FDA Commissioner: Six new compliance initiatives

FDA Commissioner Hamburg today:

Compliant industry should support these intitatives that will prevent them from being undercut by firms taking illegal shortcuts:

• 15 days for FDA to issue Warning Letters. Warning letters will no longer be held waiting for firms to respond.


• No GC reviews unless the case presents a novel legal issue. The Bush adminsitration policy of having letters reviewed by anti-consumer activitists planted in the Agency offices is cancelled.


• State coordination where state law allows rapid response to seize products and correct issues.


• A Warning Letter or recall will trigger enforcement follow up. Cases will no longer be allowed to languish or remain open with incertain resolution. Firms will get a knock on the door and an inspection.


• No multiple warning letters. The second Warning Letter to a firm will trigger increased scrutiny and follow up actions.


• After Warning Letter is satisfactorily resolved, firms may be eligible for a "close out letter" to document the matetrs have been resolved, e.g., after an FDA inspection.

Also she mentioned FDA has asked for additional power to mandatory food recalls.

The full text of the speech will be available immediately following the event here.

A video recording of the speech will be available after 4:00 this afternoon here.

FDA Food Safety Changes Round up

The FDA food safety law is written by Big Commercial Farms to keep FDA out of dirty Food, Inc.

Find out what food safety requirements didn't pass here and here, here thanks to the commercial farms that contaminate the animals we eat.

Findlaw on Food Safety: In the wake of recent food recalls, foodborne illnesses, and reports of unhygienic food processing conditions noted in some factories, the U.S. House of Representatives passed the Food Safety Enhancement Act this week in a vote of 283 to 142, significantly increasing resources for food inspection and quality control.

Although this article says FDA had no power over food imports, the law at Section 801 gives FDA MORE authority, allowing the agency to refuse to admit food that "appears" in violation, without having to prove that it is adulterated or filthy.

Here is a summary of the law.

See also foodsafety.gov/