We thought that you would be interested in learning that the Safe Cosmetics Act of 2010 was introduced in the US House of Representatives this week. If passed and enacted this legislation would increase the regulation of cosmetic product in the US and would affect both foreign and domestic companies.
Changes to the cosmetics regulatory system proposed in the legislation include:
1. Requiring all establishments that manufacture package or distribute cosmetics in the US to register with FDA annually and provide contact information, a description of the establishment’s activities, gross receipts, the number of employees, and the name and address of any company that supplies a cosmetic manufacturing establishment with ingredients for its products. Only the name and address of the companies would be published;
2. Authorizing FDA to establish fees to be assessed on companies with annual gross receipts or sales of more than $1 million to fund the costs of establishing and enforcing the new regulations;
3. Requiring that all cosmetic products, including those marketed for professional use, include a complete list of all ingredients. The law would also require full listing of ingredients on websites that sell cosmetics;
4. Requiring manufacturers and distributors of cosmetics and ingredients to submit all information they posses on the physical, chemical, and toxicological properties of ingredients, such as function and use, test results, and exposure data to FDA;
5. Requiring FDA to issue regulations listing ingredients identified by the Agency as “prohibited ingredients,” “restricted ingredients,” or “safe without limits” for use in cosmetics as well as a list of at least 300 ingredients that are not eligible for inclusion on the above lists due to lack of safety data. FDA must also make safety determinations for these ingredients;
6. Prohibiting companies from manufacturing, importing, distributing, or marketing a cosmetic or cosmetic ingredient if the company failed to provide information to FDA as required or if the company’s products contain non-permitted ingredients;
7. Requiring companies to notify FDA if a marketed product “is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic (or an ingredient or component used in any such cosmetic) will cause a threat of serious adverse health consequences or death to humans;”
8. Authorizing FDA to request a voluntary recall of the affected products, issue an order for the company to cease distribution, and, under certain circumstances, require a recall or issue an emergency recall order or adulterated or misbranded cosmetics;
9. Authorizing FDA to require that cosmetics containing nano-materials be include that information on the labels;
10. Establishing an adverse health effect reporting system;
11. Requiring FDA to publish a list of “alternative testing methods” that do not involve the use of animals to test a chemical substance and that must be used in product testing where practicable.
A voluntary registration and listing program for cosmetic companies is already in place at FDA and most of the proposed requirements simply bring regulation of the cosmetic industry up to standards already required for foods, dietary supplements and other regulated products. The requirement that FDA list the status of cosmetic ingredients could actually be helpful to industry; particularly to smaller companies who are not members of the Personal Care Product Council (www.personalcarecouncil.org), which has an enormous amount of ingredient information.
Even though the legislative process has just begun and similar bills submitted in previous years have not gained traction and become law, is not too early for US companies to contact their Representatives regarding the proposed law. It will also help your company’s long term future to consider implementing programs of information collection and ingredient verification, testing, etc. that help to ensure the quality and safety of your products.
If you have questions about current Cosmetic regulations or these proposed changes, please contact us.
You can read more about this legislation at the FDA Law Blog: The Law Blog
