FDA Panel Finds Common Decongestant Ingredient Ineffective, But Phenylephrine Products Remain on Market for Now

Phenylephrine is a common ingredient in over 200 over-the-counter decongestants but was recently revealed to be ineffective for relieving nasal congestion.
The FDA granted phenylephrine GRASE status in 1976 without rigorous modern testing. It became more widely used after other oral decongestants were restricted.
In September 2022, an FDA advisory committee concluded oral phenylephrine doesn't work, but the drug remains on the market for now.
Pseudoephedrine and nasal sprays with phenylephrine work for congestion, but shouldn't be used long-term. Nasal steroids and antihistamines are recommended.
The FDA may eventually remove phenylephrine's GRASE status and pull it from the market, but there is no set timeline yet for regulatory action.

nationalgeographic.com

Relevant topic timeline:

9/11/2023

FDA Considers Pulling Ineffective Oral Phenylephrine from Over-the-Counter Medicines

The Food and Drug Administration (FDA) is considering whether to remove oral phenylephrine, a common ingredient in over-the-counter cold and cough medicines, from the market as a nasal decongestant due to research suggesting it is ineffective in relieving nasal congestion when taken orally.

9/16/2023

Major Retailers Sued Over Ineffective Decongestant Ingredients

A new lawsuit filed in California targets 14 retailers and pharmaceutical companies, including Walmart, CVS, and Amazon, for selling over-the-counter medicines containing phenylephrine as a decongestant, despite a regulatory panel ruling that it is ineffective, with the plaintiffs seeking class-action status and damages.

9/27/2023

Medical experts are recommending alternatives to oral decongestants, such as corticosteroid nasal sprays, antihistamines, steam, and rest, after the FDA voted against the effectiveness of phenylephrine in relieving nasal congestion.

10/19/2023

CVS Removes Ineffective Cold Medicines from Shelves

CVS Health is pulling cold and cough medications containing phenylephrine from its stores after an FDA panel deemed the common decongestant as ineffective.

10/19/2023

CVS Removing Oral Decongestants With Phenylephrine Only After FDA Questions Efficacy

U.S. pharmacy chain CVS Health is discontinuing the sale of decongestants containing phenylephrine as the only active ingredient due to doubts about its effectiveness, but will continue to offer other oral cough and cold products to meet consumer needs.

10/20/2023

Rite Aid Will Keep Selling Oral Phenylephrine Despite FDA Panel Doubts; CVS To Remove Products

Rite Aid will continue to sell products with the ingredient phenylephrine, despite an advisory committee declaring it ineffective when taken orally, but will comply if the FDA decides to remove these products.

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Posted 9/29/2023, 11:32:21 AM

FDA Panel Finds Common Decongestant Ingredient Ineffective, But Phenylephrine Products Remain on Market for Now

Phenylephrine is a common ingredient in over 200 over-the-counter decongestants but was recently revealed to be ineffective for relieving nasal congestion.
The FDA granted phenylephrine GRASE status in 1976 without rigorous modern testing. It became more widely used after other oral decongestants were restricted.
In September 2022, an FDA advisory committee concluded oral phenylephrine doesn't work, but the drug remains on the market for now.
Pseudoephedrine and nasal sprays with phenylephrine work for congestion, but shouldn't be used long-term. Nasal steroids and antihistamines are recommended.
The FDA may eventually remove phenylephrine's GRASE status and pull it from the market, but there is no set timeline yet for regulatory action.

nationalgeographic.com

Relevant topic timeline:

9/11/2023

FDA Considers Pulling Ineffective Oral Phenylephrine from Over-the-Counter Medicines

9/16/2023

Major Retailers Sued Over Ineffective Decongestant Ingredients

9/27/2023

10/19/2023

CVS Removes Ineffective Cold Medicines from Shelves

CVS Health is pulling cold and cough medications containing phenylephrine from its stores after an FDA panel deemed the common decongestant as ineffective.

10/19/2023

CVS Removing Oral Decongestants With Phenylephrine Only After FDA Questions Efficacy

10/20/2023

Rite Aid Will Keep Selling Oral Phenylephrine Despite FDA Panel Doubts; CVS To Remove Products