as a medical investigative reporter for 28 years, I have seen public interest in health freedom to come and go. Right now, in 2010, it was the lowest point.
In the early 1990s, there was tremendous enthusiasm in America. Millions of people, the perception of danger from the federal government realized it could be cut off from the right to improve their health in accordance with their own desires, judgments and decisions.
In practical terms, health freedom has come to mean: a right of access to the widest possible range of nutritional supplements, health practitioners, and treatment-without government obstruction
.Back in 1993, millions of Americans believe in this principle, and sent letters to Congress. Rallies were held. Celebrities appeared and supports traditional American freedoms.
the final blow was struck with the passage of a dietary supplement Health Act of 1994 (DSHEA). He appeared to promise the results people were looking for. FDA will be allowed to restrict access to a range of nutritional supplements.
then sensation died down and people return to their lives. The Internet has grown into a giant. Millions of pages discussing health issues appeared. More freedom. More access.
However, there is overall dampening of the spirit of the early 90-ies. Many people believe the main battle is won.
to examine whether this is the case, and whether the DSHEA law is actually keeping Americans safe, I interviewed a widely respected lawyer, Jonathan Emord.
Emord is one of the nation's leading free speech lawyers. He defeated the Food and Drug Administration remarkable seven times in federal court, more often than any other attorney in American history, earning him the title "Dragon Slayer FDA ."
is the 2007 recipient of Cancer Control Society's Humanitarian Award for winning and preserving our great civil rights to life, liberty, freedom and health ."
Mr Emord practicing constitutional and administrative law in Washington, DC in the last twenty five years. He also routinely consult industry, Congress and the media on regulatory issues affecting the health freedom. The author of four critically acclaimed books: Freedom, Technology and the First Amendment (1991), Ultimate Price (2007); Rise The Tyranny of (2008) and Global Censorship of Health Information (2010 ).
I hoped Mr. Emord would give us a detailed information about the substantive issues facing Americans today. He responded in kind, and went the extra mile. He cleared up the number of popular confusion, and offered several predictions based on his long experience as a lawyer in the field of health freedom.
One of the most critical points of Mr. Emord it: Congress passes laws can be twisted by the federal agency responsible for oversight of these laws. For example, FDA has been reinterpreted health law to suit their own purposes inclined. This is extreme violations of the Constitution, and it threatens the American Republic. Federal agencies may, in fact, become illegal legislators and enforcers.
This is not a brush-off interview. G. Emord provides a comprehensive and convincing case to be read, studied and worked with other lawyers, health advocates freedom, food company executives and all citizens who value their freedom.
Jon Rappoport: DSHEA is a federal law enacted in 1994 to protect the public's right to purchase and download a wide range of nutritional supplements. This is considered our best bulwark against invasive action by the FDA. Did DSHEA really give us a reliable protection? Where things stand today?
FDA has reduced the bill in the last 16 years?
Are we in trouble?
JONATHAN EMORD: DSHEA did not provide reliable protection from the FDA FDA censorship or restrictions on access to products. In some aspects of the law itself is to blame for deficiencies in design, in comparison to other FDA is intentionally wrong law to defeat its plain and intended meaning. Congress was abandoned in combating abuse agencies-in no small measure, because the drug industry uses of these abuses and has such an impact on the home for energy and commerce committee and the Senate Health Committee that there is no sense of reform ever occur.
I was invited to comment on when the law is in draft form. I said then that certain provisions of the law would allow the FDA to censor health information and restrict access to supplements. I opposed the inclusion of these provisions without success.
Specifically, DSHEA requires supplement companies to file with the authorities, notification of use of structure / function claims [statement about the positive effects of nutrients on the structure or function of the body]. At the time the bill was discussed, and explained that the structure / function statements were protected speech under the First Amendment, there is no sound justification for requiring any company to be submitted for FDA review, and that forcing companies to do the FDA will invite and evil. I explained that the FDA will inevitably use the structure / function claims review claims to redefine the category of structure / function in the category of prohibited drug claims, thereby reducing the amount of freedom of speech available for expression. It's happened.
