Originally published in The Nano Newswire

A new federal bill will reform and amend aspects of the Food, Drug, and Cosmetic Act of 1938, to require much greater regulation of cosmetic products manufactured, imported, distributed and sold in the United States. The bill requires the detailed disclosure of ingredients, including nanomaterial ingredients and even contaminants from the manufacturing process or packaging at specified levels, that can be found in the final cosmetic products used by consumers. The disclosure is required both on product packaging and by publication, and applies to in-store, professional salon and internet retail sales of cosmetics.

The Safe Cosmetics Act of 2011 (the "Act") (H.R. 2359) was recently introduced in the House of Representatives by its lead sponsor, Rep. Janice Schakowsky of Illinois, and several co-sponsors. The Act includes a detailed scheme to require the Food and Drug Administration ("FDA") to obtain what may have traditionally been proprietary information from cosmetic manufacturers concerning the chemical ingredients and certain contaminants present in their products, and assess them for safety. The Act contains a process for phasing out of use substances that are either known to be or proven to be toxic, and making all product ingredient and contaminant information more available and transparent to consumers.

Although a comprehensive summary of the Act's provisions is beyond the scope of this blog, Section 613 of the Act is remarkable as it requires "that the label on each package of cosmetics...bears a declaration of the name of each ingredient in such cosmetic in descending order of prominence." The Act requires rule-making by the FDA to establish requirements for listing ingredients on labels, how such labels are to be made for products that are too small in size to contain the required label or are sold on the internet, and for public disclosure of the ingredients. The Act specifically authorizes regulations by FDA for requiring nanomaterial labeling concerning "minerals or other particulate ingredients" as "nano-scale" on a cosmetic label if more than one percent of the ingredients in the cosmetic "are 100 nanometers or smaller in not less than 1 dimension," or if such ingredients "possess scale-specific hazard properties." Any ingredient required by the Act to be listed on a label, shall not be treated as a trade secret, and only "[t]he concentration of cosmetic ingredients used in a finished cosmetic shall be considered confidential business information and may not be made available to the public...." These labeling requirements will become effective within 18 months of enactment of the Act, and shall apply to all cosmetics available for retail sale, and to all manufacturers, distributors, and internet vendors of such cosmetics.

The Act was referred to the Committees on Energy and Commerce and Education and the Workforce. We will follow the progress of the Act here for our readers.


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