Do you know about - The Threat to health relaxation Now
Campaign Finance Reform! Again, for I know. Ready to share new things that are useful. You and your friends.As a curative investigative reporter for 28 years, I've seen collective interest in health relaxation come and go. Right now, in 2010, it is at a low point.
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In the early 1990s, there was a gigantic fervor in America. Millions of people, perceiving a threat from the federal government, realized they could be cut off from the right to heighten their health agreeing to their own wishes, judgments, and decisions.
In practical terms, health relaxation has come to mean: the right to have passage to the widest inherent range of nutritional supplements, health practitioners, and treatments-with no government obstruction.
Back in 1993, millions of Americans believed in that principle, and sent letters to Congress. Rallies were held. Celebrities appeared and supported former American liberty.
The final blow was struck with the passage of the Dietary Supplement health Act of 1994 (Dshea). It appeared to promise the results citizens were seeing for. The Fda would not be permitted to limit passage to the full range of nutritional supplements.
Then the furor died down and habitancy went back to their lives. The internet grew into a giant. Millions of pages discussing health issues appeared. More freedom. More access.
But there has been an extensive dampening of that spirit of the early 90s. Many habitancy believe the major battle has been won.
To gawk either this is the case, and either the Dshea Law is nothing else but keeping Americans safe, I interviewed a widely revered lawyer, Jonathan Emord.
Emord is one of the nation's leading free speech attorneys. He has defeated the Food and Drug administration a remarkable seven times in federal court, more times than any other attorney in American history, earning him the title, "Fda Dragon Slayer."
He is the 2007 recipient of the Cancer control Society's Humanitarian Award for "winning and preserving our great civil ownership to life, to liberty, and to health freedoms."
Mr. Emord has practiced constitutional and executive law in Washington, D.C. For the past twenty-five years. He is routinely consulted by industry, Congress, and the media on regulatory issues that sway health freedom. He is the author of four critically acclaimed books: Freedom, Technology and the First Amendment (1991); The extreme Price (2007); The Rise of Tyranny (2008); and Global Censorship of health data (2010).
I hoped Mr. Emord would give us real and detailed data on substantive issues facing Americans today. He responded in kind, and went the extra mile. He cleared up a estimate of beloved confusions, and offered several predictions based on his long taste as an attorney in the field of health freedom.
One of the most critical points Mr. Emord makes: The laws Congress passes can be twisted by the federal agencies responsible for overseeing those laws. For example, the Fda has reinterpreted health law to suit its own slanted purposes. This is an extreme violation of the Constitution, and it endangers the American Republic. Federal agencies can, in effect, illegally come to be legislators and enforcers.
This is not a brush-off interview. Mr. Emord provides a compelling and extensive case that should be read, studied, and acted on by other attorneys, health-freedom advocates, nutritional-company executives, and all citizens who value their freedom.
Jon Rappoport: Dshea is a federal law that was passed in 1994 to safe the public's right to buy and take a wide range of nutritional supplements. It's carefully our best bulwark against invasive actions by the Fda. Did Dshea nothing else but give us dependable protection? Where do things stand today?
Has the Fda eroded that law over the last 16 years?
Are we in trouble?
Jonathan Emord: Dshea has not given dependable protection against Fda censorship or Fda restrictions on passage to products. In clear respects the law itself is to blame because of flaws in its design; in other respects Fda has purposefully misconstrued the law to defeat its plain and intended meaning. Congress has been derelict in counteracting the agency's abuses-in no small part because the drug manufactures benefits from those abuses and has such sway over the House vigor and manufactures Committee and the Senate health Committee that no meaningful reforms ever occur.
I was invited to comment on the bill when it was in draft form. I said then that clear provisions in the bill would enable the Fda to censor health data and restrict passage to supplements. I opposed inclusion of those provisions to no avail.
In particular, Dshea requires supplement clubs to file, with the government, consideration of use of structure/function claims [statements about the clear effects of a nutrient on the structure or function of the body]. At the time the bill was being debated, I explained that since structure/function claims were protected speech under the First Amendment, there was no sound justification for requiring any enterprise to submit them to the Fda for review, and that forcing clubs to do so would invite Fda mischief. I explained that inevitably Fda would use structure/function claim delineate to redefine claims from the category of structure/function to the category of prohibited drug claims, thus reducing the quantity of free speech ready for expression. That has happened.
The Dshea permits the Hhs Secretary to adopt good manufacturing institution guidelines [Gmp] for supplements [how supplements should be made in the lab-factory]. I warned at the time the bill was being debated that this provision would invite critical agency mischief, that Fda would use Gmp regulation to put the manufactures under its thumb and stop the marketing of supplements on technicalities, thereby ridding the market of any stock it did not like. That is now happening.
