The FDA's Wonderland

"A hill can't be a valley, you know. That would be nonsense," said Alice.
The Red Queen shook her head. "You may call it nonsense if you like," she said, "but I've heard nonsense, compared with which that would be as sensible as a dictionary!"

    - Through the Looking Glass and What Alice Found There,
    Lewis Carroll

n early January the FDA published final regulations regarding the "structure-function" claims for dietary supplements in the Federal Register. Under the Dietary Supplement Health and Education Act (DSHEA) structure-function claims are statements that describe how a supplement affects either the normal structure or normal function of the body. The three issues the FDA responded to were whether:

  1. To finalize the proposed definition of  "disease" or retain a 1993 definition that was in effect at the time DSHEA was enacted.
  2. To permit structure-function claims related to certain conditions associated with natural states - such as hot flashes associated with menopause, and decreased sexual function associated with aging.
  3. To permit implied disease structure-function claims.

To hear it from the popular press, on the whole the FDA's actions were favorable to the industry and the American public. For example, The Wall Street Journal wrote that "The rules expand the number of claims supplement makers can make regarding the health benefits of their products."1 It went on to say that these rules support a narrowed definition of disease that thus "allows manufacturers to make more health claims."1  But as always, there is another side to the issue, and it does not favor the cause of health.

The FDA had wanted to foist a new definition of disease on the dietary supplement industry - as absurd a definition as the one commanded by the Red Queen - but the public outcry was too great for them to think that they could get away with it. So they backed off.

Their old definition of disease was bad enough, namely: "damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that the diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition."2

That, however, was a lot better than the FDA's new definition of disease as "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by a characteristic set of one or more signs or symptoms, including laboratory or clinical measurements that are characteristic of a disease."  But they backed off. Nevertheless, by subverting the structure-function claims in accord with their definition of disease, the FDA has hurled the issue "through the looking glass" and made the public's victory a Pyrrhic one. In creating these new regulations, the FDA has given us a carefully constructed charade.

The real threat to our health freedom is the structure-function reinterpretation. This includes a more adamant - and belligerent - attitude regarding the requirement that all new supplements making structure-function claims be submitted for approval before marketing. And it gets much worse. From now on, the FDA will have much broader leeway in determining whether a statement, a name, a picture, a literature reference (if it refers to a disease), or the context of presentation represents an actionable disease claim.

With regard to products as "alternatives," that usage too will brand a product as a drug if it is referred to as a substitute for a product that is a therapy for a disease! Nor can the product augment a particular therapy or drug action that is recognized to diagnose, mitigate, treat, cure, or prevent a disease or class of diseases. Furthermore, the product cannot have a role in the body's response to a disease (vitamins could be disqualified) or to a vector of disease, nor can it treat, prevent, or mitigate adverse events associated with a therapy for a disease, if these events themselves constitute diseases or even suggest an effect on a disease or diseases.

One year ago, on January 15, 1999, the United States Court of Appeals decided unanimously in favor of the First Amendment and commercial free speech (Pearson v. Shalala, 3-0). Despite the widespread publicity given to that decision - won on behalf of health freedom for all Americans by a group of concerned citizens, including Durk Pearson and Sandy Shaw, and several organizations and companies (including Life Enhancement) - to date the FDA has ignored, and now flouted, the judgment. Regarding its court-mandated requirement to define "significant scientific agreement," the FDA has issued a guide that effectively maintains its "divine right" to obscure definitions, much as the Red Queen does.

The only bow it makes is that it will now consider in vitro and animal studies. Said Jonathan Emord, winning attorney in the Pearson v. Shalala decision, "The FDA is demanding that the industry adhere to a drug certainty standard of approval that is directly contrary to the intent of Congress in passing DSHEA. Congress pointed out the deficiencies in the FDA's approval process under NLEA [Nutrition Labeling and Education Act] and criticized it for wrongfully applying a drug standard. This guidance is asking for a level of proof in excess of what Congress wanted. Claims should be backed by scientific evidence, but the evidence does not have to conclusively prove the claim."3

In another blow to the integrity of law, the FDA has determined that a health claim relating vitamin E to a reduced risk of heart disease does not meet the "significant scientific agreement" standard.4  The claim petition had been submitted by the Washington, D.C. law firm of Emord and Associates on behalf of Julian Whitaker, M.D., Durk Pearson, Sandy Shaw, and others.

The FDA made references to the guide it had issued the previous month and, addressing the issue of vitamin E, said that it had evaluated the nutrient petition based on three "threshold questions":

  1. Have studies appropriately specified and measured the substance that is the subject of the claim?
  2. Have studies appropriately specified and measured the disease that is the subject of the claim?
  3. Are any and all conclusions about the substance/disease relationship based on the totality of publicly available scientific evidence?

Responding to the petition denial by the FDA, the petitioners filed suit on January 19 in D.C. federal court. Their complaint also mentioned the agency's November 30 denial of a health claim for the value of vitamins B6, B12, and folic acid for reduced risk of vascular disease. This petition had also been denied, on the same grounds as the vitamin E claim. Previously, Emord had sued the agency on behalf of his petitioners for denying a saw palmetto/benign prostatic hypertrophy claim.

In essence, the suit maintains that the FDA is violating the First Amendment for not authorizing the claims with appropriate disclaimers, as the federal court had ordered in Pearson v. Shalala. In addition, the complaint cites violation of the Administrative Procedures Act and the Supremacy Clause because the FDA, in its irresponsible action, was "elevat[ing] administrative law and agency convenience above contrary constitutional law."4

The plaintiffs have asked the court to order the FDA to approve the claims with appropriate disclaimers and, should further delays occur, to subject the defendants - including FDA Commissioner Jane Henney, M.D., Center for Food Safety & Applied Nutrition (CFSAN) Director Joseph Levitt, and Office of Special Nutritionals (OSN) Director  Elizabeth Yetley, Ph.D. - to sanctions, including monetary penalties. May the hammer fall hard! These bureaucrats are denying health freedom to all Americans. The Four Horsemen of the Apocalypse could do no worse than this gang of three.


  1. Adams C. FDA sets clearer boundaries for claims cited by makers of dietary supplements. The Wall Street Journal January 6, 2000
  2. Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body; final rule. Federal Register January 6, 2000;65(4):999-1050.
  3. FDA "significant scientific agreement" guidance. Nat Prod Ind Insider January 10, 2000;5:1.
  4. Vitamin E health claim falls short of significant scientific agreement - FDA. F-D-C Reports: "The Tan Sheet"  January 24, 2000;8(4)

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