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Is this the beginning of the end for Supplements?

Is this the beginning of the end for Supplements?

Recently the US FDA issued a set of 'guidelines' for NDI's (New Dietary Ingredients).  This has been anticipated for a long time but the industry and others have been shocked at just how far the FDA have taken this.

What they are proposing would make the overwhelming majority of supplements illegal because most ingredients being used have not been approved.  Even those which were in use prior to 1994 will still be affected.

Up until now it was OK to use an ingredient in a supplement product provided that there was evidence that supported its safety.  That system has been working well and thousands of products have been developed on this principle and millions of people have benefited by them.  In other words, these ingredients are OK to use in a variety of products. 

However, the FDA has now suggested that not only each ingredient has to be approved in its own right but each ‘product’ that contains that ingredient will require an NDI approval specific for that ingredient in that product.  If the concentration of that approved ingredient in that specific product is changed it will also trigger off a new NDI application.  So, you could have thousands of different NDI applications for the same ingredient but in different products from hundreds of manufacturers.

To obtain that approval the manufacturer will have to come up with hard scientific data that it is OK to combine that ingredient with another ingredient in each specific formula.  For example, combining grape seed extract with grape skin extract.  To provide that scientific proof is virtually impossible even for a simple product…but, for a complex product such as many of ours it is impossible.

Whilst these applications are being processed the product will be withdrawn from the market.  How the FDA will process what will amount to 10’s if not 100’s of thousands of applications are beyond comprehension.  They simply don’t have the resources and even if they did it would be an unwise use of resources.

Synthetic versions exempt…

Some in the industry argue that this is the next step in an attempt by the FDA to destroy the supplement industry or at least put the majority of the industry ‘out of business’ and pave the way for synthetic versions of natural ingredients.  They may be right…particularly when you consider that the synthetic versions of these natural ingredients as produced by the pharmaceutical companies are exempt from these new proposed regulations!

This is not the only ‘unfair’ aspect of this proposed regulation.  There is a move by pharmaceutical companies to take effective natural ingredients that have been proven in the dietary supplement industry and start developing drugs from them.  If they choose to do this then the FDA can deny any NDI application for that ingredient from a dietary supplement manufacturer even if that ingredient has been used for decades.

This is a very serious problem and the only way it is going to be stopped is if enough people get up in arms about it and complain to their law makers.  I really do fear that the general public protest will not be strong enough as so many people have so many other things on their minds in the current difficult economic times.  If you feel strongly about this issue please let your lawmakers know your feelings.

In case you are interested I have copied an interesting article by Byron Richards which goes into this subject in more depth.

 


The FDA’s Scheme to Reclassify Nutrients as Drugs

Tuesday, August 02, 2011  -  Byron Richards, CCN

The FDA and Senator Durbin’s latest attack against the dietary supplement industry should leave consumers for natural health options at affordable prices up in arms. This attack will target some of the most popular and effective dietary supplements, removing them from the free market and placing them under control of large pharmaceutical companies. This move will drastically drive up the price of dietary supplements while severely limiting access to extremely safe and effective nutrients. For example, the GlaxoSmithKline prescription drug version of DHA fish oil (at a therapeutic dose) sells for $189 a month, whereas the equivalent, therapeutic amount of molecularly-distilled DHA sells for $35 a month in the dietary supplement marketplace. Proven to lower triglyceride levels at therapeutic amounts, it is not surprising that DHA is one of the first nutrients the FDA plans to go after. Other powerful nutrients, such as curcumin and resveratrol, are soon to follow.

This is the second article in what will be a series of articles on this critical topic. In my first article, “Senator Durbin & the FDA Viciously Attack Dietary Supplements,” I outlined the scope and nature of the attack and called readers to take action. And it is still critically important that you do take action, so please visit our new TAKE ACTION page immediately following reading this article.

The newly-proposed FDA regulations are complicated. We are just beginning to understand the full scope of their ploy. The FDA is hoping that the complexity of their regulations will confuse consumers so they do not understand the coming changes and resulting repercussions. It is my job to give you some concrete examples of how this will affect you.  

It is not just DHA, curcumin and resveratrol that are slated for pharmaceutical industry takeover, hundreds of other nutrients and herbs are at risk. The unfortunate reality is if the FDA is allowed to carry out their illegal strategy then thousands of products currently on the market are likely to be deemed “misbranded drugs” and forced off the market under the FDA’s criminal campaign to wipe out an industry, and ultimately gain even greater power and profit. 

The Pharmaceutical Industry’s Perfect Storm of Economic Collapse

Mapping the human genome was supposed to usher in the next generation of pharmaceutical “wonder” drugs. Scientists would identify a gene or set of genes causing each and every disease. New biotech drugs operating at the genetic level would fix the problems or compensate for them, ushering in “The Golden Age of Cures” and reaping huge 21st century profits for the pharmaceutical conglomerate.

This wishful thinking is not the case. Their first biotech drugs have caused more death and injury than benefit. At the same time, rapid advancements in tools to analyze gene function made it obvious that Mother Nature already provided a treasure trove of potential golden cures—natural, safe and effective substances already widely utilized in the dietary supplement industry.

Multiple circumstances threaten hundreds of billions in drug company profits. Their pipeline of new drugs with widespread consumer application is scant, as they gamble their future on dangerous biotech drugs with limited use.  Hundreds of their top-selling drugs are losing patent protection in the next few years, exposing them to generic competitors and massively driving down inflated profits. Widely-publicized adverse side effects and unnecessary deaths caused by many commonly-used pharmaceutical drugs have cast suspicion over their entire industry. 

On the political front, Congress is looking for ways to control health care costs, even suggesting incentives for making people well—a far different tune than paying for lifetime drug prescriptions that seldom improve health. In fact, the gene science is actually proving that Western Medicine’s drugs are damaging the human genome and are a significant cause in the onset of many of the diseases of aging—the very diseases they are pretending to treat.

Pharmaceutical companies define their primary assets as patent-protected drugs, giving the drug 15 to 20 years of product sales with no competition. It is vital for them to figure out a strategy to turn dietary supplement ingredients, especially those that could be used for type 2 diabetes, cardiovascular disease, obesity, depression, Alzheimer’s, and cancer treatment into drug company “assets,” eliminating from the free market many of the most helpful dietary supplement ingredients while drastically driving up prices for consumers.

