12.01.09
Procter & Gamble has received a warning letter from FDA indicating that the company’s Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient. Both over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. FDA said these single dosage form combinations of drug and dietary ingredients cannot be marketed because they have not been proven safe and effective. The agency also said 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, 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 the applicable FDA monograph, according to the agency, and must first be evaluated and approved under FDA’s new drug approval process.