Health Impact News Editor Comments: The story below is a very common one. The FDA routinely issues warning letters to companies that produce natural products where health benefits are mentioned. According to the FDA, only approved drugs can make claims to health benefits. So if a company producing a natural product wants to publish some study mentioning health benefits related to a product they sell, according to the FDA they are violating the law, and the FDA can come in and seize their entire inventory to “protect the public.” Notice the comments from the FDA associate commissioner: “Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments.” The FDA believes they are the only ones that can define “legitimate treatments,” and they are reserved for pharmaceutical companies. So one might legitimately ask, who is really being protected here? Would anyone really be harmed by drinking elderberry juice? Would someone forgo other treatments even if they thought the juice might improve their health?
Most companies actually have no desire to pick a fight with the FDA, and do their best to comply when a warning letter is issued. The problem is that the FDA never comes back to the company to state “Yes, you are now in compliance.” They either leave you alone, or they come back at a later date, sometimes with federal marshals, and seize your inventory, effectively putting you out of business. This is going on all across America. Below is just one example. For more information on how to support legislation to stop the FDA from these actions, see: FDA Accuses Supplement Manufacturers of Selling Drugs
By ROXANA HEGEMAN
The Associated Press – KansasCity.com
Excerpts:
WICHITA | Federal authorities have seized bottles and drums of elderberry juice concentrate from a Kansas winery, contending that the company’s claims of its benefits for treating various diseases make the product a drug.
The government contends the juice concentrate is an unapproved and misbranded drug because the winery claims it is used to treat diseases such as the flu, cancer and AIDS. “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 regulatory affairs, said in a news release. “The FDA is committed to protecting consumers from unapproved products on the market.”
Wyldewood Cellars owner John Brewer said his company changed the labels as the FDA had requested in 2006. “We responded to their notice and we thought everything was fine, so this takes us totally by surprise,” Brewer said. “You think you are doing things correctly, and there hasn’t been any word, and all of a sudden you get this,” Brewer said.
Read the Full Article here: http://www.kansascity.com/2011/06/03/2924919/feds-seize-elderberry-juice-from.html
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