Procter & Gamble has been cited for the illegal marketing of combinations of dietary ingredients and drugs.
P&G products Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C lack proof of safety and efficacy, the regulator says, citing lack of scientific evidence linking vitamin C to the prevention and treatment of colds.
In addition, labeling on the two over-the-counter medicines incorrectly identifies acetaminophen, detromethorphan HBr, and phenylephrine HCl or doxylamine succinate as "other ingredients" as well as active drug ingredients; vitamin C was identified as both an inactive and active ingredient.
Corrective steps response deadline under the tougher FDA: within 15 days of the October 29, 2009, warning latter date.
- here's the article
- see the warning letter