Wednesday, September 19, 2007

FDA Warns Hand Sanitizer Maker Re: Claims It Prevents Colds

Procter & Gamble Co makes a hand sanitizer called Vicks Early Defense Foaming Hand Sanitizer that the company has claimed could prevent colds among school children and fight germs for up to three hours.

The FDA reported that it had sent P and G a warning letter about the "unlawful" marketing claims. The FDA claimed that this amounted to an unapproved drug because it did not contain proper instructions for use and carried the unsupported claims that the product could effectively fight germs that cause colds.

The FDA letter states: "Under sections 301(d) and 505(a) of the Act (21 U.S.C. §§ 331(d) and 35 5(a)), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA approved application is in effect for it. Vicks Early Defense Foaming Hand Sanitizer does not have an approved application, and its introduction and delivery for introduction into interstate commerce violates these provisions of the Act."

Also, "the product claims to be effective in fighting the "germs" that cause colds. We are not aware of sufficient evidence to show that that the product is generally recognized as safe and effective in preventing individuals from becoming infected with colds, a condition caused by viruses."

Alas, the FDA gives P and G 15 working days to take steps to take action, or more as needed. How long will it take? Stay tuned ... .