FDA Loses Battle over Claims on Dietary Supplements

When Congress created the Nutrition Labeling Education Act of 1990, it delegated the FDA to establish a "procedure and standard respecting the validity" of health claims for dietary supplements. The FDA responded with a "significant scientific agreement standard" for evaluating the validity of health claims on dietary supplements.

To make health claims on dietary supplements now required approval from the FDA. Dietary supplement marketers Durk Pearson, Sandy Shaw and two health care advocacy groups, the National Health Federation (comprised of health care practitioners), and Citizens for Health, asked the FDA to authorize four health claims for their supplements:

1. "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.


2. "Consumption of fiber may reduce the risk of colorectal.


3. "Consumption of omega-3 acids may reduce the risk of coronary heart disease.


4. .8 mg 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 FDA concluded that while there was supportive evidence for the claims, the evidence was inconclusive and therefore failed to meet the "significant scientific" standard.

Rejected by the FDA, Pearson et al. took their plea to the U.S. District Court for the District of Columbia in 1993. Judge Gladys Kessler ruled against the plaintiffs in Dec. 1997. Undaunted, the case was filed in March 1998 with the United States Court of Appeals for the District of Columbia Circuit, with an additional plaintiff, the American Preventive Medical Association (APMA).

Appellate Ruling

On January 15, 1999, the court held that four FDA "Final Rules" prohibiting certain nutrient-disease relationship claims were invalid under the First Amendment to the Constitution. It also held invalid the agency's interpretation of its "significant scientific agreement" rule for review of health claims, which the court said the agency never defined.

The court ordered the FDA to reconsider the four claims made by the appellants, and ordered the case remanded to the U.S. District Court for the District of Columbia with instructions to remand the case in turn to the FDA for reconsideration of the appellants' claims.

"This is perhaps the most significant labeling law decision handed down by a court in over 20 years," said APMA attorney Jonathan Emord, JD. "This decision invalidates the FDA's entire review regime for labeling claims on the basis that it is unconstitutional, arbitrary and capricious. Courageously, Judges Silberman, Wald and Garland did not shy away from making the right decision. Their opinion is brilliant."

"I am absolutely thrilled that the court has recognized the validity of our position and instructed the FDA, finally, to define significant scientific agreement," said APMA President Ralph Miranda, MD. "This has been an expensive, six-year battle for us. For years, dietary supplement companies have been afraid to challenge this agency for fear of retaliation. Our members, practitioners who use and prescribe dietary supplements, felt the need to step into the breach and press the case for fairness and free speech. Now, the FDA will no longer be able to get away with continually raising the bar for supplement manufacturers in an effort to prohibit the dissemination of truthful, scientific information."

In their decision,* the judges stated:

"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. 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.

"... Because it is not claimed that the product is harmful, the government's underlying, if unarticulated, premise must be that consumers have a limited amount of either attention or dollars that could be devoted to pursuing health through nutrition, and therefore products that are not indisputably health enhancing should be discouraged as threatening to crowd out more worthy expenditures. We are rather dubious that this simplistic view of human nature or market behavior is sound, but it surely cannot be said that this notion, which the government does not even dare openly to set forth, is a direct pursuit of consumer health; it would seem a rather indirect route, to say the least.

"... Although the government may have more leeway in choosing suppression over disclosure as a response to the problem of consumer confusion where the product affects health, it must still meet its burden of justifying a restriction on speech -- here the FDA's conclusory assertion falls far short.

"According, on remand, the FDA must explain what it means by significant scientific agreement or, at minimum, what it does not mean."

Implications for Dr. Koren?

While this case involved the FDA, and not the Federal Trade Commission (FTC), it does give some hope to Dr. Ted Koren's case against the FTC. As the FDA has been instructed to allow disclaimers on vitamin supplement labeling, the FTC could face a similar order to allow Dr. Koren to make many of the previously challenged claims about chiropractic provided he added reasonable disclaimers. That Dr. Koren's attorney, James Turner, was one of the attorneys who worked on the briefs for the one of the plaintiffs (APMA) is also an advantage.

This latest decision by the U.S. Court of Appeals gives a new slant to the old economic "Golden Rule." The old rule stated: "He who owns the gold gets to make the rules."

The modern version seems to be: "He who owns the gold conducts the research that makes the rules."

 

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* A copy of the complete decision can be found on line at [url=http://www.emord.com]http://www.emord.com[/url].