Surprise! U.S. Marshals Pay a Visit to a Wisconsin Supplement Manufacturer
.jpg)
The Feds paid an unwelcome visit last month to Beehive Botanical’s Wisconsin manufacturing facility seizing a wide range of products. According to an April 5th FDA press release, U.S. Marshals, at the FDA’s request, went to the site on March 31 and seized creams, capsules, tablets, gum, throat spray, and hair care products. The seizure was based on a complaint filed by the U.S. Attorney’s Office for the Western District of Wisconsin which alleged that the products were mislabeled and contained new unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act. On March 26, a judge issued a warrant for seizure of the products under §334 of that same Act.
The Natural Products Insider Blog points out that in 2007, Beehive Botanicals received a warning letter from the FDA regarding drug claims, misbranded supplements, and unapproved medical devices. In response, the company submitted new labels, but a later inspection revealed similar claims and misbranding on the new labels. The complaint and subsequent raid resulted from Beehive’s failure to comply with the FDA’s requests.
Nutrition companies should take the FDA’s warnings seriously; a facilities raid by the U.S. Marshals is obviously harmful to a business’s bottom line, not to mention its reputation. As Mike pointed out in a previous post, reviewing FDA warning letters sent to other companies is a good method for verifying compliance with labeling requirements and, in light of this news, avoiding federal court complaints and visits from your local U.S. Marshals.
http://www.essentialnutritionlaw.com/admin/trackback/196748
