Nicopure Labs, LLC v. FDA, 944 F.3d 267

Background:

E-cigarettes (ENDS) deliver nicotine via aerosolized liquids; FDA in its 2016 Deeming Rule classified them as "tobacco products" under the Family Smoking Prevention and Tobacco Control Act (TCA).
The Deeming Rule subjects e-cigarettes to TCA requirements: premarket authorization for new products, a stricter modified-risk preclearance pathway for claims of reduced risk, and a ban on free samples.
FDA found nicotine highly addictive (especially to youth), e-cigarette aerosols contain other potentially harmful chemicals, youth use rose sharply, and long-term public-health effects remain uncertain.
Nicopure Labs and Right To Be Smoke‑Free challenged the Deeming Rule and certain TCA provisions: (1) APA challenge to applying the ordinary premarket pathway to e-cigarettes; (2) First Amendment challenge to the modified‑risk preclearance requirement; and (3) First Amendment challenge to the ban on free samples.
The district court upheld the Deeming Rule and TCA provisions; the D.C. Circuit affirmed, holding the premarket regime non‑arbitrary, the modified‑risk preclearance consistent with the First Amendment, and the sample ban a permissible conduct regulation.

Issues:

Issue	Plaintiff's Argument	Defendant's Argument	Held
Applicability of TCA premarket authorization to e‑cigarettes (APA)	FDA acted arbitrarily by not tailoring a lighter pathway for e‑cigarettes and imposing onerous requirements that could destroy the industry	The premarket requirement is statutory; once e‑cigs are deemed tobacco products FDA must apply the population‑effects standard and may accept varied evidence when appropriate	Affirmed — FDA’s application of the statutory premarket regime to e‑cigarettes is not arbitrary and the agency may be flexible within the statute’s framework
Modified‑risk (MRTP) preclearance and First Amendment	MRTP pathway unlawfully burdens truthful, non‑misleading commercial speech about reduced‑risk characteristics	Regulation treats marketing claims as evidence of product type (per Whitaker); restriction targets potentially misleading claims to protect public health and youth	Affirmed — MRTP preclearance is permissible: speech can be evidence of product type and, if treated as a speech restriction, it survives Central Hudson as appropriately tailored to a substantial interest
Ban on free samples and First Amendment	Free samples convey product information to smokers and are protected commercial speech / expressive conduct	The ban regulates conduct (distribution/price), not speech; it advances youth‑protection and is a typical, rational price/conduct regulation	Affirmed — free‑sample ban targets conduct, not protected expression; even if incidental, it is related to substantial government interests and rationally applied

Key Cases Cited

FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (establishing limits and context for FDA regulation of tobacco)
Central Hudson Gas & Elec. v. Public Service Comm'n, 447 U.S. 557 (framework for commercial‑speech regulation)
Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir.) (permitting agency use of marketing/speech to determine product regulatory category)
Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (recognizing compelling interest in preventing underage tobacco use)
Sorrell v. IMS Health Inc., 564 U.S. 552 (distinguishing protections for dissemination of truthful, nonmisleading information to sophisticated audiences)
Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir.) (upholding sample restriction in context of preventing youth access)
POM Wonderful, LLC v. FTC, 777 F.3d 478 (D.C. Cir.) (consumer perception and context matter in determining misleading commercial claims)
United States v. O'Brien, 391 U.S. 367 (conduct‑speech distinction for First Amendment analysis)
Expressions Hair Design v. Schneiderman, 137 S. Ct. 1144 (price/price‑communication regulation may be non‑speech regulation)