American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration
In a lawsuit filed by eight public health and medical groups and several individual pediatricians, plaintiffs filed suit to force the U.S. Food and Drug Administration (FDA) to issue a final rule requiring pictorial health warnings on cigarette packs and advertising, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. The FDA's previous final rule was struck down in August 2012 by the U.S. Court of Appeals for the D.C. Circuit, which ruled that the proposed warnings violated the First Amendment. Ruling in a separate case in March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for pictorial health warnings, finding that this provision did not violate the First Amendment. That court found the warnings “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.” The U.S. Supreme Court declined to hear a tobacco industry appeal of this ruling. Taken together, these two federal court decisions meant the FDA was still legally obligated to require pictorial health warnings, and the agency was free to use different images than those struck down by the D.C. Circuit in 2012. The FDA stated in March 2013 that it planned to issue a new rule, but had yet to act when plaintiffs filed suit.
The judge agreed with the health groups that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action to require the pictorial warnings. The judge set a deadline of September 26, 2018, for the FDA to provide an expedited schedule for the proposal, review, and issuance of final pictorial health warnings in accordance with the law.
American Academy of Pediatrics, et al. v. U.S. Food & Drug Admin., No. 1:16-cv-11985 (D. Mass. 2018).
United States
Sep 5, 2018
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.
"This court finds that in light of the timeline originally set forth by Congress, the FDA’s current timeline (and work completed thus far), the human health and welfare at stake, and the lack of competing priorities enumerated in the FDA’s brief, the FDA has failed the TRAC factors. At this point, this court declines to defer to the agency’s timeline. See Tang v. Chertoff, 493 F. Supp. 2d 148, 155 (D. Mass. 2007) (“Nor does an agency have sole discretion to define what is a reasonable time under the APA, which would render meaningless § 706(1)’s clearly mandatory language that the ‘reviewing court shall compel agency action unlawfully withheld or unreasonably delayed.’”) (citing 5 U.S.C. § 706(1)). This court concludes that because the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action, the court must compel agency action. 5 U.S.C. § 706(1)."
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 a lawsuit filed by eight public health and medical groups and several individual pediatricians, plaintiffs filed suit to force the U.S. Food and Drug Administration (FDA) to issue a final rule requiring pictorial health warnings on cigarette packs and advertising, as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act. The FDA's previous final rule was struck down in August 2012 by the U.S. Court of Appeals for the D.C. Circuit, which ruled that the proposed warnings violated the First Amendment. Ruling in a separate case in March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for pictorial health warnings, finding that this provision did not violate the First Amendment. That court found the warnings “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.” The U.S. Supreme Court declined to hear a tobacco industry appeal of this ruling. Taken together, these two federal court decisions meant the FDA was still legally obligated to require pictorial health warnings, and the agency was free to use different images than those struck down by the D.C. Circuit in 2012. The FDA stated in March 2013 that it planned to issue a new rule, but had yet to act when plaintiffs filed suit.
The judge agreed with the health groups that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action to require the pictorial warnings. The judge set a deadline of September 26, 2018, for the FDA to provide an expedited schedule for the proposal, review, and issuance of final pictorial health warnings in accordance with the law.