FDA Warns Proctor and Gamble – You Can’t Market Cold and Flu Medicine Combined with Vitamin C as It is Illegal

If you liked having vitamin C in your cold and flu medication from Vicks, well it looks like some changes might on on hand here as the FDA states that Vitamin C lacks sufficient data as being effective in preventing or treating a cold. That’s right, you read this correctly, so if you have a cold or the flu and want to take vitamin C, go buy a separate bottle. I know myself I take Vitamin C when I feel a cold or flu coming on. Recently in the news Proctor and Gamble has been looking to get out of the “prescription” medication business.

Not too long ago we also were told that Cheerios, due to their advertising was also considered a “drug” by the FDA, so you can see how the interpretation on being correct is now being scrutinized by the FDA to ensure accurate information is being given to the consumers. In order to un muddy some waters here, it appears that they are maybe trying to clear the advertising so individuals don’t mistake misreading of labels and perhaps think that Vicks could be viewed as a vitamin supplement? So don’t go looking to Vicks for vitamin supplements it appears. I’m sure there will be more news to follow, and according to the article here, this is not the first warning received. BD

FDA: Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C SILVER SPRING, Md., Oct. 30 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO ) Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company: -- To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and -- Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

Under its OTC monograph system, the FDA allows some OTC drugs to be marketed without agency approval. Such drugs must comply with applicable monographs,which are regulations that set requirements for the drugs' labeling,formulations and indications. The two Vicks products do not comply with theapplicable FDA monograph and must first be evaluated and approved under theFDA's new drug approval process to be legally marketed.