FDA Warns P&G Over Vicks Product

WASHINGTON— FDA issued a warning letter to Procter & Gamble regarding the company’s Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C products. The agency stated the single-dosage form combinations of over-the-counter (OTC) drug ingredients and dietary supplement ingredients are illegal to market for cold and flu treatment. According to the agency, there is insufficient data that vitamin C is safe and effective in preventing or treating the common cold; furthermore, OTC drugs must comply with applicable monographs for labeling, formulations and indications, and adding vitamin C to the Vicks OTC products takes the products out of compliance with the FDA monograph, requiring approval as a new drug.