DSHEA allows the HHS Secretary to adopt guidelines of Good Manufacturing Practice [GMP] for additions [add-ons that should be made in a laboratory-factory]. I warned at the time the account was argued that this provision would invite a significant evil agency, the FDA will use the GMP regulation put the industry under the thumb to stop the marketing of supplements on the technicalities, this exemption market any product he did not like. It is happening now.
We hired Steve Hanke, a senior economist on President Reagan's Council of Economic Advisers, to assess the impact of GMP rules. He found that the annual cost of compliance [supplement companies] exceeds finance approximately one third of all dietary supplement manufacturers, which resulted in their elimination from the market. As a rule, GMP, FDA put a more conservative estimate, but acknowledged that it will eliminate around one quarter of the market. assessment, we were provided also found to be less variety of products available to consumers and that product prices will increase. The FDA has also recognized these effects in GMP Final Rule. FDA decisively carries out its inspection agenda. In the next few years we should see the fall-out. FDA has increased its reliance on direct judicial process rather than negotiating settlements of disputes with the industry. It will also result in loss of businesses and reduce consumer offerings.
provision of DSHEA forgery included language limiting the FDA to ban the activities linked to cases in which the agency can prove that they represented a significant or unreasonable risk of illness or injury. Congress intended for it to be meaningful barriers to the FDA, compelling the agency to prove supplements to cause damage before they are removed from the market. The FDA has interpreted this language to make it virtually unbridled discretion. In its ephedra ban, for example, the FDA actually rejected Paracelsian model for assessing dietary supplement forgery (ie, determine dose toxicity) in favor of the precautionary principle. Under this [precautionary] principle, if the nutrients causing damage to some doses (universal fact for all, including water, causing injuries to some doses), it would be assumed to counterfeit industry has certainly proved to doubt the second dose. It has switched the burden of proof from the FDA (where Congress put), industry (FDA, which prefers to be), allowing the FDA to ban any nutrient wants evidence that they are readily available at any dose [at preposterously high doses] to cause damage.
DSHEA include the provision to allow the dietary supplement companies for the distribution of scientific literature on nutrient-disease associations [of nutrients can help alleviate the disease] to the public, including to their clients. At that time, I was warned that its provisions are vague claims that the FDA may interpret the language to emasculate the protective intent of Congress. FDA was in fact gone further than I expected. FDA fully eviscerated this provision by taking the position that any scientific publication, which is closely related with nutrients [positive impact on] the disease ... can still be banned by the FDA because the company providing literature to customers would be a "proof of intent to sell the product as an unapproved new drug ."
I also opposed the provision that required submission of new dietary ingredient notification FDA for each nutrient first sold after the passage of DSHEA. Under this provision, if the FDA does not object to the notice, the product is legally marketable. I thought that if the product meets the definition of a dietary supplement, FDA should have the power to prevent its marketing. I warned that the FDA could use its discretion to require proof of the degree of security that was so high that it is impossible for any new dietary ingredient for entry into the U.S. market. Although FDA has not interpreted it that is absolutely forbidden, it made a very difficult market to be lawful nutrients first introduced to the U.S. market after the passage of DSHEA.
dietary supplement industry is in trouble, because the FDA Airport unscientific bias against supplements, mainly arise from its desire to protect the most prominent agencies regulatee, the drug industry. I remember when people are arguing that the GMPs are a good idea, because industry leaders have had to do with the FDA and could be convinced that the agency would not abuse their power. dietary supplement industry has never had a very effective lobby and tiny compared to the drug industry Leviathan. I've often used the following metaphor to describe the strength of the triangle at work. drug industry as a huge elephant, and the FDA is like the blind jockey on top of an elephant in a state of changing the elephant exchange. dietary supplement industry as a flea on an elephant. So long as the flea does not irritate the elephant, everything is going smoothly, but as soon as fleas cause irritation, elephant signal their discontent and blind jockey stumbles on the surface of an elephant with his riding crop nails while fleas. Some of the trades and the supplement industry are inflated view of their impact on the FDA. Drug industry is not, and the drug industry are completely optional for any regulatory crumbs that fall the industry table.
