WICHITA, Kan. (AP) — A federal judge has approved a settlement in a civil lawsuit filed by the government against a Kansas winery over claims about the medicinal benefits of elderberry juice concentrate.
U.S. District Judge Julie Robinson on Friday signed the consent decree hammered out by the Food and Drug Administration and Wyldewood Cellars of Peck. The move allows the winery to sell its product as long as it relabels it and removes from promotional materials any claims that elderberry concentrate cures or treats diseases.
Federal authorities raided the winery in June and seized bottles and drums of elderberry juice concentrate. Authorities contend the company's claims of its benefits for treating various diseases made the product a drug.
Winery owner John Brewer said Friday the settlement frees up $50,000 worth of inventory that had been sequestered by the U.S. Marshals Service in a cooler at his Mulvane facility.
Under the settlement, Wylewood Cellars has five days from the entry of the decree to remove from all labels and promotional material any representation that elderberry juice products cure or treat diseases, then provide FDA with an affidavit of compliance.
Brewer must post a $57,100 bond before any material can be released, and the winery must pay all court costs and expenses, including those incurred by the Marshal's Service.
Brewer said it would take a day to change the labeling on bottles. Most of the seized barrels of raw product need no "reconditioning" because that material is going to be made into other things like wine, jelly and syrup over which FDA has no jurisdiction, he said.
"When they were in here looking over everything we said, 'Guys, we are not trying to do anything wrong. If you see we are doing anything wrong, just let us know and we will correct it.' Well, instead of doing that, they choose to seize the material and make a big show of it," Brewer said.
The government contended in its lawsuit that the juice concentrate is an unapproved and misbranded drug because the winery claims it is used to treat diseases such as the flu and cancer.
Dara Corrigan, the FDA's associate commissioner for regulatory affairs, said in a news release that products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatment.
"If you can't prove it with FDA-sanctioned human trial studies, you cannot say anything about any benefits you might get from the food you eat," Brewer said. "It is really in my mind ... a First Amendment thing. As a manufacturer, we cannot say what it can do unless we give multimillion-dollar studies to the FDA to prove exactly what we are talking about."
An affidavit filed in federal court contended the FDA sent Wyldewood Cellars a warning in 2006 after receiving a consumer complaint over the claims. The FDA said the company continued to make the same claims on its website and at its retail outlets.
Brewer contended that when the winery got that 2006 letter saying FDA didn't like the label, he changed the label. He said he hadn't understood that he also needed to change the advertising. He blamed bad advice.
"We thought we were doing everything right, but the FDA says no, we are not," Brewer said. "So they come in to get our attention and they seize material."