The TCA directs FDA to review the PMTAs to determine whether “permitting such tobacco product to be marketed would be appropriate for the protection of the public health.” 21 U. [...] For example, if the PMTA does not address youth access to the product, youth exposure to the product’s labeling, advertising, marketing, and promotion, and youth initiation, such as describing how it proposes to restrict the sale or distribution of its product to limit potential youth access to the product (e.g., selling the tobacco product in adult-only establishments) or exposure to advertising. [...] Among other things, the statement raises the question of why, if the FDA did review the summaries, it told Petitioners that it had “not evaluated any marketing plans.” As it stands, the FDA’s statement at oral argument is at odds with the record. [...] As we explained the doctrine in one of the canonical fair notice cases: The respondents contend that the regulations should be liberally construed to give broad coverage because of the intent of Congress to provide safe and healthful working conditions for employees. [...] FCC, we held that when sanctions are drastic— in that case, the FCC dismissed the petitioner’s application for a radio station license—“elementary fairness compels clarity” in the statements and regulations setting forth the actions with which the agency expects the public to comply.
- Pages
- 85
- Published in
- United States of America
