CATrends: OTC Cold and Flu Meds Falsely Marketed as Nasal Decongestants

This article highlights a trend in class-action litigation as identified by our Class-Action Tracker. Thus the name of this feature, CATrends. (Apologies if you were expecting funny cat videos.)

An FDA panel’s recent findings regarding a popular nasal decongestant’s inability to clear clogged noses has opened the floodgates for class-action lawsuits against the makers of over-the-counter cold and flu medicines containing the ingredient at issue.

Since the advisory panel concluded last month that the latest scientific evidence does not support that oral phenylephrine actually relieves congestion, more than 60 lawsuits have been filed against the marketers of Tylenol Cold and Flu, Mucinex and Sudafed PE, among other products.

The complaints allege that the OTC medications are falsely marketed to treat nasal congestion when the active ingredient in the products – phenylephrine – is not an effective decongestant.

Sales of OTC cold and flu medicines containing phenylephrine nearly surpassed $1.8 billion in 2022, according to the FDA panel.

A September complaint against Johnson & Johnson, maker of Sudafed PE, alleges:

Defendants’ nasal decongestion health representations and omissions were a material factor in influencing Plaintiffs and the class members’ decision to purchase the oral PE Products. In fact, the only purpose for purchasing the oral PE Products is to obtain the represented nasal decongestion health benefits. Defendants’ conduct has injured Plaintiffs and the class members because Defendants’ oral PE Products are worthless and cannot support or benefit nasal decongestion health in any way.

Other brands named in the lawsuits include Advil, DayQuil, NyQuil, Robitussin and Theraflu. Several store brands are also named in the complaints, including CVS, Rite Aid, Target, Walgreens and Walmart. All of the lawsuits are pending.

What’s next 

While the FDA usually sides with its advisory panels, it could be years before the agency orders products containing oral phenylephrine removed from the market. Companies may also choose to take proactive action and reformulate their products.

In the meantime, consumers experiencing cold/flu symptoms should consult with their health care provider to determine the best treatment option.

Find more of our coverage on cold and flu medicines here.