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A Celebration of First Amendment Victories Against the FDA

April 2002

By Michele G. Morrow, D.O.


On May 26, 2001, a special event occurred to celebrate a string of legal defeats suffered by the FDA in the Federal Courts. Attending were some of the world's most prominent physicians, scientists and health freedom advocates.

The purpose of this event was to honor those responsible for past legal victories against FDA censorship. At the time this event took place, the latest Court ruling forced the FDA to allow a claim on folic acid labels stating that folic acid reduces the risk of certain birth defects. The FDA had previously prohibited this health claim, thus denying women access to knowledge that could help prevent horrendous birth defects in their unborn children. According to a recent survey, only 30% of women of childbearing age know that folic acid reduces birth defects. By censoring this information about folic acid, the FDA condemned tens of thousands of babies to crippling and irreversible birth defects.

The decision by the Federal Courts to allow this health claim was finalized only after a multi-year battle spearheaded by Durk Pearson and Sandy Shaw and The Preventive Medical Association (who were later joined by Dr. Julian Whitaker, Pure Encapsulations Inc. and others). The contention of those who sued the FDA was that the agency was violating the First Amendment, the Fifth Amendment, the Supremacy Clause of The United States Constitution as well as the Food, Drug and Cosmetic Act and the Administrative Procedure Act. The specific health claim sought by those who sued the FDA was:

"800 mcg of folic acid is more effective in reducing the risk of neural tube defects than a lower amount in common food form"

In 1999, the Federal Appellate Court ruled that the FDA had unconstitutionally suppressed this health claim. Subsequently, the FDA ignored the ruling and would not authorize the claim. The FDA was sued again based on their continued disallowance of this health claim. Those who sued the FDA even sought to have the FDA held in contempt of court for refusing to follow the Court's initial ruling. These cases were described in detail in the July 1999 and May 2001 issues of Life Extension magazine.

Paying respect to those who defended our rights

Image with Caption
Dr. Michele Morrow interviews
Durk Pearson

The theme of this awards ceremony was solemn, triumphant and patriotic. A banner of the American Flag proudly hung behind the podium where accomplished dignitaries spoke about the significance of this victory and honored those who fought to make it happen. The event opened with the national anthem sung passionately by gospel singer Elma Randolph. Her powerful performance evoked emotions in just about everyone who attended the ceremony. Little did anyone know then how patriotic we all would become after the September 11th event in New York and Washington D.C. Many of the "Who's Who" in the alternative medicine arena were present, including accomplished political activists of freedom of speech, prestigious government officials who support First Amendment rights as it applies to dietary supplements, respected scientists and alternative medicine physicians.

The honorable former Iowa Congressman Berkley Bedell served as Master of Ceremonies. Mr. Bedell is currently the Founder and President of The National Foundation for Alternative Medicine and a member of the Board of Directors of the American Preventive Medical Association. He has worked diligently with Senator Tom Harkin to establish the Office of Alternative Medicine at the National Institutes of Health with a "mandate to investigate and validate" alternative treatments for disease. He also worked with Senator Tom Daschle to assist in writing and advocating for the Access to Medical Treatment Act, which would make it possible for patients to gain access to alternative treatments not approved by the Food and Drug Administration.

Brad Clanton, who serves as the chief counsel to the house judiciary sub-committee on the Constitution, gave the keynote address outlining the legal events that led to the First Amendment victory.

In his keynote speech, Mr. Clanton provided a historical overview of this multi-year case that resulted in the FDA's humiliating defeat. Mr. Clanton began by stating that the case was initiated when Durk Pearson and Sandy Shaw sought FDA authorization of four separate health claims that could be put on the labels of their dietary supplements. The four health claims were:

  1. Consumption of antioxidant vitamins may reduce the risk of certain cancers.
  2. Consumption of fiber may reduce the risk of colon cancer.
  3. Consumption of omega 3 fatty acids may reduce the risk of coronary heart disease.
  4. 800 mcg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in common food form.

Each claim was considered separately.

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.