FDA reminds the industry that OTC drug and dietary ingredient combo products are unapproved new drugs in its latest warning letter, this time going to Procter & Gamble. The letter, dated Oct. 29 and announced Oct. 30, addresses P&G's Vicks DayQuil Plus Vitamin C and NyQuil Plus Vitamin C products, both marketed for cold and flu symptoms.
A warning letter also concerning those products was posted recently on FDA's Web site, but as "The Tan Sheet" reported here, the agency quickly retracted it, saying it was wrongly posted.
But, here it is again.
In the Oct. 29 letter, FDA notes previous warning letters regarding combination products, including the October 2008 warning to Bayer Healthcare regarding Bayer Aspirin with Heart Advantage (aspirin/phytosterols) and Bayer's Women's Low Dose Aspirin + Calcium tablets.


