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A Celebration of First Amendment Victories Against the FDA

April 2002

By Michele G. Morrow, D.O.

Mr. Clanton went on to state that after all these claims were rejected, the "plaintiffs" (Durk Pearson and Sandy Shaw, American Preventative Medical Association, et al.) filed a lawsuit based on the FDA's decision that prohibited a health claim on the labels of folic acid supplements. Initially, the courts said that if the evidence was inconclusive, the FDA could require a disclaimer on the label, which states, "The evidence in support of this claim is inconclusive." The case was remanded back to the FDA in April of 1999, and several letters were sent by the plaintiffs asking when the agency intended to comply with the decision. Several months later in September of 1999, rather than authorize the claim as the Court of Appeals suggested, the FDA published a notice asking for additional scientific data in support of the health claims and also contracted with an outside party to conduct a literature review of all four health claims. By March 31st of 2000, the FDA still had taken no action.

After many months, the FDA concluded that the weight of the evidence presented to them regarding the claim about folic acid preventing birth defects was "inherently misleading and could not be made non-misleading with such a disclaimer." Both the District Court and the Court of Appeals rejected the FDA's conclusion after conducting a cursory review of the medical literature on this subject. One study, which was particularly impressive, found that pregnant women who were given 800 mcg of folic acid in multivitamin supplements experienced a 100% reduction in neural tube defects compared with a 40% to 80% reduction resulting from a 400 mcg dosage. The District Court granted the preliminary injunction and remanded the case to the FDA for the agency to draft an appropriate disclaimer to accompany the claim.

The FDA then filed a motion for reconsideration arguing that the court had made a mistake. The District Court denied the motion and stated that the FDA' arguments for reconsideration demonstrated the FDA's reluctance to fully comply with the Court of Appeals decision.

Mr. Clanton concluded by stating, "Pearson vs. Shalala represents another victory for freedom of speech against an FDA that is becoming increasingly aggressive in attempting to suppress the dissemination of truthful and quite often potentially lifesaving information to consumers. Pearson vs. Shalala reminds us that good intentions, especially on behalf of the government, do not always bring about good results and in fact often have devastating and unforeseen consequences. The premise of our Bill of Rights, however; is that there are some things, even some seemingly desirable things, that the government cannot be trusted to do."

What was the celebration all about? "It's about freedom of speech," said Sandy Shaw

Historical information: On November 8, 1990, Congress enacted an amendment to the Federal Food, Drug and Cosmetic Act called the Nutrition Labeling and Cosmetic Act (NLEA). The NLEA prevented dietary supplements and foods that make health claims from becoming subject to the FDA's strict drug approval and drug labeling requirements. (Prior to this amendment, dietary supplements were regulated as a food unless their intended use was as a drug.)

At that time, Congress specifically directed the FDA to consider whether health claims could be authorized for a number of specified nutrient-disease relationships, including the connection between folic acid and neural tube defects. The FDA responded by publishing a proposed rule in the Federal Register on November 27, 1991, proposing not to authorize any health claim linking folic acid with a reduction in the risk of neural tube defects. On January 6, 1993, the FDA adopted a final rule prohibiting claims associating folic acid with neural tube defects. On October14, 1993, the FDA reversed its position and proposed authorizing certain claims associating folic acid with a reduction in the risk of neural tube defects. On January 28, 1994, Plaintiffs Durk Pearson and Sandy Shaw and the American Preventive Medical Association filed comments asking the FDA to authorize the folic acid claim mentioned in this article.

Plaintiffs wished to use this claim on the labels and in the labeling of their dietary supplements. This is when the Pearson versus Shalala battle began. It took nearly a decade of frustrating battles and appeals processes, which consisted of multiple stall tactics by the FDA for this valuable information to finally be allowed to be made available to the public on folic acid labels. It is this achievement that we celebrate.

The Freedom Awards presentations

Image with Caption
Dr. Julian Whitaker at the podium

The First Amendment Freedom Award is in recognition of and grateful appreciation for the Pearson plaintiffs' constant and unyielding Defense of the First Amendment to the United States Constitution and of Freedom of Informed Choice in the health care marketplace. The freedom award recipients were:

  • Durk Pearson and Sandy Shaw
  • Dr. Julian M. Whitaker
  • Pure Encapsulations, Inc.
  • The American Preventive Medical Association
  • XCEL Healthcare

The first to receive "The Pearson vs. Shalala First Amendment Freedom Award" were long time pioneers in the field of aging prevention, Durk Pearson and Sandy Shaw. Referred to as the "Thomas Jefferson and James Madison of the modern era," Durk and Sandy were not only the leading plaintiffs in the Pearson vs. Shalala case, but they have been advocates for freedom of speech and lobbyists against FDA censorship of health information since as early as 1978. Durk and Sandy are the co-authors of the #1 Best-seller list book, Life Extension-A Practical, Scientific Approach. Durk Pearson and Sandy Shaw have been studying the aging process for over 30 years. They popularized Dr. Denham Harman's free radical theory of aging and age related diseases years ago. Today, this free radical theory is common knowledge among those "in the know." They are also honored for their courageous and tenacious efforts in the fight against the FDA's censorship and violation of the first amendment rights.

Sandy Shaw stated, "When we first became interested in life extension in 1968, the limit to what you could do to extend your life span was information because we didn't know very much about what caused aging. Now, today, the limit to what you can do about extending your life span is not information because we know a lot more about aging now. The limit now is regulatory barriers, particularly those barriers erected by the FDA, and one of the most important of those barriers is the limit on communication of truthful non-misleading information on labels and in advertising about supplements. Without that information, how can people benefit from research that has been done, research that in most cases has been paid for by public money?"

Sandy alluded to the anti-federalists who advocated for a Bill of Rights when the United States Constitution was being formed. "They were afraid that the people's rights would not adequately be protected without this Bill of Rights. If not for the anti-federalists, we wouldn't have a Bill of Rights and we could not have won this case," she said. "Freedom of Speech is a very important issue to us."

Durk Pearson added, "These fights are not over. The next fight is going to be applying the First Amendment to foods. The FDA says the Pearson vs. Shalala does not apply to foods. Well, the courts are going to be telling them otherwise. In the very near future we are going to be filing a health petition so that we can put a truthful, non-misleading claim on a designer food, one which states that one or more servings will reduce your risk of a heart attack. The active ingredient in this designer food is EPA/DHA," says Durk, "but it doesn't taste like or smell like fish."

During the appeals process, the FDA had one of the lawyers say in a meeting with a judge that they didn't think the first amendment applied to the FDA, Durk said. "That is frightening. The practical consequences of the FDA's violating the first amendment of the Bill of Rights are appalling. Since we have been suing the FDA concerning folic acid and neural tube defects, the FDA is responsible for over 10,000 dead and crippled babies.