We hired Steve Hanke, the Senior Economist on President Reagan's Council of Economic Advisors, to rate the impact of the Gmp rule. He carefully that the cost of yielding per year [to supplement companies] would exceed the finances of practically one-third of all dietary supplement manufacturers, resulting in their elimination from the market. In the Gmp rule, Fda put the estimation more conservatively, but admitted that it would eliminate about one-quarter of the market. The estimation we were in case,granted also complete that there would be less collection of stock ready to consumers and that the cost of stock would increase. The Fda also admitted these effects in its Gmp Final Rule. Fda is vigorously pursuing its inspection agenda. Within the next several years we should see the fall-out. Fda has increased its reliance on direct court activity instead of negotiated settlements of disputes with the industry. That too will result in a loss of clubs and a reduction in buyer offerings.
The Dshea adulteration provision included language limiting Fda activity to ban supplements to instances where the agency could prove that they presented a critical or unreasonable risk of illness or injury. Congress intended for this to be a meaningful fence to Fda, compelling the agency to prove supplements capable of causing harm before removing them from the market. Fda has construed this language to give it virtually unbridled discretion. In its ephedra ban, for example, Fda in result rejected the Paracelsian model for assessing dietary supplement adulteration (i.e., dose determines toxicity) in favor of the precautionary principle. Under that [precautionary] principle, if a nutrient causes harm at some dose level (a universal fact because everything, including, water, causes injury at some dose level), it would be presumed adulterated until the manufactures proved it safe beyond doubt at other dose level. That shifted the burden of proof from Fda (where Congress placed it) to the manufactures (where Fda prefers that it be), enabling Fda to ban any nutrient it wishes on evidence easily ready that at some dose level [at preposterously high doses] it causes harm.
The Dshea included a provision to permit dietary supplement clubs to distribute scientific literature on nutrient-disease associations [a nutrient can help alleviate a disease] to the public, together with to their customers. At the time, I warned that the provision included ambiguous requirements that Fda could interpret to emasculate the speech-protective intent of Congress. Fda has in fact gone farther than I had anticipated. Fda fully eviscerated this provision by taking the position that any scientific publication that company a nutrient with a [positive result on a] disease...can still be forbidden by Fda because enterprise provision of the literature to customers would constitute "evidence of an intent to sell the stock as an unapproved new drug."
I also opposed the provision that required submission of a new dietary-ingredient consideration to Fda for every nutrient first sold after the date of passage of the Dshea. Under that provision, if Fda does not object to the notice, the stock is legally marketable. I concept that if a stock met the definition of a dietary supplement, Fda should have no power to forestall its marketing. I warned that Fda could use its discretion to need a degree of proof for protection that was so high as to make it impossible for any new dietary ingredient to enter the American market. While Fda has not construed it to be nothing else but prohibited, it has made it very difficult to market lawfully any nutrient first introduced to the American market after the date of passage of Dshea.
The dietary supplement manufactures is in trouble because the Fda harbors an unscientific bias against supplements, principally arising from its desire to safe the agency's leading regulatee, the drug industry. I remember when folks were arguing that the Gmps were a good idea because manufactures leaders had connections with Fda and could assure that the agency would not abuse its power. The dietary supplement manufactures has never had a very effective lobby and is a Lilliputian compared to the Leviathan drug industry. I have often used the following metaphor to delineate the power triangle at work. The drug manufactures is like an gigantic elephant, and the Fda is like a blind jockey atop the elephant incapable of altering the elephant's course. The dietary supplement manufactures is like a flea on the elephant. So long as the flea does not irritate the elephant, all proceeds smoothly, but as soon as the flea causes irritation, the elephant signals its displeasure and the blind jockey whacks about the outside of the elephant with his riding crop until he nails the flea. Some in the trades and in the dietary supplement manufactures have an inflated view of their sway over Fda. The drug manufactures they are not, and to the drug manufactures they are entirely beholden for any regulatory crumb that falls off that industry's table.
Rappoport: Many commentaries about Codex have circulated on the Web over the past decade.
What is Codex and what is its goal, vis-à-vis nutritional supplements?
Are the American habitancy going to be forced to accept the provisions of Codex? Is this a looming reality?
