Update: A spokeswoman says FDA posted the warning letter in error and has no further comment at this time. Should the agency re-post the warning, Over The Counter Today and "The Tan Sheet" will be ready for it.
FDA has sent a warning letter to Procter & Gamble regarding a pair of Vicks products that combine acetaminophen, dextromethorphan, an antihistamine/nasal decongestant and vitamin C. The products in question are DayQuil Plus Vitamin C and NyQuil Plus Vitamin C.
Curiously, FDA appears to have posted the letter on its warning letters page and subsequently removed it. Reuters reports that the agency takes issue with P&G listing vitamin C as a dietary ingredient in the "Supplement Facts" box and as an inactive ingredient. According to the Reuters story, the agency fears this double-listing could confuse consumers.
P&G issued a statement saying, "The addition of moderate levels of a vitamin supplement such as Vitamin C provides a new benefit for consumers who want it."
So far, this looks to be the most significant action FDA has taken on a drug/supplement combination product since its warning letters to Bayer a year ago regarding Bayer Aspirin With Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium, which "The Tan Sheet" noted here. We followed that story with a recent report on Bayer's reformulation of its phytosterol product without aspirin and its re-labeling of the aspirin/calcium product to nix bone health claims.
Look for our continued coverage of the FDA warning and P&G's response as the situation unfolds. As always, click here to subscribe to "The Tan Sheet," your source for the latest news on OTC drugs, supplements, and all those things somewhere in-between.
- Dan Schiff (d.schiff@elsevier.com)
