Procter & Gamble Warned About Vicks Nyquil Cold and Flu Medicines

The Food and Drug Administration today warned Procter & Gamble about the company’s popular Nyquil and DayQuil cold medications with vitamin C, which authorities said are illegal combinations of drug and dietary ingredients.

The over-the-counter cold and flu remedies contain vitamin C, which means they violate rules for marketing such non-prescription products, according to the FDA. The agency said the products “legally cannot be marketed because they have not been proven safe and effective.”

In a warning letter dated October 29, the agency said there is not enough data to show that vitamin C is safe and effective in preventing or treating the common cold to justify allowing the products to remain on the market without further study and evaluation.

“The two Vicks products do not comply with the applicable FDA monograph and must first be evaluated and approved under the FDA’s new drug approval process to be legally marketed,” the FDA said in a statement announcing the sending of the warning letter.

Earlier Warnings Have Been Issued

The FDA said it previously warned manufacturers of products that combine drug ingredients with dietary ingredients, such as vitamin C, in 2001 and 2008.

“The agency’s position on the marketing of vitamin C for preventing or treating the common cold … has been stated in a number of previous warning letters,” the agency said.

This Time, It’s for Real

Regular readers of AttorneyatLaw.com may recall earlier this month, when we reported that the FDA had sent a warning letter about the Nyquil and DayQuil with vitamin C. But a few days later, the FDA apologized and said the letter had been posted on the agency’s website in error.

Turns out the letter wasn’t supposed to be publicized after all, the FDA said at the time.

We wondered then how the mix up had happened and whether a warning letter was in fact coming for Nyquil and DayQuil with vitamin C. How else, we thought, would a detailed warning letter been prepared and accidentally leaked on line?

Well, today we know the answer. The warning was just a few weeks premature.

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