Emord: The Codex Alimentarius Commission is an organization of the United Nations Food and Agriculture organization and the World health Organization. It is a acceptable setting body. The standards it adopts each member state is foreseen, to implement or, if not, to interpret why it has chosen not to do so. If the failure to adopt a acceptable caused a member state to discriminate against imports, that state could be challenged for its failure before the World Trade Organization. More commonly, however, the Codex Commission serves as a forum for member states to exercise sway over one other in the adoption of domestic standards governing the availability of dietary supplements and the dose levels in the market. By adopting a standard, as Codex has done, recommending that member states rule either vitamins and minerals are safe at particular dose levels and ban them at dose levels not carefully safe, the Commission places the onus on members to implement regulatory regimes based on dose and, implicitly, on the government-preferred precautionary principle. That has encouraged the development of extensive Eu prior restraints on the availability of dietary supplements in the market and has developed the European attachment to and advocacy for the precautionary principle as the best means to assess toxicity. In short, Codex has come to be a coercive force in favor of restrictions on dietary supplements and what can be said [what health claims can be made] about them.
The U.S. Food and Drug administration admires the European system of controls and can alter its interpretative construction of existing regulations to "harmonize" the American model more intimately with the European model of regulation. U.S. Delegates to Codex should be opposing the movement toward greater restrictions on supplements and claims. Instead, they quietly acquiesce in those restrictions and work toward effecting similar restrictions within the United States straight through reinterpretation of existing agency rules.
Rappoport: while the turn over and run-up to the passage of ObamaCare, the national health assurance plan, I heard very slight concern expressed in the health relaxation community about the time to come implications of this bill. It's clear to me that, with control being vested in the agency of health and Human Services, we could eventually see the day when alternative health care and food are edged out additional and additional from permitted treatments. And citizens would be required to accept approved curative treatments, either they want them or not.
Along a similar line, I see very slight evidence, these days, of activity being taken by health relaxation groups and nutritional clubs to keep health relaxation alive. Certainly, we see nothing like the gigantic campaign launched in the early 1990s, when Congress received millions of letters protesting the actions of the Fda to limit our passage to supplements, and celebrities came out of the woodwork to preserve health freedom.
What am I missing? Is some back-door deal in place now? Have nutritional clubs been given assurances that, if they keep their heads down and their mouths shut, they'll be allowed to do enterprise as usual?
I'm at a loss to interpret the eerie silence from groups that should be continuing to fight Very Visibly for our relaxation in this area. I sense a soft attitude.
I was very active in the health relaxation movement of the early 90s. My advent was to go after the Fda for their ongoing crimes, to attack. At the time, some habitancy told me to dial it back, we were going to get a good bill passed in Congress, and aggressive actions could injure our cause. Is that the prevailing mood now? Is something on the table we don't know about? A new bill?
Emord: There has been a recurrent pattern by supplement trade groups and clear leading clubs in the manufactures (epitomized by the manufactures move to draft and advocate Fda adoption of Gmp rules giving Fda broad discretion) to engage in self-flagellation. In its nascent, more contentious years, the manufactures more stridently opposed Fda regulation. The movement of consumers away from specialty supplement brands towards less high-priced generic varieties combined with bad economic times contributed to consolidation of the supplement market, and clear manufactures leaders have for the last several years moved away from robust contest with Fda to compromise with the agency. There is an economic motive for this, to be sure. Large [supplement] manufactures players believe they advantage from greater Fda regulation because it creates high-priced barriers to entry that keep out smaller competitors.
There is also a mistaken view promoted by clear manufactures trade associations that if the manufactures confesses fault to Fda and Congress, even when no fault exists, and professes a keen interest in ridding itself of bad practices, even when those practices are unrepresentative of the industry, it will curry favor with the powers that be. Instead, it has in case,granted those powers with more ammunition to use against the industry, compounding the industry's problems and creating a major collective relations problem.
The fact is dietary supplements with few exceptions are the safest ingestible products, far safer than foods and far safer than drugs. That is a remarkable fact that one would think the manufactures would delineate at every turn. Instead, clear trade associations and manufactures leaders voice grave concerns about supplement protection and agree to greater federal regulation on the concept that greater regulation is either clear or will favor the market position of the leading companies. To listen to what Congressmen Waxman or Dingell have to say, you would swear that supplements were fissile materials. It is the rare exception rather than the rule that a dietary supplement causes harm.
By buying into the self-flagellation consulation (the consulation of supplement opponents that there is something inherently wrong with the market that necessitates amazing new regulation lest we all succumb), the manufactures is interesting its own demise.
