FDA warns, then withdraws letter over combining vitamin C and Vicks cough-cold formulations

ROCKVILLE, Md. The Food and Drug Administration on Wednesday initially issued a warning letter to Procter & Gamble for combining the dietary supplement vitamin C with its Vicks NyQuil and Vicks DayQuil cough-cold formulations, according to published reports, and then withdrew that letter from its Web site Thursday citing that the posting was made in error.

The letter initially read: “Because the vitamin C in these products is an active drug ingredient, it is therefore both false and misleading to state that it is an inactive ingredient in these drug products.”

P&G on Wednesday claimed that its marketing of the combination product was appropriate. “P&G has clearly differentiated benefits by the NyQuil or DayQuil active ingredients versus the dietary supplement vitamin C,” stated spokeswoman Crystal Harrell.

Bayer fell under similar criticism last year with its Bayer Aspirin with Heart Advantage (since removed from the market), which contained low-dose aspirin and phytosterols. The Council for Responsible Nutrition, in a statement issued soon after that initial Bayer warning letter, stated: “CRN continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated healthcare and wellness. … Our hope is that FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.”

CRN noted then that FDA in 1994 stated in the Federal Register that “FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances. Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem.” Since that 1994 publishing, FDA has issued a few warning letters addressing specific combinations of supplement and OTC drug ingredients, but has never publicly reversed its view that combination products with dual labeling can be developed that would satisfy the agency’s appropriate concerns for safety.