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The FDA has been busy this past month, sending out warning letters left and right on a variety of topics.  Here they are in brief:

This warning letter attacks a purportedly novel type of hand sanitizer called SkinWear that claims to work for up to 8 hours without alcohol in order to prevent the transmission of H1N1 Flu Virus.

Andrew Weill is in the FDA and FTC cross-hairs for claims that “astragalus, a well-known immune-boosting herb that can help ward off colds and flu” is available in the Weill Immune Support Formula product.

Similar claims were found at the site for Mountain Meadow Herbs who offer Anti-Inflammatory, Herbal Respiratory, T&C Formula, Flu Season (now marketed as Winter-Immune Booster), Infa-Flu, Blood Pressure Formula (now marketed as Herbal CardioCare), ClarkRx, and other products that FDA claims violate the FD&C Act.

And then there’s P&G and its Vicks DayQuil Plus Vitamin C product.  Mixing OTC drugs and supplements has been a sure way to elicit a warning letter lately.  The latest products to come under scrutiny are Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C which FDA says are illegally marketed combinations of drug ingredients and a dietary ingredient.  To read the warning letter click here. But wait, there’s more!  FDA has issued a press release telling the world that P&G is “unlawfully marketing” medicines!  Very scary!  To read the release, click here.


Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.