The Poison-Dispensing Era of Western Medicine

Until the advent of the new gene-regulating drugs, virtually all medications worked on the principle of poisoning the function of a cell or enzyme system to hopefully produce a change that the doctor thinks “beneficial.” If taking a drug results in a better-looking blood sugar, blood pressure, or cholesterol number, then doctors automatically assume the person is healthier. Rather, health has nothing to do with it.  It is in the financial interests of drug companies to dispense more and more drugs, on an ongoing basis. 

There is a night-and-day difference in quality of health between a person who has good numbers because they are healthy and a person who has reasonably-looking numbers because they are poisoned with drugs. Studies using high doses of metabolic and cardiovascular drugs to attempt to drive numbers down to the levels of healthy people invariably injure and even kill the participants—clearly failing to improve health quality and extend lifespan.

To make matters worse, the pharmaceutical industry fraudulently hides the actual risks of the drugs from both patients and doctors. This includes slanting, to blatantly falsifying, studies routinely published in medical journals and used for marketing, illegally promoting off-label use of drugs, using funding to bribe research universities to publish only favorable results and blacklisting researchers who refuse to accept, and paying influential doctors to present their data as independent research at medical meetings.

The scope and magnitude of the drug safety issue is a nightmare. In 2006 the Institute of Medicine (IOM) conducted interviews with FDA management and hundreds of FDA employees to ascertain issues leading to drug safety problems. Widespread conflict of interest and many other issues led IOM investigators to label FDA management as dysfunctional. Little has changed.

The Gene-Experimentation Era of Western Medicine

The human body is no slouch when it comes to elaborate complexity. It is often the case that the same exact gene signal is “good” or “bad” depending on the context in which it is activated. In fact, the same genes often behave differently in different areas of the body. Unlike earlier toxic drugs that force cell and enzyme behavior at a rather crude level, biotech drugs turn gene signals “on” or “off” at a powerfully fundamental level of cell function. Unfortunately for consumers, our understanding of genes is in its infancy.  There is daunting complexity in gene regulation, making use of any gene-regulating drug highly questionable.  

One example of this problem involves diabetes drugs Avandia and Actos, which turn on the gene PPAR gamma. This gene signal helps to break down triglycerides. These drugs also stimulate the formation of new fat cells, which are more metabolically fit and therefore produce more adiponectin that stops insulin resistance. Thus, in theory, they are potentially great drugs for lowering triglycerides and benefiting people with type 2 diabetes. As these drugs became blockbusters it was soon observed that the patients taking them were experiencing devastating side effects. These drugs have no way to know the context in which they should be operating. They activate PPAR gamma in the wrong places, such as the heart, leading to a 40 percent increased risk for heart failure or heart attack. Additionally, inappropriate PPAR gamma activation in bones causes them to break more easily.

The FDA rushed these drugs to market despite the objections of its own safety supervisor who wanted to employ a black box warning for heart failure. In other words, the FDA knew about the risks but prevented the public from understanding them, and still allowed the drugs to go to market. This was a major scandal at the FDA. The FDA has finally restricted Avandia, but Actos remains available in full swing. Actos has recently been highly restricted in Europe, but in America, the FDA continues to drag its feet. This is likely because the FDA has mud on its face for approving these biotech nightmares in the first place and would rather consumers suffer injury and even die than look bad. The mainstream media fails to aggressively report on or investigate this tragic issue as they are large recipients of drug company advertising dollars.  Even when one of their own, Tim Russert, was likely killed by Avandia or Actos, they turned a blind eye.

DHA is a Superior and Intelligent Gene-Regulating Nutrient

The plot thickens. Nature’s nutrient DHA, typically in fish oil, is a powerful activator of PPAR gamma, helping to break down triglycerides as well as make new metabolically-fit fat cells that boost adiponectin and help fight type 2 diabetes—the exact objectives of Big Pharma’s Avandia and Actos. DHA is a near-miracle nutrient for the heart and overall cardiovascular health and also supports strong bones. It has all of the benefits of Avandia and Actos and none of the side effects.  

And this is why Big Pharma is so interested in taking over many dietary supplement ingredients. The nutrients know how to work in harmony with gene function in the human body, since nutrition was a key part of human evolution. These nutrients appear to have inherent intelligence that no drug could possibly have. They understand the context of the gene signal and thus support the beneficial gene activity. They know how to behave differently in different areas of the body to promote healthy function at every turn

Under the FDA’s new draft guidance that redefines the 1994 Dietary Supplement Health and Education Act (DSHEA), the FDA targets many nutrients for elimination from the market, and DHA is one of them. DHA is a component of fish oil, which is a pre-DSHEA nutrient. This means that it should be grandfathered in and not subjected to the newly-published New Dietary Ingredient (NDI) guidelines.

Various companies have been able to concentrate the DHA as well as remove toxins from the oil, enabling consumers to take higher amounts of the most important ingredient in fish oil. Consumers can now easily and safely reach doses of DHA that are consistent with studies showing extreme health benefit. Such doses of DHA are known to be safe, have been tested in clinical trials sponsored by the National Institutes of Health (NIH), and are consistent with the amounts consumed by people who regularly eat fish.

The FDA’s point man on NDI guidance issues, Daniel Fabricant, has been telling the supplement industry what to expect. In a recent webinar he was asked, “Should it be necessary to submit an NDI notification over a small change in the ratios of the long chain omega-3 fatty acids EPAto DHA in one fish oil supplement versus another? Is this really a big safety issue?”  Shockingly, Fabricant responded “If it is a different ingredient, a different chemical entity, then it should trigger an NDI notification.”

Fabricant is saying that any modification of basic fish oil should trigger an NDI notification. This is utter nonsense, but it is exactly what the FDA is attempting to do. What Fabricant did not bother to say to the supplement industry webinar audience was that an NDI application for modified fish oil would be denied, since GlaxoSmithKline already has a fish oil prescription drug on the market called Lovaza. Again, shocking.

