FDA Stings Bee-Derived Products over Website Drug Claims
On April 5, the Food and Drug Administration (FDA) announced that federal marshals had seized contract manufacturer Beehive Botanicals... (Haywood, WI) proprietary line of bee-derived consumer products. FDA said that the products were misbranded as drugs on several websites by claiming to diagnose, cure, and prevent diseases such as asthma, dermatitis, and ulcers.
On April 5, the Food and Drug Administration (FDA) announced that federal marshals had seized contract manufacturer Beehive Botanicals... (Haywood, WI) proprietary line of bee-derived consumer products. FDA said that the products were misbranded as drugs on several websites by claiming to diagnose, cure, and prevent diseases such as asthma, dermatitis, and ulcers.
FDA said that on one of the Beehive Botanicals... websites, the company claimed that products with such bee-derived ingredients as propolis, royal jelly, bee pollen, and honey could aid in the treatment or prevention of cancer, liver or kidney disease, insomnia, bone fractures, and skin disorders, and that the products were 'proven to have antibiotic, antiviral, and antifungal properties'ÃÂ and could be 'used to prevent and ameliorate a wide variety of medical conditions.'ÃÂ Such claims would classify the products as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.
Dozens of products were seized on March 31, including creams, capsules, tablets, gum, throat spray, and shampoo. The agency said that it has not received any reports of adverse health events related to the products.
FDA said that it had first issued a warning letter regarding drug claims on the company...s product labeling and website in March 2007. Following the warning, Beehive Botanicals submitted new labeling, which FDA deemed acceptable. However, in the fall of 2009, the agency said that it determined that drug claims were still being made for the products through several websites.
Beehive Botanicals says that those websites were 'oversights,'ÃÂ and that they were third-party websites linked to the company...s main website, as well as a beta-testing site established by the company...s former webmaster--a website that was not meant for public viewing.
'We were mortified when we learned of the unauthorized site through the FDA complaint,'ÃÂ said company president and CEO Linda Graham. 'We had thought that we had fully responded to all of the issues raised in the FDA 2007 Warning Letter and were shocked to realize that we had an issue on our website contrary to FDA requirements.'ÃÂ
'We hope to resolve this matter with the FDA in a manner that leaves the Agency comfortable on compliance issues while allowing Beehive to continue normal operations,'ÃÂ she added.
The company...s contract manufacturing operations for clients is still currently operational.
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