The U.S. Food and Drug Administration has proposed that oral phenylephrine, commonly used in cold and cough syrups, not be used as an active ingredient in over-the-counter drugs because it is ineffective, health regulators announced Thursday.
Phenylephrine is widely used in a variety of over-the-counter flu and cold medicines, including popular products such as Benadryl, Advil, and Tylenol.
It is also an ingredient in nasal sprays to treat nasal congestion.
However, the FDA’s action pertains only to orally administered phenylephrine, not to nasal sprays.
Last year, an external panel of experts unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no further trials were needed to prove its effectiveness. .
Companies including Procter & Gamble and GSK are accused in lawsuits of misleading consumers about cold medicines containing this ingredient.
FDA is currently soliciting public comment on this proposed order.
For now, companies may continue to sell drugs containing oral phenylephrine as a nasal decongestant.
But the FDA said it would give manufacturers adequate time to reformulate drugs containing oral phenylephrine or remove such drugs from the market.
The Consumer Healthcare Products Association states: statement “We are disappointed in FDA’s proposal to reverse its long-established position on oral phenylephrine.”
The association added that it will consider the proposed order and submit comments accordingly.
Tylenol makers Kenview, GSK, Haleon and Procter & Gamble did not immediately respond to Reuters’ requests for comment.