Yes, the new guidance document makes it clear that if an existing drug contains any form of the nutrient DHA, a NDI will not be allowed (section IV.C.8-11). In other words, if modified DHA did not require an NDI notification, it qualified as a grandfathered nutrient, an obvious part of fish oil. But if the FDA decides that the newly manufactured form of the nutrient, in this case DHA, is different than its typical concentration in food, it can require that nutrient to have an NDI notification. By retroactively applying this definition to nutrients that compete with drug applications, that nutrient will automatically be denied NDI status. As of now, this is the intended fate of DHA. It is gravely unfortunate, as DHA is one of the most beneficial and effective nutrients offered by the dietary supplement industry.  

This is a blatant power play to hand the entire high-grade DHA market to GlaxoSmithKline, one of the largest drug companies in the world. Lovaza already costs five to seven times what a similar amount of high-grade DHA costs—imagine how high their price will go up when there is no competition.

The Rise of Epigenetics

The new frontier of science is the field of epigenetics. A true genetic change means there is a change in the DNA sequence. Epigenetics explains factors that are not such DNA changes. Rather, epigenetic changes relate to how genes are expressed. Some are set in response to early environmental influences such as prenatal malnutrition or nutrient deficiency.  As cells split and divide, however, epigenetic factors play a large role in determining life-long human health and are strongly linked to poor health and the onset of disease. Epigenetic weaknesses magnify during aging and are major factors in the cause of cancer, heart disease, neurological and cognitive disorders, obesity, diabetes, infertility and sexual dysfunction. 

This new science is finding that when toxins interfere with the human genome, they can cause lasting damage in the form of adverse epigenetic changes which can occur at any point in one’s life. This is not simply an issue of pollution. Researchers are now demonstrating that regular use of many drugs can cause adverse toxic epigenetic changes, a finding that has alarming implications for today’s medical practices. Up to this point in time, drug safety has not involved studying the impact of any drug on epigenetics.  Science now has the ability to see what is going on in this realm. The pharmaceutical industry and the FDA, unsurprisingly, have no interest in understanding and considering this new, ground-breaking information as the public would significantly reduce their intake of drugs. 

On the hand, research on dietary ingredients is showing them to be powerful regulators of epigenetics and some show extreme promise for helping to treat metabolic disease and even cancer. Nutrients are showing that they possess “intelligence” and are able to tell the difference between a stressed and struggling cell (one with epigenetic weaknesses) and a cell with cancer. In the case of the stressed cell, the nutrients can fix it. In the case of the cancerous cell, the exact same nutrient can actually help kill the cancer without any adverse side effects—even overcoming mechanisms that make cancer resistant to drug treatments. Two of the very best nutrients in this category are curcumin and resveratrol, making them potential prizes for the pharmaceutical industry.

As I reported in my recent article, “Curcumin Helps Change Gene Function to Combat Cancer,” curcumin and resveratrol are under extensive genetic study at the MD Anderson Cancer Center. Regarding cancer, these researchers are at the forefront of all things drug and biotech. The last commissioner of the FDA, Andrew von Eschenbach, was in charge at the MD Anderson Cancer Center before joining the FDA.  Researchers at the MD Anderson Cancer Center are practically drooling over the virtues of curcumin and resveratrol. Some quotes from their recent study include the following:

Recently, natural compounds, such as curcumin, epigallocatechin gallate (EGCG), and resveratrol, have been shown to alter epigenetic mechanisms, which may lead to increased sensitivity of cancer cells to conventional agents and thus inhibition of tumor growth. Curcumin (diferuloylmethane), a yellow spice and the active component of the perennial herb Curcuma longa, commonly known as turmeric, is one of the most powerful and promising chemo-preventive and anticancer agents, and epidemiological evidence demonstrates that people who incorporate high doses of this spice in their diets have a lower incidence of cancer. Furthermore, epidemiological evidence exists indicating that there is a correlation between increased dietary intake of antioxidants and a lower incidence of morbidity and mortality…. How curcumin exerts its powerful anticancer activities has been thoroughly investigated, and several mechanisms of action have been discovered…. curcumin exerts its biological activities through epigenetic modulation.

Extensive research over the past five decades has indicated that curcumin reduces blood cholesterol levels; prevents low-density lipoprotein oxidation; inhibits platelet aggregation; suppresses thrombosis and myocardial infarction; suppresses symptoms associated with type II diabetes, rheumatoid arthritis, multiple sclerosis, and Alzheimer disease; inhibits HIV replication; suppresses tumor formation; enhances wound healing; protects against liver injury; increases bile secretion; protects against cataract formation; and protects against pulmonary toxicity and fibrosis. These divergent effects of curcumin seem to depend on its pleiotropic molecular effects, including the regulation of signal transduction pathways, and direct modulation of several enzymatic activities. Most of these signaling cascades lead to the activation of transcription factors.

Interest in the effects of dietary compounds such as resveratrol which activate class III HDACs (sirtuins) is growing rapidly because of their demonstrable role in extending lifespan and in reducing, or delaying, age-related diseases including cancers…. Resveratrol, a natural compound found in the skin of red grapes and a constituent of red wine, is believed to play a significant role in the reduction of cardiovascular events.  Multiple studies have shown that resveratrol can activate sirtuin 1 (SIRT1), a histone deacetylase, and inhibit p300. Sirtuins, the class III HDACs, are widely distributed and have been shown to regulate a variety of physiopathologic processes, such as inflammation, cellular senescence and aging, cellular apoptosis and proliferation, differentiation, metabolism, stem cell pluri-potency, and cell cycle regulation.

Experimental evidence accumulated in the recent years clearly supports the idea that dietary nutraceuticals such as curcumin have great potential as epigenetic agents.

These researchers go on to cite all of the human safety and efficacy trials with curcumin, resveratrol and many other natural substances.

This is not dietary supplement companies extolling the virtues of these powerful nutrients. These are mainstream drug development researchers, stunned by the ability of nutrients to regulate epigenetics to support health and at the same time combat diseases that plague large numbers of people. The inherent capacity of these nutrients outshines that of any drug.  

There should be no question in anyone’s mind as to why the pharmaceutical industry wants to claim these powerful nutrients as patent-protected drug assets. The question is more about how they plan to pull off this major scheme, this heist, from the dietary supplement industry.

Curcumin (tumeric) has been around for thousands of years and is consumed in very large amounts in Eastern and Middle Eastern cultures. This means the basic spice is protected by DSHEA. Unfortunately, curcumin has relatively poor bioavailability and raw material companies have sought to produce purified extracts with advanced production technology and combine curcumin with other nutrients such as piperine, which can elevate the biological activity up to 2,000 percent. Researchers at MD Anderson Cancer Center have conducted cancer research specifically with one such curcumin product, made by Sabinsa, and found it very promising.  

Under the proposed FDA guidelines for NDIs, such curcumin extracts would retroactively become NDIs as they were not available prior to 1994. The immediate impact would be the removal of curcumin from the dietary supplement market while submitting an NDI application. Sabinsa, however, has already been granted several investigational new drug applications for their curcumin complex as they work with researchers at MD Anderson Cancer Center. Under the new FDA guidelines the net result would be eliminating all high grade curcumin extracts from the dietary supplement market, as no NDI will be granted for any ingredient that is under investigation as a new drug. Sabinsa, a dietary supplement raw material supplier, will be able to sell its rights to its curcumin compound to the highest pharmaceutical bidder while all other competing curcumin extracts, including Sabinsa’s product, will be forced off the dietary supplement market.

It is a similar story for resveratrol, which is also under investigation as a new drug. In fact, numerous highly-effective and therapeutic extracts will be targeted in this way by the pharmaceutical industry. The FDA has a glaring conflict of interest and can easily approve investigational new drug applications for any nutrient of interest to the pharmaceutical cartel, automatically blocking them from entry or existence in a competitive dietary supplement marketplace. Dietary supplement companies could spend millions trying to get the FDA to pass a NDI application. The FDA just sits on the NDI application, to ultimately approve the nutrient as an investigational new drug and deny the dietary supplement company’s NDI application.

Consumer options for therapeutic nutrition will rapidly dwindle. What is left on the market will be far more expensive and many nutrients will no longer be available without prescription. Once the pharmaceutical industry gains control of the nutrient, the new price will be ten to fifty times what consumers pay now.

A Call for Consumer Action

The most important force capable of preventing skyrocketing prices and the elimination of therapeutic nutrition from the dietary supplement marketplace is you, the consumer.  If you wait to act until the products actually begin to disappear, it could be too late. Act now and help preserve your right to a wide range of these powerful and valuable dietary supplement ingredients and products at affordable prices. Say NO to the FDA’s illegal strategy to help drug companies take over the dietary supplement industry.  Go to our TAKE ACTION page and, please, let your voice be heard.

Take Action!

If you value your access to dietary supplements, click here to take action today!




Comments  (34)

  • Alexandra Petrich
    August 12, 2011

    Thanks for posting this information.  I had vaguely heard of it, but this is really shocking.  I tried to use the FDA website to post a comment, but (naturally) it is totally user unfriendly.  I will have to use snail mail, I guess.  Of course, if I was a CEO of Big Pharma, I could just call my D.C. lobbyist and he/she could deliver my comments to the FDA in person.

  • David Campbell
    August 12, 2011

    How long is it going to take for people to realize that the governments  they elect to make decisions regarding their health and welfare are really wolves in sheep's clothing. I suppose it is entirely possible that some  politicians actually think they are acting in good faith.That is truly scarey. Money is the key word here. Just take a look around and and hopefully enough of us will wake up and smell the coffee.

  • dana
    August 12, 2011

    How does this impact Xtend life supplements and shipment to the US?

  • Jackie
    August 12, 2011

    This will really be very detrimental to us if it is passed. It really all about money and control.. The sadest thing is that so many people will sit back and do nothing..they wont even use the resource your provide to let their voices be heard.  Thank you so much for providing the information, it is truely invaluable the service you provide.

    Thanks...

  • Alex
    August 12, 2011

    Yes, this is really shocking. I've taken action...

    Thanks for the update.

  • Image for Warren Matthews
    Warren Matthews - Chairman
    August 12, 2011

    Dana...you ask how this will impact Xtend-Life and by extension our customers.  Hard to say at this stage as the 'guidelines' have not as yet become law and they are likely to change.  I suspect that if there is enough consumer and industry reaction that they will be 'watered' down and it will become manageable but will increase costs.  Some ingredients may be lost however.

    I don't think that there will be an overnight detroying of the supplement industry (Unless the FDA is stubborn and refuses to budge).  It will be more by stealth.  For example, some of the most onorous components of this proposed regulation will no doubt be dropped but will be resurrected at a later time and possibly sneak through in little 'bites'.

    Many of the laws that have come into place that have impacted on the supplement industry have been warranted.  For example, the GMP codes.  Even though much of the industry has complained and are still not compliant, most manufacturers welcomed it.  However, this current set of 'guidelines' are way over the top and are certainly not warranted. 

    We will be attending a number of industry conferences in Las Vegas in October and at that stage will be in a better position to comment further.  In the meantime the more people who can become aware of what is going on the better.

  • Yumin Tchen
    August 13, 2011

    Thank you Warren for the heads up on another attempt the FDA is making to try to get safe and effective health supplement products out of our hands and into the sole financial pocket of Big Pharma, because as you pointed out, they know their prescription drugs all have serious side effects and often do not work as well, so they are trying to get their greasy palms on naturally available products that do not have side effects and then charge a ton for them.

    The FDA has long been controlled by the chemical, pesticide, additive, and pharma companies, with FDA top guys going into high paid jobs in those industries and vice versa, an old boys club in the worst sense. And some in Congress profit, hopefully enough who don't want to play along to risk our health and free choice.

  • Jesse
    August 13, 2011

    It is all a matter of money.  The drug companies want to make more money and the supplement companies want to make money as well. Neither is to be entirely trusted.

  • karen edwards
    August 13, 2011

    This makes me very angry. It's just another way Big Government sticks its nose into things that are none of their business! I'm really afraid to see what is going to happen in our Country when people get pushed too far and are denied their freedom to choose.

  • Bruce S
    August 13, 2011

    This is seriously alarming, to say the least!  I was unaware of it until reading your blog this week.  I was going to use some excerpts from your blog to start a petition about it, but somebody beat me to it...

    http://www.thepetitionsite.com/takeaction/493/669/808/?z00m=20039662

    This is another way to take action and stand up for your freedom of access, so I would encourage all readers to visit this site and sign the petition.

  • Yumin Tchen
    August 13, 2011

    To Dr (?) A K (The fast doctor):
    1. Where are your experimental studies showing supplements "Help keep sick cells alive...". Don't you think there would be a mass media blitz if such a study came out? There are any number of positive studies for supplements that Warren just mentioned the FDA wants to control, such as fish oil, Resveratrol, curcumin, etc. 2. Many supplements have been used for thousands of years to balance an unbalanced system. Our current modern diet is nutrition-depleted and contains many toxic additives permitted by the FDA, things that supplements are good at dealing with in a balanced way. Would you rather wait to get sick and then take some heavy drugs?
    3. It's generally harmful to fast over three days.

  • ej
    August 13, 2011

    I have taken action! We all MUST.

    If you are lazy and don't want to look up your senators' addresses, go to www.lef.org (I hope xtend-life won't mind).  This is not an endorsement; They have an easy link that sends your complaint letter directly to your senators (from your zip code). Whatever you do, do not sit this one out. Let your voice be heard. Place it on your Facebook page as well. The FDA is about to see pushback the likes of which they've never seen. Act today!
    Thank you xtend-life for all you do. 

  • John
    August 13, 2011

    Hi Warren,

    Thanks for the very informative blog on FDA plans.  I wonder what effect this stupidity will have on the Canadian market for your products & hope that you will be able to address that subject soon.  Meanwhile keep up the great work & the fine supplements that X-Tend Life provides.  I know that I feel great taking your products & as an older man (70ish), I am relieved that I do not have to take any drugs or prescription meds. I credit life style, good eating habits & X-Tend Life supplements for that situation. 

    Best wishes,  John

  • Image for Warren Matthews
    Warren Matthews - Chairman
    August 13, 2011

    Dr A.K,

    You are making a pretty serious statement here by suggesting that supplements serve primarily to keep 'sick cells' alive and thus promote cancer...and turbo charge the aging process.

    Just like supplement manufacturers should not make claims that their products cure cancer you should not make the reverse claim that they cause them. 

    I challenge you to provide the 'strong' evidence that you claimed to have accumulated in the last 30 years.

    I also challenge you to match your health against mine. Assuming that you started your research when you were 20 that would make you around 50 years old.  I am 64 years old.

    Are you prepared to be transparent and match your medical records against mine?  I have been relying on our supplements for the last 11 years to slow down the aging process and it has been highly successful.  But, under your scenario I should be in not good shape...so...what do you think?  Are you prepared to accept that challenge?

  • Karenina Kliber
    August 13, 2011

    Dear Warren Matthews,

    This is very worrying indeed; once again it is all about money! How can I do this from my country, UK please?

    Many thanks.

    Karenina


  • Dr A K (The Fast Doctor)
    August 13, 2011

    Dear, dear Warren, I accept the "challenge" with open arms. Problem is, there are no medical records as, since I stopped taking any form of "supplement" more than a quarter century ago, I have not needed any medicine nor medical care of any sorts other than for injuries. Indeed that holds for my entire life, about 8 years less than yours at this stage. Even the notoriously recurrent HSV(I) stopped recurring after I stopped "supplements".. and for sure I will not make the mistake again. See you all when I'm 120 years young!

    AK

  • Dan H
    August 15, 2011

    I find it speaks to the character of the way Xtend-Life conducts their business, by allowing Dr. A K's comments to remain on what is a private business blog. A private business certainly has the right to moderate whatever postings they choose, and Dr A K's, are not only hostile but completely unfounded.


    Dr. A K is obviously very anti-supplement and sees no harm in using the force of law to shut down companies he doesn't agree with. Presumably, Dr. A K is perfectly fine with pharmaceutical companies, whose products he believes are beneficial. (I didn't see a remark from him above about using the law to shut down the manufacture of prescription drugs).

    In light of this, I found this story (copied below) which I just came across quite interesting.

    The gist is that pharmaceutical companies have enjoyed a protected status on social media giant's site Facebook. The protected status prevented anyone from commenting on the page "wall" that a pharmaceutical may set up about a drug of theirs.

    Apparently, Facebook, as a private business, has for whatever reason thought this through and is now taking away this protected status that the pharmaceutical companies enjoyed. (Good for them, I say and it's their right to do so).

    And, what's interesting is Pharm's reaction to Facebook's actions: many pharmaceutical companies are simply shutting down those Facebook pages!

    As the article points out, perhaps these pharmaceutical companies do not enjoy an 'open' forum/discussion about their products....such as consumer stories about bad side effects and so forth.

    Article here:

    http://www.washingtonpost.com/national/health-science/pharmaceutical-companies-lose-protections-on-facebook-decide-to-close-pages/2011/07/22/gIQATQGFBJ_story.html

    In light of this, I commend Xtend-Life for keeping the comments to their blog open, even though I personally think there's a line in the sand that should be drawn. As Warren rightly pointed out, if it's not acceptable for supplement companies to claim supplements cure cancer (which Dr. A K would also presumably feel would be criminal), how is it proper for a so-called Dr. to come on a private entity's blog and claim the exact opposite.

    Best Regards,
    Dan

  • Rado
    August 15, 2011

    Oh no! I could almost say "I know that it will happen". When I entered reading in this article after highlight "Synthetic versions exempt…" my heart started to bounce, unhappily!
    We consume daily and love your products and mentioned them too in our <a href="http://www.traditionaloven.com/articles/388/fish-oil-omega-3-supplement-benefits">fish oil</a> article.

  • Beth
    August 15, 2011

    It is another way the Government can control the populace & make sure only the rich can afford the "new" medicines & that the poor die off.  After all, who wants poor, sick, & homeless people around to offend the sight of the beautiful, elite & priviledged.  The almighty $$ once again rears its ugly head. This is certainly the age of greed.

     

    Natural is far better than synthetic & that does not even need to be proven.  If that were not true, mankind would not have survived.  After all, synthetic products are a product of the modern world & it has been proven that not all synthetics are good for you.  Case in point, synthetic hormones vs. bio-identical hormones, etc.   



    Grrrrrrr......this is enough to make my blood boil...................



    Thank you for a most enlightening article!


  • Doris Clark
    August 15, 2011

    After spending an entire year being extremely fatigued and feeling terrible, my doctor suggested that I drop off all prescription drugs except coumadin.  At the time I was taking medication for cholesterol, (Lipitor) as well as bone density medication, medication for essential tremor, and reflux. After being off these medications for 4 months, I began to feel better.  Every time I tried to add a medication back to my regimen I began to have symptoms again.  I started taking large doses of Omega 3/DHA, Cinnamon, niacin and grape juice with Certo to control my cholesterol.  I have felt better and have kept my cholesterol levels (LDL) down and my HDL up (92).  I order my Omega 3/DHA from Extend Life in New Zealand.  If  they are forced to stop producing Omega 3/DHA, I will be in trouble.  I cannot take synthetic products.  The natural products work much better for me with  no side effects. I will be in touch with my Representatives to ask that they leave our natural products alone.

  • Marius
    August 15, 2011

    I would say this is the beginning of the end for the unethical pharmaceutical companies. I think they've made a terrible mistake and disrupted the dragon's sleep. Ironic kudos for those in charge of their aggressive lobbying strategies. This attempt of theirs at pushing forward an unfair FDA strategy will only blow up in their faces. They succumbed to greed, believing they are the smartest guys out there, surrounded by stupid sheep that will eat whatever is put in front of them and will even pay extra for it -- what else is new in the corporate world with shaky business ethics? And like all empires with clay feet, they will eventually collapse under the weight of their own excessive ambitions. They will fall. People know or learn instinctively what's good and what's bad. For a while, you can fool a few guys here, and a few guys there, but you can't build a solid, long-lasting business that way. People wake up from their ignorance or slumber and they take action.

  • Image for Warren Matthews
    Warren Matthews - Chairman
    August 16, 2011

    Hi Dr AK,

    Glad to hear you are prepared to accept the challenge.  Lack of medical records are not a problem.  This is all we need to do...through a reputable clinic or hospital.

    1. Blood pressure, pulse and respiration rate.
    2. Examination for any skin lesions.
    3. Hearing and eyesight exams and reports.
    4. A full Biochemistry report and liver function.
    5. A full Haematology report.
    6. A full immunology report include PSA and AFP and CEA (tumor markers)
    7. A complete hormone panel including all forms of testosterone.
    8. Serology (IGF1)
    9. Special Immunology.  (C-reactive protein high sensitivity)
    10. Complete stool examination.
    11. Urinalysis
    12. Ultrasound scan or upper and lower addomen checking on liver, pancreas and gall bladder.
    13. Chest X-Ray to check for any abnormalities.
    14. Resting EKG
    15. Exercise stress test report

    All pretty simple.  Naturally the results will have to be signed off by someone of standing who can attest that the results are for the person listed on the documents. 

    We could both publish our results for comparision.  In the interest of fairness you should also put them on your website/blog as well.  Given that you are only 56 years old and I am 64 years old your results should be better than mine don't you think?  Particuarly if you believe that supplements are not beneficial is sustaining good health.

    So, its now in your ball court.  Hey, if your results are better you could increase your readership from our customers...and, if mine are better we would no doubt get some new customers from the followers of your blog.

    This will be interesting.
    Warren

  • Yumin Tchen
    August 17, 2011

    Dear Dr A K,
    I see you stated you did not have any medical records: is that an excuse to beg off on Warren's challenge, or are you going to man up and show us all some honesty?

  • Yumin Tchen
    August 17, 2011

    This was my response to Sen. Chuck Schumer's email to me:

    Dear Senator Schumer,

    I have no qualms regarding your response to my objections to S.1310, there is nothing wrong with companies registering the ingredients to their products and so forth. However, S.1310 goes much farther than that: it demands that NDI (New Dietary Ingredients) be experimentally verified to the tune of millions of dollars each, and for each combination! Also, if a supplement is being tested as a pharmaceutical drug, then it cannot be accepted for supplement testing until that drug is cleared, and then when cleared it cannot be used any longer as a supplement even if it has been used for thousands of years: think of curcumin, resveratrol, fish oil, grape seed extract, etc. The drug companies would corner the market, making huge profits from these because they are effective and do not have the side effects that the drugs they currently make do have. This would be a serious blow both to our nation's finances and personal finances in this economic recession, as well as to the right of individuals to make safe health choices that have been made without problems for a very long time. I hope you consider all aspects of this bill carefully.

  • Matthew
    August 17, 2011

    Fasting?  Seriously?  All these "cleanses" and fasting programs and whatnot is a bunch of hogwash. If you eat a diet of unprocessed food with ample fruits and vegetables (especially if organic), you are *cleansing* your body each day!


    I am a very active and athletic 35-year old male, who lifts weights and participates in cardiovascular exercise at least 5 out of 7 days.  I eat ample portions of food.  My bodyfat is somewhere just under 10%.  I am in excellent condition and to the vast majority of observers, look 5-10 years younger than my actual age.  

    So how is my fast metabolism causing me to age faster?  I'd love to hear it.  If I didn't eat regularly, my metabolism would slow down, and I would lack energy to exercise. My testosterone levels and muscle mass would drop.. hmm... now THAT sounds like aging.  Fasting and calorie restriction is a sure path to lethargy.  I am willing to bet my life savings that eating robustly and exercising profusely will give me a longer life than a calorie-restricted one.

    I should mention that I haven't felt even remotely ill (unless I had too much to drink) for over two years.

    Oh yeah I also take Total Balance Plus everyday:)

  • Dr A K (The Fast Doctor)
    August 17, 2011

    Dear Chairman, I accept that "challenge" with open arms, most of these studies I do from time to time to check on my absolutely superb health status.. without "supplements" that only swell the bank account of "manufacturers" that adulterate Nature's nutrients into something they can make money out of.

    Nothing wrong with vitamins like Folic Acid for alcoholics, just like Penicillin for tonsillitis.. but "supplements" are medicines.. and in the same way, they should be used at the lowest effective dosage for the shortest possible period of time. This will allow the body to regain control of the balances it needs for ultimate health.

    I'll be back in my home country within 2 months and will get these tests done.. please meanwhile prepare your own.

    This is going to be an interesting exercise.

    Meanwhile I am saving lots of money by getting my nutrients from real food, not some adulterated chemical mixture called "supplement".

    A.K.

  • Marius
    August 18, 2011

    Dear A.K.,

    I don't know what kind of supplements were available "a quarter century ago", when you say you stopped taking them in "any form", but there's a good chance science made some progress meanwhile and came up with better formulas.

    Also, how can you possibly conduct "both scientific and natural health care research" for "almost 30 years" with "no medical records"? These are your words, right? Do you have any idea how research is done and how scientific opinion is backed up with hard conclusive data? Data that is also recorded for others to consult, agree with, or "agree to disagree?"

    I know that fast has its cleansing virtues when done in moderation and I'm aware of supposedly poisoning cases caused by vitamin overdose, but cancer and death? Come on; name one solid study that establishes beyond any doubt a causal relationship between vitamin intake at any dose and cancer of any kind, so I can ponder upon it.

    Also, you have to discern between different companies and their products. Like in any other business there can be a lot of useless dirt in the supplements' zone, but you can find some gold nuggets too. You can’t just go around saying "Oh, I know better then you and I’ll prove it ... two months from now or some day. Just wait." That doesn't work, especially if you want to be taken seriously.

  • Ruthie
    August 18, 2011

    This is SICK!!!! I would actually go to war over this. If this could be stopped by someone dying, I would volunteer to be the one who dies! I have never felt so strongly regarding a cause. I HATE THE F.D.A.!!!!! I HATE THE GOVERNMENT!!! This speeks soooooo loudly that they are only money driven and don't care about anyone's health! RISE UP PEOPLE!!!!!!! LETS DO SOMETHING!!!!!!!!!

  • Dale
    August 21, 2011

    Having read with some interest the dispute between Warren and Dr. A K, I wouldn't not want to suggest that genetics and phsycological wellbeing (including environmental conditions) are likely to be the significant factor in the result of each others health reports. In fact, childhood conditions and how we model our world are a huge factors in wellbeing. The very fact you both have very different opinions stems from a life-time of neural stimulus, outside the scope of any test (unless you hold religious beliefs in which case you'll have to wait until Dr A K is 120 years +). I think celebrity deathmatch on MTV would be about as credible a contest (keeping things light hearted). There is no fair-test, only two opinions and then ours and like everything else - politics.

    How would everyone reading this feel about a simple resolution to this dispute - as follows:

    Let's look at this from a position above this topic entirely, as observers. From a point of view above this discussion it is clear to see that Dr A K has entered the house of Warren. What is in this for Dr A K because we know what is in it for Warren (passion for subject and money - in that order)? What is important for someone with true health-and-wellbeing to come to someone elses home to dispute their belongings (being that there is no financial gain)?

    Wouldn't not experience suggest that if Dr A K was indeed fit-and-healthy then he wouldn't not need to feel like he has to discredit Warren in his own home. In fact, the happiest and healthiest people I know care not for blog's, Facebook and Twitter at all because there is nothing in it for them that they do not already have. I myself read this blog because I have goals I am on the road to achieving, I must obviously seek the approval of others (otherwise this message would not exist) and I have concerns for my health, otherwise I would be outside in the garden (certainly not on this website).

    Everyone is entitled to their own opinion.  In my book when you go into someone's home and upset their family and friends, then you cross-the-line of credibility. From a top level view, experience suggests that Dr A K has a subconcious interest in supplements he is not consciously aware of, otherwise he would also be in the garden (his garden - mine is intruder-free).

    The only fair way to settle this dispute is to remove the comments of DR A K from this blog because the most powerful factor in health, wealth and wellbeing is self-belief and if you CHOOSE to take supplements as YOUR RESPONSE to ill-health or to aid your strategy-for-life, for whatever reason, then choose what you read CAREFULLY.

    Everything you read goes in and your subconcious picks what it believes is right based on all experiences and all experience are first born of the imagination. If you truly believe a supplement will work then it will work, if you have doubts, choose another solution. In the end, all that matters is that you make your own opinion - this is why politics falls short because the individual is lost in the masses.

    Yes this is deep - so are the oceans and we know little about them too. On a positive note, I have made the choice to by some supplements today even though Dr A K is living life to the max - I have health improvements to achieve and choosing fasting gets a negative response from my subconcious, so I'll go with Warren.

    Nice website by the way :¬) Live the dream everyone. Dale, England.

  • Dale
    August 22, 2011

    Having read with some interest the dispute between Warren and Dr. A K, I wouldn't not want to suggest that genetics and phsycological wellbeing (including environmental conditions) are likely to be the significant factor in the result of each others health reports. In fact, childhood conditions and how we model our world are a huge factors in wellbeing. The very fact you both have very different opinions stems from a life-time of neural stimulus, outside the scope of any test (unless you hold religious beliefs in which case you'll have to wait until Dr A K is 120 years +). I think celebrity deathmatch on MTV would be about as credible a contest (keeping things light hearted). There is no fair-test, only two opinions and then ours and like everything else - politics.

    How would everyone reading this feel about a simple resolution to this dispute - as follows:

    Let's look at this from a position above this topic entirely, as observers. From a point of view above this discussion it is clear to see that Dr A K has entered the house of Warren. What is in this for Dr A K because we know what is in it for Warren (passion for subject and money - in that order)? What is important for someone with true health-and-wellbeing to come to someone elses home to dispute their belongings (being that there is no financial gain)?

    Wouldn't not experience suggest that if Dr A K was indeed fit-and-healthy then he wouldn't not need to feel like he has to discredit Warren in his own home. In fact, the happiest and healthiest people I know care not for blog's, Facebook and Twitter at all because there is nothing in it for them that they do not already have. I myself read this blog because I have goals I am on the road to achieving, I must obviously seek the approval of others (otherwise this message would not exist) and I have concerns for my health, otherwise I would be outside in the garden (certainly not on this website).

    Everyone is entitled to their own opinion.  In my book when you go into someone's home and upset their family and friends, then you cross-the-line of credibility. From a top level view, experience suggests that Dr A K has a subconcious interest in supplements he is not consciously aware of, otherwise he would also be in the garden (his garden - mine is intruder-free).

    The only fair way to settle this dispute is to remove the comments of DR A K from this blog because the most powerful factor in health, wealth and wellbeing is self-belief and if you CHOOSE to take supplements as YOUR RESPONSE to ill-health or to aid your strategy-for-life, for whatever reason, then choose what you read CAREFULLY.

    Everything you read goes in and your subconcious picks what it believes is right based on all experiences and all experience are first born of the imagination. If you truly believe a supplement will work then it will work, if you have doubts, choose another solution. In the end, all that matters is that you make your own opinion - this is why politics falls short because the individual is lost in the masses.

    Yes this is deep - so are the oceans and we know little about them too. On a positive note, I have made the choice to by some supplements today even though Dr A K is living life to the max - I have health improvements to achieve and choosing fasting gets a negative response from my subconcious, so I'll go with Warren.

    Nice website by the way :¬) Live the dream everyone. Dale, England.

  • Reg
    August 24, 2011

    Just a thought Warren, but have you tried getting in touch with any major news organizations?
    This topic sounds like perfect fodder for news affiliates without any discernible (I know, difficult to determine) links to big Pharma.
    We could send links related to this travesty of justice in the making to The Economist, The Financial Times, The New York Times, The Wallstreet Journal (worth a shot despite their vested right wing leanings and corporate interests).
    Readers & viewers, people who either take supplements or rely solely on prescriptions, or those who are completely neutral on the subject can surely find something interesting in this narrative.
    Why wouldn't long-form journalists be willing to write on the systemic and substantiated fraud perpetuated on the general public by the actions of the gluttenous and morally reprehensible pharmaceutical industry.  
    And wouldn't this shed far more light on the issue than a small segment of American society (people like me who take supplements everyday) voicing their concerns to elected officials?  I for one am pessimistic about our propects of making any real difference alone.  
    Just a thought...

  • Reg
    August 26, 2011

    @RB Thanks for the links.  Wouldn't considers Alex Jones ajor news organizations or having as nearly as much reach to the general public, but hey, it's better than nothing.

  • Dr A K (The Fast Doctor)
    September 03, 2011

    I also think Warren Matthews is exceptionally brave and shows the courage of his conviction by allowing a critic like myself to post on this blog. I salute you Warren!

    Being a bit of an extremist myself with perhaps excessive faith in Nature rather than synthetic man made or altered/processed Nutrients, I did a quick search for scientific evidence and found the following 2:

    http://nccam.nih.gov/health/antioxidants/introduction.htm
    and
    http://www.informationisbeautiful.net/play/snake-oil-supplements/

    which weighs in somewhere between the views of myself and Warren. Thus perhaps we should both mellow a bit but indeed I am enthusiastic about comparing health.. if only Biochemistry was an adequate measure! To be holistic one would need everything from a psychogram to molecular biology plus history and environment. Perhaps I can one day come over to the States and we visit a reputable institute like the Mayo Clinic together for an objective evaluation.

    AK

  • Dale
    September 09, 2011

    Having read with some interest the dispute between Warren and Dr. A K, I wouldn't not want to suggest that genetics and phsycological wellbeing (including environmental conditions) are likely to be the significant factor in the result of each others health reports. In fact, childhood conditions and how we model our world are a huge factors in wellbeing. The very fact you both have very different opinions stems from a life-time of neural stimulus, outside the scope of any test (unless you hold religious beliefs in which case you'll have to wait until Dr A K is 120 years +). I think celebrity deathmatch on MTV would be about as credible a contest (keeping things light hearted). There is no fair-test, only two opinions and then ours and like everything else - politics.

    How would everyone reading this feel about a simple resolution to this dispute - as follows:

    Let's look at this from a position above this topic entirely, as observers. From a point of view above this discussion it is clear to see that Dr A K has entered the house of Warren. What is in this for Dr A K because we know what is in it for Warren (passion for subject and money - in that order)? What is important for someone with true health-and-wellbeing to come to someone elses home to dispute their belongings (being that there is no financial gain)?

    Wouldn't not experience suggest that if Dr A K was indeed fit-and-healthy then he wouldn't not need to feel like he has to discredit Warren in his own home. In fact, the happiest and healthiest people I know care not for blog's, Facebook and Twitter at all because there is nothing in it for them that they do not already have. I myself read this blog because I have goals I am on the road to achieving, I must obviously seek the approval of others (otherwise this message would not exist) and I have concerns for my health, otherwise I would be outside in the garden (certainly not on this website).

    Everyone is entitled to their own opinion.  In my book when you go into someone's home and upset their family and friends, then you cross-the-line of credibility. From a top level view, experience suggests that Dr A K has a subconcious interest in supplements he is not consciously aware of, otherwise he would also be in the garden (his garden - mine is intruder-free).

    The only fair way to settle this dispute is to remove the comments of DR A K from this blog because the most powerful factor in health, wealth and wellbeing is self-belief and if you CHOOSE to take supplements as YOUR RESPONSE to ill-health or to aid your strategy-for-life, for whatever reason, then choose what you read CAREFULLY.

    Everything you read goes in and your subconcious picks what it believes is right based on all experiences and all experience are first born of the imagination. If you truly believe a supplement will work then it will work, if you have doubts, choose another solution. In the end, all that matters is that you make your own opinion - this is why politics falls short because the individual is lost in the masses.

    Yes this is deep - so are the oceans and we know little about them too. On a positive note, I have made the choice to by some supplements today even though Dr A K is living life to the max - I have health improvements to achieve and choosing fasting gets a negative response from my subconcious, so I'll go with Warren.

    Nice website by the way :¬) Live the dream everyone. Dale, England.

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