PART 1 of 2
Investigating Journalist Jon Rappoport
November 8, 2010
An Exclusive Interview With Attorney Jonathan Emord
As a medical investigative reporter for 28 years, I’ve seen public interest in health freedom come and go. Right now, in 2010, it is at a low point.
In the early 1990s, there was a tremendous fervor in America. Millions of people, perceiving a threat from the federal government, realized they could be cut off from the right to improve their health according to their own wishes, judgments, and decisions.
In practical terms, health freedom has come to mean: the right to have access to the widest possible 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 traditional 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 looking for. The FDA would not be permitted to limit access to the full range of nutritional supplements.
Then the furor died down and people 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 overall dampening of that spirit of the early 90s. Many people believe the major battle has been won.
To examine whether this is the case, and whether the DSHEA Law is actually 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 rights to life, to liberty, and to health freedoms.”
Mr. Emord has practiced constitutional and administrative 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 affect health freedom. He is the author of four critically acclaimed books: Freedom, Technology and the First Amendment (1991); The Ultimate Price (2007); The Rise of Tyranny (2008); and Global Censorship of Health Information (2010).
I hoped Mr. Emord would give us real and detailed information on substantive issues facing Americans today. He responded in kind, and went the extra mile. He cleared up a number of popular confusions, and offered several predictions based on his long experience 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 become 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.
RAPPOPORT: DSHEA is a federal law that was passed in 1994 to protect the
public’s right to buy and take a wide range of nutritional supplements.
It’s considered our best bulwark against invasive actions by the
FDA. Did DSHEA really give us reliable protection? Where do things stand
Has the FDA eroded that law over the last 16 years?
Are we in trouble?
JONATHAN EMORD: DSHEA has not given reliable protection against FDA censorship or FDA restrictions on access to products. In certain 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 measure because the drug industry benefits from those abuses and has such influence over the House Energy and Commerce 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 certain provisions in the bill would enable the FDA to censor health information and restrict access to supplements. I opposed inclusion of those provisions to no avail.
In particular, DSHEA requires supplement companies to file, with the government, notice of use of structure/function claims [statements about the positive 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 company to submit them to the FDA for review, and that forcing companies to do so would invite FDA mischief. I explained that inevitably FDA would use structure/function claim review to redefine claims from the category of structure/function to the category of prohibited drug claims, thus reducing the quantity of free speech available for expression. That has happened.
The DSHEA permits the HHS Secretary to adopt good manufacturing practice 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 considerable agency mischief, that FDA would use GMP regulation to put the industry under its thumb and stop the marketing of supplements on technicalities, thereby ridding the market of any product it did not like. That is now happening.
Steve Hanke, the Senior Economist on President Reagan’s Council
of Economic Advisors, to evaluate the impact of the GMP rule. He determined
that the cost of compliance per year [to supplement companies] would exceed
the finances of roughly one-third of all dietary supplement manufacturers,
resulting in their elimination from the market. In the GMP rule, FDA put
the estimate more conservatively, but admitted that it would eliminate
about one-quarter of the market. The evaluation we were provided also
concluded that there would be less variety of product available to consumers
and that the cost of product 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 action instead of negotiated
settlements of disputes with the industry. That too will result in a loss
of companies and a reduction in consumer offerings.
The DSHEA adulteration provision included language limiting FDA action to ban supplements to instances where the agency could prove that they presented a significant or unreasonable risk of illness or injury. Congress intended for this to be a meaningful barrier 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 effect 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 industry proved it safe beyond doubt at another dose level. That shifted the burden of proof from FDA (where Congress placed it) to the industry (where FDA prefers that it be), enabling FDA to ban any nutrient it wishes on evidence readily available that at some dose level [at preposterously high doses] it causes harm.
The DSHEA included a provision to permit dietary supplement companies to distribute scientific literature on nutrient-disease associations [a nutrient can help alleviate a disease] to the public, including to their customers. At the time, I warned that the provision included ambiguous requirements that FDA could construe to emasculate the speech-protective intent of Congress. FDA has in fact gone farther than I had anticipated. FDA completely eviscerated this provision by taking the position that any scientific publication that associates a nutrient with a [positive effect on a] disease…can still be forbidden by FDA because company provision of the literature to customers would constitute “evidence of an intent to sell the product as an unapproved new drug.”