Industry leaders who buy into this on the concept that it will sell out competition and shore up their market shares are in fact deluded, however, because, in the end, the Fda is the drug industry's, not the supplement industry's, to control. In other words, Fda will be pleased to expand its regulatory power over the supplement manufactures but not for the advantage of the supplement industry's leaders. Rather, Fda will invariably use greater regulatory power over the supplement manufactures to aid its favored regulatee, the drug industry, not to shore up the market share of large supplement companies. The drug industry, not the supplement industry, holds practically all the cards at Fda and in Congress. The supplement manufactures has relatively slight clout by comparison.
Instead of interesting in self-flagellation, the manufactures ought to refute false representations against supplement protection and efficacy and promote collective awareness of the many benefits supplements bring to consumers. Supplements are rarely the cause of human injury. The science regarding their health improving effects abounds and grows weekly. The inherent for nutrients to sell out the risk of, prevent, and even treat disease is profound. Science is unraveling truths about human biochemistry that preserve the end that our lifestyle choices very much sway our disease risks and that remedial living in reliance on organic foods, above levels of clear key nutrients, reduction in stress, and faith and hope have a profound impact on our health, our quality of life, and our longevity.
Rather than engage in self-flagellation, the manufactures should celebrate its strengths, advertise them continually to the collective and the government, and act to defend on grounds of principle the relaxation to market and sell safe and potentially life-saving and health improving supplements.
Ppoport: This past summer, Congress took up a food protection bill (S.510). What's its present status? Does its wording nothing else but suggest we may be field to Codex regulations vis-à-vis the sale of nutritional supplements? What are the shortcomings of the bill?
Emord: This bill is a critical threat to the supplement industry. It contains a provision that permits Fda to payment the hourly cost of its inspections of [nutritional-supplement] establishments if the agency finds a violation warranting a re-inspection. That creates an incentive for Fda to find fault on first inspections and to do re-inspections as a revenue raiser. The bill also includes a provision that encourages Fda to rate harmonization between domestic and foreign regulation. That invites the agency to interpret its regulations to result a convert in them favoring the Eu model. At a time when the Fda is in great disrepute for abusing its powers (approving unsafe drugs, failing to force the resignation of unsafe drugs form the market, and censoring health data regarding supplements), the Congress is about to entrust the agency with yet more vast new regulatory powers. That is a big mistake. Congress should be interesting rapidly in the other direction, taking away power from this corrupt agency. The qoute is that Congress, too, is quite corrupt. Senator Harry Reid said that he would not move the bill forward in the Senate until after the election. The choice is likely to result in Republican control of the House and either Republican control of the Senate or a loss of Democratic dominance in the Senate. If that happens, S. 510 could come to be a casualty of an angry electorate desirous of stopping the regulatory train before it leaves the station.
Rappoport: In a radio interview we did some months ago, you made a estimate of points that need much wider dissemination. I'd like you to expand on two of those points. First, you said we have a federal government that, nothing else but and disastrously, is run by and straight through its regulatory agencies, whose employees stay on while one administration after another. And two, despite your string of unprecedented victories in court against the Fda, you have the sense that the agency is quite prepared to ignore the court rulings limiting its illegal intrusions into our affairs-in fact, the agency fully intends to carry on without paying one iota of attention to those court rulings...making it, in my eyes, a rogue Agency.
Emord: In my book, The Rise of Tyranny, I interpret how our federal government has been transformed from a slight federal republic into a bureaucratic oligarchy since the 1930s. Under our Constitution, Congress is vested with the power to make laws. We have a disjunction of powers that prevents any one field from exercising combined legislative, executive, and judicial powers, and we have a non-delegation doctrine, that forbids those branches vested with those powers from delegating them to other entities. In the 1930's, the supreme Court at first held efforts by President Roosevelt to delegate governing power to bureaucratic agencies unconstitutional. In response, President Roosevelt advocated the passage of legislation that would have packed the court, adding a justice for every one sitting who had reached 70 and one-half years, thus altering the blend of the Court to receive jurists who would favor the New Deal agencies. The bill was not passed but caused what the media of the day referred to as "the switch in time that saved nine." In 5 to 4 majority decisions, the Court switched from defending the disjunction of powers and the non-delegation doctrines to abandoning them. Since that time, despite the creation of over 183 federal agencies, many with these combined powers, there has not been a particular instance in which the supreme Court has held the delegation of governing power outside the [three basic] constitutional branches to be a violation of the non-delegation doctrine. As a result, today over ninety percent of all federal law is not the stock of our elected representatives but regulation promulgated by unelected heads of the bureaucratic agencies. We founded this country on the concept that no American should be taxed without being represented, and yet today we are taxed and those who originate practically all laws governing us are unelected. James Madison, Thomas Jefferson, John Adams, Alexander Hamilton, and George Washington each stated that if ever our country were to reach a point where legislative, executive, and judicial powers were combined in particular hands that would be the end of liberty and the birth of tyranny. Sadly, I believe we are there. A bill I wrote for Ron Paul would restore constitutional governance by preventing any regulation from having the force of law until it was passed into law by Congress in the way the Constitution requires. That bill, the Congressional accountability and accountability Act, is pending in Congress.
