FDA withdraws Procter and Gamble warning letter

By Shane Starling

- Last updated on GMT

Related tags Common cold Fda

The FDA has withdrawn a warning letter published on its website and issued to two Procter and Gamble vitamin C-fortified dietary supplement/drug combination products.

The withdrawn letter was issued for two P&G products – Vicks Nyquil and Dayquil​which it said contained a prohibited combination of pharmaceuticals and vitamins.

“We have not received the warning letter from the FDA that was temporarily posted on the FDA’s website yesterday,” ​a P&G spokesperson told NutraIngredients-USA.com.

“We cannot speculate as to what might have happened, but we intend to work with the FDA to gain more information and resolve their concerns.”

The letter quoted an expert panel that found, "no study which has demonstrated that vitamin C is unequivocally effective for the prevention or treatment of the common cold."

The products, launched in September, 2008, claimed to “help blunt"​ cold symptoms.

The pharmaceutical ingredients were the pain reliever, acetaminophen; a cough supressant called dextromethorphan; and the decongestant, phenylephrine.

Related topics Regulation

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