FDA Announces Removal of Unapproved Cold, Cough, and Allergy Drugs from U.S. Market

Mar 03, 2011   

On Wednesday of this week, the FDA announced its intent to remove approximately 500 unapproved prescription medicines from the U.S. market. The unapproved drugs are all intended for the relief of allergy, cough, and cold symptoms. The FDA alleges that none of these drug products have gone through an agency review of their safety and effectiveness.

Because these drug products have never undergone review for safety and effectiveness, the FDA believes that the products pose a risk to consumers. According to the FDA, because there are so many FDA-compliant over-the-counter (OTC) and approved prescription drug products available to consumers to treat cough, cold, and allergy symptoms, the unapproved drug products for these conditions are not necessary for the treatment of the public.

This ordered removal of cold medications is the latest wave of enforcement action by the FDA in the agencys attempt to remove unapproved drug products from the market. A large number of the targeted, unapproved drugs have been marketed in the U.S. since before the 1962 federal law requiring drugs to undergo federal review for safety and effectiveness.

FDA officials cited specific concerns regarding risky combinations of ingredients in the unapproved products as well as “time-released” products that may release active ingredients too slowly, too quickly, or inconsistently. Furthermore, the FDA has indicated that some of these unapproved products bear names that are similar to other products which could result in medication mix-ups or errors.

The manufacturers of the drugs ordered to be removed from the market have been given 90 days to stop manufacturing and 180 days to stop distribution of the drugs.

The FDAs list of unapproved drugs marketed in the United States can be found here.