FDA Cosmetics Relocation Should Be Priority To Eliminate Distraction – CTFA

Delaying the move of FDA's Office of Cosmetics & Colors from two temporary facilities to one main office is hindering progress on the office's top program priorities, the Cosmetic, Toiletry and Fragrance Association asserts in comments to the Center for Food Safety & Applied Nutrition Aug. 4.

"We urge CFSAN to expedite the steps that need to be taken to move the Office of Cosmetics & Colors into one facility that fulfills the needs of all components of that office," CTFA contends, adding, "Too often we have heard that 'the move' is diverting the energies of FDA employees from other activities."

Completing the move should be one of the cosmetics office's "A" list program priorities in the upcoming fiscal year, which begins Oct. 1, the association states.

While the majority of CFSAN relocated to College Park, Md. in 2002, the cosmetics and colors offices were temporarily moved to FDA offices in Washington, D.C. and Chantilly, Va., respectively. The cosmetic teams are slated to move into expanded space at the facilities in College Park in mid-2004, according to CFSAN.

"The dislocation resulting from this separation of different functions in the Office of Cosmetics & Colors, the recently completed moves and additional planned moves in the future are resulting in a distraction from substantive issues," CTFA states.

Among the initiatives that have been languishing in the cosmetics office is final guidance on labeling for alpha hydroxy acid-containing cosmetics, the association says. The Office of Cosmetics & Colors released a draft guidance document in December (¹ (Also see "Interim AHA Labeling Guidance Proposed By FDA Pending NTP Study Results" - HBW Insight, 9 Dec, 2002.), p. 3).

CTFA followed up with comments in January, urging FDA to apply the labeling regs only to products containing AHA ingredients that function as an exfoliant, rather than all AHA-containing products. The issue has been on CFSAN's "A" list of priorities for the cosmetics office since 2000, and CTFA requests completion of the final guidance be made an "A" list priority in the upcoming fiscal year.

Other initiatives CFTA urges CFSAN to address in the upcoming year include adoption of the European Colour Index nomenclature for color additive labeling in place of agency-required nomenclature, a request the association also submitted in comments to the center last year (² (Also see "CFSAN Colour Index Nomenclature Acceptance Tops CTFA Priority Request" - HBW Insight, 26 Aug, 2002.), p. 3).

Recognition of the Latin botanical nomenclature system as the basis for assigning primary ingredient names for botanicals also should be an "A" list priority, CTFA recommends. Adopting the system, which identifies the species and genus of a plant, would eliminate the confusion surrounding botanicals' English "common" names when designating a botanical name under the International Nomenclature for Cosmetic Ingredients (INCI), CTFA says.

The group notes the nomenclature is gaining traction in Europe, where EU member states are considering inclusion of species and genus in the botanical name as part of the first update to the EU Inventory of Cosmetic Ingredients.

CTFA has been incorporating the botanical nomenclature into the International Cosmetic Ingredient Dictionary since 1994. More recently, the association began designating the species and genus as a primary name, with the common name as a parenthetical, beginning with its 8th edition published in 2000 and continuing in follow-up editions.

According to CTFA, FDA indicated in 1995 it would consider an amendment to labeling regulations adopting botanical nomenclature if the trade group submitted a petition in support of the system.

However, an FDA official recently "referenced a previous edition of the dictionary, and offered the opinion that the Latin genus and species names as published in the 8th and 9th editions would not be acceptable for cosmetic product labeling," CTFA says.

"CTFA believes that there has been a sufficient time for education of the medical community and the consumer regarding the use of Latin for botanical nomenclature, and that it would be helpful now for the FDA to acknowledge the advantages of these INCI names," the association adds.

The trade group also encourages CFSAN to implement the Web-based voluntary cosmetic registration program, an "A" list initiative in FY 2003 that has not been completed. While CTFA worked with FDA to beta test the system in 2002, the group is "concerned that the inability to consistently focus resources on this effort and complete the system may ultimately undermine its chances of success."