Food and Drug Administration sends warning letter to Wyldewood Cellars

UPDATED — Wyldewood Cellars is back in another legal tangle with the U.S. Food and Drug Administration, but Wyldewood owner John Brewer calls it a “misunderstanding.”

The FDA sent a warning letter to Brewer late last month in response to an October inspection at his manufacturing and processing facility in Peck.

The letter states that its “investigator observed significant deviations from current good manufacturing practice” for dietary supplements.

Brewer says he’s a juice concentrate producer.

“They sent us a warning letter based on us producing a dietary supplement … that we’re not producing.”

The FDA has had past issues with Wyldewood over its concentrate, and Brewer says he repeatedly has complied with steps the FDA wanted him to take.

“We have, because of the FDA, changed the labeling some six different times,” Brewer says. “I’m getting tired of being picked on by these guys.”

The investigator referred calls to the FDA’s public affairs office. A spokeswoman in that office says the FDA generally does not comment beyond its warning letters.

“We’re making a juice product, and we’re perfectly set up to do that,” Brewer says.

He says he changed his elderberry concentrate from being labeled a supplement to a food product instead. Brewer says that has far fewer regulations.

At the time of the unannounced October inspection, Brewer says he was in a “cleaning cycle” and couldn’t show the inspector his production system. Then, he says he had a couple of production malfunctions that further delayed inspection.

Brewer says he believes the inspector “was upset because he thought we were putting him off.”

When the inspection finally happened, Brewer says, the inspector had “some good points.”

He says he’s not doing anything illegal, though.

According to the warning letter from the FDA – which Brewer has to respond to by early next week – he has to correct violations or face legal action that could include seizure and injunction.

Brewer thinks if the FDA takes another look at his situation, everything should be OK.

“At least until they decide to change their mind again.”

Brewer says the issue is a labeling one that has nothing to do with how good his concentrate is.

“We have never had a single, solitary complaint that the concentrate was bad,” he says. “We haven’t had any returns … that involves the product not being any good.”

Brewer says since it’s been more than half a year between the FDA’s inspection and its letter, that must mean something.

“They’re not too terribly worried about it.”