Federal authorities have seized scores of misbranded creams, capsules, and shampoos from a Wisconsin company that allegedly made false medical claims about the products.
The Food and Drug Administration (FDA) requested that U.S. Marshals seize the products from Beehive Botanicals, Inc. of Haywood, Wisconsin, alleging the items were misbranded and unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The FDA said the company claimed on links on its Web site, and in labeling and promotional materials that some of the products seized could diagnose, treat, cure, and prevent such illnesses as cancer, liver or kidney disease, bone fractures, and asthma,
The company also claimed that several of its bee-derived products -- including royal jelly, bee pollen, and honey -- were proven to have antibiotic, antiviral and antifungal properties, and could be used to prevent and ameliorate a wide variety of medical conditions, the FDA said.
Those claims made the products new drugs and subject to FDA regulation, the agency said. The FDA, however, said it has not approved the products as safe and effective in treating any of the diseases or conditions the company claimed.
Despite previous requests and warnings from the FDA, Beehive Botanicals has continued to market products with unfounded medical claims, the FDA said in a statement released today.
Michael Chappell, FDAs acting associate commissioner for regulatory affairs, added: 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.
In March 2007, the FDA issued a warning letter to Beehive Botanicals requesting it remove drug claims about the products from its Web site and product labeling, the agency said. The company later submitted proposed new labeling, but the FDA said it was acceptable under the Act.
During an inspection between September and October 2009, the FDA discovered the company was still making drug claims for the products through related Web sites and advised Beehive Botanicals that was not acceptable.
ConsumerAffairs.com contacted Beehive Botanicals today about the FDAs action. A woman who answered the phone said the company had no comment about the seizure. She did, however, tell us the company is considered a contract manufacturer that has handled and made bee products since 1972.
The FDA said it has not received any reports of illnesses linked to the companys products.
