FDA Announces Reforms To Protect Consumers

Many Georgians were affected by the recent salmonella outbreak related to peanut butter. Some were sickened by the defective product and others lost jobs in the peanut processing plant that became ground zero for the recall. Now, the Food and Drug Administration has announced it 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,
New FDA commissioner Margaret Hamburg has been in office only 8 weeks but has made positive moves to protect citizens. During the past several years, the FDA has faced a 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 rightly criticized for not acting quickly or strongly enough when it encounters violations of the law.
The new Commissioner admitted that 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.
But now, she has announced that the FDA is streamlining its internal processes to speed and strengthen enforcement. The new guidelines being implemented are:
• 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.
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 is expected to vote on the legislation in the fall.