November 3, 2009

After retracting its warning letter to Procter & Gamble on October 14 and blaming a computer error for its release, the U.S. Food and Drug Administration (FDA) formally issued another warning on October 29 notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks NyQuil Plus Vitamin C are being illegally marketed as “drug-dietary supplement” combination products. The FDA considers the Vicks products misbranded because their labels do not identify vitamin C as an active drug ingredient.

“The vitamin C in these products could be marketed separately as a dietary supplement,” the FDA wrote. “However, where, as here, drug and dietary ingredients are combined into a single dosage form, the combination becomes a drug.” The warning also notes that the products are misleading to customers because the labels suggest that the vitamin C is an inactive drug ingredient, whereas the FDA claims that it is an active drug ingredient.

In the warning letter, the FDA explains that four previous companies have received warning letters as a result of similar combination products. Bayer HealthCare’s aspirin with phytosterols was the most notable product to receive a warning letter; others included acetaminophen with melatonin, acetaminophen with glucosamine, and acetaminophen with chondroitin sulfate.

P&G has until November 19, fifteen working days from the release of the warning letter, to inform the FDA that is has taken steps to correct the violations noted in the letter. In a phone conversation on October 16, P&G representatives indicated to FDA that some or all of these Website claims had been removed.

Related NBJ links:
OTC Drug-Supplement Combo Products Now Caught in Regulatory Quagmire
American Herbal Products Association asks FDA for clarity on marketing of OTC Drug-Dietary Supplement Combination Products
FDA Sends Warning to Bayer About Drugmaker’s OTC-Supplement Combo Products
FDA to General Mills: Cholesterol Claims Render Cheerios a Drug

Related NPI Center links:
FTC Charges Marketers with Making Baseless Weight-Loss Claims Despite Order to Stop