I also opposed the provision that required submission of a new dietary-ingredient notice 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 product is legally marketable. I thought that if a product met the definition of a dietary supplement, FDA should have no power to prevent its marketing. I warned that FDA could use its discretion to require a degree of proof for safety 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 absolutely 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 industry is in trouble because the FDA harbors an unscientific bias against supplements, principally arising from its desire to protect the agency’s foremost regulatee, the drug industry. I remember when folks were arguing that the GMPs were a good idea because industry leaders had connections with FDA and could assure that the agency would not abuse its power. The dietary supplement industry 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 describe the power triangle at work. The drug industry is like an enormous elephant, and the FDA is like a blind jockey atop the elephant incapable of altering the elephant’s course. The dietary supplement industry is like a flea on the elephant. So long as the flea does not irritate the elephant, everything proceeds smoothly, but as soon as the flea causes irritation, the elephant signals its displeasure and the blind jockey whacks about the surface of the elephant with his riding crop until he nails the flea. Some in the trades and in the dietary supplement industry have an inflated view of their influence over FDA. The drug industry they are not, and to the drug industry 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 people 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 standard setting body. The standards it adopts each member state is expected to implement or, if not, to explain why it has chosen not to do so. If the failure to adopt a standard 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 influence over one another 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 determine whether vitamins and minerals are safe at particular dose levels and ban them at dose levels not determined 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 advanced the European attachment to and advocacy for the precautionary principle as the best means to assess toxicity. In short, Codex has become 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 closely 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 through reinterpretation of existing agency rules.
RAPPOPORT: What can you tell us about the legal status of nutritional supplements in Europe? Is the EU really destroying the public’s right to buy a wide range of nutrients? What’s the situation? Are there serious implications for America?
EMORD: Under the European Union Directive governing dietary supplements, no dietary supplement is legal to market without first being found safe and bioavailable by the European Food Safety Authority [EFSA]. Moreover, no claim—not even structure/function claims—concerning health effects of a dietary supplement may appear on labels, in labeling, or in advertising of a dietary supplement in Europe without first being approved by EFSA. This massive system of prior restraint has imposed a nutrition Dark Age on Europe. As the EFSA determinations continue to be enforced by the EU member states, hundreds of products that had been safely consumed for decades will be removed from the market. Also, claims will disappear, leaving Europeans in the dark as to the potential of nutrients to affect health and disease.
This system is a form of Lysenkoism or state created orthodoxy over science. It is dumbing down the European market and removing from it health enhancing substances. In the end, there will be a rise in age-related diseases for which risk is diminished by supplementation, such as cancer and cardiovascular disease. EFSA will be responsible for creating a very unhealthy environment all in the guise of protected European consumers from anything less than certain science.
In truth almost nothing in science is certain; nearly everything is inconclusive, yet we make decisions every day based on the inconclusive science—based on personal bets on the extent to which we think evidence of association [is] correctly indicative of ultimate outcome. Remove from us that evidence of association by force of law and we become incapable of making informed bets.
EU censorship of all information in the market not proven conclusively true necessarily censors information on nutrient-disease relationships that will in time be proven true. That present censorship will cause those who would bet on the ultimate truths to be denied the opportunity of guessing right and, thus, they will lose out in potentially fatal ways.
That is precisely what happened to the FDA. We sued the FDA when it refused to authorize a claim associating folic acid with a reduction in the risk of neural tube defects [NTD]. FDA took the position that the association had not been proven that folic acid containing supplements could reduce NTD risk. FDA censored the information for some six years, contributing to over 2,500 preventable NTDs each year and to countless NTD related abortions. We ultimately defeated FDA’s censorship in Pearson v. Shalala. That then led in time to FDA allowance of the claims when we beat the agency a second time for refusing to permit the claims. The result has been a steady reduction in the incidence of NTDs in the United States as more and more women of child bearing age learn of the need to take folic acid supplements containing 400 (and preferably 800) mcgs each day before they become pregnant.
What will the scientists within EFSA think of themselves if five, ten, twenty, or more years from now proof positive arises that certain nutrients they have condemned are associated with significant reductions in the risk of cancer and cardiovascular disease such that tens of thousands of Europeans could have lived had they been given market access to information concerning the association years prior?
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The EU ban on supplements and supplement claims (unless pre-approved by EFSA) is now in place. EU depends on its member states for enforcement. Each state is variously engaged in enforcement with some using more aggressive methods than others. Over the next several years, however, we can expect to see crack downs in each of the member states with products being removed from the market following each crack down. For Part two click below.
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� 2010 Jon Rappoport - All Rights Reserved
Jon Rappoport has worked as an investigative reporter for 30 years. Nominated for a Pulitzer Prize early in his career, Jon has published articles on medical fraud, politics, alternative health, and sports in LA Weekly, CBS Healthwatch, Spin, Stern, and other magazines and newspapers in the US and Europe.
He is the is author of several books, including The Secret Behind Secret Societies and The Magic Agent (a novel).
Jon is the author of a new course for home schoolers, LOGIC AND ANALYSIS.
E-Mail: [email protected]
Web site, www.nomorefakenews.com