The U.S. House of Representatives Committee on Energy and Commerce released a Discussion Draft of the "Food and Drug Administration Globalization Act of 2008." The “Discussion Draft is meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety of . . . food, drug, medical device, and cosmetic” products, according to a memorandum accompanying the draft legislation.
The Discussion Draft is likely to undergo significant changes during hearings and markup. Among the interesting proposals:
- an annual registration fee of $2,000 for food facilities operating in the U.S. or exporting food to the U.S.
- provide a voluntary FDA-certification program
- require 2-year inspection intervals of foreign and domestic food establishments if not certified
- require country-of-origin labeling of foods
- require labeling whether certain foods have been treated with carbon monoxide
provide FDA with mandatory recall authority
- a registration fee to cover the cost of drug and device inspections
- drug and device country-of-origin labeling
- cosmetic facilities registration with the FDA at a cost of $2,000 per facility
adverse-event reporting for cosmetics
- increase the capacity of FDA to monitor foreign facilities
- Fees registration, reinspection, certification, certifying agent accreditation, laboratory accreditation, export certification, and importer registration.
The Energy and Commerce Committee predicts that the food registration fees will generate approximately $600 million for food safety activities at FDA. In addition, the bill provides for the levying of substantial fines for violations of the new requirements.
A hat tip to FDA Law Blog for writing of this.