The U.S. Food and Drug Administration has proposed removing oral phenylephrine, commonly used in cold and cough syrups, as an active ingredient in over-the-counter nasal congestion medications, saying it is ineffective, the health regulator said Thursday.
Phenylephrine is commonly used in a variety of over-the-counter flu and cold medications, including popular products such as Benadryl, Advil, and Tylenol.
It is also an ingredient in nasal sprays to treat congestion.
However, the FDA’s action only affects orally administered phenylephrine and not the nasal spray form.
Last year, an outside panel of experts voted unanimously against the effectiveness of orally administered phenylephrine for nasal congestion, adding that no further studies were needed to prove otherwise.
Companies such as Procter & Gamble and GSK were among the many accused in lawsuits of misleading consumers about cold medicines containing the ingredient.
The FDA is now seeking public comment on this proposed order.
For now, companies can continue to market drugs containing oral phenylephrine for nasal congestion relief.
However, the FDA said it would give manufacturers sufficient time to reformulate drugs containing oral phenylephrine or remove such drugs from the market.
Phenylephrine is commonly used in several over-the-counter flu and cold medications, including Benadryl, Advil, and Tylenol. Bloomberg via Getty Images
The Consumer Healthcare Products Association said in a statement that it was “disappointed in the FDA’s proposal to reverse its long-standing views on oral phenylephrine.”
The association added that it would review the proposed decision and submit comments accordingly.
Tylenol maker Kenvue, GSK, Haleon and Procter & Gamble did not immediately respond to Reuters’ request for comment.