st 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 is more effective in reducing risk of neural tube defects than a lower amount n foods in common form.”  The FDA determined that all four claims failed to rise to “significant scientific agreement,” and therefore would not be approved for the labels of the dietary supplements. The FDA also refused the plaintiff’s alternative of permitting the claims with a disclaimer such as “The FDA determined that the evidence supporting the claim is inconclusive.”
The plaintiffs in Pearson v. Shalala claim that their First Amendment rights have been violated because the FDA has refused to allow the manufacturer to use disclaimers, which would serve the government’s interest and allow the plaintiff freedom of expression. Furthermore, they argue that the FDA has failed to adequately define the standard “significant scientific agreement” and such failure is a violation of the plaintiff’s Fifth Amendment right to due process. The First Amendment claim was evaluated based on the commercial speech doctrine. The Court found that truthful advertising is entitled to First Amendment protection. The government argues, however, that because the claims are potentially misleading and the consumer has no way to independently evaluate the claim, the consumer may assume that the government has approved the claim. The Court proceeded to evaluate the government’s argument using the three-part test for commercial speech set out in Central Hudson . The first issue is whether the government’s interest is substantial. The Court agreed that “public health and consumer fraud” were two important governmental concerns. The next issue to consider is “whether the regulation directly advances the government interest asserted.” The FDA asserts that barring all health claims that are not FDA approved protects the consumer’s interest. The court is skeptical of this paternalistic attitude. The real problem for the government, however, is meeting the third part of the test, whether the fit between the government’s means and the desired ends are reasonable. The 