Courts Slaps FDA and FTC for Unjustified Attacks

[tankdude]

http://healthimpactnews.com/2012/courts-slaps-fda-and-ftc-for-unjustified-attacks/

 

Did you know it’s currently illegal for a food or supplement producer to tell you about their products’ scientifically proven health benefits? As unbelievable as it sounds, a person can be thrown in jail for telling you the walnuts they grow may slow down the growth of prostate tumors, or cherries ease symptoms of arthritis and gout, even though this is truthful, accurate and helpful information for a consumer to know.

 

This is why a case that was recently heard before U.S. District Court Judge Vanessa L. Bryant could turn out to be a landmark event, as she ruled that the “FDA went too far” in censoring health claims related to green tea and cancer.
FDA Wording Too Strong, “Effectively Negates” Qualified Health Claims

 

The U.S. Food and Drug Administration (FDA) allows food and supplement manufacturers to use a qualified health claim (QHC) when “there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition.”

 

However, because the evidence is still emerging, the FDA requires “qualifying language” to be included with the claim “to indicate that the evidence supporting the claim is limited.” In the case of Fleminger, Inc., which sells green tea and filed a health claim petition in 2004 to highlight green tea’s anti-cancer properties, the FDA suggested that this disclaimer be added to the health claim:

 

“FDA concludes that it is highly unlikely that green tea reduces the risk” of breast cancer or prostate cancer.

Obviously, this essentially contradicts the health claim. So, in 2010 (after a petition to review the FDA’s disclaimer was denied), the FDA threatened to seize Fleminger’s products if they did not use the exact disclaimer above.  Eventually the FDA sent a revised claim, which still negated the point of the health claim:

 

“Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.”

 

This is a major win for natural food and supplement producers alike, as the FDA is being required to revise the disclaimer so as not to negate the health claim being made. At this point, Fleminger took the case to court, where Judge Bryant ruled:

“The FDA’s language “effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.”

Why Can’t Foods Have Truthful Health Claims on Their Labels?

 

This is perhaps the underlying question: why must manufacturers petition the FDA to make truthful, science-based health claims in the first place and then have them subjected to disclaimers? This is a serious waste of tax dollars – not to mention an assault on your freedom of access to information (and for the manufacturers, on their freedom of speech).

 

The fact is, QHCs are currently the only way that companies can make truthful health claims about natural foods or supplements. However, they are not easy to come by (the FDA approved only 12 QHCs from 1999 to 2010). Under current FDA law, if a food or natural supplement makes a medical claim without a QHC, it’s automatically classified as a drug. The Alliance for Natural Health explains:

 

“Outside of QHCs, food and supplements are not allowed to speak of the specific health benefits of their products because the FDA takes the position that any such statement magically turns them into drugs. And, as drugs, they would have to go through exorbitantly expensive drug trials, a cost which the manufacturer could never recoup, since food and supplements are natural products and cannot be patented. Without a patent, anyone can sell them, so paying as much as a billion dollars for a drug trial is essentially money down the drain.”

 

Believe it or not, the FDA recently sent a warning letter to Diamond Food for making truthful, science-backed health claims about the omega-3 fats in walnuts. But because the research cited health claims that omega-3 fats in walnuts may prevent or protect against disease, the FDA said walnuts would be considered “new drugs” and as such would require a new drug application to become FDA-approved.

 

The FDA’s current position is that foods such as walnuts, cherries, broccoli, turmeric, green tea and the like should be subjected to the full FDA approval process. But obtaining a new drug application, as the FDA suggests, can cost billions of dollars. And let’s face it – small food and supplement producers cannot come close to affording that!

 

In related news, the U.S. Federal Trade Commission (FTC) also suffered a loss in its efforts to hold Garden of Life, the marketer of various dietary supplements, in contempt of a previous consent order.  The FTC alleged that Garden of Life violated the order by making false and baseless claims about its vitamin C and omega-3 fat based products, but the court ruled that the FTC had failed to prove that any of the challenged claims violated the consent order. It’s a small win, but it could have major repercussions for other natural supplement makers who are being unjustly attacked by the FTC or another government agency.

