As a medical investigative reporter for 28 years, I’ve seen the 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 hunger 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 wishes, judgments, and decisions. In practical terms, health freedom means the right to access the widest possible range of nutritional supplements, health practitioners, and treatments without government obstruction.
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 Dietary Supplement Health Act of 1994 (DSHEA). It seemed 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, and people returned to their lives. The internet grew into a giant. Millions of pages discussing health issues appeared. More freedom. More access.
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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 keeping Americans safe, I interviewed a widely revered lawyer, Jonathan Emord. Emory 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 than any other attorney in American history, earning him the title “FDA Dragon Slayer.
He is the 2007 Cancer Control Society’s Humanitarian Award recipient for “winning and preserving our great civil rights to life, liberty, and health freedoms. Mr. Emord has practiced constitutional and administrative law in Washington, D.C., for 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 several popular confusions and offered predictions based on his long experience as an attorney in health freedom.
One of the most critical points Mr. Emord makes is that 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 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.
JON RAPPOPORT: DSHEA is a federal law 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 the FDA’s invasive actions. Did DSHEA give us reliable 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 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, the 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 the inclusion of those provisions to no avail.
In particular, DSHEA requires supplement companies to file, with the government, notice of the use of structure/function claims [statements about the positive effects of a nutrient on the structure or function of the body]. When 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, the 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 that the bill was being debated, that this provision would invite considerable agency mischief and that the 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.
We hired 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, the FDA put the estimate more conservatively but admitted that it would eliminate about one-quarter of the market. Our evaluation also concluded that less variety of products would be available to consumers and that the product cost 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 fallout. 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 this to be a meaningful barrier to the 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, the FDA 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 the FDA (where Congress placed it) to the industry (where the FDA prefers that it be), enabling the 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 and their customers. At the time, I warned that the provision included ambiguous requirements that the FDA could construe to emasculate the speech-protective intent of Congress. FDA has gone further 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 the FDA for every nutrient first sold after the date of passage of the DSHEA. Under that provision, the product is legally marketable if the FDA does not object to the notice. If a product meets the definition of a dietary supplement, the FDA should have no power to prevent its marketing. I warned that the FDA could use its discretion to require a degree of proof for safety so high as to make it impossible for any new dietary ingredient to enter the American market. While the FDA has not construed it as prohibited, it has made it very difficult to lawfully market 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 regulated drug industry. I remember when folks argued that the GMPs were a good idea because industry leaders had connections with the FDA and could ensure 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. Still, as soon as the flea irritates, 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 the dietary supplement industry have an inflated view of their influence over the FDA. The drug industry they are not, and the drug industry is entirely accountable to 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?
Will the American people 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 adopting domestic standards governing dietary supplements’ availability and the market’s dose levels.
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. It can alter its interpretative construction of existing regulations to “harmonize” the American model more closely with the European regulation model. U.S. delegates to Codex should oppose the movement toward greater restrictions on supplements and claims. Instead, they quietly acquiesce to those restrictions and work toward effecting similar restrictions within the United States by reinterpretation existing agency rules.
RAPPOPORT: During the debate and run-up to the passage of ObamaCare, the national health insurance plan, I heard very little concern expressed in the health freedom community about the future implications of this bill. It’s obvious to me that, with control vested in the Department of Health and Human Services, we could eventually see the day when alternative health care and nutrition are edged further and further from permitted treatments. And citizens would be required to accept conventional medical treatments, whether they want them or not.
Along a similar line, I see very little evidence these days of action by health freedom groups and nutritional companies to keep health freedom alive. Certainly, we see nothing like the enormous campaign launched in the early 1990s, when Congress received millions of letters protesting the FDA’s actions to limit our access to supplements, and celebrities came out of the woodwork to support health freedom.
What am I missing? Is some back-door deal in place now? Have nutritional companies been assured that if they keep their heads and mouths shut, they’ll be allowed to do business as usual?
I can’t explain the eerie silence from groups that should continue fighting VERY VISIBLY for our freedom in this area. I sense a soft attitude.
