Researchers Call on FDA (Again) to Remove ‘Ineffective’ OTC Cold and Flu Medicines

The 2022-23 cold and flu season has proven to be one of the worst on record and though the peak is hopefully behind us, if you are looking for effective relief from a cold or flu medicine, you may not find it over the counter.

Every year, Americans spend billions of dollars on OTC cold and cough remedies. But according to researchers at the University of Florida College of Pharmacy, many OTC cold and flu medicines marketed to clear up stuffy noses and relieve sinus congestion don’t work.

Drs. Randy Hatton and Leslie Hendeles are renewing their call for the FDA to remove OTC nasal decongestant products containing oral phenylephrine from the market. This comes after the researchers filed a citizen’s petition with the FDA in 2015 that would later gain the support of the American Academy of Allergy, Asthma and Immunology.

“Phenylephrine is now the number one ingredient in oral nose and sinus products; it is found in 261 such products,” Hatton and Hendeles wrote in an editorial published in the Annals of Pharmacotherapy last year.

Despite its ubiquity among OTC cold and flu medicines, including versions of DayQuil, Mucinex and Tylenol Cold and Flu, oral phenylephrine is ineffective as a decongestant because too little of the ingredient gets into the bloodstream after being metabolized in the gut, Hatton and Hendeles argued, citing four studies they say show it performs no different than a placebo.

“Consumers should not waste their money on products that contain oral phenylephrine,” Hatton told TINA.org. “Consumers should read labels, look for oral phenylephrine, and reject these products.”

TINA.org reached out to the makers of DayQuil (Procter & Gamble), Mucinex (Reckitt Benckiser) and Tylenol (Johnson & Johnson) for comment. None of the companies responded. The Consumer Healthcare Products Association, an industry trade group, said the “FDA has recognized that phenylephrine is a safe and effective oral nasal decongestant” and its member companies comply with federal regulations. An FDA spokesperson said the agency will respond directly to the University of Florida researchers.

In their editorial Hatton and Hendeles suggested that one of the reasons the FDA has yet to act is because the products at issue are generally safe to use at the recommended dosages.

“A fundamental principle for FDA is risk-based enforcement,” they wrote. “Safety gets priority over lack of effectiveness.”

Find more of our coverage on OTC cold and flu medicines here.