US FDA to seek public opinion before banning popular cough syrup ingredient

[September 15, 2023]  (Reuters) -The U.S. Food and Drug Administration said on Thursday it would seek public opinion before finalizing its decision to remove a decongestant widely used in cough syrups from the agency's list of ingredients for over-the-counter (OTC) use.

The FDA's clarification follows a unanimous vote by its panel of outside experts on Tuesday against the effectiveness of oral OTC medicines made with phenylephrine, an ingredient widely used in cold and cough syrups.

If the FDA concurs with the panel's view, it will first issue a proposed order removing phenylephrine from the list of ingredients that are allowed in OTC drugs, and seek public comment on it.

After considering the comments, if the FDA continues to conclude phenylephrine is not effective, the agency would issue a final order on it and work with manufacturers to reformulate products to effectively treat symptoms of cold or allergies.

Meanwhile, a lawsuit was filed against Johnson & Johnson and Procter & Gamble, which makes Vicks NyQuil, accusing the companies of deceiving consumers about decongestant cold medicines.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Kenvue's Tylenol and GSK's Advil are among the prominent cough and cold syrups containing phenylephrine that are sold in the United States. Johnson & Johnson spun off its consumer healthcare unit as Kenvue this year.

Besides cough syrup, phenylephrine is also an ingredient used in nasal sprays, but the agency said that its order would only be related to the oral drugs and not the spray form.

(Reporting by Leroy Leo in Bengaluru; Editing by Shailesh Kuber and Devika Syamnath)

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