 drug laws, which require much greater scrutiny. The NLEA was a response to consumer interests, changes in the marketplace, and advances in science. As the advances in science showed the connection between a healthy diet and decreased risk of disease, it was necessary for the FDA to recognize these links. Although the FDA did not issue any new regulations to address these issues in the 1980s, the FDA did relax its policies. Surprisingly, FDA did not take regulatory action against Kellogg’s All-Bran® when the label included a statement that fiber could reduce the risk of cancer. In 1990, Congress ended the ambiguousness of their 1980s policy by enacting the NLEA.
The NLEA allows health claims to appear on food labels. The health claim must be preapproved by the FDA through notice and comment rulemaking. In order to obtain approval for a health claim it was necessary to meet a very high scientific standard. The FDA will approve health claims if the totality of the publicly available scientific evidence indicates that there is significant scientific agreement among qualified experts that the claim is supported by scientific evidence. In addition, the food may be disqualified if it goes above the specified levels for fat, saturated fat, or sodium. The substance that is the subject of the health claim must be contained in the food at a minimum threshold level and have minimal nutritional value. Lastly, the health claim must identify factors besides the substance in a person’s diet that influence the diet-disease relationship.
From 1990-1994 the FDA used the NLEA in an effective manner by approving several health claims and assuring that no misleading claims appeared on food labels. The success of the NLEA was short lived, the Food and Drug Administration Modernization Act of 1997 (FDAMA) ended FDA’s authority to require approval of each and every health claim. Manufacturers may now make health claims based on an authoritative statement published by a scientific body of the United States government. The manufacturer must submit the following three things to the FDA: (1) notification to the FDA within 120 days prior to marketing of the food, (2) provide support for the claim with an authoritative statement of a scientific body who has official responsibility for public health or research directly related to human nutrition, and (3) submit balanced literature supporting the claim. Once this information is submitted, the claim is approved unless the FDA issues a regulation prohibiting the claim within 120 days. The FDAMA greatly limits the authority to control the legitimacy of health claims on food that was given to the FDA through the NLEA. Although FDA no longer approves each claim, proponents of FDAMA argue that the claims are still subject to the same requirements as defined by the NLEA. The claim must still meet the significant scientific agreement requirement, the food must contain at least ten percent of the recommended daily allowance of vitamin A, vitamin C, calcium, protein, or fiber, and the food must not have excessive levels of fat, saturated fat, or sodium.
Under these new laws health claims were prohibited on both food and dietary if they were not supported by adequate scientific support. In Pearson v. Shalala , the U.S. Court of Appeals heard a challenge to NLEA based on the first amendment rights of the manufacturer of dietary supplements. This was the first challenge to limit the authority of the FDA over health claims. In 1999, the District Court for the District of Columbia limited the power of the FDA and determined that the health claim was not misleading and should be allowed. The plaintiff, a dietary supplement marketer, attempted to gain approval from the FDA for four specific health claims. These claims were (1) “consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers,” (2) “Consumption of fiber may reduce the risk of colorectal cancer,” (3) “Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease,” and (4) “.8 mg of folic acid in a dietary supplement