The US Food and Drug Administration (FDA) has proposed a new rule to eliminate oral phenylephrine from popular cold and flu medications, citing evidence that the ingredient is ineffective as a decongestant.
Phenylephrine, a staple in many over-the-counter (OTC) products, appears in well-known brands such as Sudafed PE, Mucinex, Benadryl, Advil, Tylenol, Vicks, and Dimetapp. The FDA’s proposal impacts a significant portion of the US decongestant market, valued at roughly $1.76 billion as of 2022, potentially reshaping consumer options on pharmacy shelves.
Phenylephrine became a primary ingredient in OTC decongestants following restrictions on pseudoephedrine, which is more effective but regulated due to its use in methamphetamine production. Since 2006, phenylephrine has largely replaced pseudoephedrine in OTC medications as it is easily accessible, allowing consumers to purchase it off the shelf without restrictions.
Despite its widespread availability, phenylephrine’s efficacy has been questioned for nearly two decades. Early studies funded by the industry, which supported its approval in the 1970s, have been scrutinized for methodology concerns. In recent years, a growing body of research has shown that phenylephrine has minimal decongestant effects when taken orally, leading to an advisory committee recommendation in 2022 that it be removed from OTC products. Studies indicate that when ingested, phenylephrine is mostly broken down in the digestive system, with little to none reaching the nasal passages.
The proposed FDA order, which is currently open for public comment, would affect a range of products from familiar brands, including Advil Sinus Congestion & Pain, Sudafed PE Nasal Decongestant, Vicks DayQuil and NyQuil, and Tylenol Cold & Flu Severe. If the order is finalized, manufacturers will be required to reformulate these products or remove them from shelves. The ruling does not apply to nasal sprays or eye drops containing phenylephrine, which are considered effective due to their direct delivery to nasal tissues.
According to Dr. Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, the agency’s primary role is to ensure the effectiveness and safety of drugs.
“We are taking this next step to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” Cavazzoni stated.
She reflected the FDA’s commitment to align products with evidence-based efficacy.
For consumers seeking effective decongestant options, pseudoephedrine-based products remain available, though they require purchase from behind the pharmacy counter and often necessitate identification. Products with pseudoephedrine, such as regular Sudafed, are still considered highly effective by healthcare professionals. Some physicians, including Dr. Geoffrey Rutledge, Chief Medical Officer at HealthTap, do not recommend phenylephrine products and suggest pseudoephedrine or other symptom-targeted medications.
Alternatives like nasal sprays containing phenylephrine or oxymetazoline may provide relief directly at the source but should be used with caution due to the potential for “rebound congestion” if used for extended periods. For allergy sufferers, options like nasal steroid sprays (e.g., Flonase) or antihistamines can target underlying symptoms without relying on decongestants.
While the FDA’s proposed ban has not yet impacted the availability of products, major retailers like CVS have preemptively removed some phenylephrine-only products from their shelves. Consumers are encouraged to check the “active ingredients” on product labels and consult healthcare providers if they are unsure of which medication best suits their needs.
With input from the Daily Mail, CNET, and Science Alert.
