Florida : Now that the FDA’s outside experts have unanimously determined the meds’ active ingredient is ineffective, regulators must decide whether to pull many of the most popular nonprescription cold meds off store shelves. In the meantime, people are filing suits seeking damages for the products they’ve already purchased.
At least two class-action lawsuits were filed this week in federal courts in Florida and New Jersey on behalf of consumers who purchased over the counter, phenylephrine-containing oral medications made by Johnson & Johnson, Procter & Gamble, Reckitt Benckiser, Kenvue, GSK and Walgreens. Those companies make popular cold meds that include Sudafed, Vicks NyQuil, Tylenol and Benadryl.
The Florida lawsuit seeks orders prohibiting the sale of certain cold products and requiring a recall and corrective advertising campaign, in addition to damages. The New Jersey lawsuit aims to force the companies to disclose how long they knew the ingredient was ineffective but continued to sell the products anyway.
What the FDA experts’ recommendation vote means: The advisers’ vote Tuesday panning the effectiveness of phenylephrine opens the door to the FDA yanking pills that contain the ingredient off store shelves. The FDA doesn’t have to follow its committees’ advice, but it typically does.
Still, any such move is a ways off, and while FDA staff who reviewed the most recent phenylephrine studies agree that the current dosage is ineffective, the experts’ vote doesn’t determine what the FDA might do next even though the agency usually follows its committees’ advice. The agency issued a statement Thursday that it said “clarifies” the results of the Tuesday meeting.
“FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine,” it said.
If the FDA determines the ingredient is ineffective when taken orally — its inclusion in inhalers isn’t being debated — the regulator would issue a proposal pulling its “safe and effective” status. The agency would then take public comment before deciding whether to issue a final order.
“FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies,” the agency said.
The way forward: Jason Richards, an attorney leading the Florida lawsuit against J&J and Procter & Gamble, said he expects multiple lawsuits to be filed nationwide and eventually consolidated into multidistrict litigation.
A settlement could yield millions of dollars in proceeds going back to consumers who purchased the medications, he said.
“So many millions of people have used these products that seemingly everyone has one under their kitchen cabinet or bathroom cabinet,” he said.
Most named companies didn’t respond to requests for comment, and Walgreens declined to comment on active litigation. But it’s worth noting that J&J spun off its consumer health portfolio into Kenvue last year, and GSK made a similar move with Haleon, to which it referred questions.