Rappoport: There are many comments on the Code were circulated on the Web in the past decade
.What is Codex and what is your goal, vis-à-vis nutritional supplements?
the American people will be forced to accept the provisions of the Code? Is this looming reality?
EMORD: Codex Alimentarius Commission is an organization of the United Nations Food and Agriculture Organization and World Health Organization. This is the standard setting body. standards adopted by each member state is expected to be implemented, or if not, to explain why he chose not to do so. If you are not adopting the standard challenged member states to discriminate against imports, this could be challenged for its failure before the World Trade Organization. More often, however, the Codex Commission serves as a forum for member states exercise influence over one another in making the local standards governing the availability of dietary supplements and doses on the market. By adopting standards such as Codex has done, with a recommendation to Member States to determine whether the vitamins and minerals are safe in some doses, and a ban on them is not determined a safe dose, the Commission places the burden on members to implement a regulatory regime based on the dose and, by implication At the state desired precautionary principle. It encouraged the development of a comprehensive EU before the restrictions on the availability of dietary supplements on the market and advanced European commitment and dedication to the precautionary principle as the best tool for assessing toxicity. In short, the Code has become a coercive force in favor of restrictions on dietary supplements and what we can say [what health claims can be made] on them.
U.S. Food and Drug Administration admire European system of control and can change its interpretive construction of the existing regulations to "harmonize" the U.S. model more closely with European regulatory model. American delegates Code should be opposing the movement toward greater restrictions on the ins and claims. Instead, they quietly accept such limitations and work towards effecting a similar restriction in the United States through a reinterpretation of existing rules agencies.
Rappoport: During the debate, and the run-up to the passage Obamacare, national health insurance plan, I have heard very little concern expressed in community health freedom on the future implications of this law. It is obvious to me that, with control vested in the Department of Health and Human Services, in the end we could see the day when the alternative health care and nutrition are edged out farther and farther from the permitted treatment. And citizens will have to accept the conventional medical treatments, whether they want them or not.
Along similar lines, I see very little evidence, these days, actions and health freedom groups and food companies to keep health freedom alive. Of course, we see nothing like the huge campaign launched in the early 1990s, when Congress received millions of letters protesting the FDA action to restrict access to supplements, and celebrities came out of the woodwork to support the Health Freedom.
What am I missing? Is there a back-door deal in place now? Food companies have given assurances that if they keep the head down and mouth shut, they will be allowed to do business as usual?
I'm at a loss to explain the eerie silence from the group that should be continued in the fight against the very visible for our freedom in this area. I sense a soft attitude.
I've been very active in the health freedom movement since the early 90-ies. My approach was to go after the FDA for their crimes in progress, for the attack. At that time, some people told me it back, we were going to get a good law passed by Congress, and aggressive action could hurt our efforts. Is that the prevailing mood now? Is there anything on the table, we do not know about? new law?
EMORD: There is a recurrent pattern in addition to trade groups and some leading companies in the industry (summarized in the industry move for the elaboration and adoption advocate FDA GMP rules give the FDA broad discretion) to engage in self-flagellation. In its nascent, competitive years, the industry more stridently opposed to FDA regulation. consumer movement away from the addition of specialty brands to cheaper generic varieties, combined with poor economic times contributed to the consolidation of the supplement on the market, and some industry leaders in recent years moved away from robust competition with the FDA to compromise with the agency. There is an economic motive for this, to be sure. Large [widget] industry players believe that the benefits of greater FDA regulation, because it creates a costly barrier to entry to smaller competitors.
There is a wrong view of promoting a particular industry trade association that if the industry recognizes the fault of the FDA and Congress, even when no fault exists, and to profess a keen interest in ridding itself a bad practice, even when those practices are unrepresentative Industry , it will curry favor with the powers that be. Instead, it was provided that these powers with more ammunition to use against the industry, compounding the problems of industry and the creation of major public relations problem.
