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Tuesday, June 07, 2011

FDA Flex Muscles on Elderberry Manufacturer

If ever one needed evidence regarding how medicine's health officials around the globe prioritise what's regulated and what's not then look no further than the American medicines regulator, the Food and Drug Administration.

The latest victim of the FDA's crackdown on business trying to make a buck is Wyldewood Cellars, Inc. Their apparent crime? Well, their website violated the Federal Food, Drug, and Cosmetic Act.

Way to go FDA, where would we be without you.

Wyldewood Cellars, Inc were sent a letter from the FDA back in 2006, the crux of which was the FDA bitching about Wyldewood Cellars Elderberry-Juice Concentrate.

In a letter to John A. Brewer, Ph.D., Owner of Wyldewood Cellars, District Director of the Public Health Service for the Food and Drug Administration, John W. Thorsky, writes:

The Food and Drug Administration (FDA) has reviewed your firm's website at Our review of your website found violations of the Federal Food, Drug, and Cosmetic Act...

It appears the FDA were pissed because of the various claims made by Wyldewood Cellars about their Elderberry-Juice Concentrate, such claims included that various cultures, including the Native Americans, had used the elderberry plant to treat colds, asthma diabetes, rheumatism, and nervous disorders such as insomnia and migraines. They also claimed that one teaspoon of Elderberry Juice Concentrate provided a daily preventative dose for most colds and it was a medically proven strong antiviral.

The FDA took umbrage to these claims:

Because your product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. Under section 505 of the Act (21 U.S.C. 355), a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). This drug is also misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], in that its labeling does not bear adequate directions for use.

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

Wyldewood Cellars made adjustments to their labelling and thought no more of it. Imagine their surprise when the FDA recently sent US Marshalls on a mission to the Wyldewood Cellars warehouse, where they duly confiscated the said product.

One moment whilst I wipe the tears of laughter from my eyes...

Here we have the FDA pulling out all the stops to make sure a product is not making false claims. You know where I'm going with this, right?

The FDA, which is basically akin to a pharmaceutical agent, are surely barking up the wrong tree here by going after a piddling wine-maker, doncha think?

Let's take a look at some of the claims that the FDA and other medicines regulators have stood by over the years for various pharmaceutical products.

Cipramil, known as Celexa in the US
"Now indicated for panic disorder"
Panic disorder cannot be diagnosed using 21st century technology.
The FDA/MHRA see no problem with this claim.

Seroxat, known as Paxil in the US, Aropax in Australia.
Early promotion of Seroxat saw the manufacturer claim that it 'corrected a chemical imbalance'
Public pressure and basic common sense saw GSK later remove this claim. They were never charged by the FDA or MHRA for this false claim.
Glaxo also promoted this drug for use in children by way of a ghost-written paper, when they knew it was not safe for children.
After a four year investigation by the MHRA, Glaxo were sent a letter saying they had been naughty and not to do it again.

Ribena "contains four times as much vitamins as oranges"
It took two New Zealand schoolgirls to debunk this claim made by Glaxo. They were effectively doing the job of the food and drug regulators. Glaxo were fined a pittance and told not to do it again. Their manufacturing plants were never raided.

The list of psychiatric medications that are promoted for fixing or helping this and that is quite large. Both the FDA and MHRA have made no attempt to debunk any of the claims made by the manufacturers of these products.

Unlike Wyldewood Cellars, I can't think of one pharmaceutical company who have had their production plants raided by the police because of the claims made on packets. Maybe Wyldewood Cellar Inc should have touted the 'benefit vs risk ratio' at the FDA or maybe they should have told them that their Elderberry Juice Concentrate was thought to correct a chemical imbalance in the big toe of those who drank it. I hardly think the FDA would have been in a position to dispute any such claim seeing as they have, for years, stood by the claims of the pharmaceutical industry.

Difference with Wyldewood Cellars juice and pharmaceutical products is crystal clear. Their juice has never made anyone feel suicidal or homicidal. Their juice can be stopped without withdrawal problems. Their juice does not claim to fix something that does not exist.

Your move pharma.

Hat-tip - Natural News