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Posted at 10:15 AM ET, 03/ 2/2011

FDA cracks down on unapproved cold, cough, allergy drugs

By Rob Stein

Federal health officials announced Wednesday that they were cracking down on certain prescription cold, cough and allergy products that had never been approved by regulators.

The Food and Drug Administration said the products had not been evaluated to make sure they were safe and effective and so about 500 products will be removed from the market. Some of the products are labeled for use for young children. Some are supposed to be time-released, which can be difficult to produce.

"Removing these unapproved products from the market will reduce potential risks to consumers," said Deborah Autor, the director of the FDA's Office of Compliance in the Center for Drug Evaluation and Research. "There are many FDA-approved prescription products, as well as appropriately marketed over-the-counter products, available to treat cough, cold, and allergy symptoms; so, we expect little or no negative impact on consumers from the removal of these unapproved products."

Companies making the affected products must stop manufacturing them within 90 days and stop shipping the products within 180 days, the agency said.

For a list of the affected products click here.

For more information about the FDA's action, click here.

By Rob Stein  | March 2, 2011; 10:15 AM ET
Categories:  FDA  
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The GMO artificial sweetener, Aspartame, was found to be unsafe for human consumption seven times by the FDA itself, and yet it is not only still on the market, it is in over 6,000 foods and beverages in this country. Aspartame is now included on the EPA's Potentially Dangerous Chemicals List! The FDA officials must take the hypocritical oath.

Posted by: meadowrock | March 3, 2011 10:31 AM | Report abuse

The FDA is a joke. They approved meat that is cloned to be sold for human consumption without needing to be labeled. Also, genetically-altered plants and animals are fine for human consumption without extensive testing (thanks Monsanto).

FDA doesn't remember why it was brought to bear. Like many parts of our gov't, they are nothing more than enablers of corrupt corporations. They don't really care about our safety. And if the EPA was worth a damn these days, we'd actually do more than fining companies that repeatedly break the law with pollution.

Posted by: fbutler1 | March 3, 2011 10:45 AM | Report abuse

No story here. The overwhelming majority of these drugs are common combinations of drugs that have been used in "approved" OTC cold meds for 30-40 years.

It is not the active ingredient drugs in question. It seems to be this list of products from certain manufacturers that failed to go through some FDA check-off process.

These are primarily low-cost manufacturers, the expensive, big-name manufacturers are not here and will continue to be available. My primary concern with any drug is if the listed active ingredients are actually in there, and they are the only active ingredient in there. Unfortunately, the FDA process is not very good at finding that.

Posted by: mellwood1 | March 3, 2011 12:27 PM | Report abuse

I worked for the FDA for 30 years as a lab scientist; when I started, we did things like analyze samples coupled to complaints about potency. Gradually, the pharmaceutical industry funded enough lawmakers in both parties to have considerable sway in Congress, esp. those on key committees. More and more, funds for lab science were cut, and areas of responsibility were added without any funding. The Prescription Drug User Fee Act (PDUFA) has played a big role, giving the industry enormous control over the FDA funding levels, and over how the agency used those funds. The major emphasis has been on the speed of the review process; the quality of the review became less important, and the ability to do laboratory tests further diminished. The agency has become an industry lap dog at this point, and lives in fear of offending Congress. And we truly have the best Congress that money can buy.

Posted by: Bushman1969 | March 3, 2011 9:11 PM | Report abuse

There's general agreement worldwide that Aspartame is safe:

just like saccharine.

Posted by: GWGOLDB | March 3, 2011 10:22 PM | Report abuse

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