The fact is a dietary supplement with a few exceptions are the safest ingestible product, which is far safer than food, and far safer than drugs. It is a remarkable fact that one would think that the industry is spoken everywhere. Instead, some companies and the leading voice of grave concern for the safety of supplement and I agree with most federal regulations on the idea that more regulation is inevitable and will benefit the market position of leading companies. To listen to the Congressmen Waxman and Dingell have to say, you would swear that the supplements fissile material. This is the rare exception rather than the rule that a supplement causes harm.
the purchase of self-flagellation argument (argument widget opponents that there is something inherently wrong with a market that requires an extraordinary new regulation that we all die), the industry is calling his death.
industry leaders, who buy into the idea that this would reduce competition and support their market shares are in fact deceive, however, because at the end, the FDA's drug industry, rather than supplement industry, for control. In other words, the FDA will be pleased to extend its regulatory power over the supplement industry, but not for the benefit of addition of industry leaders. Instead, the FDA will always use the greater regulatory power over the supplement industry to help their favorite regulatee, the drug industry, not to shore up market share from big companies to supplement. the drug industry, rather than supplement industry, holds almost all the cards on the FDA and Congress. supplement industry has been relatively little weight in comparison.
Instead of engaging in self-flagellation, industry needs to refute false statements against the addition of safety and efficiency and raise public awareness of the many benefits that supplements lead to the consumer. Supplements are rarely the cause of human injury. The science of enhancing their health effects is abundant and grows weekly. the potential for nutrients to help reduce the risk of, prevent and even cure disease is profound. Science is unraveling the truth about human biochemistry that support the conclusion that our lifestyle choices really affect our risk of disease and the healthy life in reliance on organic foods, above the level of certain key nutrients, stress reduction, and faith and hope to have a profound effect on our health, our quality of life, and our longevity.
Rather than engage in self-flagellation, the industry should celebrate their strength, that they always advertise in the public and the government, and act to defend based on the principle of freedom to market and sell a safe and potentially life-saving and health improvement supplements.
PPOPORT: This past summer, Congress took account of food security (S.510). What is the status today? Do you actually own words suggest that it may be subject to Codex rules vis-à-vis sales of dietary supplements? What are the disadvantages of the law?
EMORD: This law is a significant threat supplement industry. It contains a provision that allows the FDA to charge hourly cost of its inspection [Food widget] facilities if the agency finds a violation warrant re-examination. This creates an incentive for the FDA to find a fault on the first review and make re-inspections as a revenue contribution. The law also contains a provision that encourages the FDA to review the alignment between domestic and foreign regulations. To call the agency interpreted its regulations to force change in their favor the EU model. At a time when the FDA was in great disrepute to abuse their powers (the approval of unsafe drugs, not to force the withdrawal of unsafe forms of drugs on the market, and the censoring of information about health supplements), Congress has entrusted the agency with even more great new regulatory powers. It was a big mistake. Congress should be moving quickly in another direction, taking away power from this corrupt agency. The problem is that Congress, too, was quite damaged. Senator Harry Reid said he will not move forward legislation in the Senate until after the election. The choice is likely to result in Republican control of the House and Republican control of either the Senate or the loss of Democratic dominance in the Senate. If this happens, S. 510 could become the victim of an angry electorate eager to stop the regulatory train before it leaves the station.
Rappoport: In a radio interview with me several months ago, and he made a number of points that need to be more widely spread. I'd like you to expand on two of these points. First, you said we have a federal government that, in fact, a disaster, water, and through their regulatory agencies, whose employees will stay on for one administration to another. And two, despite his unprecedented string of victories in court against the FDA, you have the feeling that the Agency is quite willing to ignore court rulings limiting the illegal intrusion into our affairs, in fact, the Agency fully intends to continue without paying one iota of attention to those legal decisions ... making it, in my eyes, rogue agencies.
Rappoport: In a radio interview with me several months ago, and he made a number of points that need to be more widely spread. I'd like you to expand on two of these points. First, you said we have a federal government that, in fact, a disaster, water, and through their regulatory agencies, whose employees will stay on for one administration to another. And two, despite his unprecedented string of victories in court against the FDA, you have the feeling that the Agency is quite willing to ignore court rulings limiting the illegal intrusion into our affairs, in fact, the Agency fully intends to continue without paying one iota of attention to those legal decisions ... making it, in my eyes, rogue agencies.
