© Whole Foods Magazine

September 2003

 

Bringing the FDA into Compliance: Part 1

Making a Difference

How one man’s efforts are forcing the FDA to obey the Constitution, discontinue illegal censorship of truth, and bring better, more accurate health information to the public.

An Interview with Constitutional Rights Attorney Jonathan W. Emord

By Richard A. Passwater, Ph.D.

The results are slowly becoming apparent. In my May 2003 column, I was delighted to announce that the Food & Drug Administration (FDA) was finally going to permit health claims that "selenium may reduce the risk of certain cancers" and "selenium may produce anticarcinogenic effects in the body." At that time, I promised to provide you with more of the story behind the FDAs sudden shift in tactics. I have asked the man behind this momentous change of the collective "heart" of the FDA to explain a little about what has been quietly going on over the past few years to cause the agency to undergo what is nothing less than a paradigm shift. Consider this: on July 10, the FDA announced that it is now interested in making it easier to bring scientific information about dietary supplements to the public. This is the agency that has consistently prohibited the use of any statement informing consumers how a dietary supplement can promote health. And, now, this very same FDA has decided to help individuals become informed about supplement science? Yeah, right!

Talk about making lemonade out of lemons, the FDA is in the midst of a public relations campaign to gloss over its decades of illegal activity now that it has been ordered to so by the courts. Over the last couple of years, a series of lawsuits against the FDA have been won that requires the agency to discontinue its restrictive policies. Nevertheless, until recently, the regulators have ignored these court orders. Now, apparently, the FDA is at last beginning to realize that our constitutional rights are not just nuisances, but the law of our land. The July 10 press release was entitled "FDA to Encourage Science-based Labeling and Competition for Healthier Dietary Choices." Did you catch the newspaper headlines? On the front page of its July11 paper, The Washington Post declared, "FDA Eases Rules On Touting Food As Healthful." I guess Ill have to start calling this body the "NEW FDA." The "Old FDA" did not seem much interested in helping individuals stay healthy.

In another development, the FDA is even taking credit now for requiring that trans fat content be listed on food labels. It took a long fight led by Dr. Mary Enig and others (See the November 1993 to January 1994 columns) to cause the FDA to finally admit the harm of trans fats. For decades, the agency had looked the other way while margarine manufacturers implied in their ads that margarine was heart healthy, and that using a little pat of margarine instead of natural butter would prevent heart disease. The reality was that these margarines were high in trans fats, making them more atherogenic than most saturated fats. The FDA claimed it was the job of the Federal Trade Commission (FTC) to monitor the misleading ads. Meanwhile, the FDA said it would permit the margarine manufacturers to label the amount of polyunsaturated fats their products contained, but would not require them to label the amount of harmful trans fats. Well, on July 10 the FDA finally made it mandatory to label the amount of trans fats, and the agency now wants you to know that trans fats are not healthy. It seems we have entered a brave new world.

Please keep in mind that I recognize the need for a legal, scientific, and active regulator of the health food industry. I am a strong advocate for an intelligent and responsible FDA. What I am opposed to is unscientific bias, suppression of constitutional rights and corruption. What needs to be done is to have the regulatory agency become scientific, lawful and non-corrupt, and to properly enforce the legal powers that it already has. Finally, recent events are indicating that the FDA hierarchy has finally realized that their agency cant survive if it continues to pursue arbitrary and caprious unconstitutional ways of illegal censorship of scientific truth. The FDA is no longer its own judge and jury, as well as the regulator and enforcer. It is finally being brought to obey the Constitution of the United States of America, but the battle is far from over. More cases must be brought against the FDA to fine-tune and firmly establish our constitutional rights.

One man, Jonathan Emord, essentially single-handedly is bringing the FDA into compliance with the Constitution, and hopefully, his efforts will help establish the credibility that the FDA needs to be effective. Its not that the health food movement has been lacking excellent legal advice in its past battles against the federal agency. There have been and are several outstanding attorneys defending the health food movement on a case-by case basis. Several outstanding attorneys, including Milton Bass, Bob Ullman, Scott Bass, Marc Ullman and their colleagues, among others, have helped preserve your freedom to continue buying and selling effective dietary supplements alive. This task hasnt been easy. What is new about Emords approach is that he attacks the very cause of the problems—the illegal approach of the FDA. And, in many instances, where he has challenged the agencys denial of basic rights, he has proved its acts to be unconstitutional and in need of remedies ordered by the courts.

Passwater: Jonathan, why did you undertake a career in constitutional law?

Emord: In my view, there is no greater calling in the law than to help preserve and protect our great constitutional heritage. I have long been fascinated by the intellectual foundations of the Constitution, believe preservation of those foundations indispensable to the survival and success of liberty, and thank my clients for giving me the opportunity to fight on their behalf against the enemies of liberty.

Passwater: What brought the attention of the FDAs unlawfulness to your attention?

