 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 government agues that the commercial speech doctrine does not prefer disclosure over complete censure. The Court does not agree with the government’s position, responding that “disclaimers as constitutionally preferable to outright suppression.” Since the FDA failed to consider whether disclosure would satisfy the government’s interest in protecting the consumer, they have blatantly disregarded a less restrictive method. The case was remanded and the FDA was required to consider whether the disclaimer would sufficiently satisfy the government’s interest. In addition, the FDA was required to provide guidance on the meaning of “significant scientific agreement.”
The paternalistic approach to FDA would be replaced with a more flexible approach as required by the Pearson decision. The FDA could no longer censure all health claims on a determination that they may be misleading. Instead the FDA is now required to consider less restrictive approaches. Agencies have been instructed that the paternalistic assumption that the public will use this information unwisely will not justify suppression. Pearson instructs the FDA to recognize the consumer need to receive information.
Even after Pearson , the FDA remained conservative in its approach to health claims. In 2001, there were approximately seventeen approved health claims that could be used on food labels. Each claim is authorized with model language to be used on the label and criteria that must be met in order for the food manufacturer to make the claim. One example of an approved health claim is for the connection between fruits and vegetables and cancer. The approved model claim is “Low-fat diets rich in fruits and vegetables (food that are low in fat and may contain dietary fiber, vitamin A or vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors.” The criteria that must be satisfied are that that the food must actually be a fruit or vegetable, that it must be low in fact, and must be a good source (without fortification) of