P&G labeling missteps garner warning

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

Suggested Articles

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.

A warning letter says Chinese API maker Yibin Lihao Bio-technical was found lying to the FDA about manufacturing unapproved heparin.

It took four tries over four years, but Perrigo has finally gotten FDA approval of its generic of Teva’s tricky-to-make ProAir HFA asthma inhaler.