Emord: My clients Durk Pearson and Sandy Shaw contacted me early on and explained to me the speech suppressive effects FDA health claims regulation had on their ability to communicate truthful and non-misleading nutrient-disease information to the American public. After studying the area, I came to the conclusion that FDA health claims regulation grossly violated the First Amendment and was based on the repugnant, elitist, and erroneous assumption that consumers if given truthful scientific information could not be trusted by government to exercise informed choice in their own self interest. I knew then that I would do all I could to bring down FDAs barriers to freedom of speech.

Passwater: Just in case some of our younger readers are not familiar with Pearson and Shaw, they are scientists and writers who have made a considerable mark in the health food movement. Their 1982 book, Life Extension: A Practical Scientific Approach, not only was a best-seller that helped improve the lives of many people, but helped popularize the health food movement through their many TV guest appearances on talk shows, particularly, The Merv Griffin Show. If you werent around then, it was indeed a popular program, regularly seen by millions.

My first contact with Durk and Sandy was when they wrote to me in 1978 asking for more details of my research. They were also doing research at that time as part of Spectrum Technology Service. Life Extension was a major advance for many reasons, but in my opinion it was the first major book to explain the health advantages of supplementation with individual amino acids. In their book, Pearson and Shaw also recommended quantities of vitamins and minerals that exceeded what I had recommended in my 1975 book, Supernutrition: Megavitamin Revolution. I welcomed this, as it confirmed the additional safety and effectiveness of my research, at the same time making me a "moderate" in the view of the press

Many of our readers were not around in the days when the FDA would arbitrarily rule that books couldnt be sold in health food stores near products. Would you please remind us briefly of how the FDA was treating the health food movement before you started protecting our constitutional rights?

Emord: FDA had a long, rather sordid history of taking enforcement action against health food stores to stop the sale and distribution of books on the basis that they contained unapproved nutrient-disease claims related to dietary supplements sold in those stores. Of course the freedom to publish and disseminate all manner of scientific information is a hallmark of our First Amendment precedent, so the courts acceptance of FDA injunctions against book sales and prosecution of health food store owners constituted an egregious anomaly in our otherwise consistent precedent against such censorship. Several changes in the law (statutory, regulatory, and precedential) have largely brought an end to this form of censorship, but we may see this form of censorship recur and, so, eternal vigilance is again the price of freedom.

Passwater: Another FDA anti-supplement tactic at the time was to attempt to prevent nutrients such as individual amino acids and other non-vitamin nutrient factors from being allowed in dietary supplements by trumping up a ridiculous claim that these nutrients were "unapproved food additives," not nutrients. One case in particular irked me as the FDA tried to ban Dimethylglycine (DMG). The FDA said DMG was not a nutrient but an unapproved food additive, and supplies were confiscated. The manufacturer fought back, but the FDA prevailed. In court, it was ruled that as long as DMG was pure and not mixed with excipients so that tablets could be made, it was legal. But add in an approved food-based glidant or lubricant to permit tableting and it was illegal. So the manufacturer devised a method of pressing small amounts into a tiny pill that was tightly sealed in an aluminum pouch. This was not only inconvenient but costly to the consumer. Needless to say, the legal battle was very costly to the manufacturer.

When I first met you, we were guests on a national TV show. I believe it was David Suskind’s program.. The show delved into the topic of responsible health information and the freedom of choice in taking dietary supplements. You explained the unconstitutionality of what the FDA was doing. At that time, I must admit I had my doubts that you or anyone could do anything about it. What was your first step?

Emord: We began by filing comments with the FDA demanding that the agency end its system of prohibiting health claims that were, at worst, only potentially misleading. We argued to the agency that the First Amendment prohibited government from banning such speech; that such speech was protected under the First Amendment; and that FDAs solution to the problem of less than conclusive scientific information was to disclaim it, informing the public of that fact, not suppress it and deny its precious scientific truths from ever reaching the public. At that time FDA was prohibiting the folic acid/neural tube defect (NTD) risk reduction claim that my clients advocated. It did so for several years, producing what Congress found to be an estimated 2,500 preventable neural tube defect births a year. During my clients litigation against FDA, the agency capitulated on that claim, and now public health authorities report a significant reduction in NTDs due to broad dissemination of the claim.

Passwater: The deliberate actions of the FDA caused many thousands of children to be born with needless birth defects. How about health claims? What claims have you been able to get approved after the FDA ruled against them?

Emord: The Pearson and Whitaker cases have caused FDA to permit the following claims (with disclaimers): (1) folic acid/neural tube defect risk reduction; (2) folic acid in supplement form being superior to folic acid in food form as a means to reduce neural tube defects; (3) antioxidant vitamins/cancer risk reduction; (4) omega-3 fatty acids/coronary heart disease risk reduction; (5) vitamins B-6, B-12, and folic acid/vascular disease risk reduction; (6) selenium/cancer risk reduction; and (7) phosphatidylserine/cognitive dysfunction and dementia risk reduction.

