US FDA Proposes to Remove Oral Phenylephrine from Over-the-Counter Drugs
Proposal Aimed at Ensuring Effective Treatment for Nasal Congestion
The US Food and Drug Administration (FDA) has proposed to remove oral phenylephrine, a widely used ingredient in cold and cough syrups, as an active ingredient in over-the-counter (OTC) drugs for nasal congestion. According to the FDA, phenylephrine is not effective in treating nasal congestion.
Background on Phenylephrine
Phenylephrine is commonly used in various OTC flu and cold medicines, including popular products such as Benadryl, Advil, and Tylenol. It is also an ingredient in nasal sprays used to treat congestion. However, the FDA’s proposal only affects orally administered phenylephrine and not the nasal spray form.
Expert Panel’s Decision
Last year, an outside panel of experts unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant. The panel concluded that no more trials were required to prove otherwise.
Companies Accused of Deception
Several companies, including Procter & Gamble and GSK, have been accused in lawsuits of deceiving consumers about cold medicines containing phenylephrine.
Public Comment Period
The FDA is now seeking public comments on its proposed order. For now, companies may continue to market drug products containing oral phenylephrine as a nasal decongestant. However, the FDA will provide manufacturers with appropriate time to either reformulate drugs containing oral phenylephrine or remove such drugs from the market.
Industry Reaction
The Consumer Healthcare Products Association expressed disappointment with the FDA’s proposal, stating that it would review the proposed order and submit comments accordingly. Other companies, including Kenvue, GSK, Haleon, and Procter & Gamble, did not immediately respond to Reuters’ request for comment.
Conclusion
The FDA’s proposal aims to ensure that OTC drugs are effective in treating nasal congestion. The decision is a significant step towards promoting safe and effective treatments for consumers. The FDA will now seek public comments on its proposed order and provide manufacturers with time to reformulate or remove oral phenylephrine-containing drugs from the market.
FAQs
Q: What is the purpose of the FDA’s proposal?
A: The proposal aims to ensure that OTC drugs are effective in treating nasal congestion by removing oral phenylephrine, which has been deemed ineffective by experts.
Q: What products contain oral phenylephrine?
A: Oral phenylephrine is commonly used in various OTC flu and cold medicines, including products such as Benadryl, Advil, and Tylenol.
Q: What is the industry’s reaction to the proposal?
A: The Consumer Healthcare Products Association expressed disappointment with the proposal, stating that it would review the proposed order and submit comments accordingly. Other companies did not immediately respond to Reuters’ request for comment.
Q: What is the next step in the process?
A: The FDA will seek public comments on its proposed order and provide manufacturers with time to reformulate or remove oral phenylephrine-containing drugs from the market.
