Untested Allergy, Cold Medicine Pulled by FDA
Spring cleaning came early for the Food and Drug Administration (FDA). The FDA has ordered the removal of more than 500 allergy and cold medicine drugs from the market, according to the New York Times.
The medications are being removed because they were never tested or reviewed for their safety and effectiveness. Deborah Autor, the director of the office of compliance in the FDA’s drug division, says:
“We don’t know what’s in them, whether they work properly or how they are made. We do not know if they are safe. We do not know if they are effective. We do not know if they have adequate quality. We do not even necessarily know who they are. And we believe that poses an untenable risk to consumers."
The FDA requires all new prescription drugs be submitted for scientific review before being released to the public. However, many cold and allergy drugs predate these regulations and escaped scrutiny.
So the agency said manufacturers of the unapproved cold drugs have 90 days to cease production and 180 days to stop shipping them, reports the Washington Post.
"Removing these unapproved products from the market will reduce potential risks to consumers," Autor said.
FDA officials are confident that relief from colds and allergies can be found in over-the-counter products that have already been approved.
The FDA promotes public health by regulating consumer goods such as food, drugs, tobacco and medications. Most of their power comes from the Drug and Food and Drug and Cosmetic Act, and the Public Health Service Act.
Here is a full list of the Unapproved Prescription Cough, Cold, and Allergy Products.
- FDA cracks down on untested cold medicines (CBS News)
- FDA Pulls 500 Prescription Cold and Allergy Drugs (Time Magazine)
- Consumer Protection (Findlaw.com)
- Prescription Drug Liability (Findlaw.com)
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