 

[new york kevin]

It's really a clash of the pharmaceutical lobbyist against the natural and homeopathic industries here in the US. Western medicine as well, as it is practiced in the USA. Natural and homeopathic supplements can greatly reduce the need for the more expensive "drug" therapies. Therefore the drug companies cannot thereby charge $700 a pill for something they have patented . Or $20 a pill for that matter. Western Medicine as practiced in Europe incorporates natural and homeopathic supplements, as well as pharmaceutical medications as well.

A supplement like Zeolite enhanced with DHQ is a excellent full body detoxifier. It also helps bring the body more into a ph neutral environment. Why do pharmaceutical company's dislike this ? They dislike this supplement and their claim because they know that cancer cannot grow in a ph neutral environment. Cancers and bacterial also require oxidants and toxins to manifest, Zeolite with dhq also has powerful anti-oxidants. As mentioned above it is effective in detoxifying the body and liver from heavy metal toxins based on its micro biological structure. Anti-oxidants are something we all have a passing familiarity with.

I, a Nurse, take natural and homeopathic supplements, like zeolite with DHQ, for preventative purposes. When I do catch a cold they seem to help shorten the lengths of the cold. If I had cancer, I would follow the advice of my Oncologist! I would take the Zeolite to supplement the chemo/radiation treatments in order to help prep the body for recovery from the damaging effects of chemo/radiation. Perhaps after chemo/radiation has completed.

[Thaiexpat]

Slowly, but surely we can all push back against these fiends and win true freedom. Always good posts TD

 

NYK: What is neutral ph? (Strictly speaking it is 7.0) What part of the body is in neutral Ph?

[MillieChatham]

We've known for 20 years - In the United States of American and free speech be damned...you cannot say that a supplement "heals, cures or ameliorates " ANY disease condition. Because in this country, by legal,definition only a DRUG can heal, cure, etc.

Don't you love it? She said sarcastically.

[divemaster5734]

It's really a clash of the pharmaceutical lobbyist against the natural and homeopathic industries here in the US. Western medicine as well, as it is practiced in the USA. Natural and homeopathic supplements can greatly reduce the need for the more expensive "drug" therapies. Therefore the drug companies cannot thereby charge $700 a pill for something they have patented . Or $20 a pill for that matter. Western Medicine as practiced in Europe incorporates natural and homeopathic supplements, as well as pharmaceutical medications as well.

A supplement like Zeolite enhanced with DHQ is a excellent full body detoxifier. It also helps bring the body more into a ph neutral environment. Why do pharmaceutical company's dislike this ? They dislike this supplement and their claim because they know that cancer cannot grow in a ph neutral environment. Cancers and bacterial also require oxidants and toxins to manifest, Zeolite with dhq also has powerful anti-oxidants. As mentioned above it is effective in detoxifying the body and liver from heavy metal toxins based on its micro biological structure. Anti-oxidants are something we all have a passing familiarity with.

I, a Nurse, take natural and homeopathic supplements, like zeolite with DHQ, for preventative purposes. When I do catch a cold they seem to help shorten the lengths of the cold. If I had cancer, I would follow the advice of my Oncologist! I would take the Zeolite to supplement the chemo/radiation treatments in order to help prep the body for recovery from the damaging effects of chemo/radiation. Perhaps after chemo/radiation has completed.

 

 

Slowly, but surely we can all push back against these fiends and win true freedom. Always good posts TD

 

NYK: What is neutral ph? (Strictly speaking it is 7.0) What part of the body is in neutral Ph?

 

 

We've known for 20 years - In the United States of American and free speech be damned...you cannot say that a supplement "heals, cures or ameliorates " ANY disease condition. Because in this country, by legal,definition only a DRUG can heal, cure, etc.

Don't you love it? She said sarcastically.

 

 

 

Just look at what happened to Treadau, think they finally managed to lock him up.

 

When the US government shares patents with Monsanto, the conflict of interest is staggering.

 

Not only did the USFS allow Monsanto to plant "test" crops all over the US in public forests, they planted across streets from working farms, and when the consumer crops were "accidentally" cross pollinated, the gov sided with monsanto's claim the farmers crops now belonged to monsanto, and let their lawyers sue several small farmers into bankruptcy. It sent a clear message, and thats why most every large agri operation is using monsanto seed, is nothing short of a mafia protection racket, except you and I are forced to consume the lower quality product the farmers are forced to grow and sell.