Passwater: Very important health information indeed. Again, the policies of the FDA caused thousands to develop heart disease prematurely that could have been prevented with dietary supplements such as fish oils and B-vitamins. Thousands of people needlessly developed and died from cancers that could have been prevented with antioxidant dietary supplements. And the needless suffering due to preventable birth defects and dementias.

You mentioned Dr. Whitaker. He, of course, is Dr. Julian Whitaker, a nationally known California physician who is an advocate of responsible use of safe dietary supplements. He is also a well-read medical writer who has written several books and writes a popular medical/nutritional newsletter.

Although the accomplishments you just mentioned are impressive, I know that you have done even more. Please tell our readers of some of the other actions that you have taken to gain our freedom? The Dietary Supplement Health and Education Act of 1994 (DSHEA) clearly provided for claims for dietary supplements on nutrient-disease relationships. Have you been able to address this issue?

Emord: I have had the good fortune of representing clients in actions against FDA attempts to prevent dietary supplement and food claims concerning how those substances affect existing diseases and disease symptoms. FDA takes the view that such claims may only be permitted if a new drug application is filed and approved. That is an effective death sentence for unpatentable nutrients; no dietary supplement company is willing to expend hundreds of millions of dollars on a slim chance of drug approval without any opportunity to recoup those expenditures in the unlikely event of FDA approval. FDAs position violates the plain meaning of the health claims approval provisions of the statute and the First Amendment.

The case Whitaker v. Thompson now before the United States Court of Appeals for the D.C. Circuit will help determine whether FDA will get away with this form of speech suppression. Dr. Whitakers threatened suit against FDA for effectively censoring the sale of books on stevia helped result in a change in agency policy to prevent such actions in the future. We also represent an association that is endeavoring to revise FTC policy in non-public investigations of dietary supplement and food companies to stop First Amendment violations that are endemic in that process. That association has filed a petition with FTC demanding immediate changes. The FTC does not explain to parties it investigates precisely what content it regards as deceptive, whether that content is inherently or potentially misleading (the latter being protected from government suppression by the First Amendment), whether there exist alternatives to self-censorship of content (such as disclaimers) that would satisfy FTC, and the precise scientific grounds for FTCs conclusion that content is deceptive. FTC fails to explain these points before imposing substantial costs on parties to answer often detailed and oppressive interrogatories and document production demands. That constitutes an unconstitutional burden on speech.

Passwater: DSHEA also mandated the FDA to develop and enforce Good Manufacturing Practices (GMPs) for dietary supplement manufacturers. Importantly, DSHEA requires that these GMPs be no more onerous than the GMPs for foods, and not be as burdensome as pharmaceutical GMPs. How do you view the proposed GMP regulations?

Emord: We are all for protecting public health but the current cGMPs FDA is proposing for dietary supplements are grossly (and unnecessarily) anti-competitive, a recipe for disaster, threatening to reduce significantly the number of supplement companies in the market without any demonstrable improvement in public health and safety. The proposed cGMPs have no prescribed limits on the exercise of official discretion, yet vest in FDA virtually unbridled discretion over everything from where hand washing facilities are located to whether testing methods used to confirm purity and potency are adequate. Consequently, we can anticipate field inspectors making unreasonable demands for change without proof of public benefit that may carry with them huge price tags, bringing down non-compliant companies. We are fighting to prevent that from happening by refocusing FDA attention on true safety and away from blanket grants of regulatory control over the means of production.

Passwater: Do you plan on taking action?

Emord: Yes, my clients have hired a renowned economist to evaluate the new rules and we are fast at work identifying all of the legal defects. My clients will file comments, and we will litigate against these new rules unless they are revised substantially to eliminate anti-competitive elements and to place limits on the exercise of agency discretion. The statute starts with the proposition that dietary supplements are presumed safe, and the burden of proof is on FDA to prove the contrary in a specific case. The cGMPs start with the unwritten presumption that all dietary supplements are unsafe and that the industry must prove their safety (even in the absence of evidence of any harm to the public). That effective reversal in the statutory presumption cannot be allowed to stand. There is no reason why the cGMPs cannot be revised to protect that presumption and, yet, to ensure that those who truly do pose a threat to public health are prevented from making such threats realities.

Passwater: Id like to chat with you a little more about the change in how the FDA evaluates scientific data and the new manner in which it allows additional health claims. But, lets leave that discussion for a future column.

Thanks for providing a background for us on your efforts to bring the FDA into compliance with law. Readers may wish to read more detail about what we have discussed briefly here by visiting your website at www.emord.com. They can also help continue your efforts by donating to the Pearson & Shaw Litigation Fund, c/o Emord & Associates, 5282 Lyngate Court, Burke, VA 22015. Small donations are welcomed and may help change the health of Americans. WF

© 2003 Whole Foods Magazine and Richard A. Passwater, Ph.D.

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