Rappoport: more general question: From your experience and training as a constitutional lawyer, what is your view about what the Constitution put in place, through the words and intentions with respect to individual freedom? Constitution, what is the meaning and scope of freedom?
EMORD: Our Constitution is deliberately freedom. It is extraordinarily unique. Declaration of Independence is perhaps best sums up the legal belief that underlies the Constitution. Only governments are instituted among men to protect the rights regulated. Only governments are derived from the consent of the governed. When governments become destructive of these rights, it is the duty of people to alter or to abolish it, in order to return control to protect, but deviation from those rights.
The Constitution is an extraordinary document because it is written, a limit on state power. Before him, no government in the world have written such a limit. According to him, no power rightfully exists in the country, except what is specifically their instrument. He enumerates the powers of Congress, she shared the legislative, executive, and judicial authorities, it seems right to make the province elected branches, but only for specified purposes, it seems the war declaration and the province of the same branch, although the prosecution of war the province of the executive power. This makes the contract negotiations, the province of the executive authority, but retains the Senate's approval of contracts negotiated. It makes the individual sovereign, limiting the powers of federal, state conservation authority as a check on the federal ones, and prohibits the Bill of Rights the government from acting beyond the powers specified in the Constitution against the rights reserved by the State and nation. They reserved the right thing for our universe of freedom that is supposed to be extremely wide. Its scope is perhaps best expressed in Thomas Jefferson's definition of freedom:
"I would say that freedom in abundance throughout its extent, it's smooth action in accordance with our will. But the legitimate freedom of peaceful action according to our will within limits drawn around us equal rights of others. I do not add" in limits of the law "because law is often but the tyrant's will, and always so when it violates the right ofof the individual ."
This is an ideal, that the scope of freedom, do not currently have, because plain and intended meaning of the Constitution is now generally respected.
Rappoport: What is your view on the so-called "living, evolving Constitution, " promote the many, many judges
?I have given much thought to it. My opinion is reflected in my books Freedom, Technology and the First Amendment and Global Censorship of Health Information.
In short, the Constitution words spring from the fundamental principles. These principles are static. However, as we progress in science, technology and knowledge, we are faced with new facts. This environment, of life, is dynamic. The Constitution allows the precise modification procedure prescribed in Article V of its meaning, ie, the principles of deliberately protected their words, can not be explained in the document, or change, except as modified in the way that identifies the document. Accordingly, these principles must be preserved in the face of the evolution of our Republic, but that does not mean that facts arising from this development, because previously known, justify departure from first principles. On the contrary, the goal must be to ensure that the first principle is accepted in spite of evolution. For example, while the electronic media were not known to the founders, it is still the media and therefore should be entitled to the same full First Amendment protections afforded to print media. We are on the way to preserve freedom for the message (first goal of the amendment) regardless of the medium.
Rappoport: What do you think our best strategy is, here in America, to prevent what the FDA will make
?EMORD: In my book, The Rise of Tyranny I provide a detailed explanation of the changes necessary to restore the Framer's Republic. In short, I urge people to vote out of office those who are not supported deregulation and press members of Congress to support two bills I wrote to Congressman Ron Paul, congressional accountability and responsibility, and the Law on Health Freedom Act. former will prevent any regulatory agency from enforcing any regulation is published as a regulation was enacted by Congress in a way that the Constitution means. This will prevent agencies from exercising unchecked power and that the legislation will restore the function of Congress to prevent a lot of abuse from ever regulations came into force. the latter law will be no power to disarm the FDA to require pre-review requests for supplements. This system of prior restraint violated the First Amendment and should be removed. Those who will deceive the public falsely advertising their products should be prosecuted after the fact, but those who want to tell the truth should not be necessary to convince the FDA before they are allowed to speak. There are many other reforms we need to run, including the removal of the FDA drug approval authorities, and vesting in universities, blinded by the system, so that reviews of drugs is a science rather than politics and favoritism, determine the outcome of drug evaluation.
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