Launching a Web-based system for color certification and the implementation of the electronic Voluntary Cosmetic Registration Program as well as a health hazards assessment for tattoo inks are primary priorities for FDA's Office of Cosmetics and Colors this year, according to Director Linda Katz.

Katz spoke during a discussion on current OCC activities during a "Meet the Regulators" conference, sponsored by the Cosmetic, Toiletry and Fragrance Association, in Washington D.C. Feb. 1.

The launch of the Web-based system for color certification is slated to be complete this month, Katz noted. The program is designed to improve communication between industry and the agency, she added.

Implementation of the electronic VCRP is the first of the cosmetic office's major goals to be accomplished, Katz said.

The electronic program, which allows firms to register product establishments and file cosmetic formulations online, was made available Dec. 1 (¹ 'The Rose Sheet' Dec. 12, 2005, In Brief). To date, 85 accounts have been opened and 30 registrations established, she noted.

OCC's assessment of tattoo inks, particularly permanent makeup inks, responds to reports a number of women experienced adverse reactions after use of the products. Last year, more than 50 reports surfaced detailing allergic responses, including some that were "permanently disfiguring," Katz said.

"We have been working with CDC over the past year to see if we could come up with a [reason] as to why these particular women had the reactions that they did," she stated, adding "We're almost done with the research with CDC and as soon as that becomes available, CDC will publish that information."

Last spring, the CDC published a letter to the editor in the Archives of Dermatology to alert physicians they may see patients with such reactions, in addition to providing guidance on how to treat such cases, Katz noted. OCC also placed information on its own Web site.

Katz discussed other activities within the agency, including its review of proposed guidance from CTFA on 21 CFR 740.10 warnings statements.

21 CFR 740.10 warning statements would apply to products containing ingredients that have been determined by the Cosmetic Ingredient Review Expert Panel to be unsafe or to have insufficient data to support safety.

Last year, the Center for Food Safety & Applied Nutrition sent a letter to CTFA stating it would consider taking action against cosmetic manufacturers marketing such products (² [A#02260080002], p. 3).

Developing draft guidance on 21 CFR 740.10 was considered a fiscal 2005 program priority for the office. "This is still an issue under discussion within the agency itself, with our general counsel," Katz said.

The cosmetics office also is in the process of renewing a memorandum of understanding between CFSAN and the Center for Drug Evaluation & Research, according to Katz.

The existing memorandum, developed as a three-year agreement, is due to expire June 1. A new memorandum will allow both CDER and CSFAN to initiate action against cosmetic marketers making drug claims for their products, Katz noted.

The cosmetics office is working on a number of ingredient issues, with plans to publish phthalates data in the spring, Katz said. Staffers are evaluating color variants as well, and OCC is "looking for contaminants and how that might affect the products that are marketed," she added.

Percutaneous absorption of nanoparticles continues to be a focus for OCC, which is working with FDA's National Center for Toxicological Research on nanotechnology research that incorporates the use of quantum dots, semiconductor nanocrystals that act as tracking devices in studies.

Regarding harmonization efforts, Katz noted the cosmetics office is working to improve communication with international regulatory bodies.

Moving forward, Katz noted BSE will become a bigger issue for industry, and stressed companies must "keep vigilant" in ensuring prohibited cattle parts under FDA's final rule are not used in cosmetics formulas.

- Eileen Francis

FDA Cosmetics Office Goals Include Color Certification Web Launch

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