FDA cracks down on unapproved cold, cough, allergy drugs
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.
| March 2, 2011; 10:15 AM ET
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