FDA Globalization Act to Effect Beauty Industry
Posted: April 25, 2008
The U.S. House Committee on Energy and Commerce recently released a draft of legislation, The Food and Drug Administration (FDA) Globalization Act of 2008, intended to stimulate discussion about how to provide adequate funding and authority for the FDA to ensure the safety of the nation's food, drug, medical device and cosmetic supply in an increasingly globalized marketplace. The committee plans to hold hearings on the draft over the next few weeks and mark up the legislation soon thereafter.
The draft legislation contains several provisions that will impact the beauty industry:
- Create an up-to-date registry of all cosmetic facilities serving American consumers. All facilities operating within or exporting cosmetics to the US would be required to register with the FDA annually. Registration would require payment of a $2,000 fee per facility.
- Require adverse event reporting. All cosmetic facilities would be required to report adverse events resulting from the use of their products to the FDA.
- All cosmetic facilities would be required to comply with good manufacturing practices established by the Secretary of Health and Human Services.
- All importers of drugs, devices, foods and cosmetics would need to register with the FDA annually and pay a registration fee. To improve the accuracy of data and the ability of the FDA to more quickly identify parties involved in a crisis, facilities would be given a unique identification number.
- The FDA would be given additional resources to monitor foreign facilities producing food, drugs, devices and cosmetics for American consumers.