FDA Proposes Ending Use of Oral Phenylephrine in OTC Nasal Decongestants

The U.S. Food and Drug Administration (FDA) has proposed ending the use of oral phenylephrine as an active ingredient in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion. This move comes after an extensive review of available data determined that oral phenylephrine is not effective for this use. The proposed order is based on effectiveness concerns, not on safety concerns.

Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many OTC monograph drug products. It is important to note that some products only contain oral phenylephrine as a single, active ingredient, while others contain oral phenylephrine and another active ingredient, such as acetaminophen or dextromethorphan. The presence of oral phenylephrine in these medicines does not affect how other active ingredients work to treat the symptoms for which they are intended.



The FDA's decision is a significant shift in the market for OTC nasal decongestants. Companies like Procter & Gamble, Bayer, and Johnson & Johnson spinoff Kenvue will need to reformulate their products or remove them from the market if the final order is issued. This change could lead to a temporary loss of market share and revenue for these companies, as consumers may seek alternative treatments.



The FDA's action presents an opportunity for alternative decongestant products to fill the gap left by the removal of oral phenylephrine. With approximately 242 million bottles of phenylephrine-containing drugs sold in 2022, generating nearly $1.8 billion in sales, the market is substantial. Companies like CVS and Walgreens, which sold these products, could benefit from reformulating their offerings with alternative decongestants such as pseudoephedrine or nasal sprays. Additionally, nasal sprays containing phenylephrine remain unaffected by the FDA's proposal, presenting another market opportunity.

The FDA's proposed order to end the use of oral phenylephrine as a nasal decongestant will significantly impact the reformulation of existing products. Manufacturers will need to reformulate their products to remove phenylephrine, which is found in hundreds of OTC cold and allergy medications, including popular brands like NyQuil, Benadryl, Sudafed, and Mucinex. This change will require substantial resources and time, potentially leading to temporary shortages or increased costs for consumers.

In the wake of the FDA's proposal, consumers will likely seek alternative decongestants or treatment options. One popular choice is nasal spray versions of phenylephrine, which the FDA's decision does not affect. Additionally, consumers may turn to other decongestants like pseudoephedrine, which is available behind the pharmacy counter due to its potential misuse in making methamphetamine. Other alternatives include antihistamines for allergy-related congestion and expectorants for mucus buildup.

The FDA's decision to remove oral phenylephrine as a nasal decongestant is a significant development in the OTC market. While it presents challenges for companies and consumers, it also opens up opportunities for alternative decongestants and treatment options. As the market adapts to this change, investors should closely monitor the performance of companies in this sector and consider the potential impact on their portfolios.