05.03.10
At the request of FDA, U.S. Marshals seized a range of consumer products, including creams, capsules, tablets, gum, throat spray and shampoos from Haywood, WI-based Beehive Botanicals in late March. The U.S. Attorney’s Office for the Western District of Wisconsin filed a complaint on March 25 seeking the seizure of the products at Beehive Botanicals Inc. The complaint alleges that the products are misbranded and unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act. The company claimed through links on its website and in labeling and promotional materials that some of the products could be used to diagnose, cure and prevent diseases such as asthma, dermatitis and ulcers. Additional company claims indicated that the products could aid in the treatment or prevention of cancer, liver or kidney disease, insomnia, bone fractures and skin disorders. Beehive Botanicals also claimed that several products have been “proven to have antibiotic, antiviral and antifungal properties,” and could be “used to prevent and ameliorate a wide variety of medical conditions.”
The company makes disease claims for propolis, royal jelly, bee pollen and honey, which are the bee-derived ingredients used to make the company’s products. As a result of these claims, the products are new drugs and therefore subject to FDA regulation, according to the agency. Further, despite previous requests and warnings from FDA, Beehive Botanicals continued to market products with unfounded medical claims. In March 2007, the agency issued a warning letter to Beehive Botanicals requesting that drug claims about its products be removed from its website and product labeling. The company subsequently submitted proposed new labeling, which the agency found acceptable under the Federal Food, Drug, and Cosmetic Act. But during a later inspection conducted between September 2009 and October 2009, FDA found that drug claims were still being made for the products through related websites and advised the company that this was not acceptable.
The company makes disease claims for propolis, royal jelly, bee pollen and honey, which are the bee-derived ingredients used to make the company’s products. As a result of these claims, the products are new drugs and therefore subject to FDA regulation, according to the agency. Further, despite previous requests and warnings from FDA, Beehive Botanicals continued to market products with unfounded medical claims. In March 2007, the agency issued a warning letter to Beehive Botanicals requesting that drug claims about its products be removed from its website and product labeling. The company subsequently submitted proposed new labeling, which the agency found acceptable under the Federal Food, Drug, and Cosmetic Act. But during a later inspection conducted between September 2009 and October 2009, FDA found that drug claims were still being made for the products through related websites and advised the company that this was not acceptable.