I was very active in the health freedom movement of the early 90s. My approach was to go after the FDA for its ongoing crimes and attacks. At the time, some people told me to dial it back. We would get a good bill passed in Congress, and aggressive actions could injure our cause. Is that the prevailing mood now? Is there something on the table we don’t know about? A new bill?
EMORD: There has been a recurrent pattern by supplement trade groups and certain leading companies in the industry (epitomized by the sector move to draft and advocate FDA adoption of GMP rules, giving FDA broad discretion) to engage in self-flagellation. The industry strongly opposed FDA regulation in its nascent, more competitive years. Consumers’ movement from specialty supplement brands towards less costly generic varieties, combined with bad economic times, contributed to the consolidation of the supplement market. For several years, certain industry leaders have moved away from the robust contest with the FDA to compromise with the Agency. There is an economic motive for this, to be sure. Large [supplement] industry players believe they benefit from greater FDA regulation because it creates costly barriers to entry that keep out smaller competitors.
Certain industry trade associations also promote a mistaken view that if the industry confesses fault to the 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 provided those powers with more ammunition to use against the industry, compounding its problems and creating a major public relations problem.
Dietary supplements, with few exceptions, are the safest ingestible products, far safer than foods and drugs. That is a remarkable fact that one would think the industry would recite at every turn. Instead, certain trade associations and industry leaders voice grave concerns about supplement safety. They agree to greater federal regulation on the notion that greater regulation is inevitable 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 argument (the argument of supplement opponents that something inherently wrong with the market necessitates extraordinary new regulation lest we all succumb), the industry is inviting its demise.
However, industry leaders who buy into this on the notion that it will reduce competition and shore up their market shares are deluded because, in the end, the FDA is the drug industry’s, not the supplement industry’s, to control. In other words, the FDA will be pleased to expand its regulatory power over the supplement industry but not for the benefit of the supplement industry’s leaders. Rather, the FDA will invariably use greater regulatory control over the supplement industry to aid its favored regulated, the drug industry, not to shore up the market share of large supplement companies. The drug industry, not the supplement industry, holds almost all the cards at the FDA and Congress. The supplement industry has relatively little clout by comparison.
Instead of engaging in self-flagellation, the industry ought to refute false representations against supplement safety and efficacy and promote public awareness of the many benefits supplements bring to consumers. Supplements are rarely the cause of human injury. The science concerning their health-enhancing effects abounds and grows weekly. The potential for nutrients to reduce the risk of, prevent, and even treat disease is profound. Science is unraveling truths about human biochemistry that support the conclusion that our lifestyle choices very much affect our disease risks and that healthful living in reliance on organic foods, above levels of certain 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 engaging in self-flagellation, the industry should celebrate its strengths, advertise them continually to the public and the government, and act to defend on the grounds of the principle of the free of dom to market and sell safe and potentially life-saving and health-enhancing supplements. PROPERTY: This past summer, Congress passed a food safety bill (S.510). What’s its present status? Does its wording suggest we may be subject to Codex regulations vis-à-vis the sale of nutritional supplements? What are the shortcomings of the bill?
EMORD: This bill is a significant threat to the supplement industry. It contains a provision that permits the FDA to charge the hourly cost of its inspections of [nutritional-supplement] establishments if the Agency finds a violation warranting a re-inspection. That incentivizes the FDA to find fault on first inspections and do re-inspections as a revenue raiser. The bill also includes a provision encouraging the FDA to evaluate harmonization between domestic and foreign regulations. That invites the Agency to construe its rules to effect a change favoring the EU model.
At a time when the FDA is in great disgrace for abusing its powers (approving unsafe drugs, failing to force the withdrawal of hazardous drugs from the market, and censoring health information concerning supplements), Congress is about to entrust the Agency with yet more vast new regulatory powers. That is a big mistake. Congress should be moving rapidly in the other direction, taking away power from this corrupt Agency.
The problem is that Congress, too, is quite corrupt. Senator Harry Reid said he would not move the bill forward in the Senate until after the election. The election will likely result in Republican control of the House and Republican control of the Senate or a loss of Democratic dominance in the Senate. If that happens, S. 510 could become 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 several 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, actually and disastrously, is run by and through its regulatory agencies, whose employees stay on during 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 explain how our federal government has been transformed from a limited federal republic into a bureaucratic oligarchy since the 1930s. Under our Constitution, Congress is vested with the power to make laws. We have a separation of powers that prevents any branch from exercising combined legislative, executive, and judicial powers. A non-delegation doctrine forbids those branches vested with those powers from delegating them to other entities.
