Federal Government Seizes Dozens of Misbranded Drug Products
FDA warned company about making medical claims for bee-derived products
At the request of the U.S. Food and Drug Administration, U.S. Marshals on March 31 seized a range of consumer products, including creams, capsules, tablets, gum, throat spray, and shampoos from a Haywood, Wis., manufacturer.
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 "Act").
The company claimed on links on its Web site, 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 drug products.
As a result of these claims, the products are new drugs and therefore subject to FDA regulation. The products are not FDA approved as safe and effective in treating any of the stated diseases or conditions. Despite previous requests and warnings from the FDA, Beehive Botanicals has continued to market products with unfounded medical claims.
"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, FDA's acting associate commissioner for regulatory affairs.
In March 2007, the FDA issued a warning letter to Beehive Botanicals requesting that drug claims about its products be removed from its Web site and product labeling. The company subsequently submitted proposed new labeling, which the agency found acceptable under the Act. But during a later inspection conducted between September 2009 and October 2009, the FDA found that drug claims were being made for the products through related websites and advised the company that this was not acceptable.
To date, the agency has not received any reports of consumer illnesses tied to the company's products.
Health care professionals and consumers may report serious adverse events (side effects) or quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.
Online: www.fda.gov/MedWatch/report.htm1
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
Fax: 800-FDA-0178
Phone: 800-332-1088
For more information
2007 Warning Letter to Beehive Botanicals
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076314.htm3