April 6, 2010
HAYWOOD, Wis.On March 31, U.S. Marshals, acting on behest of FDA, seized a range of consumer products from Beehive Botanicals Inc., alleging the products are misbranded and unapproved new drugs. The U.S. Attorneys Office for the Western District of Wisconsin filed a complain March 25 seeking the seizure of products, including creams, capsules, tablets, gums, throat sprays and shampoos, after reviewing product labeling, promotional materials and Web site links that claimed some of the products could diagnose, cure or prevent serious diseases including asthma, dermatitis, cancer and skin disorders. Beehive Botanicals also claimed several products, made with bee-derived ingredients such as propolis and royal jelly, have been proven to have antibiotic, antiviral and antifungal properties, and could be used to prevent and ameliorate a wide variety of medical conditions.
FDA issued a warning letter to Beehive Botanicals in March 2007, requesting drug claims be removed from its Web site and product labeling. The company did submit proposed new labeling; however, inspections in late 2009 found similar claims were being made through related Web sites. The claims position the products as new drugs, subject to FDA regulation, and have not been approved by the agency as safe and effective in treating the stated conditions.
This seizure shows that the FDA will seek enforcement action against companies that promote therapeutic benefits of products not yet evaluated by the agency for safety and effectiveness, said Michael Chappell, FDAs acting associate commissioner for regulatory affairs.
Marc Ullman of Ullman, Shapiro & Ullman LLP, Beehive Botanicals legal counsel, issued a statement to INSIDER about the charges: In response to the 2007 Warning Letter, Beehive undertook a comprehensive review and revision of its Web site and labeling. FDA signed off on all label changes. It appears that FDA is complaining about one link to a third-party Web site that was inadvertently left on the site during the 2007 compliance review by the company. The other Web site FDA is complaining about is a beta-testing site established by Beehives former webmaster on his own time and without the knowledge of the company. Beehive was mortified when it learned of this site through the FDA Complaint. The company intends to attempt to resolve this matter with FDA in a manner that leaves the Agency comfortable on compliance issues while allowing Beehive to continue normal operations.
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