Tags: decongestant | phenylephrine | otc | ineffective | public | opinion | fda

FDA to Seek Public Opinion on OTC Decongestant

cold medicines on shelf in pharmacy
(AP)

Thursday, 14 September 2023 12:29 PM EDT

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.

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.

© 2024 Thomson/Reuters. All rights reserved.


Health-News
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...
decongestant, phenylephrine, otc, ineffective, public, opinion, fda
237
2023-29-14
Thursday, 14 September 2023 12:29 PM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved