If you work in the dietary supplement industry or closely follow the political developments now being played out all over the world, you know that dietary supplement rights and personal health freedoms are under attack by corrupt governments and the pharmaceutical drug cartels that fund them.
It's sad but true: world governments are in bed with multi-national drug companies and government scientists go to work for multi-national drug cartels upon government retirement. This essentially makes world governments nothing more than prostitutes to lobbyists and special interest groups.
Those of us who work in the dietary supplement industry have been witness to the years of government action, regulation and crackdown on our industry. While world governments in general, and the United States government in particular, have allowed dangerous drugs like Thalidomide to mutilate and deform unborn babies, Vioxx to induce heart attacks in the healthy, and PhenFen to destroy the heart valves of millions of obese and overweight persons, they've banned benign dietary supplements like phenylalanine, ephedrine and prohormones.
The funny thing is that they are not done yet.
Currently, the restrictive Codex Alimentarius regulations in Europe are law. Europeans can no longer use many dietary supplements, as they are now classified and regulated as drug products, available only by physician's prescription and for purchase at very high prices.
In the United States, the Dietary Supplement Health and Education Act (DSHEA) is under assault by a "Codex-like" bill that will limit access to dietary supplements and eliminate personal health freedoms. This bill, The Dietary Supplement Access and Awareness Act (H.R. 3156), was introduced by Democratic Congresspersons Henry A. Waxman, Susan A. Davis and John D. Dingell and it promotes anything but "access" to and "awareness" about dietary supplements.
Bill H.R. 3156 proposes to subject dietary supplements to strict and expensive regulatory procedures, the results of which will be to stifle innovation, drive up costs and further harm or totally destroy our industry. That's not all.
At the command of the organized multi-national pharmaceutical lobby, the United States government is acting to use every means at its disposal to destroy the dietary supplement industry and destroy personal health freedoms.
Government Threats... Government Lawsuits.
Recently, the Federal Trade Commission (FTC), whose mandate is to "prevent deceptive, misleading, or unsubstantiated claims" and to ensure that all claims on products are "...true, non-misleading, and substantiated at the time they are made", has attacked several dietary supplement manufacturers, and has circulated threatening letters to supplement makers and internet retailers of Human Growth Hormone boosting supplements, demanding "compliance" with its arbitrary and vague demands.
In addition to threatening internet retailers and supplement companies with poorly written letters, the government has sued several companies that it has deemed to be "in violation" of arbitrary FTC regulations.
A recent lawsuit was launched by the FTC against Cytodyne Technologies - the makers of the popular Xenadrine line of weight-loss dietary supplements. In court documents, the FTC alleged that Cytodyne Technologies made "false and unsubstantiated claims for Xenadrine EFX."
I'm going to briefly examine these two cases and discuss their implications for our industry. It will become clear later exactly why these two cases of government action will profoundly affect our industry. Each case is a microcosm of the government's pharmaceutically-backed war on the dietary supplement industry and our health choice freedoms.
Case 1: The FTC and HGH
The previously mentioned threatening letter that was distributed by the FTC to internet retailers and dietary supplement manufacturers is attached for your review. As you can see from reviewing this letter, the FTC demands that internet retailers and dietary supplement manufacturers provide "competent and reliable scientific evidence" to support claims that natural dietary supplements designed to elevate human growth hormone levels are effective.
After issuing this demand, the FTC continues by writing "Studies showing that injected HGH provides anti-aging benefits do not constitute competent and reliable scientific evidence that a pill or spray will provide the same benefits...[these claims must be] discontinued immediately."
This demand is then followed by a brief outline of previously successful FTC legal action against non-compliant businesses, and instructions on how to comply with their demands within a specified time limit.
While the case of the FTC in this matter appears sound prima face, a careful and thorough analysis of their case reveals that it is inconsistent, unfair and illogical.
Recall that the stated mandate of the FTC is to "prevent deceptive, misleading, or unsubstantiated claims" and to ensure that all claims on products are "...true, non-misleading, and substantiated at the time they are made"
In this case, the government has requested "competent and reliable scientific evidence" to support claims about natural HGH boosting dietary supplements. Subsequent to this request for scientific evidence showing HGH dietary supplements effective, the government cited a lack of scientific evidence showing HGH dietary supplements effective as the basis for its claim that HGH boosting dietary supplements are ineffective. Their letter stated as much: "We are aware of no competent and reliable scientific evidence supporting such claims."
The problem with this request - and the problem with the government's entire case in this matter - is that science does not make truth - it discovers it.
A Note On The Proper Role of Science...
The scientific method is a method of detection, observation and discovery that allows scientists to test hypotheses in an attempt to develop theories that explain how things work. Consider the dietary supplement creatine monohydrate as an example.
When creatine monohydrate was first developed into a dietary supplement, many claims were made about its effects. Early creatine marketers claimed that creatine monohydrate could increase muscle mass, cause weight gain, reduce body fat, increase strength, improve moods, provide energy and enhance athletic performance.
When creatine monohydrate debuted on the market, the FTC circulated threatening and poorly written letters claiming that they were "aware of no competent and reliable scientific evidence supporting such claims." Simply, they cited a lack of scientific evidence as the basis for concluding that creatine monohydrate was ineffective.
After years of anecdotal testimony and scientific study, we now know that creatine monohydrate performs as advertised. With this example and the role of science in mind, the question begs:
Did creatine monohydrate build muscle tissue and improve athletic performance before or after organized science studied it?
The obvious answer to this question is that creatine monohydrate built muscle tissue and improved athletic performance long before it was studied by academia. As is often the case, anecdotal evidence amassed and attracted academic attention.
As more anecdotal evidence amassed, researchers realized that the "law of greater numbers" made it impossible for the placebo effect to be responsible for all of the reports, and so they found creatine monohydrate to be a "research-worthy" metabolite. They then studied it in earnest to understand creatine monohydrate and the circumstances under which it worked.
As should be clear, a true claim can be made about a substance even if established science has not yet studied that claim or substance. And, a substance can function in a certain way even though science has not yet established how it works.
What this means, then, is clear: an unverified statement about a product can still be true at the time that it is made, even if science has not yet caught up to anecdotal reports. Something does not become true or act in a specific way only after science has examined it. By definition, the object of scientific scrutiny must already exist at the time of scientific inquiry; otherwise there is nothing for the scientist to discover.
Simply: The proper role of science is to discover already existing truths.
Once these truths are discovered - once they become organized facts of reality that are assimilated into the collective knowledge base - they are used to evaluate and test claims about reality.
Back to HGH...
In the case of HGH stimulating dietary supplements, anecdotal evidence from users has been mostly positive, and while it is generally accepted that Human Growth Hormone (HGH) elevating dietary supplements are ineffective for young persons who already have optimal growth hormone levels, there is evidence to suggest that these supplements may be effective for elderly persons.
Most of the "human growth hormone" dietary supplements on the market today are made from human growth hormone secretagogues - amino acids. Despite claims by the FTC in the attached letter, amino acids like L-lysine and L-arginine that form the base of these HGH supplements are known to stimulate pituitary HGH release.1,2,3
Additionally, one unpublished study apparently showed that a human growth hormone product elevated IGF-1 levels significantly (IGF-1 is stimulated when HGH levels rise and is used as an indirect measure of HGH levels).4
While there are concerns about the design and validity of these studies, these studies do exist and show an effect on HGH levels that result from HGH dietary supplement use (the effects of placebo are unknown).
Other Problems With the FTC - The Double Standard.
As outlined, the FTC claims that they are "aware of no competent and reliable scientific evidence supporting such claims" about HGH dietary supplements and their claimed ability to build muscle, improve strength, improve cognition, and slow aging.
Even if one disregards the above studies on the account of study design and questions about validity, one still finds problems with the FTC's case in this matter if their statement about a lack of scientific evidence is to be accepted.
It is true that the scientific evidence on HGH boosting dietary supplements is scant. In fact, the questionable studies already mentioned were the only studies to date done on HGH boosting dietary supplements and their effects or non-effects.
Because there are almost no scientific studies on HGH boosting dietary supplements, claims either for or against HGH boosting dietary supplements are impossible to prove or disprove.
Despite this fact and despite the fact that claims must be backed by "scientific evidence" to be "substantiated," thereby meeting government standards, the government goes on to cite a lack of scientific evidence as the basis for its conclusion that HGH products are ineffective and the associated claims are false and fraudulent.
In short, they make a statement that HGH products do not work, based on a total lack of scientific studies, and not on the abundance of studies they "require" to meet their own "standards" for statement truth.
If no science can currently validate or disprove the effectiveness of HGH boosting supplements, how can the government conclude that HGH boosting dietary supplements are ineffective? Also, how can they can expect companies and retailers to prove that these supplements are effective? Why can the government make a claim, and retailers cannot, especially when both are using the same non-evidence?
The Final Word on the FTC and HGH.
If internet retailers and product manufacturers cannot make valid claims about what HGH boosting dietary supplements can do, then the FTC cannot reasonably make claims about what these supplements cannot do; including that they are ineffective because both parties suffer from a lack of evidence to substantiate their claims.
The retailers in this case may not meet the FTC's standards, but the FTC doesn't even meet its own standards for truth. This violation is inexcusable. As a government agency that sets standards for industry and that is supposedly run by "experts", the FTC should at least meet its own standards before expecting others to meet them.
The FTC in this case has double standards - one standard for itself, and a different standard for the people and companies that it targets. The FTC is clearly incompetent, lacks credibility and is in professional and legal disrepute. Simply, they cast disgrace on the government and the legal system that allows them to persecute an industry while they suffer from these glaring contradictions and inconsistencies.
2. The FTC and Cytodyne.
The FTC recently launched a lawsuit against Cytodyne Technologies, the makers of the popular Xenadrine line of weight-loss dietary supplements.
From the court documents, the FTC's complaint against Cytodyne was as follows:
"According to the FTC, the defendants and respondents advertised Xenadrine EFX heavily in print and on TV, including in such publications as People, TV Guide, Cosmopolitan, Glamour, Let's Live, Men's Fitness, and Women's World. They also disseminated Spanish language ads for Xenadrine EFX.
The advertisements claimed that Xenadrine EFX causes rapid and substantial weight and fat loss, such weight-loss without the need to diet or exercise, permanent or long-term weight-loss, and is clinically proven to work. The ads relied heavily on testimonials from supposedly satisfied customers, some of whom claimed to have lost over 100 pounds."
FTC filed court documents continue:
"The FTC's complaint alleges that the New Jersey-based Chinery defendants made false and unsubstantiated claims for Xenadrine EFX, including that it was clinically proven to cause rapid and substantial weight-loss and clinically proven to be more effective than leading ephedrine-based diet products.
According to the complaint, Robert Chinery commissioned several studies of Xenadrine EFX, none of which showed substantial weight-loss. The complaint alleges that in one of these studies, subjects taking Xenadrine EFX lost an average of only 1.5 pounds over the 10-week study, while a control group taking a placebo lost an average of 2.5 pounds over the same period."
As we can see from these court document excerpts, Cytodyne Technologies made industry-standard claims about the effects of their weight-loss dietary supplement product Xenadarine EFX (or the ingredients in it).
Like the previous case that examined the FTC's action against the manufacturers and internet retailers of HGH boosting dietary supplements, the FTC's case against the makers of Xenadrine EFX appears solid prima face. However, a critical and careful examination of this case reveals the same contradictions, double standards, logical breakdowns and outright government incompetence that were present in the first case.
The FTC begins its case against Cytodyne by claiming that Cytodyne made "false and unsubstantiated claims" about Xenadrine EFX - mainly that Xenadrine EFX caused weight-loss without the need to exercise. The question here is: how did the FTC determine that this weight-loss claim was false and unsubstantiated?
The truth or falsity of this claim depends upon the intended meaning of "weight-loss." Simple "weight-loss" of any kind can occur by a number of processes, including water loss, muscle loss, fat loss, organ or connective tissue mass losses, or any combination of two or more of these processes.
While it is common knowledge that proper exercise habits and correct nutritional practices are required to burn fat tissue while preserving lean muscle tissue, it is also known by most intelligent people that almost everyone rapidly loses "weight" in the form of water in the first hours following thermogenic / diuretic administration.
With these basic biochemical facts foremost in mind, it's clear that Cytodyne made a truthful claim when advertisements claimed Xenadrine EFX would cause rapid and immediate "weight-loss." It is also clear from court documents that the government believed "weight-loss" to mean "fat loss." It's beyond me how every FCT "medical expert" failed to distinguish between the basic processes of water loss and fat loss.
The second major aspect of the FTC's complaint in this case is that Cytodyne claimed Xenadrine EFX to cause substantial weight-loss. Again, the FTC alleges that this is a false and unsubstantiated claim. Does this FTC allegation have merit?
As before, the truth or falsity of this claim depends upon the definition of a term - this time it's the definition of the term "substantial."
It is not unreasonable to expect or claim that Xenadrine EFX (or any other fat burner) may cause weight-loss when used in conjunction with sound exercise and nutrition practices. However, because of individual pharmacodynamics and sex differences, individual results from product use will vary from person to person. Additionally, the results obtained by one user may be deemed "substantial" while the same results obtained by another user may be deemed "insubstantial."
As an example, consider a weight-loss result of 10 lbs. For an overweight or obese person who has spent a lifetime battling a weight problem, a weight-loss result of 10 lbs. can be very "substantial." For the athlete who wants to lose 50 lbs. during the pre-contest phase, will see a 10 lb. weight-loss as disappointing and deemed "insubstantial."
If all of this is true (it is), and if the exact effects of Xenadrine EFX on each users weight-loss results cannot be determined precisely because of individual genetic makeup and pharmacodynamics, how did the government determine Cytodynes claims about Xenadrine EFX to be false and unsubstantiated?
Do the same government "experts," that can't tell the difference between simple water loss and simple fat loss, suddenly know how to determine the unknowable? Do the same experts suddenly know how every person in America will respond to Xenadrine EFX?
The final aspect of the FTC's complaint in this case against Cytodyne alleges that Cytodyne Technologies claimed Xenadrine EFX to be more effective than ephedra-based products for weight-loss results. Pay close attention to this aspect of the FTC complaint, because it reveals the true nature of the agency's stand on dietary supplements and the true motivator of their actions against this industry.
Problem #1: Contradictions, Incompetence and Double-Speak.
Several years prior to the filing of this FTC complaint against Cytodyne Technologies, the United States government made the manufacture and sale of ephedra-based dietary weight-loss supplements illegal. The government did so on the grounds that its experts stated ephedra and its alkaloids to be unsafe, potentially fatal, and totally ineffective for weight-loss.
In this FTC complaint against Cytodyne, however, we see the same government and the same government experts indirectly stating that ephedra and its alkaloids are effective for weight-loss by stating that Xenadrine EFX is not as effective for weight-loss as ephedra-based dietary weight-loss supplements.
There are three possible explanations for the obvious and glaring contradictions in this aspect of the governments claim. They are:
1. The government and its experts are incompetent and unprofessional
2. The government intentionally acted maliciously against Cytodyne
3. A combination of the above two options
It is not inconceivable to think that the government and its "experts" are incompetent, biased and unprofessional. The government has proven many times that it is a giant bureaucracy which is about as intelligent, coordinated, and responsive as bull at the end of mating season.
It is unsurprising, therefore, that the same group of government "experts," that can't tell the difference between simple water loss and simple fat loss also state that ephedra is NOT effective for weight-loss, while claiming that ephedra IS effective for weight-loss. But, stupidity alone may not be to blame for the government double-speak.
Problem #2: Vicious Government Action, Abuses of Power and Killing a Hog-Tied Victim.
If the FTC were to adhere to the same position stand on ephedra in this case that the government earlier adhered to and subsequently forced the dietary supplement to adhere to (that ephedra is ineffective for weight-loss), then prosecution of Cytodyne on this aspect of its claim would be impossible.
Here is why:
If ephedra were truly ineffective for weight-loss as the government claimed when it made ephedra illegal for weight-loss purposes, and if Xenadrine EFX is really ineffective for weight-loss as the government claims, then the two products are at least equal to each other in effectiveness, and thus no "unsubstantiated claim" about Xenadrine EFX occurred.
To avoid the situation of having a weak case in this aspect of its claim, the FTC did a "Richard Nixon" - it adapted itself and its position on ephedra to suit the immediate legal circumstances. Simply, the FTC warped and abused the legal system by choosing a convenient stand on the effectiveness of ephedra so that it could successfully prosecute this company and damage our industry.
But it doesn't end there.
The greatest scandal in the FTC vs. Cytodyne case results from two government actions:
1. The illegalization of ephedra-based weight-loss dietary supplements
2. The FTC claim that Xenadrine EFX is not as effective as ephedra-based weight-loss dietary supplements
The illegalization of ephedra-based weight-loss supplements on the testimony of government experts occurred prior to the FTC action against Cytodyne, and this government act made the second FTC allegation especially dangerous and malicious. Here's why:
When ephedra-based weight-loss dietary supplements were made illegal for manufacture, distribution, possession and sale, this ruling effectively barred these products from being studied by established science. Remember that according to FTC regulation all claims about a product must be supported by "competent and reliable scientific evidence" to be deemed substantiated.
By first making ephedra-based dietary weight-loss supplements illegal, barring them from scientific study, and subsequently making claims against Xenadrine EFX by holding ephedra based products as the weight-loss standard, the government made it impossible to legally test Xenadrine EFX against ephedra-based weight-loss supplements to test for relative effectiveness.
Simply, the government and the FTC hog-tied Cytodyne and made any legal defense against this FTC claim impossible!
The FTC in this case did not take action to protect consumers from fraudulent claims - its action against Cytodyne was meant as a warning shot to this industry. The FTC made an example of Cytodyne and set a dangerous legal precedent. In so doing, the FTC effectively tied not only the hands of Cytodyne, but the legal hands of all companies in this industry.
Once again, the FTC in this case has double standards - one standard for itself [whatever standard it chooses in the moment], and a different standard for the people and companies that it targets. And, the FTC in this case is not only incompetent, inconsistent, and unprofessional, but they are also vicious, malicious and aggressive.
As a satisfying conclusion to this disgraceful government action, the FTC realized the weakness of its case against Cytodyne and revealed the true motivation behind its actions when it came running to Cytodyne to accept a "first offer" financial settlement proposal. The government wanted one thing: Money, charity, and as charity cases often do, they accepted the meager scraps thrown from the masters table.
The Bottom Line.
When consumers read that a dietary supplement company has been targeted by the government for "non-compliance" issues or "violations" of government policy, they often automatically believe that the said company is guilty of "scamming" consumers and deserves to be punished for their transgressions.
While consumers deserve protection from marketers of "male-enlargement" pills and other similar scams, it does not follow automatically that "protection" means government action. In a "free trade" economy that's based on laze-faire capitalism, consumer protecting is inherently afforded by market forces. Simply, consumers will no longer buy a product if it is a scam and scam artists and crooks will seek other profit centers.
In most "consumer protection" cases, the government is good at doing only what government's do: extracting revenue from an unwilling citizenry. It appears that imposing heavy taxes upon industry and citizens annually in the form of taxes to pay corrupt officers of the privately German-owned Federal Reserve System is not enough. The government also wants more wealth to which it is not entitled.
It is clear, from the cases examined here, that the government abuses and warps the legal system for financial advantage. In the two cases examined here we see a pattern of government incompetence, corruption, and abuse of power.
It's clear from these cases that "consumer protection" becomes the last thing on the governments mind when money enters the picture. When dead presidents speak, consumers are shoved to the background and corrupt government crooks line up for financial payout like bums at a soup kitchen on a cold winters' day.
We Need Your Help!
While the FTC does the bidding of big pharmaceutical companies and wages a legal war on the companies of this industry, the other side of the war on your health freedoms is being waged in Congress.
There are three people who aim to further restrict, and ultimately destroy, your freedom to use dietary supplements. These "shining examples" of health are puppets to the architects of 'The Dietary Supplement Access and Awareness Act (H.R. 3156),' and they aim to establish the government as the final word on truth and health.
These three people are:
Henry A. Waxman California-30th, Democrat 2204 Rayburn HOB Washington, DC 20515-0530 Phone: (202) 225-3976 http://www.henrywaxman.house.gov/
Susan A. Davis California-53rd, Democrat 1224 Longworth HOB Washington, DC 20515-0553 Phone: (202) 225-2040 http://www.house.gov/susandavis/index.html
John D. Dingell Michigan-15th, Democrat 2328 Rayburn HOB Washington, DC 20515-2215 Phone: (202) 225-4071 http://www.house.gov/dingell/
Here's how you can help:
If you value your health and you use dietary supplements to improve your quality of life, please telephone these three people and voice your opposition to their disgraceful actions. Then, call your representative and voice the same opposition.
If you're inclined to go one-step further, and if you want your vote to be your voice, then I would actively encourage you to work toward getting these "representatives of the few" un-elected in the next election.
A democracy without the participation of its citizens becomes a tyranny by default. Your action is desperately needed to save your freedoms from being forcefully removed. Remember that freedom isn't free, but is worth fighting for because it is the American way.
Will you do what's right? Will you do your duty for freedom?
1. Isidori A, et al. A study of growth hormone release in man after oral administration of amino acids. Curr Med Res Opin 1981;7:475-81. 2. Kasai K, et al. Stimulatory effect of glycine on human growth hormone secretion. Metabolism 1978;27:201-8. 3. Welbourne TC. Increased plasma bicarbonate and growth hormone after an oral glutamine load. Am J Clin Nutr 1995;61:1058-61. 4. Essman WB. Clinical evaluation of a human growth hormone secretagogue. Poster Presentation for 6th International Congress on Anti-Aging and Biomedical Technology, 1998 Dec 11-13, Las Vegas, Nev.
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