-Caveat Lector- from: http://www.zolatimes.com/V3.4/pageone.html <A HREF="http://www.zolatimes.com/V3.4/pageone.html">Laissez Faire City Times - Volume 3 Issue 4</A> The Laissez Faire City Times January 25, 1999 - Volume 3, Issue 4 Editor & Chief: Emile Zola ----- FDA Loses Landmark First Amendment Case by Durk Pearson & Sandy Shaw FDA regulations of truthful speech have been ruled unconstitutional. On Jan. 15, 1999, in a landmark decision (Pearson and Shaw, American Preventative Medical Association—and, joined with us by the Court from a separate suit, Citizens for Health—vs. Donna E. Shalala, Secretary, United States Department of Health and Human Services et al), the U.S. Court of Appeals for the District of Columbia Circuit ruled 3-0 in favor of plaintiffs and against the FDA on all issues before the Court, including the question of whether requirements of the FDA’s health claim approval process were unconstitutional. Also losing the case were amici curiae who supposed the FDA information restrictions on appeal: American Cancer Society, American Heart Association, Center for Science in the Public Interest, Public Citizen, and Consumer Federation of America. Additional winners (who filed amicus briefs in support of our First Amendment position) are Direct AIDS Alternative Information Resources, People Against Cancer, and the Foundation for Advancement of Innovative Medicine. It all started for us in 1992, when we began filing Public Comments in response to the FDA’s proposed rules regulating what health claims they will permit for dietary supplements. As far as we were (and are) concerned, the Constitution’s First Amendment makes it clear that the federal government has no authority to regulate truthful speech at all. It seemed to us that the idea that "commercial speech" (what you say when it accompanies a commercial transaction) is somehow less deserving of constitutional protection than other kinds of speech (though the First Amendment says nothing of the kind) makes those of us involved in commercial transactions—either as buyers or sellers—into second class citizens. Earlier, in 1986, we had become aware of this "commercial speech" doctrine and we realized that it was allowing government agencies, such as the FDA, unprecedented control over the communication of truthful scientific information when it accompanied a product. In 1993 we published a book on this subject: Freedom of Informed Choice: FDA vs. Nutritional Supplements (Common Sense Press), in which we discussed the constitutional and scientific issues of FDA’s regulation of the dissemination of scientific information. We also explained what a disastrous effect upon the public health the FDA was having in drastically slowing the flow of truthful health information concerning dietary supplements, such as antioxidant vitamins. One of our examples was low-dose aspirin; in the "Physician’s Health Study" published in 1989 [1], it was reported that in previously healthy men over 50, an aspirin every other day reduced the risk of a first heart attack by about 44 percent. Ten years later, the FDA still unconstitutionally prohibits aspirin companies from communicating this information to the general public. During this period, hundreds of thousands of people have died of heart attacks unnecessarily because they did not know about and were not taking low-dose aspirin (the latest evidence places the most protective dose for most people over 50 in the range of 1/4 to 1/2 aspirin a day). As a result of publishing our 1993 FDA book, we met Jonathan Emord ( http://www.emord.com/), the attorney who has skillfully guided our case from its initial filing in 1994 through the legal mazes to this long-awaited victory. (The FDA may appeal, but we do not expect they will be able to reverse this decision.) We spent a lot of our own money in this case, but also got major help along the way in paying the legal bills from Julian Whitaker, M.D., and the American Preventive Medical Association. Some additional financial help came from the National Health Federation, Life Enhancement Products, Life Extension Foundation, and Greg and Michelle Pryor of Life Priority, Inc. The new decision may be downloaded from http://www.ll.georgetown.edu/Fed-Ct/Circuit/dc/opinions/98-5043a.html . We began reading U.S. Supreme Court decisions in "commercial speech" cases in 1993 to learn how the Court and how individual justices viewed the constitutional limits on government regulation of advertisements and of product labels. We found a well developed jurisprudence that provided for an awkward "balancing test" (of free speech vs. government interests in regulating speech) that attempted to allow--yet provide limits to--government regulations of truthful speech accompanying the sale of a product. We considered FDA’s regulations on truthful health claims to have gone beyond the bounds set by the Court and by Congressional statutes and far beyond the bounds set by the First Amendment ("Congress shall make no law . . . abridging the freedom of speech or of the press") and filed suit against the FDA in 1994. We thought, in doing so, we might push the envelop to freedom of speech to help restore constitutional restraints in the area of what is called "commercial speech." The D.C. Appeals Court in our case logically developed the consequences of prior U.S. Supreme Court decisions concerning First Amendment limitations on government censorship, with particular focus on the communication of scientific information as part of "commercial speech." In so doing, this decision has enlarged the boundaries of freedom of speech recognized by the Courts as being beyond constitutional federal government regulatory power. In fact, the Court did something very unusual. Courts generally examine constitutional challenges to laws after they have considered procedural challenges. If a law can be thrown out on a procedural basis, a Court will do that in preference to taking on a constitutional challenge. Rarely do the constitutional questions get a review. In our case, however, the Court stated, "Normally we would