The FDA Globalization Act of 2008

The U.S. House Committee on Energy and Commerce is proposing legislation entitled “The FDA Globalization Act of 2008.” The legislation intent is to stimulate discussion about ways to provide adequate funding for the FDA and contains several provisions that are sure to impact the cosmetics industry. The most important changes related to cosmetics would be:

1. All US or foreign facilities that manufacture, warehouse or import cosmetics for sale in the U.S. will have to register annually with the FDA and pay a $2,000 per facility registration fee (subject to annual increases).

2. All cosmetic manufactures will have to register their products with the FDA and will be required to file adverse event reports.

3. All cosmetic facilities would be required to comply with Good Manufacturing Practices (GMP) established by the Secretary of Health and Human Services.

4. All cosmetic importers would be required to register annually with the FDA and pay a $10,000 registration fee.