However, John Brewer, co-founder of Wyldewood, says that after receiving the initial FDA warning letter, his company hired a consultant familiar with FDA regulations to help his company reword their product descriptions. After making the appropriate changes, and clarifying that the elderberry products in question were supplements, Brewer says his company had done what it needed to in order to be in compliance.
“We haven’t heard anything from (the FDA) since,” he told reporters, noting that following the changes up until the raid, the FDA had ceased communicating with Wyldewood. “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 do this. (Supplements) seems to be one of their hot buttons these days.”
This tactic, of course, has become all too common in recent years. A company receives a warning letter from the FDA, makes the appropriate changes, never hears anything further from the FDA, and out of nowhere gets raided. Such actions on behalf of the FDA are ultimately unwarranted and illegal, and the offended parties have every right to sue the agency for damages.
“You think you are doing things correctly, and there hasn’t been any word, and all of a sudden you get this,” said Brewer to The Kansas City Star.
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