Thread: FDA chief vows new, tougher stance on food, drug safety

FDA chief vows new, tougher stance on food, drug safety

Updated 6m ago
By Elizabeth Weise, USA TODAY

The Food and Drug Administration is moving towards stronger, more aggressive and much faster responses to enforcing the laws and regulations that govern the safety of drugs, medical devices and much of the U.S. food supply, the agency's new commissioner said Thursday.
In eight weeks in her new position, Commissioner Margaret Hamburg said she has heard loud and clear that the public, and Congress, wants a strong FDA.


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FDA must be vigilant, it must be strategic, quick and visible, she told the audience in a speech to the Food and Drug Law Institute in Washington D.C.

Over the past several years, FDA has faced a larger number of high profile food recalls, including pistachios, peanuts, spinach, tomatoes, hot peppers, cookie dough, pet food and various meats, as well as problems with medical devices and drugs. The agency has also been criticized for not acting quickly or strongly enough when it encounters violations of the law.

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"FDA must show industry and consumers that we are on the job." That means publicizing enforcement actions and the reasons for them widely, she said. The pathway to enforcement is sometimes too long and arduous when the public health is at risk, she said.

"In some cases, serious violations have gone unaddressed for far too long. These include violations involving product quality and safety, adulteration and misbranding. false, misleading, or otherwise unlawful labeling; and misleading advertising," she said.

But now, FDA is streamlining its internal processes to speed and strengthen enforcement, Hamburg added.

"Companies must realize that if they are crossing the line they will be caught and if they fail to act, we will," she told the audience. The new guidelines:

• When FDA inspectors find significant problems at a food, drug or medical device firm, the company will generally have no more than 15 days to respond.

•FDA warning letters will go out much more quickly with review by its lawyers limited to only significant legal issues.

•FDA will work more closely with local, state and international officials, who often have more authority to take action more quickly than FDA.

•FDA will prioritize enforcement follow-up after warning letters are sent or a product is recalled.

• FDA will no longer issue multiple enforcement letters before taking action.

• Finally, FDA will create a "close-out" process and issue a "close-out letter" indicating violations corrected.

Hamburg is in the processing of creating that close-out process and hopes that "receiving a close-out letter quickly becomes a top industry priority," she said.

FDA recently received an increase in funding from Congress, which will aid in this overhaul. In addition, last Thursday the House passed major food safety legislation, which among other things would give FDA mandatory recall authority. The Senate will vote on the legislation in the fall.

http://www.usatoday.com/news/health/200 ... oner_N.htm

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Just keep the FDA and other fool gov't out of our farms and home gardens.

Originally Posted by ELE

Just keep the FDA and other fool gov't out of our farms and home gardens.

The FDA doesn't inspect home gardens. They don't care if you poison yourself.

They just don't want others to poison you or you to poison others.

Just like the Health Department doesn't inspect your kitchen but they inspect the
kitchens of restaurants so that they don't kill you with bad food.