Nicopure Labs, LLC v. Food and Drug Administration
A manufacturer of e-cigarette devices and liquids challenged a federal regulation that deemed e-cigarettes to be “tobacco products.” This rule subjects e-cigarettes to the same federal laws as traditional cigarettes under the Tobacco Control Act (TCA). The manufacturer argued that the Food and Drug Administration (FDA), which issued the regulations, did not have the authority to regulate empty e-cigarettes or nicotine free e-liquids, because they were not made or derived from tobacco. The company also argued that the TCA’s ban on distributing free samples and pre-approval for modified risk statements was arbitrary and violated their First Amendment rights.
In this decision, the District Court upheld the FDA’s rule. The TCA gives the FDA the power to regulate “components” of tobacco products. The court found empty e-cigarettes and nicotine-free e-liquids are “components” of a tobacco product because together they make up an electronic nicotine delivery system. Further, the court found that the rule did not violate the manufacturers’ First Amendment rights because the ban on free samples was regulating conduct, not speech. The court also held that pre-approval for modified risk statements did not violate the First Amendment because it does not ban modified risk statements, it only requires the claims be substantiated. Finally, 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 not arbitrary.
In an amicus brief, the Campaign for Tobacco-Free Kids and other public health groups argued that such premarket review is a powerful tool for FDA to understand what is on the market and to evaluate whether any of these products should be allowed to continue to be marketed, given their adverse impact on public health, particularly those that appeal to kids because of their fruit and candy flavors (see "Related Documents").
Nicopure Labs, LLC v. Food and Drug Administration, 266 F.Supp.3d 360, U.S. District Court, District of Columbia (2017).
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.
"Nicopure also argues that the Deeming Rule ignores evidence “that vaping products are far less risky than cigarettes.” Nicopure Mem. at 19 (emphasis in original). It states that the agency has disregarded evidence that “inhalation of e-vapor ‘is of less risk to a user than the inhalation of . . . smoke from combusted tobacco products,’ and that use of vaping products ‘is likely less hazardous for an individual user than continued smoking of traditional cigarettes.’” Id., quoting Deeming Rule, 81 Fed. Reg. at 29,033, 29,035. For that reason, Nicopure argues that the Rule is “at war with itself.” Nicopure Mem. at 15–16. But this argument is not persuasive. Just because there is evidence that e-cigarettes may be less risky than conventional cigarettes does not mean that e-cigarettes are not risky at all, and the agency detailed its concerns about the addictive nature and health risks of nicotine inhalation alone, particularly in adolescents."
"...the Court concludes that the distribution of free samples is not protected speech, and that even if the act of handing out one’s product involves some expression, the FDA’s restriction of this activity passes the O’Brien and Central Hudson tests."
"Plaintiffs object to the characterization of an empty ENDS device as a component on the basis that those devices are “separate consumer product[s] that contain[] neither tobacco nor anything derived from tobacco.” See Nicopure Mem. at 10. But an empty open vaping system is not a generic consumer item with multiple potential functions, like a box or a bowl. The purpose of those items might not be evident until the consumer chooses to use them in a certain way. But an open-system vaping device is a unique item with a single function, and it is fundamental to the vaping process: you can’t vape without it. Therefore, the FDA’s interpretation of the term “component” to encompass an empty open system vaping device is based on a permissible construction of the TCA. Chevron, 467 U.S. at 843. The Court reaches the same conclusion with respect to plaintiffs’ challenge to the agency’s treatment of e-liquids..."
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.
A manufacturer of e-cigarette devices and liquids challenged a federal regulation that deemed e-cigarettes to be “tobacco products.” This rule subjects e-cigarettes to the same federal laws as traditional cigarettes under the Tobacco Control Act (TCA). The manufacturer argued that the Food and Drug Administration (FDA), which issued the regulations, did not have the authority to regulate empty e-cigarettes or nicotine free e-liquids, because they were not made or derived from tobacco. The company also argued that the TCA’s ban on distributing free samples and pre-approval for modified risk statements was arbitrary and violated their First Amendment rights.
In this decision, the District Court upheld the FDA’s rule. The TCA gives the FDA the power to regulate “components” of tobacco products. The court found empty e-cigarettes and nicotine-free e-liquids are “components” of a tobacco product because together they make up an electronic nicotine delivery system. Further, the court found that the rule did not violate the manufacturers’ First Amendment rights because the ban on free samples was regulating conduct, not speech. The court also held that pre-approval for modified risk statements did not violate the First Amendment because it does not ban modified risk statements, it only requires the claims be substantiated. Finally, 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 not arbitrary.
In an amicus brief, the Campaign for Tobacco-Free Kids and other public health groups argued that such premarket review is a powerful tool for FDA to understand what is on the market and to evaluate whether any of these products should be allowed to continue to be marketed, given their adverse impact on public health, particularly those that appeal to kids because of their fruit and candy flavors (see "Related Documents").