Control & Prevention - based in part on OCC's input - should provide greater insight into the etiology of tattoo-related complications and those populations most at risk.

Another priority for OCC this year was the electronic Voluntary Cosmetic Registration Program - implemented in December 2005, about two months after the fiscal year began.

Since that time, 575 accounts have been opened and more than 6,100 formulations listed, according to CFSAN.

The listing of ingredients - as well as updates as formulations are discontinued - will provide OCC with a clearer picture of the marketplace, CFSAN says.

In February, OCC addressed a third priority by launching a Web-based system for color certification, allowing companies to not only submit materials electronically but also to keep tabs on the status of their applications.

The office pledged to analyze all batches of color additives and determine certification status within an average of five working days; it met that challenge as well in FY 2006, CFSAN says.

Ongoing activities include OCC's work with industry to develop guidance related to 21 CFR 740.10 warning statements, which would apply to products that incorporate ingredients determined by the Cosmetic Ingredient Review Expert Panel to be unsafe (¹ Also see "FDA Cosmetics Office Goals Include Color Certification Web Launch" - HBW Insight, 6 February, 2006., p. 3).

Efforts at harmonization with regulatory counterparts in Europe, Canada and Japan also will continue, CFSAN says.

CFSAN's priority objectives for FY 2007 are currently undergoing review.

It remains to be seen whether enduring budget constraints will mean that the bulk of available resources go to ensuring cosmetics safety (² Also see "CFSAN FY 2006 Program Priorities For Cosmetics Limited To Safety" - HBW Insight, 8 May, 2006., p. 8).

- Ryan Nelson

CFSAN Reports Hitting Four Of Four Priority Goals For Cosmetics In FY 2006

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