Court finds combo drug ads not misleading

By Shane Starling

- Last updated on GMT

Related tags: Fda warning letter, Law

An Ohio court has found that a Procter & Gamble, vitamin C-pharma combination cold and flu product was not marketed misleadingly under state law, despite the presence of an FDA warning letter that said the contrary.

In Loreto v Procter & Gamble​, an Ohio District Court dismissed a class action mounted against Procter & Gamble for making misleading claims, because it found the presence of vitamin C in the pharma product did not discount the claims being made for it.

The Food and Drug Administration found the opposite to be true in an earlier warning letter issued to P&G.

According to an interpretation of the ruling by the legal firm Shook, Hardy and Bacon, the decision is significant because it demonstrates the limitations of FDA warning letters in the law courts.

“Determining whether the plaintiffs had stated a claim upon which relief could be granted, the court emphasized that nothing in the warning letter or the complaint suggested that, ‘the addition of vitamin C renders the other ingredients in the products literally ineffective as ‘pain reliever/fever reducer, cough suppressant, nasal decongestant, and antihistamine’,”​ the firm observed.

The ruling may make pomegranate juice maker POM Wonderful breathe a little easier as the Californian company is the subject of a class action in a Florida court that cites an FDA warning letter over misleading claims as partial backing for the action.

The Ohio court noted that Ohio state law was written to enforce the federal Food, Drug, and Cosmetic Act which the FDA found P&G to be in breach of, but found that did not give it the right to order P&G to pay damages to any parties to the class action, especially as it had not been clearly established exactly what those damages were.

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