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LE Magazine April 2003

A New Day at FDA?
After years of battling in the courts,
the FDA may finally be forced to comply with the law... AGAIN

Over five hundred years before the drafting of the United States Constitution, medieval barons in England fed up with regal abuse created their own set of laws known as the Magna Carta. Latin for "Great Charter," the Magna Carta was a series of written promises designed to force any king-in this case John-to govern the land according to the customs of law and not by whim.

Although originally unwilling to yield any of his royal power, after months of violent battle-and being literally at the point of a sword-the reluctant King John finally agreed to the demands of his barons and signed the document.

Centuries later, the FDA-this time at the point of a legal sword-finally acquiesced to judicial pressure and protests by health activists and created the "Better Health Information for Consumers" initiative, a policy that allows for greater latitude when disseminating information about health foods and nutritional supplements.

In this article, we examine the latest First Amendment victory won in the courts and the FDA's recent capitulation on the issue of dietary supplement health claims.

The Food and Drug Administration (FDA) has consistently fought the use of any statement describing how a nutritional supplement can promote health. Over the past several years, a series of historic court cases has systematically required the FDA to revamp its restrictive policies and allow manufacturers to make health benefit claims for nutritional supplements and foods. The FDA, however, has not always chosen to comply fully with the rulings of the court.

Each of these court cases focused on just a few simple sentences of information that the FDA deemed dangerous and illegal. The result of this litigation and the FDA's partial compliance are finally becoming visible in the marketplace as supplement labels and foods begin to carry expanded information concerning their potential health benefits. For example, bottles of vitamin E may now claim that the supplement helps boost the immune system as well as maintain red blood cells and cardiac muscles. Prior to these court cases, the FDA prohibited such statements. While these rulings support the health industry, the clear winner is the American public, who can now make more informed choices concerning the maintenance of its own health.

Winning out over censorship

Recently, there have been two new significant developments in the quest to limit the FDA's censorship of health claims. The first was the announcement by the FDA on December 18, 2002 of a broad new initiative, "Better Health Information for Consumers," aimed at making available more information about the health benefits of dietary supplements and foods for the prevention of disease. This new policy represents a one-hundred-and-eighty-degree turn from the traditional FDA stance that no nutrient-disease claims should be allowed for foods or supplements unless they are proven to a "near conclusive degree."

The second development occurred on December 23, 2002 when the FDA lost yet another court case (Whitaker vs. Thompson) concerning its continued suppression of a health claim. What the FDA objected to was the simple statement, "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers." This legal action was brought by Dr. Julian M. Whitaker, along with Durk Pearson, Sandy Shaw and Pure Encapsulations, Inc., among others.

Judge Gladys Kessler of the United States District Court for the District of Columbia ruled that these censoring actions by the FDA were a violation of the Constitution's free speech clause. This is the second time that the FDA was brought into court over this exact statement of antioxidant benefit. The first time was in the 1999 case of Pearson vs. Shalala (commonly referred to as Pearson I) in which the judge ordered the FDA to allow the antioxidant claim with the disclaimer, "These statements have not been evaluated by the Food and Drug Administration." Despite the court's decision, the FDA refused to comply. According to Jonathan W. Emord, the attorney for the plaintiffs in all of these cases, "these victories have resulted in a First Amendment revolution at the FDA. The agency must now expand health information that will enable the public to reduce the risk of disease and live longer."

Judging by the December 18 announcement, the FDA seems to have finally gotten the message. In the past, whenever the court ruled against FDA censorship, the agency strategically took one-step forward and two steps back. The result was that the FDA only partially complied with the Judge's order and additional legal motions had to be filed to bring the FDA in line.

Previous First Amendment victories

As a background to the recent victory of Whitaker vs. Thompson, it is essential to look at its two predecessors, Pearson I and Pearson II.

The complaint against the FDA in Pearson I was that the agency refused to allow the following four health claims:

• "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer." (This was again taken up in Whitaker vs. Thompson.)
• "Consumption of fiber may reduce the risk of colorectal cancer."
• "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease."
• "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 foods in common form."

The plaintiffs (Durk Pearson, Sandy Shaw, Julian Whitaker, et al) fought to have the FDA's health claim ban deemed unconstitutional. The court ruled that suppression of these statements was a violation of the First Amendment and ordered the FDA to allow these four claims to enter the marketplace. In reviewing the case, the court found the standard by which the FDA measured the efficacy of a health claim to be purely subjective. It is interesting to note that the FDA was not banning actual products, but only specific claims that spoke to the application of these nutritional products.

For the next two years, the FDA failed to comply with the court's original decision in Pearson I. As a result, attorney Emord and his clients went back to court to seek enforcement of Pearson I as well as relief from the FDA's continued speech suppression.

Their new case in 2001, titled Pearson II, focused on the FDA's refusal to allow the original claim that folic acid supplements were effective in reducing neural tube defects. The court stated, "The scientific consensus, even as acknowledged by the FDA, confirms that taking folic acid substantially reduces a woman's risk of giving birth to an infant with a neural tube defect. The public interest is well served by permitting information about the ability of folic acid to reduce the risk of neural tube defects to reach as wide a public audience as possible." Again, the court ruled in Pearson et al's favor on the same folic acid statement. The FDA was again ordered to comply. In effect, the court had stripped the FDA of any power to ban health claims of nutritional supplements unless the FDA had solid evidence that the claims actually mislead.

What was especially egregious about the FDA's failure to immediately respond to the court's first decision was the potential harm it was causing to unborn children. Folic acid is a safe and low-cost nutrient to prevent neural tube defects. Yet the FDA would not move from its position of refusing to allow such an important statement into the market place. This is a perfect example of how public health can be harmed by excessive regulation. Thankfully, despite the FDA's attempt at suppression of this information, the mass media picked up on the story and the public quickly learned about the benefits of folic acid supplements for pregnant women. Doctors now routinely encourage their patients during pregnancy to follow a regimen that includes folic acid in order to prevent unnecessary birth defects.

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