FDA says Wyldewood Cellars making false claims; elderberry juice products seized
06/03/2011 2:52 PM
06/03/2011 2:52 PM
U.S. marshals have seized elderberry juice concentrate products distributed by a Mulvane area-based company because a federal agency said the products make false claims about prevention and treatment of diseases.
The Food and Drug Administration said today that Wyldewood Cellars has been distributing products that are non-approved and misbranded drugs.
Wyldewood claims that its elderberry juice concentrate cures, treats or prevents various diseases such as AIDS, diabetes and flu, according to the FDA complaint.
But John Brewer, who co-founded the business in 1994, said Wyldewood doesn't make any such claims.
"This is a matter of the attorneys talking to each other, find out what the complaint is and we'll fix it," Brewer said.
Marshals came to Wyldewood's main distribution center near Mulvane on Wednesday and moved all the elderberry juice concentrate to a back room.
"They put some stickers on it saying we can't touch it," Brewer said.
Barry Grissom, U.S. Attorney for Kansas, said that Wyldewood was first notified in 2006 in a warning letter that its claims for the medicinal powers of elderberry juice are unproven and violate federal law.
Wyldewood responded by promising to remove all such claims from its websites, the FDA said.
But the FDA said it discovered during subsequent inspections that the company continues to make the same claims.
Brewer said the company did receive that warning letter and the issue was over labeling. A consultant familiar with FDA regulations was hired by Wyldewood to make changes so the label reflected that the product was being sold as a supplement.
"We haven't heard anything from (the FDA) since," he said. "They've been in our facility multiple times.
"It's like, 'C'mon guys, we changed our label, we changed everything we thought we were supposed to do.' And then they show up and so this. (Supplements) seems to be one of their hot buttons these days."
The FDA filed its complaint against the company on May 27.
"Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments," Dara Corrigan, the FDA's associate commissioner for regulator affairs, said in a statement.
There are no claims by the FDA that drinking elderberry juice concentrate causes any health concerns, said Jim Cross, a spokesman for Grissom.
Wyldewood has retail stores in west Wichita, Lawrence, Paxico and St. Joseph, Ill. Cross said the government has sought to seize the products except for the facility near Mulvane.
Wyldewood produces more than 40 types of Kansas wine, according to the company's website.