FDA Takes Unapproved Cold Medicine Off Shelves

NEW YORK (MainStreet) —  The Food and Drug Administration announced on Wednesday that it will remove unapproved prescription cough, cold and allergy medications from the market as part of its ongoing initiative to stop the sale of drugs that aren’t up to current standards.

Over 500 prescription medications are involved in the atest round up, including Pseudo Cough Syrup, ColdMist Extended Relief tablets and Pediahist, a cold formula labeled for babies as young as one month old. You can find the complete list of products on the FDA’s website.

Many doctors and health care providers unaware of the status of certain drugs have continued to prescribe them because the labels do not disclose that they lack FDA approval, according to the agency.

“Removing these unapproved products from the market will reduce potential risks to consumers,” Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research said in a written statement.

Such a widespread recall begs the question: How exactly did these products end up on the market in the first place?

As MainStreet has previously reported, these drugs were essentially grandfathered onto store shelves. While the FDA now requires that companies submit all new prescription drugs for review before they are put on the market, they haven’t always.

In fact, it wasn’t until 1962 that regulations were introduced requiring drugs to prove their effectiveness. Many drugs that predate the legislation have managed to stay on the market without submitting to the required testing.

In 2006, the FDA launched its current initiative to get these medicines off of shelves, at least until they go through the approval process.
Affected companies that have already registered their products for FDA testing will have to stop manufacturing them within 90 days and stop shipping the unapproved products within 180 days. Companies that have not yet registered their products must stop manufacturing and shipping them immediately.

Additionally, the FDA suggests that consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.

Autor said they are not anticipating any drug shortages in relation to the withdrawal of these medications, given that so many cough, cold, and allergy drug products exist that are FDA-approved or appropriately marketed over-the counter.

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