FDA Issues Warning Letter To P&G

FDA has 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. Both the OTC medicines are being marketed as treatments for cold and flu symptoms.

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 as 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 FDA added that 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.