TOBACCO CONTROL LAWS

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:

  1. 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.
  2. 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.
  3. 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”).

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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
View Case History

Parties

Plaintiff

  • Nicopure Labs, LLC
  • Right to be Smoke-Free Coalition
  • American E-Liquid Manufacturing Standards

Defendant Food and Drug Administration

Legislation Cited

Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 81 Fed. Reg. 90 (May 10, 2016)

Family Smoking Prevention and Tobacco Control Act, Public Law 111-31, June 22, 2009

Administrative Procedure Act

Related Documents

TFK Amicus Brief in USCA DC Nicopure

Type of Litigation

Challenge to Government Policies Relating to Tobacco Control/Public Health
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.

Tobacco Control Topics

Contents and Disclosures Measures
Measures for testing, measuring, regulating, or disclosing the contents and emissions of tobacco products. (See FCTC Arts. 9 and 10)
Packaging and Labeling Measures
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)
Advertising, Promotion and Sponsorship
Measures restricting any form of direct or indirect tobacco advertising, promotion and sponsorship. (See FCTC Art. 13)
Sales to or by Minors
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)

Substantive Issues

Right to Equal Protection
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.
Right to Freedom of Expression
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.
Right to Procedural Due Process
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.
Procedural Defect
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.
Sufficiency of Scientific Evidence
A discussion on whether current scientific evidence is sufficient to justify the regulatory measures.
Ultra Vires Regulation
Subsequent regulations exceed the scope of the originating law.

Type of Tobacco Product

E-cigarettes and other ENDS products
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.
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