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 [1]
- see the warning letter [2]
Related Articles:
Warner Chilcott pays $3.1B for P&G drug unit [3]
P&G plots sale of pharma brands [4]
Links:
[1] http://www.medpagetoday.com/ProductAlert/OTC/16758
[2] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm188361.htm
[3] http://www.fiercepharma.com/story/warner-chilcott-pays-3-1b-p-g-drug-unit/2009-08-24
[4] http://www.fiercepharma.com/story/p-g-plots-sale-pharma-brands/2009-02-05