June 7, 1999
Gerald N. McEwen, Jr., Ph.D., J.D.
Vice President - Science
Cosmetic, Toiletry, and Fragrance Association
1101 17th Street, N.W.
Washington, D.C. 20036-4702
Dear Dr. McEwen:
This replies to your letter of May 11, 1999, in which you request that the Food and Drug Administration (FDA) provide the Cosmetic, Toiletry and Fragrance Association (CTFA) with an interpetation of current and proposed regulations for the labeling of cosmetic products containing color additives. You specifically asked for confirmation that such labeling can omit the terms "FD&C", "D&C", "No.", the cation identification of color additive lakes and that "Ext." will be allowed to replace the term "Ext. D&C".
As you indicated in your letter, subsequent to publication of the June 6, 1985 proposed rule on the use of abbreviations for the labeling of foods, drugs, cosmetics, and medical devices, the Agency announced that the regulated industry could commence using abbreviated names for certain color additives used in FDA-regulated commodities, including cosmetics, in accordance with the provisions of the proposal, pending publication of a final rule.
In the March 4, 1996 proposed rule to permanently list color additive lakes, the use of abbreviated color additive names on cosmetic product labels was further addressed. FDA specifically proposed to amend the cosmetic ingredient nomenclature requirements of 21 CFR 701.3(c) to allow for the optional use of the "FD&C" and "D&C" prefix and the term "No." in the ingredient declaration. The Agency also indicated that the prefix "Ext." must be included in the declaration. With respect to the declaration of color additive lakes, we stated that while it was not necessary to identify the cation precipitants or the substrate, the term "Lake" must be included in the declaration.
Pending publication of the final rule on the permanent listing of color additive lakes, at this time FDA does not intend to object to the immediate use of abbreviated labeling for declaring the presence of certified color additives in cosmetics, in accordance with the discussion on cosmetic ingredient labeling found at pages 8402 - 8403 and the examples provided in the proposed amendment to 21 CFR 701.3(c) found on page 8417 of the March 4, 1996 proposed rule.
If we can be of further assistance to you, please let us know.
John E. Bailey, Jr., Ph.D.
Office of Cosmetics and Colors
Center for Food Safety and Applied Nutrition