 

The US allowed monsanto to patient a single piglet DNA genome.

All of Europe has been scrambling for the last 5 years to get their family livestock DNA charted and recorded, because monsanto just randomly picked a singular genome from a pig, and claimed they "owned' it. They did not say how they "made" it, or when, only that any p[ig with that one genome in their DNA is theirs.

Everyone is "allowed" to feed "their" pigs, give them health care, etc, but when the pig is sold, monsanto gets their "royalty" cut.

They also said only they are allowed to chart their pigs DNA, and any lab that charts someone elses pig, and it turns out to have their DNA, it is a $100,000 fine to the lab.

They are working on the international patent, and families that have been farming in europe since the dark ages and breeding their own livestock have been having trouble finding a lab willing to even do the DNA chart.

 

Thanks for the post TD

[SnowGlobe7]

Kevin Treadau update

 

http://articles.chicagotribune.com/2014-03-17/business/chi-kevin-trudeau-sentenced-20140317_1_kevin-trudeau-global-information-network-guzman

Edited November 18, 2015 by SnowGlobe7

[tankdude]

new york kevin - here's a little proof about Big Pharma -

 

Novartis pays $370M for drug-pushing scheme

http://www.usatoday.com/story/money/business/2015/11/20/novartis-pays-370m-drug-kickbacks/76120766/

 

NEW YORK -- Novartis Pharmaceuticals, the maker of Excederin, Ritalin and other popular drugs, agreed to pay $370 million for providing kickbacks to pharmacies to push its drugs on patients.

 

Novartis paid the fine in a deal announced Friday to settle a civil fraud lawsuit filed against it by Manhattan U.S. Attorney Preet Bharara.

Bharara's office said Novartis' scheme, which started in 2007, involved two drugs, including Exjade, which is used to reduce iron overload in patients who are receiving long-term blood transfusions.

 

Starting in 2007, sales of Exjade fell below internal targets due in part to side effects that were "more frequent and more severe than initially expected," the U.S. Attorney said. Exjade can cause kidney and liver failure.

 

To increase Exjade sales, Novartis pressured several so-called specialty pharmacies to hire or assign nurses to call patients and, under the guise of education or clinical counseling, encourage them to order more refills, Bharara's office said.

 

In January 2008, for example, specialty pharmacy Accredo provided Novartis with a call template that the nurse at Accredo would follow to cajole patients to take Exjade, according to Novartis' statement of admission. That template directed the nurse to tell patients why Exjade was important for their treatment, but it did not suggest a discussion of the risks involved.

 

Novartis pressured the pharmacies by threatening to terminate or reduce its relationship with them, according to Novartis' statement of admission. Novartis also doled out rebates to pharmacies that met certain shipment goals -- an arrangement that remained in place until March 2012, the admission statement said.

Specialty pharmacies focus largely on medications for people with serious conditions such as cancer, organ transplants, or HIV/AIDs.

They have come under scrutiny lately for their ties to drug makers.

 

Drug maker Valeant, for example, recently cut ties with a specialty pharmacy Philador after it was revealed that Valeant had an undisclosed option to buy the pharmacy company.

 

In a statement, Novartis said it will implement certain agreed-upon controls "to ensure appropriate support for patients, and compliance with all Federal Healthcare program requirements related to its interactions with specialty pharmacies."

 

Novartis "is committed to high standards of ethical business conduct and has a comprehensive compliance program in place to help ensure we consistently act in a responsible manner," the statement said.

 

Novartis is the U.S. affiliate of Basel, Switzerland-based Novartis AG.

 

Friday's deal marks the third settlement tied to the same lawsuit. In January 2014 and in April 2015, two of the specialty pharmacies, Bioscrip and Accredo, agreed to pay a total of $75 million to resolve federal and state claims based on the same allegations.

 

The drug maker also paid rebates to pharmacies in return for their recommendation to doctors to switch their patients to Myfortic, a drug that seeks to prevent organ transplant rejection by suppressing the immune system, Bharara's office said

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