Certain OTC Cold Symptom Medications Fail to Provide Decongestant Relief as Advertised, Pharmacy Alleges

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An Arkansas-based retail pharmacy claims in a proposed class action that several notable consumer health companies have misled the public by marketing over-the-counter (OTC) medications containing phenylephrine (PE) as effective nasal decongestants.

If you’ve bought cold and flu medicine containing phenylephrine, let us know here.

According to the 25-page lawsuit, Newton’s Pharmacy alleges that Procter & Gamble Company (P&G), GlaxoSmithKline (GSK), Reckitt & Benckiser LLC, Kenvue Inc.—formerly part of Johnson & Johnson—and Kenvue subsidiary McNeil Consumer Healthcare have knowingly misrepresented their OTC medications as providing nasal decongestant relief when, in fact, the active ingredient has failed to demonstrate any such benefit.

The suit relays that the OTC medications at issue include Vicks NyQuil Severe Cold and Flu, Vicks NyQuil Sinex, Vicks DayQuil Severe Cold and Flu, Vicks Sinex Severe, Vicks Flu Therapy Night Severe Cold and Flu, Sudafed PE, Benadryl Allergy Plus Congestion, Tylenol Cold + Flu, Advil Sinus Congestion & Pain and Robitussin. In addition, the case takes issue with OTC medications containing PE sold under the Mucinex and Theraflu brands.

The defendants’ respective websites, advertisements and product packaging similarly misrepresent that PE—the active ingredient in their OTC medications and a drug most often used to treat symptoms of the common cold—provides nasal decongestant relief, the complaint contends.

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Despite the representations, however, the Nonprescription Drug Advisory Committee (NDAC) to the federal Food and Drug Administration (FDA) published a report on September 11 of this year clearly concluding that “PE when used orally does not work as a decongestant,” the filing shares.

Per the lawsuit, the FDA is currently considering whether to ban PE from oral medications and pull hundreds of products from the market. As a result, retail pharmacies such as the plaintiff business, which have large inventories of the drugs at issue, are now “stuck having to decide whether to pull these products from [their] shelves, cancel wholesaling contracts, or impose disclaimers that the manufacturers of these products have failed to include on their own products,” the suit argues.

The defendants’ “unfair” and misleading practices have resulted in plummeting prices for oral medications containing PE and a decline in sales at retail pharmacies that stock the items, the case claims.

Consumers would not have purchased the ineffective OTC medications had they known that PE did not provide decongestant relief as represented, the complaint alleges. Likewise, had retail pharmacies known of this fact, they, too, would have chosen not to “devote[] shelf space to these products,” the filing states.

The lawsuit looks to represent any retail pharmacy that purchased oral nasal decongestant medications containing phenylephrine manufactured by P&G, GSK, Reckitt & Benckiser, Kenvue or McNeil Consumer Healthcare.

If you’ve bought cold and flu medicine containing phenylephrine, let us know here.