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
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”).