FDA Cosmetics Office Aims To Achieve Three “A” List Priorities In 2002

FDA's Office of Cosmetics & Colors will tackle three "A" list items and 10 "B" list goals in fiscal 2002 under the Center for Food Safety & Applied Nutrition's program priorities report issued Jan. 28.

The center has placed color additive certification at the top of its cosmetics-related priorities with a goal to "analyze all batches of color additives and determine certification status within an average of five working days," CFSAN says.

Color certification has been included as one of the cosmetic office's priorities in the past and was the only cosmetics program priority listed as successfully completed in the center's 2001 report card, also released Jan. 28.

During a same-day briefing CFSAN Director Joseph Levitt touted the center's move from Washington, D.C. to new facilities in College Park, Md. as a "major accomplishment" in 2001. However, in a new development, the cosmetics office will no longer be moving to the facility.

Instead, to make room for new counter-terrorism positions at the College Park location, the Office of Cosmetics & Colors will take up residence in existing FDA offices at 1110 Vermont Ave. in Washington, D.C. Levitt said.

Other cosmetics program goals for FY 2001, such as labeling guidance for products containing alpha hydroxy acids, have been carried over to the fiscal 2002 priority list. The Cosmetic, Toiletry and Fragrance Association submitted a "sun alert" labeling proposal to FDA in 2000 (¹ (Also see "AHA "Sun Alert" Labeling Recommended In CTFA Citizen Petition" - HBW Insight, 10 Jul, 2000.), p. 8).

Another "A" list priority, listed under "enforcement and compliance," is to complete a memorandum of understanding with FDA's Center for Drug Evaluation & Research. The memorandum would allow the Office of Cosmetics & Colors "to manage enforcement actions for certain cosmetic products whose label or labeling contains structure/function or disease claims," FDA says.

Development of risk assessment approaches for diethanolamine has moved from the cosmetics office's "A" list last year to the "B" list in FY 2002, but ranks among the office's "highest-level B-list items."

Another "A" list priority last year - development of warning letters based on Cosmetic Ingredient Review insufficient data conclusions - also has been moved to the high-level "B" list. In comments to the agency, CTFA recommended the warning letters should be one of the office's top priorities in 2002 (² (Also see ""Insufficient Data" Labeling "Framework" Should Be CFSAN Priority - CTFA" - HBW Insight, 24 Sep, 2001.), p. 7).

Other priorities listed on the office's "B" list include development of a final rule permanently listing color additive lakes through FDA, continued support of international harmonization and support for long-term glycolic acid and salicylic acid testing being conducted by the National Toxicology Program.

Implementing a Web-based Voluntary Cosmetic Registration Program also made the office's "B" list, as did an effort to issue a Cosmetic Handbook to industry.

CFSAN is aiming to complete 90% of the 92 "A" list items on its agenda by the close of the 2002 fiscal year, which ends Sept. 30, Levitt said. Items placed on the "B" list "are those we plan to make progress on, but which we may not complete," according to Levitt. High-level "B" list items often are considered two-year projects that will be considered for the "A" list the following year, he noted.

However, any goals published in the FDA work plan could be postponed due to an increased emphasis on food safety as a result of the Sept. 11 terrorist attacks, Levitt warned The Office of Cosmetics & Colors already has seen a shift in priorities due to agency-wide counter-terrorism and bovine spongiform encephalopathy prevention efforts (³ (Also see "FDA Cosmetics Office Shifts Focus As Bioterrorism, BSE Take Priority" - HBW Insight, 19 Nov, 2001.), p. 3).

In addition, the cosmetics office could face additional delays as it continues to operate without a permanent director since John Bailey, PhD, left more than a year ago. The former director recently joined CTFA as director of cosmetic chemistry (⁴ (Also see "CTFA Taps Former FDA Cosmetics Director Bailey For Chemistry Post" - HBW Insight, 28 Jan, 2002.), p. 10).

Since Bailey's departure, the leadership role has been filled by a rotation of acting directors including Adele Dennis, PhD, and Raymond Decker (⁵ (Also see "FDA Cosmetics & Colors Permanent Director Sought But Not Imminent" - HBW Insight, 5 Nov, 2001.), p. 13). Office of Cosmetics & Colors Medical Officer Ella Toombs, MD, stepped into the acting director position effective Jan. 2 for a 60-day rotation. FDA is advertising for a permanent successor to head the operation.