discuss the non-constitutional argument first, particularly because we believe it [that an undefined standard is no standard] has merit. We invert the normal order here to discuss first appellants’ most powerful constitutional claim, that the government has violated the First Amendment by declining to employ a less draconian method—the use of disclaimers—to serve the government’s interests [of protecting the public from misleading information]." Thus, the Court said, "even if ‘significant scientific agreement’ were given a more concrete meaning, appellants might be entitled to make health claims that do not meet that standard—with proper disclaimers." The court decided this [that health claims may not have to meet "significant scientific agreement"], even though it was not one of the issues we raised in this case because we didn’t think the courts were ready for it! It looks to us as if they are pointing the way for the FDA—how, if the FDA takes the decision seriously, they can thereby avoid both violating the First Amendment’s constitutional prohibitions and the otherwise inevitable next FDA First Amendment suit! The Court’s discussion of the First Amendment implications of the FDA’s not permitting disclaimers was a response to our complaint that the FDA refused to permit four claims that we wished to make. They prohibited all four proposed claims (such as "antioxidant vitamins may reduce the risk of certain cancers") by claiming that there was not "significant scientific agreement" (which they would not define) and would not permit us to qualify the claim by including, for example, information about the limits of the current evidence of cancer risk reduction by antioxidant vitamins and what types of evidence exist (cell cultures, animal, clinical studies, epidemiological studies, etc.). One specific rule the new decision throws out is the FDA’s purported "significant scientific agreement" standard for health claims. The Court agreed with our argument that the FDA has established no standard since the FDA has refused to define what "significant scientific agreement" means. This is a statutory violation because Congress required in the DSHEA that the FDA establish a procedure and standard for accepting health claims [2]. The FDA will now have to proceed with rulemakings in which it attempts to decide what "significant scientific agreement" might mean when they cannot define it simply as whatever the FDA says it is on a case by case basis. We think it likely that the FDA will first attempt to propose the same old constitutional rules dressed up in new verbiage. You can be sure we will be filing Public Comments! The Court seems to have found some of the government’s arguments a bit ridiculous. For example, on page 10, the Court notes, "As best we understand the government, its first argument runs along the following lines: that health claims lacking ‘significant scientific agreement’ are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for them to exercise any judgment at the point of sale [emphasis in original]. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous." Both of us got a good laugh out of that. The Court also said, "The government’s general concern that, given the extensiveness of government regulation of the sale of drugs, consumers might assume that a claim or a supplement’s label is approved by the government, suggests an obvious answer. The agency could require the label to state that ‘The FDA does not approve this claim.’" We had suggested such an approach, which we called a "split label," in our early Public Comments to the FDA, but the FDA rejected it. Perhaps they were concerned that people might see "The FDA does not approve this claim" everywhere and wonder why they needed the FDA in the first place. In fact, the FDA has approved only two health claims for dietary supplements during the entire eight-year period since the Nutrition Labeling and Education Act required the FDA to review and approve health claims for dietary supplements and foods. The Court’s decision has made us feel great (as a friend of ours put it, we feel "like the ‘minutemen’ did!"). It is possible, with enough conviction, careful choice of case, court and attorney, plus time and money, to put teeth into the Constitution’s limits on federal actions. Notes [1] "Final Report on the Aspirin Component of the Ongoing Physicians’ Health Study," New England Journal of Medicine 321(3):131-135 (July 20, 1989) [2] It is also unconstitutional because the Constitution authorizes only one federal institution to make laws, the Congress. See U.S. Constitution, Article I, Section 1. The federal agencies can carry out the will of Congress pursuant to Congressionally created law, but cannot make rules in the absence of statutory authorization. This is a constitutional principle that is widely flouted by federal agencies. (For one thing, why limit your rulemaking to that authorized by Congressional statute when nobody in a regulatory agency has ever been thrown in jail or lost their job or even been disciplined by the Congress for making law that went beyond or even defied the explicit will of Congress as expressed in statute?) A time is coming when a properly chosen regulatory agency rule or rules should be challenged on the basis of Article I, Section 1 of the constitution; however, we didn’t judge that this case was the right one for such a challenge or that the courts were ready for it. ------------------------------------------------------------------------ Medical researchers Durk Pearson & Sandy Shaw are the authors of Life Extension: A Practical Scientific Approach, as well as other books on health and freedom. They may be reached at People for the Constitution, P.O. Box 3666, Tonopah, NV 89049. -30- from The Laissez Faire City Times, Vol 3, No 4, Jan. 25, 1999 ----- Published by Laissez Faire City Netcasting Group, Inc. Copyright 1998 - Trademark Registered with LFC Public Registrar All Rights Reserved Disclaimer The Laissez Faire City Times is a private newspaper. 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