Rappoport: A more normal question: From your taste and training as a constitutional lawyer, what is your view on what the Constitution put in place, straight through word and intent, regarding individual freedom? Constitutionally, what is the meaning and range of freedom?
Emord: Ours is designedly a Constitution of liberty. It is remarkably unique. The notification of Independence possibly best sums up the legal creed that underlies the Constitution. Just governments are instituted among men to safe the ownership of the governed. Just governments are derived from the consent of the governed. When governments come to be destructive of those rights, it is the duty of the habitancy to alter or abolish them so as to restore governance in protection of, rather than derogation of, those rights.
The Constitution is an amazing document nothing else but because it is a written limit on the power of the state. Before it, no government on earth had such written limits. Under it, no power rightfully exists in the state except that which is expressly given to it by the instrument. It enumerates the powers of Congress; it separates legislative, executive, and judicial powers; it makes law-making the province of an elected field but only for enumerated purposes; it makes war notification the province of that same branch, albeit war prosecution the province of the executive. It makes treaty negotiation the province of the executive, but reserves consent to the Senate for treaties negotiated. It makes the individual sovereign by limiting federal powers, preserving state powers as a check on the federal ones, and forbids in the Bill of ownership government from acting beyond the powers enumerated in the Constitution against the reserved ownership of the states and the people. Those reserved ownership originate for us a universe of relaxation that is meant to be very broad. Its scope is possibly best conveyed in Thomas Jefferson's definition of liberty:
"Of liberty I would say that in the whole plenitude of its extent, it is unobstructed activity agreeing to our will. But rightful liberty is unobstructed activity agreeing to our will within limits drawn nearby us by the equal ownership of others. I do not add 'within the limits of the law,' because law is often but the tyrant's will, and all the time so when it violates the right of an individual."
That ideal, that scope of freedom, we do not presently have because the plain and intended meaning of the Constitution is now largely dishonored.
Rappoport: What is your view of the so-called "living, evolving Constitution" promoted by many, many judges?
I have given much concept to this. My reasoning is reflected in my books Freedom, Technology, and the First Amendment and Global Censorship of health Information.
In brief, the Constitution's words spring from fundamental principles. Those system are static. Yet, as we expand in science, technology, and knowledge, we are confronted with new facts. That environment, the life of the Republic, is dynamic. The Constitution permits amendment straight through a strict process prescribed in report V. Its meaning, i.e., the system designedly protected by its words, may not be reasoned out of the document or altered, except by amendment in the way the document designates. Consequently, those system must be preserved in the face of the evolution of our Republic, but that is not to say facts arising from that evolution, because not previously known, interpret departure from first principles. To the contrary, the aim must be to ensure that first system are upheld despite the evolution. So, for example, while the electronic media was not known to the Founders, it is nevertheless media and therefore should be entitled to the same full First Amendment protections afforded the print media. We thus preserve relaxation for the message (the aim of the First Amendment) regardless of the medium.
Rappoport: What do you think our best strategy is, here in America, to head off what the Fda is going to do?
Emord: In my book The Rise of Tyranny I supply a detailed explanation of the changes needed to restore the Framer's Republic. In short, I urge habitancy to vote out of office those who have not supported deregulation and to press members of Congress to preserve two of the bills I have written for Congressman Ron Paul-the Congressional accountability and accountability Act and the health relaxation Act. The former would forestall any regulatory agency from enforcing any regulation it promulgated until that regulation is passed into law by Congress in the way in which the Constitution designates. This would forestall the agencies from exercising unchecked power and would restore the law-making function to Congress, preventing a lot of abusive regulation from ever being enforced. The latter bill would disarm Fda of any power to need expand delineate of claims for supplements. That system of prior restraint violates the First Amendment and should be dismantled. Those who would defraud the collective by falsely advertising their products should be prosecuted after the fact but those who wish to tell the truth should not be required to convince the Fda before they are allowed to speak. There are many other reforms we need to institute, together with removing from Fda the drug approval power and vesting in universities, straight through a blinded system, drug reviews so that science, rather than politics and favoritism, determines the outcome of drug evaluations.
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