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J&J unit, P&G, Walgreens misled shoppers about decongestants–lawsuits By Reuters

© Reuters. FILE PHOTO: Signage is seen exterior of the Meals and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Picture

By Jonathan Stempel

(Reuters) – Procter & Gamble (NYSE:), Walgreens and Johnson & Johnson (NYSE:)’s former client enterprise are amongst a number of firms accused in lawsuits of deceiving shoppers about chilly medicines containing an ingredient {that a} unanimous U.S. Meals and Drug Administration advisory panel declared ineffective.

Proposed class actions had been filed on Wednesday and Thursday, after the panel reviewed a number of research and concluded this week that the ingredient phenylephrine marketed as a decongestant was primarily no higher than a placebo.

In response to an company presentation, about 242 million merchandise with phenylephrine had been offered in the USA final 12 months, producing $1.76 billion of gross sales and accounting for about four-fifths of the marketplace for oral decongestants.

The primary lawsuit appeared to have been filed in Pensacola, Florida, federal court docket.

It mentioned Johnson & Johnson Client and Procter & Gamble ought to have identified by 2018 that their advertising claims about merchandise with phenylephrine had been “false and misleading.”

That 12 months was when new FDA steering for evaluating signs associated to nasal congestion demonstrated that earlier information about phenylephrine’s effectiveness might not be relied upon, the criticism mentioned.

The plaintiff Steve Audelo, a Florida resident, mentioned he purchased Johnson & Johnson’s Sudafed PE and Benadryl Allergy Plus, and Procter & Gamble’s Vicks NyQuil, primarily based on the businesses’ claims that the merchandise labored.

Comparable lawsuits had been filed on Thursday in opposition to GSK, which makes TheraFlu; Reckitt Benckiser (LON:), which makes Mucinex Sinus Max, and Walgreens, which produces generic decongestants.

Johnson & Johnson’s client enterprise is now referred to as Kenvue (NYSE:) after a Might 3 preliminary public providing. It additionally makes Tylenol Chilly & Flu, whose substances embody phenylephrine. Kenvue can be a defendant in one of many lawsuits.

In an announcement on Friday, Johnson & Johnson mentioned: “Johnson & Johnson isn’t named within the lawsuits, which is sensible as a result of it didn’t manufacture or promote decongestant chilly medicines and, following our separation, Johnson & Johnson Client Inc isn’t part of Johnson & Johnson.”

Kenvue declined to remark. Different defendants declined to remark or didn’t instantly reply to requests for remark.

The FDA typically follows however doesn’t all the time undertake its advisory panels’ suggestions.

On Thursday, the company mentioned it could search public touch upon whether or not merchandise with phenylephrine needs to be pulled from retailer cabinets.

The Florida case is Audelo v Johnson & Johnson Client Inc et al, U.S. District Court docket, Northern District of Florida, No. 23-24250.

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