Saturday, April 19, 2008

FDA Globalization Act of 2008

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.

1 comment:

Chelsea said...

THIS from an agency that fails miserably in it's job to even inspect our meat properly. It's the height of arrogance & delusional for the FDA to think they can drive millions of small companies out of business in the USA virtually overnight with the Globalization Act. Aside from reaping a windfall of revenue from this act, the FDA seeks to sidestep being held accountable when there is a health scandal related to food, drugs & cosmetics. This way they can point the finger of blame at the businesses involved & say they didn't comply with the laws so it's not the FDA's fault. I still think that individuals in the FDA should be held legally liable & criminally accountable for approving drugs that result in massive deaths like the recent Bayer scandal. This act is going to completely prevent holding the FDA accountable for anything other than shuffling paperwork. I urge everyone to use your search engine of choice & type in Globalization Act of 2008 & start going down the list to find every petition you can sign against this act. Then write all your government representatives & demand they do something to stop these unAmerican regulations from going into effect & condemning millions of businesses to fold.