Food Regulation. Neal D. Fortin
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Название: Food Regulation

Автор: Neal D. Fortin

Издательство: John Wiley & Sons Limited

Жанр: Техническая литература

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isbn: 9781119764298

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СКАЧАТЬ is important in this context not because it will lead to the discovery of any objective “truth,” but because it is essential to our system of self‐government.

      The notion that more speech is the remedy to expose falsehood and fallacies is wholly out of place in the commercial bazaar, where if applied logically the remedy of one who was defrauded would be merely a statement, available upon request, reciting the Latin maxim “caveat emptor.” But since “fraudulent speech” in this area is to be remediable under Virginia Pharmacy Board, the remedy of one defrauded is a lawsuit or an agency proceeding based on common‐law notions of fraud that are separated by a world of difference from the realm of politics and government… . For in a democracy, the economic is subordinate to the political, a lesson that our ancestors learned long ago, and that our descendants will undoubtedly have to relearn many years hence….

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      5.6.2 Compelling Commercial Speech

      NOTE

      1 5.1. Suppressing speech—ag‐gag laws. Since the 1990s, a number of states adopted “ag‐gag” laws. These laws prohibit filming or recording of agricultural activity without the consent of the owner. Some of the laws also ban applying for work at or entering an agricultural facility under false pretenses. These laws target undercover investigators who gain access to agricultural production facilities by taking jobs there to expose mistreatment of animals. Because of problems passing with laws, some states created “rapid‐reporting” legislation that requires turning over any animal abuse recordings to authorities within a short amount of time, such as 24 or 48 hours.Proponents of these laws argue that they protect farmers against propagandists presenting animal agriculture in a misleading way. Opponents argue that these are secrecy laws designed to hide animal abuse from the public. Courts have invalidated several of these state laws for violating the First Amendment's free‐speech protections. Even if a state can show a compelling interest behind these laws, they must still be narrowly tailored. See, e.g., Animal Legal Defense Fund v. Herbert, No. 13‐cv‐00679 (D. Utah Jul. 7, 2017).

      The FDA rejected four proposed health claims by the Pearson plaintiffs. Each of these four claims linked the consumption of a particular dietary supplement to the reduction in risk of a disease:

      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.”

      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.”

      Relying on arguments grounded in the First Amendment and the Administrative Procedures Act (APA), the U.S. Court of Appeals invalidated the FDA regulations prohibiting those health claims and required the FDA to reconsider its disapproval of the plaintiffs’ claims. The court ruled that the FDA violated the First Amendment by banning misleading health claims without considering the use of curative disclaimers, and violated the arbitrary and capricious standard of the APA by failing to clarify the standard of “significant scientific agreement.”

      Health claims are a form of “commercial speech” and, under First Amendment protections, the FDA cannot unnecessarily restrain such speech. FDA argued that health claims lacking “significant scientific agreement” are inherently misleading to consumers and, therefore, are incapable of being cured by disclaimers. However, the Court of Appeals ruled that the FDA had no basis to reject the health claims without first assessing whether the use of a disclaimer could communicate meaningful, nonmisleading information to the consumer. Where commercial speech is potentially misleading but can be “presented in a way that is not deceptive,” the government cannot ban it.

      The court also found that FDA had not followed appropriate administrative procedures because it failed to fully explain why the four health claims did not meet the “significant scientific agreement” standard applicable to health claims. The FDA had not defined the criteria being applied to determine whether such agreement exists. The Court noted the legal and practical need to provide a governing rationale for approving or rejecting proposed health claims on the basis of a lack of “significant scientific agreement.” The court concluded that FDA’s denial of these health claims without defining “significant scientific agreement” constituted arbitrary and capricious action under the APA. Accordingly, СКАЧАТЬ