§ 10.30, requesting that the Commissioner of Food and Drugs amend the regulation3 governing State and local petitions for exemption from the preemptive effects of the Food, Drug, and Cosmetic Act’s (FDCA) nutrition and menu labeling standards.4 The proposed changes would provide a more efficient and fairer petitioning 1 CSPI, America’s Food and Health Watchdog, is a non-profit consumer education a. [...] CSPI was instrumental in passage of the Nutrition Labeling and Education Act (NLEA), which amended the Food, Drug, and Cosmetic Act (FDCA) to include uniform nutrition labeling, and the organization continues to advocate for improvements to nutrition and menu labeling at the local, state, and Federal level, including additions of the trans fat and added sugars lines on the Nutrition Facts label. [...] The term “unduly,” as used in the FDCA, and the term “excessive,” as used in the Pike balancing test, of course, are synonymous.42 Indeed, before the NLEA amended the FDCA in 1990, and since then, the Supreme Court has repeatedly used the two terms interchangeably when applying the Pike balancing test.43 This leaves little doubt that Congress intended FDA to use the Pike balancing test when analyz. [...] While the agency agrees with the comments’ interpretation of the statute, an agency decision to grant an exemption from preemption is likely to be based largely on the agency’s evaluation of the situation within the requesting State. [...] CERTIFICATION The undersigned certify that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioners which are unfavorable to the petition.
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