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 http://www.elderberry.net. 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

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
US & CANADA HERE OR UK FROM CHIPMUNKA PUBLISHING 

My Thoughts on the Psychopharmacuetical Monopoly

Since I returned from LA I've wrote a lot about other SSRi's and personal stories, in particular the death of 17 year old Toran Henry from New Zealand [Prozac] and the death of Matthew Schultz [2 hours old] [Effexor]

In the past I have wrote about Sara Carlin [Seroxat/Paxil], Sharise Gatchell [Seroxat/Paxil] and have other personal stories lined up, stories of children who have left us and left behind grief stricken families.

What LA taught me was there is a huge problem with SSRi medication. It is effecting all walks of life, adults, children, pregnant mothers.

There is something dark at work here folks, it stretches far beyond the manufacturers of these drugs and embroils psychiatry, medicine regulators, government and coroners.

With such a powerful field of opposition the small man has very little chance of getting his voice heard.

We have the pharmaceutical industry denying that they have done any wrong in not being open and honest about SSRi clinical trials, psychiatrists being paid by the said pharmaceutical companies to 'big up' the drugs, medicine regulators who, quite honestly, are about as useful as a chocolate kettle, government officials that only care about any issues if it benefits them getting votes at the next local elections and coroners who are so distanced from grief that they cannot see the wood through the trees.

All of he above are part of the problem. All of the above are responsible for the grief stricken parents, the thousands, if not millions, of people who struggle on a day-in - day-out basis with withdrawal from these addictive drugs. Their only form of defence is:

1. What else is there?

2. These drugs are safe, those that speak out are Scientologists

3. The benefits outweigh the risks

Do they understand how utterly ridiculous they look when they tout 1,2 and 3?

More and more families are being introduced into the seedy world of the Psychopharmacuetical Monopoly. Their children are being targeted by psychiatrists that invent labels of some new psychiatric disorder that the majority of us passed off as being 'just life' when we were children. Family doctor's are agreeing with them because they need a solution for Mrs Jones son who is being boisterous and rebellious in class or Mr Smith's daughter who, at 15, is having mood swings.

We've got complete buffoonery going on with an Australian psychiatrist who cannot only predict if your child has a 'disorder', he can predict if they will get one in future years! For this absurd fantasy he was voted as 'Australia's Man of the Year!

Cheekily, I added myself to his Facebook page and threw out the following question to him:

"Hey, do you think you could predict this weeks Lotto numbers for me, only I hear you can predict whether or not a child will get some sort of mental illness in future years."

He deleted me from his page...without answering. To be honest, I expected nothing less.

So, to fight back, what do we, as advocates, concerned citizens, have at our disposal?

Well, we have lawyers. Go bust this pharmaceutical company for us and show the public just what they are really like. In Britain, at least, a law firm against a pharmaceutical company is akin to a flea biting an elephant, no more better than the average blogger speaking out against this sick industry. At least we, as bloggers, don't have to bow down to lawyers etiquette. We can pretty much go for the jugular when writing about pharmaceutical companies and regulators and their complete lack of transparency, at least that's what I try to do with my writing.

There are an abundance of human beings suffering at the hands of drugs that were given to them to make them feel better. When they seek help they are told it's not the drugs. When they are vocal, they are attacked from pharmaceutical whores, those in the pocket of the industry, those who clearly have their own agenda's in suppressing the truth.

Coroner's will drag out their reports, leaving a family in limbo, often refusing to carry out the toxicology tests that would show traces of SSRi medication. Once dragged to the limits of a two year wait for such a report, the family are handed the report... time barred from seeking any recourse from the pharmaceutical industry because...well, that's the way the law is.

The limp-wristed cowards that make up the medicines regulators sleep well at night because their sub-committees highlight that there are problems with SSRi's, they forward letters of warnings to doctor's, nurses, psychiatrists who don't even have to open them. Why would they? I can only assume that they think the regulators are basically those who grant licences to drugs, anything else they have to offer is of no importance.

Then along comes a group of noisy revelers, bloggers, campaigners, lobby groups who highlight the dangers of these drugs only to be appeased by the powerless regulators who spend more time targeting natural remedy shops than those they claim to protect from unsafe prescription drugs [the public]

You know, filling an adverse reaction report in and sending it off to a regulator shouldn't just be it. Any reports collected should be thoroughly researched, instead it's just another statistic put into a database that shows that the regulator are doing their job when in reality they are merely sweeping this problem under a very big carpet.

Every single child who commits suicide should have a screening to see if traces of antidepressant medication is found, not a standard screening either, a thorough one. The wizard psychiatrists are quick to screen them when they are alive so why not allow them the dignity of a screening process when they are dead?

I was recently asked if I wanted to attend a meeting with the MHRA to discuss SSRi withdrawal issues. A campaigner had written to the UK Health Minister who, in turn, had passed the letter of concern onto the MHRA. Same old story, pass the buck until the campaigners grow tired. I refused to be part of any such meeting as I have been down that road before. Why sit with a bunch of people who nod their heads when they hear horrific stories of withdrawal, suicide, self-harm then do absolutely nothing to eradicate the problem.

"Oh, we will send a letter out to warn doctor's"

Whoopiefuckingdoo!

They are at a loss of what to do because they are paid for by the pharmaceutical industry, how could they chastise their paymasters?

Our government are scared to speak out because the industry will just move their business elsewhere leaving an already depleted Britain in a further financial mess. Meantime, more and more children will fall into the system of the Psychopharmacuetical Monopoly - Pharmaceutical companies - Psychiatry - Regulators - Coroner's.

1. Pharmaceutical companies - Manufacture a remedy
2. Psychiatry - Create an illness for that remedy
3. Regulators - Grant licence for remedy to treat the illness created by psychiatry
4. Coroner's - Find no apparent connection with treatment - blame it on the created illness.

It's a vicious cycle of greed, manipulation and cowardice, each one finding excuses to blame the person before them.

Psychiatrist - It wasn't my fault I prescribed the drug, it's the manufacturer of said drug.

Regulator - It's not our fault, we sent warning letters out to psychiatrists.

Coroner's - We have been assured by the pharmaceutical industry that these drugs do not cause suicide.

Pharmaceutical companies- These drugs are not meant to be given to children.

In truth, the pharmaceutical companies have a good argument, thing is, they know their drugs are being given to children and they do nothing about it.

As a parent, would you allow  someone to give a cigarette to your 4 year old, or maybe half a bottle of vodka?

Same thing, the pharmaceutical industry know this goes on but it makes them bucket loads of cash, more cash to pay psychiatrists to invent new illnesses...and so the cycle continues.

They can tout the 'these drugs are not meant for children' all they want - It's obviously a lie, why else would GlaxoSmithKline be trialling out Paxil/Seroxat on children as young as 7 in Japan?

Chances are the CEO's are pharmaceutical companies have children and grandchildren, what's the betting that they are never given psychiatric drugs?

Same goes for regulators families, why allow their children, grandchildren to take a class of drugs that they know so much about...but do very little about it.

No doubt the MHRA will swarm over this post - if they don't like it.... let them send me a letter.

I won't open it.


Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING