American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration
In 2016, the Campaign for Tobacco-Free Kids, in conjunction with seven other health organizations, medical groups, and several individual pediatricians, filed a lawsuit to force the U.S. Food and Drug Administration (FDA) to issue a final rule requiring graphic health warnings on cigarette packing and marketing, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. In September 2018, the District Court ruled in favor of the health groups finding that the FDA had both “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic health warnings.
In March 2019, the District Court ordered that the FDA must issue a final rule by March 2020 for graphic health warnings on cigarette packaging and marketing. The ruling also requires the FDA to finish its study on the labels by April 15, 2019, and submit its proposed rule by August 15, 2019.
For the earlier decision, see: American Academy of Pediatrics, et al. v. U.S. Food & Drug Admin., No. 1:16-cv-11985 (D. Mass. 2018).
American Academy of Pediatrics, et al. v. U.S. Food & Drug Admin., No. 1:16-cv-11985-IT (D. Mass. 2019).
United States
Mar 5, 2019
U.S. District Court for the District of Massachusetts
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.
Measures to regulate the marketing on tobacco packages. This includes both bans on false, misleading, deceptive packaging, as well as required health warnings on packaging.
(See FCTC Art. 11)
Measures restricting any form of direct or indirect tobacco advertising, promotion and sponsorship.
(See FCTC Art. 13)
Substantive Issues
None
Type of Tobacco Product
None
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.
"Defendant proposes a thirteen months period from publication of the proposed rule to publication of the final rule. [#53]. Again, this timeline ignores the Congressional mandate of a total two year period for promulgation of a rule and the tools that are available to speed up OMB review. Accordingly, for the reasons set forth herein and in the Memorandum and Order [#50],
the Plaintiffs’ Request for Urgent Action [#54] and Renewed Request for Urgent Action [#55] are ALLOWED. Defendant FDA shall:
1. take all steps necessary to obtain an OMB control number immediately, and complete the final qualitative study of nine graphic warnings and analysis of that study by April
15, 2019;
2. submit the proposed rule mandating color graphic warnings on cigarette packs and in cigarette advertisements as required by Tobacco Control Act for publication in the Federal Register by August 15, 2019; and
3. submit the Final Rule mandating color graphic warnings on cigarette packs and in cigarette advertisements as required by Tobacco Control Act for publication in the Federal Register by March 15, 2020."
"Despite this court’s admonition that Congress’s two-year deadline had restarted when the matter was remanded to the agency in 2013, and the court’s directive that the FDA propose an expedited schedule, in an October 2018 response, the FDA proposed publication of a final rule in the Federal Register in May 2021, more than two and a half years from the date of the proposal, more than four and a half years after the Plaintiffs brought this litigation, and more than eight years after advising Congress that it was undertaking research to support a new rule. The court rejects FDA’s proposed schedule."
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.
In 2016, the Campaign for Tobacco-Free Kids, in conjunction with seven other health organizations, medical groups, and several individual pediatricians, filed a lawsuit to force the U.S. Food and Drug Administration (FDA) to issue a final rule requiring graphic health warnings on cigarette packing and marketing, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. In September 2018, the District Court ruled in favor of the health groups finding that the FDA had both “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic health warnings.
In March 2019, the District Court ordered that the FDA must issue a final rule by March 2020 for graphic health warnings on cigarette packaging and marketing. The ruling also requires the FDA to finish its study on the labels by April 15, 2019, and submit its proposed rule by August 15, 2019.
For the earlier decision, see: American Academy of Pediatrics, et al. v. U.S. Food & Drug Admin., No. 1:16-cv-11985 (D. Mass. 2018).