Tens of millions of Americans suffer from nasal and sinus congestion every year. People had come to rely on an increasing number of over-the-counter nasal decongestants to relieve their symptoms. The active ingredient in these products was pseudoephedrine. Unfortunately, instead of using the pseudoephedrine products as intended, for nasal and sinus congestion, some people began converting the products into methamphetamine. As a result, Congress passed The Combat Methamphetamine Epidemic Act of 2005, which was signed into law in 2006. This legislation created new requirements for the sale of products containing pseudoephedrine. The requirement most people are aware of is the need to buy pseudoephedrine from the pharmacist behind the counter with proper photo identification. The pharmacy is supposed to keep information about your purchase for two years in order to monitor the volumes being purchased.

In order to fill the void of over-the-counter decongestants, companies changed their product ingredients to substitute phenylephrine for pseudoephedrine in 2006. In September 2023, the Food and Drug Administration (FDA) released its briefing document on oral phenylephrine use. Although phenylephrine is generally recognized as safe by the FDA, FDA committees have been reviewing efficacy studies of phenylephrine since 2007. The Nonprescription Drugs Advisory Committee met September 11-12, 2023, and released a briefing document that concluded, “we have now come to the initial conclusion that orally administered PE [phenylephrine] is not effective as a nasal decongestant at the monographed dosage (10 mg of PE hydrochloride every 4 hours) as well as at doses up to 40 mg (dosed every 4 hours).” The headlines were quick to note the conclusion and speculate that the product would be pulled from shelves.

Two days later on September 14, 2023, the FDA published on its website the current Nonprescription Drugs Advisory Committee conclusion that “current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant.” However, the panic may have been premature as the FDA explained there are more steps needed:

“If FDA determined that oral phenylephrine is not effective, the agency would first issue a proposed order removing phenylephrine from this monograph. The public would then have the opportunity to comment on the proposed order. If, after considering the comments, FDA continued to conclude phenylephrine is not effective, the agency would issue a final order removing this ingredient from the monograph, and phenylephrine would no longer be considered GRASE [generally recognized as safe and effective]. FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies.”

In 2022, sales in the United States of products that contained phenylephrine resulted in an estimated $1.8 billion. The Consumer Healthcare Products Association (CPHA) commissioned a survey of consumers in July 2023 that found consumers relied on phenylephrine products and the removal would hurt older adults in rural communities. The CHPA also noted that during 2023, half of United States households have purchased phenylephrine products. Since the FDA announcement, CVS indicated it would be pulling all oral phenylephrine products from its shelves. Walgreens has a question and answer page and recommends alternative products.

It has been four months since the FDA’s last comment on the status of phenylephrine. While phenylephrine may not have a future as a decongestant, there is no definitive answer yet from the FDA and no required removal of products with oral phenylephrine. Litigants, however, are not waiting. Dozens of potential class actions were filed against multiple drug manufacturers after the FDA’s September announcement. The cases have been consolidated into MDL 3089, In Re: Oral Phenylephrine Marketing and Sales Practices Litigation. Additional class actions were filed alleging that Kenvue, the maker of Sudafed PE and Tylenol Sinus and other common medications, knew before its May 2023 initial public offering that its over-the-counter phenylephrine medications were under investigation. The issues in the IPO and MDL cases will be different, but both will seek internal company knowledge. Besides costly discovery, the litigation may be further complicated if the FDA makes any additional announcements or orders the removal of oral phenylephrine products. We will track developments at FDA and in this litigation and publish updates to this post as warranted.