February 5, 2007
Klaus Peter Löbbe
Chairman and Chief Executive
100 Campus Drive
Florham Park, NJ 07932
Dear Mr. Löbbe:
The Food and Drug Administration (FDA) has reviewed the regulatory status of composite pigments for use in cosmetics as shown on your Internet web site, http://www.engelhard.com. (The web site states that Engelhard was acquired by BASF in June 2006.) In the section entitled "Special Effect Pigments for Cosmetics and Personal Care Overview," there are a number of composite pigments listed for cosmetic use. In the section entitled "Cosmetics manufacturing," the website states that "Engelhard's effect enhancing pigment line includes mica flakes coated with titanium dioxide and/or many other colorants, bismuth oxychloride crystals, natural pearl essence derived from fish scales and titanium dioxide and/or colorant coated borosilicate." Product lines for the pigments described on your website include Bi-Lite®, Cloisonne®, Chroma-Lite®, Cosmica®, Flamenco®, Gemtone®, Shinju®, and Reflecks™.
These products are adulterated under section 601(e) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 361(e)), because they contain color additives deemed unsafe under section 721(a) of the Act, (21 U.S.C. 379e). The regulations pertaining to color additives are located in Title 21, Code of Federal Regulations (21 CFR), Parts 70-82.
Specifically, the composite pigments described on your web site are distinct color additives subject to premarket approval. Although the resultant pigments might include some chemical components similar to those listed as color additives exempt from certification in Part 73, the manufacturing processes for the composite pigments do not comply with the specifications in any current listing for cosmetics use. FDA recently listed composite pigments made from synthetic iron oxide, titanium dioxide, and mica, similar to your Cloisonne®, Cosmica® and Flamenco® products. These mica-based pearlescent pigments were listed as color additives for use in drugs (21 CFR 73.1128) and foods (21 CFR 73.350). These color additives have not been listed for cosmetic uses.
Furthermore, based on the agency's experience with the manufacture of pigments, such as mica-based pearlescent pigments, whereby the coating on the substrate mica is formed in situ by the addition of starting compounds and the application of heat or other physio-chemical processes, the agency is aware that residues are commonly formed as a result of the manufacturing process. The safety determination for the color additives must include consideration of such residues when used as cosmetics.
You should take prompt action to correct these violations. We request that you respond within 30 days from receipt of this letter with your planned corrective actions. Please forward your response to the attention of Kristen L. Moe, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, HFS-607, College Park, MD 20740-3835.
Jennifer A. Thomas
Division of Enforcement
Center for Food Safety and Applied Nutrition