In the 1930s, President Roosevelt’s Supreme Court held efforts to delegate governing power to bureaucratic agencies unconstitutional. In response, President Roosevelt advocated the passage of legislation that would have packed the Court, adding justice for everyone sitting who had reached 70 and one-half years, thus altering the Court’s composition to receive jurists favoring the New Deal agencies.
The bill was not passed but caused what the media of the day called “the switch in time that saved nine.” In 5 to 4 majority decisions, the Court switched from defending the separation 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 single instance in which the Supreme Court has held the delegation of governing power outside the [three basics] constitutional branches be a violation of the non-delegation doctrine. As a result, today, over ninety percent of all federal law is not the product of our elected representatives but regulation promulgated by unelected heads of bureaucratic agencies.
We founded this country on the notion that no American should be taxed without being represented, and yet today, we are taxed, and those who create almost all laws governing us are unelected. James Madison, Thomas Jefferson, John Adams, Alexander Hamilton, and George Washington stated that if ever our country were to reach a point where the legislative, executive, and judicial powers were combined in single 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 Responsibility and Accountability Act, is pending in Congress.
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RAPPOPORT: A more general question: From your experience and training as a constitutional lawyer, what is your view on what the Constitution put in place, 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 Declaration of Independence perhaps best sums up the legal creed that underlies the Constitution. Just governments are instituted among men to protect the rights of the governed. Just governments are derived from the consent of the governed. When governments destroy those rights, the people must alter or abolish them to restore governance in protecting, rather than derogating, those rights.
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The Constitution is an extraordinary document precisely because it is a written limit on the state’s power. 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 branch but only for enumerated purposes; it makes war declaration 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 the Bill of Rights government from acting beyond the powers enumerated in the Constitution against the reserved rights of the states and the people. Those reserved rights create a universe of freedom meant to be extremely broad for us. Its scope is perhaps best conveyed in Thomas Jefferson’s definition of liberty:
I would say liberty is unobstructed action according to our will in the whole plenitude of its extent. But rightful liberty is unobstructed action according to our will within limits drawn around us by the equal rights of others. I do not add ‘within the limits of the law’ because the law is often but the tyrant’s will, and always so when it violates an individual’s right.
That idea, 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 judges? I have given much thought to this. My thinking 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 underlying principles. Those principles are static. Yet, as we progress in science, technology, and knowledge, we are confronted with new facts. That environment, the life of the Republic, is dynamic. The Constitution permits amendment through a precise process prescribed in Article V. Its meaning, i.e., the principles designedly protected by its words, may not be reasoned out of the document or altered, except by an amendment in the way it designates.
Consequently, those principles must be preserved in the face of the evolution of our Republic, but that is not to say facts arising from that evolution because they are not previously known, justifying the departure from first principles. On the contrary, the aim must ensure that first principles are upheld despite the evolution. So, for example, while 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 to print media. We thus preserve freedom for the message (the aim of the First Amendment) regardless of the medium.
RAPPOPORT: What do you think our best strategy here in America is to head off what the FDA will do? EMORD: In my book The Rise of Tyranny, I explain the changes needed to restore the Framer’s Republic. In short, I urge people to vote out of office for those who have not supported deregulation and press members of Congress to support two of the bills I have written for Congressman Ron Paul: the Congressional Responsibility and Accountability Act and the Health Freedom Act. The former would prevent 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 prevent the agencies from exercising unchecked power and restore the law-making function to Congress, preventing many abusive regulations from ever being enforced. The latter bill would disarm the FDA of any power to require an advance review of claims for supplements. That system of prior restraint violates the First Amendment and should be dismantled. Those who defraud the public 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. We must institute many other reforms, including removing the drug approval power from the FDA and vesting in universities through a blended system and drug reviews so that science, rather than politics and favoritism, determines drug evaluations.
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