The FDA wants to ban a common ingredient in over-the-counter cold and allergy medications

The U.S. Food and Drug Administration (FDA) announced today that it is proposing a new rule to stop the use of an ingredient in popular over-the-counter cold and allergy medications.

The rule would remove oral phenylephrine from the administration’s list of approved active ingredients that can be used in over-the-counter (OTC) drugs like NyQuil (PG+1.50%), Benadryl (JNJ-0.68%), and Mucinex (RBGLY-1.20%).

The agency noted that this proposal is based on concerns over the ingredient’s effectiveness and not its safety. Phenylephrine is believed to relieve congestion by reducing swelling in blood vessels inside nasal passages. Following a review of available data, the agency determined that phenylephrine, when taken orally, does not actually work as a nasal decongestant. Last September, an FDA advisory committee reached the same conclusion.

“It is the FDA’s role to ensure that drugs are safe and effective,” said the director of the FDA’s Center for Drug Evaluation and Research (CDER), Patrizia Cavazzoni, in a press release. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

The FDA is now seeking public comment on the proposed rule, with the comment period closing in May. If the rule is finalized, the agency will provide manufacturers with time to reformulate their products or remove them from the market. The rule would not affect phenylephrine-based nasal products.

“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” said Theresa Michele, director of the Office of Nonprescription Drug Products in CDER. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”

The FDA reported in 2022 that about 242 million bottles or packages of OTC cold and allergy medications with oral phenylephrine were sold in stores that year.

In 2023, CVS (CVS-7.27%) voluntarily removed from its shelves medications that contained oral phenylephrine as its only active ingredient.