Nicopure Labs, LLC v. Food and Drug Administration
Nicopure, an e-cigarette manufacturer, and Right To Be Smoke-Free Coalition, an e-cigarette industry group, raised three challenges to the district court's decision:
The FDA violated the Tobacco Control Act (TCA) and the Administrative Procedure Act (APA) by not providing an easier premarket authorization pathway for e-cigarettes.
The premarket review standards applicable to modified risk tobacco products, contending that the standards impermissibly burden what they say are truthful, non-misleading statements about e-cigarettes.
The ban on distribution of free samples of tobacco products, including e-cigarettes, as suppression of constitutionally protected expressive conduct.
The DC circuit court affirmed the district court’s judgment sustaining the TCA and its application to e-cigarettes. The court found because of the public health risks associated with nicotine and increasing rates of e-cigarette use in adolescents and adults, the decision to subject e-cigarettes to the TCA was rational and not arbitrary. Further, the First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers substantiate those claims. Finally, the court found that the rule did not violate the manufacturers’ First Amendment rights because free samples are not expressive conduct and preventing their distribution is unrelated to the suppression of expression.
In an amicus brief, the Campaign for Tobacco-Free Kids and other public health groups argued that appellants exaggerate the scientific evidence of claimed health benefits of e-cigarettes relative to conventional cigarettes and ignore real health risks posed by e-cigarettes. They also argue that FDA review of modified risk claims for e-cigarettes is necessary to determine whether e-cigarettes, as actually used, benefit the health of individuals and the public and is consistent with the First Amendment (see “Related Documents”).
Nicopure Labs, LLC v. Food and Drug Administration, No. 17-5196, U.S. Court of Appeals, District of Columbia (2019).
United States
Dec 10, 2019
U.S. Court of Appeals for the District of Columbia
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.
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 tobacco sales to or by minors, as well as other retail restrictions relating to point-of-sale, candy and toys resembling tobacco products, vending machines, or free distribution.
(See FCTC Art. 16)
A violation of the right to equal protection under the law, or another form of discrimination. The industry may claim that regulations discriminate against tobacco companies or tobacco products. Smokers may claim that addiction is a health condition, so regulations discriminate against them based on their health condition. Facilities subject to smoke free laws may claim that smoke free (SF) exceptions (e.g., hotel rooms, mental hospitals, etc.) unfairly discriminate against SF businesses because the law should apply to all locations equally.
A violation of the right to expression, free speech or similar right to express oneself without limitation or censorship. The industry may claim that a regulation infringes on their right to communicate with customers and the public. Similarly, they may claim that mandated warnings infringe on their freedom to communicate as they desire.
A violation of the right to procedural fairness. For example, a party may claim that a government agency did not consult with public or stakeholders when issuing regulations.
The court might consider procedural matters without touching the merits of the case. These might include: improper joinder, when third parties, such as Health NGOs or government officials, seek to become parties to the suit; lack of standing, where a plaintiff fails to meet the minimum requirements to bring suit; lack of personal jurisdiction, where the court does not have jurisdiction to rule over the defendant; or lack of subject matter jurisdiction, where the court does not have jurisdiction over the issue at suit.
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.
"E-cigarettes are indisputably highly addictive and pose health risks, especially to youth, that are not well understood. It is entirely rational and nonarbitrary to apply to e-cigarettes the Act’s baseline requirement that, before any new tobacco product may be marketed, its manufacturer show the FDA that selling it is consistent with the public health. What is more, the First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers have shown that they actually are safer as claimed. That conclusion is amply supported by nicotine’s addictiveness, the complex health risks tobacco products pose, and a history of the public being misled by claims that certain tobacco products are safer, despite disclaimers and disclosures. Finally, nothing about the Act’s ban on distributing free e-cigarette samples runs afoul of the First Amendment. Free samples are not expressive conduct and, in any event, the government’s interest in preventing their distribution is unrelated to the suppression of expression. We accordingly affirm the district court’s judgment sustaining the Tobacco Control Act and its application to e-cigarettes."
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.
Nicopure, an e-cigarette manufacturer, and Right To Be Smoke-Free Coalition, an e-cigarette industry group, raised three challenges to the district court's decision:
The DC circuit court affirmed the district court’s judgment sustaining the TCA and its application to e-cigarettes. The court found because of the public health risks associated with nicotine and increasing rates of e-cigarette use in adolescents and adults, the decision to subject e-cigarettes to the TCA was rational and not arbitrary. Further, the First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers substantiate those claims. Finally, the court found that the rule did not violate the manufacturers’ First Amendment rights because free samples are not expressive conduct and preventing their distribution is unrelated to the suppression of expression.
In an amicus brief, the Campaign for Tobacco-Free Kids and other public health groups argued that appellants exaggerate the scientific evidence of claimed health benefits of e-cigarettes relative to conventional cigarettes and ignore real health risks posed by e-cigarettes. They also argue that FDA review of modified risk claims for e-cigarettes is necessary to determine whether e-cigarettes, as actually used, benefit the health of individuals and the public and is consistent with the First Amendment (see “Related Documents”).