A Food and Drug Administration advisory panel declared on Tuesday that a common oral decongestant, phenylephrine, is not effective in relieving a stuffy nose, leaving many consumers and pharmaceutical companies with questions heading into the cold and flu season.

Phenylephrine became more widely used as an oral decongestant in the early 2000s, when the Drug Enforcement Agency began more closely to regulate the more effective drug pseudoephedrine due to its use as an ingredient in methamphetamine.

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Researchers, however, began reevaluating the efficacy of phenylephrine shortly thereafter, with results of a 2007 study demonstrating its insufficient efficacy compared to placebos. The FDA met in 2007 to examine this evidence but ultimately voted to uphold its efficacy.

Now, phenylephrine is the most common over-the-counter decongestant medication, accounting for $1.8 billion in sales each year, and is found in a variety of products, including NyQuil, Benadryl, Mucinex, and Sudafed PE.

Here is everything you need to know about the decongestant market to be prepared for the coming flu and fall allergy season.

How do decongestants work?

Both phenylephrine and pseudoephedrine work by restricting blood vessels in the nasal passageways, making it easier to breathe. Because of their effects on blood vessels, both drugs have the side effects of raising blood pressure and should be avoided by those with cardiovascular problems.

But pseudoephedrine restricts blood vessels to a much greater extent than phenylephrine due to the way the chemicals are absorbed into the bloodstream.

"Why is oral phenylephrine so useless? It is extensively metabolized, starting in the gut wall," explained organic chemist Derek Lowe in a 2022 article published in Science. Lowe said that the useful rate of absorption "increases at higher doses as you apparently saturate out some of the metabolic pathways, but at the 10mg dose typically used for decongestants, you can forget it."

The FDA advisory committee did not present any data indicating that phenylephrine is unsafe to patients other than the already recognized possible side effects.

What other products are on the market to relieve symptoms?

The FDA's recommendation on Tuesday only affects the efficacy standard of the 10 mg oral dose of phenylephrine, as the same compound found in nasal spray decongestants has been found to be still effective. This is in part because the drug is able to work more immediately on blood vessels in the nose rather than indirectly via general blood steam absorption.

In many states, pseudoephedrine is also available in limited quantities without a prescription at pharmacy counters. The Combat Methamphetamine Epidemic Act of 2005, incorporated into the PATRIOT Act, requires the patient to present a photo ID for purchase, and pharmacies must keep this information for at least two years after purchase.

How will this affect the pharmaceutical industry?

The Consumer Healthcare Products Association, an organization representing over-the-counter medication manufacturers and distributors, said in a statement on Tuesday it was "disappointed" by the panel's vote.

The organization also asked the FDA to consider the "significantly negative unintended consequences associated with any potential change" as the agency considers revoking phenylephrine's status as "generally recognized as safe and effective."

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FDA data indicate that retail stores sold 242 million products containing phenylephrine in 2022, which is a 30% increase from 2021 levels.

A spokesperson for the FDA declined to specify to reporters when the agency will be making its final decision, but the agency typically sides with the deciding vote of its advisory committees.