American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration, et al.
The Campaign for Tobacco-Free Kids, in conjunction with other public health and medical organizations and several individual pediatricians, challenged the U.S. Food and Drug Administration (FDA) decision to allow e-cigarettes to remain on the market until 2022 before applying for FDA authorization and permitting products to remain on the market during review. The FDA also delayed the deadline for cigar manufacturers to file such applications until 2021. The court found that the FDA had exceeded its legal authority and the FDA’s delay had played a role in the skyrocketing youth use of e-cigarettes. The court gave the plaintiffs 14 days to submit additional briefing regarding a remedy and the FDA 14 days to respond.
American Academy of Pediatrics, et al. v. Food and Drug Administration, et al., No. PWG-18-883 (D. Md. 2019).
An individual or organization may sue their own government in order to advance or protect the public interest. For example, an NGO may sue the government claiming the government’s weak tobacco control laws violated their constitutional right to health.
Electronic and/or battery-operated devices designed to deliver an inhaled dose of nicotine or other substances. Examples include electronic cigarettes (e-cigarettes), electronic cigars, electronic cigarillos, electronic hookah, vaporizers, and vape pens. ENDS does not include any device or medication approved by the government as nicotine replacement therapy.
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"[T]he decision here, not to enforce the premarket review requirements against any manufacturers, does not “share . . . the characteristics of the decision of a prosecutor . . . not to indict” to any extent; it is more akin to an across-the-board statement that no one will be indicted for a certain crime for a period of time. In sum, the FDA’s action cannot fall within its enforcement discretion. Its action is inconsistent with the Tobacco Control Act and in excess of its statutory authority, and it cannot stand."
"These statutes include mandatory language like that in Acosta, not the permissive language at issue in Chaney. The term “shall,” which appears repeatedly in these statutory provisions, “normally creates an obligation impervious to . . . discretion.” Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lynch, 523 U.S. 26, 35 (1998); see also Cook v. Food & Drug Admin., 733 F.3d 1, 7 (D.C. Cir. 2013) (applying Lexecon holding with regard to judicial discretion to conclude that agency did not have absolute discretion where mandatory language appeared in the statute). Giving the statute’s language its ordinary meaning, these provisions require premarket review (involving applications and decisions on those applications) within a specific timeframe, and the August 2017 Guidance suspends the deadlines for both until 2021 or 2022 or later. Moreover, the plain language of the statute prohibits products from entering the market without the FDA’s approval. Therefore, the FDA’s “wholesale suspension” of the application filing and approval requirements constitutes a rule amendment or revocation that is subject to review by this Court. Acosta, 363 F. Supp. 3d at 18; see also Elecs. of N.C., 774 F.2d at 1266."
"The August 2017 Guidance’s provisions, which do not require manufacturers to submit their applications (accompanied by research in support) for five or more years and announce that the FDA will defer enforcement during that period, deny the Organizational Plaintiffs “access to information required to be disclosed by statute.” Dreher, 856 F.3d at 345; Friends of Animals, 828 F.3d at 992; see, e.g., Phillips (ACS CAN) Decl. ¶¶ 12–13 (“When FDA does not conduct premarket review, it is far more difficult for ACS CAN to advocate effectively for its members. Scientific data on the contents of novel tobacco products and their physiological consequences are crucial to ACS CAN’s ability to identify effective and feasible product standards. Without such data, designing and proposing a product standard is akin to building a highway without knowing how to make asphalt. And such data largely comes from FDA, because tobacco manufacturers typically release as little information about their products’ specific contents and interactions as possible. For example, JUUL, currently one of the most popular e-cigarettes among school-aged youth, has not gone through the premarket review process. If it did, it would have to provide information to FDA about its contents and their effects, and FDA would make that information public if it approved JUUL. Having that information would allow ACS CAN to determine whether there were specific aspects of JUUL that were troublingly carcinogenic and determine whether there are product standards that would minimize the carcinogenic effects of all e-cigarettes. Without premarket review, however, that information is simply unavailable.”). Further, Congress intended for the research provided pursuant to the Tobacco Control Act to be publicly available promptly after product approval. 21 U.S.C. § 387j(a)(4)(B); Pub. Law. 111-31, at § 3(2), (6), 123 Stat 1776, 1781, 1782. Therefore, through this deprivation of information, Plaintiffs are suffering “the type of harm Congress sought to prevent by requiring disclosure." Dreher, 856 F.3d at 345; Friends of Animals, 828 F.3d at 992."
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
The Campaign for Tobacco-Free Kids, in conjunction with other public health and medical organizations and several individual pediatricians, challenged the U.S. Food and Drug Administration (FDA) decision to allow e-cigarettes to remain on the market until 2022 before applying for FDA authorization and permitting products to remain on the market during review. The FDA also delayed the deadline for cigar manufacturers to file such applications until 2021. The court found that the FDA had exceeded its legal authority and the FDA’s delay had played a role in the skyrocketing youth use of e-cigarettes. The court gave the plaintiffs 14 days to submit additional briefing regarding a remedy and the FDA 14 days to respond.