The FDA Globalization Act's Impact on Fragrance
Posted: April 25, 2008
The US House Committee on Energy and Commerce recently released a draft of legislation, The Food and Drug Administration Globalization Act of 2008, which is 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 which will impact the fragrance industry:
- Create an up-to-date registry of all cosmetic facilities serving American consumers. All facilities operating within the United States or exporting cosmetics to the United States 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 requird 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 FDA annually and pay a registration fee. To improve the accuracy of data and the ability of FDA to identify more quickly 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.
This discussion draft presents significant challenges for the fragrance industry. The Fragrance Materials Association (FMA) intends to arrange a meeting with the appropriate Committee staff to discuss its concerns with these provisions. Click here (pdf, 182 kb) to view the draft bill (69 pages). (Source: FMA)