FDA’s Letter to P&G over VICKS DayQuil and NyQuil Plus Vitamin C is Back (for now?)

November 2, 2009

By Ricardo Carvajal

FDA has again posted a warning letter to Procter and Gamble stating that the company’s VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C are unapproved new drugs and are  misbranded.  The letter states that, when “drug and dietary ingredients are combined into a single dosage form, the combination becomes a drug under section 201(g)” of the FDCA.  As noted in the letter to P&G, FDA previously staked out that position in warning letters in October 2008 to Bayer for its products combining aspirin with either phytosterols or calcium, and in 2001 to Omni Nutraceuticals for its products combining acetaminophen with either glucosamine sulfate or glucosamine sulfate and chondroitin sulfate, and to B.F. Ascher its product combining  acetaminophen and melatonin. 

FDA first posted a warning letter to P&G over VICKS on October 14, but then removed the posting, citing an administrative error.  The fact that this latest posting is accompanied by a press release emphasizes that this time it’s for real.