The US Food and Drug Administration (FDA) has initiated action against companies that manufacture, distribute or market certain unapproved prescription oral cough, cold, and allergy products.
Unapproved prescription products have not been evaluated by the FDA for safety, effectiveness and quality, and cannot be legally marketed in the US.
Companies that have previously listed unapproved prescription cough, cold and allergy products are required to stop manufacturing them within 90 days and stop shipping them within 180 days.
Companies that have not previously listed products are required to stop manufacturing and shipping their products immediately.
According to the FDA, people may be at greater risk when using these products than using FDA-approved prescription drugs or over-the-counter drugs.
The regulator noted that many healthcare providers have unknowingly prescribed unapproved products as the drugs’ labels do not disclose that they lack FDA approval.
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Deborah Autor, director of the Office of Compliance at the FDA Center for Drug Evaluation and Research, said that removing the unapproved products from the market will reduce potential risks to consumers.
“There are many FDA-approved prescription 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,” Autor said.
The move is a part of FDA’s Unapproved Drugs Initiative, which began in June 2006. It seeks to bring all unapproved new drugs into the approval process.