Wis. company that makes bee products will limit buzz about medical benefits under FDA deal

Wis. maker of bee products to limit health buzz

MADISON, Wis. — A Wisconsin company will get back products seized by federal marshals as long as it stops claiming ingredients derived from honeybees can treat disease.

Beehive Botanicals, Inc., will work to bring its gum, throat spray, shampoos, creams, supplements and other products into compliance with Food and Drug Administration regulations under a settlement announced this week.

At the FDA’s request, federal marshals seized an estimated $1.2 million worth of products and ingredients from the firm in Hayward, Wis., on March 31. They took hundreds of pounds of creams and royal jelly powder and 400 gallons of propolis, a substance that bees collect from the buds of trees, among other items.

Marc Ullman, a lawyer for the company, said the seizure was a traumatic event for employees. The FDA defended the move as necessary to stop unauthorized drugs from entering the marketplace and misleading consumers with medical claims that haven’t been proven.

Both sides praised the settlement for allowing the company to stay in business while protecting consumers.

Days before the seizure, the U.S. Attorney’s office in Madison, Wis., filed a sealed complaint alleging Beehive’s Web site had links to two others that claimed its products containing honey, royal jelly, pollen and propolis had amazing medical benefits.

The complaint said the company put similar claims in promotional materials, saying the products treat ailments ranging from cancer to arthritis to infertility and high blood pressure. The complaint said the company could not make those claims without FDA approval.

Ullman, the company lawyer, called the settlement “a very reasonable resolution” for the privately held firm, which has more than 40 employees. He said Beehive is taking steps to ensure “no claims are present that could suggest the products could treat, cure, prevent or mitigate disease” and has removed links to the objectionable Web sites, he said.

Company President and CEO Linda Graham, whose father founded the firm in 1972, said in a statement last month one of the sites was established and owned by its former webmaster and not intended for public viewing.

The other was a link to the website of the American Apitherapy Society, Inc., which promotes “bee therapy” as a way to treat everything from multiple sclerosis to infections.

Ullman said the company had no plans to seek FDA review and approval so its products could contain such claims.

The FDA had sent a letter to Beehive in 2007 warning the firm to remove such claims from its marketing materials. The agency approved the company’s new materials last year, but an investigator discovered the additional problems during an inspection.

Under the settlement, Beehive Botanicals must post a $200,000 bond while it brings the products into compliance. If it fails to do so, the money will be forfeited, assistant U.S. Attorney Leslie Herje said.

The company also must hire an expert to make annual compliance reviews and fix any alleged violations within seven days. Beehive Botanicals would have to pay $1,000 for each day it violates the order and $1,000 for each shipment of products that contain “drug claims.”

“This announcement shows that the FDA will take action to remove from the market products that promote therapeutic benefits not yet evaluated by the agency for safety and effectiveness,” spokeswoman Erica Jefferson said Friday.

The FDA has not received any reports of illnesses tied to the company’s products.