The Food and Drug Administration has taken aim at a Kansas winery over its marketing of Elderberry Juice Concentrate, accusing the business of promising unproven health benefits.
Last week, U.S. Marshals seized and locked up thousands of bottles of Elderberry Juice Concentrate at Wyldewood Cellars Winery, near Mulvane.
In a state released Friday, the Food and Drug Administration called the products "unapproved and misbranded drugs."
Nearly five years ago, the FDA sent winery owner John Brewer a letter, claiming his company was in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA) because of claims that its Elderberry Juice Concentrate cures, treats, or prevents various disease conditions, including AIDS, diabetes and flu."Kansas consumers should be aware that Wyldewood Cellars has been under notice since 2006 that its claims for the medicinal powers of elderberry juice are unproven and violate federal law,” U.S. Attorney Barry Grissom said in a statement.
"We thought we were doing everything correctly," Brewer told Eyewitness News Friday.
Brewer said he did change the label on Elderberry Juice Concentrate to read: "This product is not intended to diagnose, treat, cure, or prevent any disease."
"We've had no warning whatsoever, no communication that there was a problem, until they (U.S. Marshals) showed up," he said.
Brewer said he believes this is part of a larger government crackdown on supplements. He said he personally uses Elderberry Juice Concetrate to boost his immune system and that scientific studies support that use.
Brewer said he is waiting for attorneys on both sides to figure out what the exact sticking points are, so he can get them corrected quickly.
To learn more, read a press release below from the Food and drug Administration:
At the request of the U.S. Food and Drug Administration, U.S Marshals seized elderberry juice products that have been distributed by Wyldewood Cellars Inc., based in Peck, Kan., because the products are unapproved and misbranded drugs.
According to the FDA’s complaint, Wyldewood Cellars makes claims in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA) that its elderberry juice concentrate cures, treats, or prevents various disease conditions, including AIDS, diabetes and flu. The complaint was filed on May 27, 2011, in the U.S. District Court of Kansas.
“Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “The FDA is committed to protecting consumers from unapproved products on the market. We will continue to take actions against companies that do not meet federal standards for safety, effectiveness and quality.”
The FDA previously issued a warning letter to Wyldewood Cellars for violating the FFDCA by promoting and distributing its products as drugs. The company responded to the warning letter promising to remove all such claims from its websites. The FDA discovered during subsequent inspections that the company continues to make such claims.
The FFDCA governs the safety and accurate labeling of a trillion dollars worth of products annually, including prescription and over-the-counter drugs, cosmetics, medical devices, blood and tissue products, and the nation's entire food supply except for meat and poultry.