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NLEA REGS COULD FACE FIRST AMENDMENT CHALLENGE

This article was originally published in The Tan Sheet

Executive Summary

NLEA REGS COULD FACE FIRST AMENDMENT CHALLENGE from a dietary supplement company once the final regulations appear, Edward Dunkelberger of the Washington, D.C. law firm Covington & Burling predicted during a Dec. 14 presentation at the Food & Drug Law Institute's Annual Educational Conference. The dietary supplement industry "seems to have the most at stake" he suggested, and will "eventually . . . challenge the FDA [nutrition and health claim] regulations . . . on First Amendment grounds." Dunkelberger said the food industry objects to "the restrictive nature of the regulations" because they "counter First Amendment protections assured by the Supreme Court." "Undue restrictions in the health claims regulation," Dunkelberger maintained, "defeat[s] the very purpose of the NLEA, which was to bring to consumers an understanding of the relationship between their diets and the impact upon health." Center for Science in the Public Interest Legal Affairs Director Bruce Silverglade suggested that the costs involved in waging a court battle on First Amendment grounds present a significant hurdle for parties interested in challenging the NLEA regs. Should a case be brought against FDA regarding the NLEA regulations, Silverglade asserted, it "would take four years, cost $ 5 mil., and have less than a 60/40 chance of winning." According to Dunkelberger, FDA initially justified NLEA regulations under the agency's basic tenet that "food labeling is not commercial speech" and, therefore, is not protected under the First Amendment. The agency also argued, Dunkelberger said, that food labeling is a "distinct category of regulatory speech subject to limited scrutiny under the First Amendment." In these two instances, Dunkelberger maintained, FDA's arguments "do not hold water." Dunkelberger contended that food labeling "clearly . . . qualifies for commercial speech" if it meets the standards set out by the Supreme Court that state: (1) it is in the form of advertising; (2) it refers to a specific product; and (3) it is motivated by economic interest. Dunkelberger also asserted that a number of Supreme Court cases hold that "labeling is commercial speech" and cannot be distinguished from advertising. FDA's reference to a separate regulatory category for food labeling, Dunkelberger commented, is not supported by any Supreme Court commercial speech case. In fact, he continued, the agency cited only one SEC case, which "makes no reference to labeling" to support its position. "Ultimately," Dunkelberger contended, FDA addressed the health claims regulation under the Supreme Court's protected commercial speech ruling. Dunkelberger said that FDA's legal position on health claims under this framework holds that: (1) health claims are not protected under the First Amendment if they are inherently misleading; and (2) government regulation of health claims regulation is permissible in order to prevent consumer deception and promote public health. Dunkelberger suggested that such a position is not supportable based on FDA's approval of health claims for seven nutrient- disease relationships. Silverglade supported FDA's position that health claims "not based on 'significant scientific agreement' are inherently misleading and . . . do not have constitutional protection." Silverglade explained that many health claims are "based on preliminary evidence that don't really have the support of the scientific community." Consumers, he continued, "lack technical expertise" to interpret the evidence. In reference to FDA's interest in preventing consumer deception and promoting the public health, Dunkelberger conceded that "a ban on all unapproved claims undoubtedly screens out some false or misleading claims" while restrictions on approved claims "prevent some deceptive statements." However, he asserted that "restricting or suppressing health claims" does not "directly advance . . . the government's interest in educating consumers and promoting healthful diets." Restrictions in the regulations, Dunkelberger maintained, "defeat, rather than advance, those purposes and benefits" of the NLEA.
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