## Facts

- FDA issued the 2016 “Deeming Rule,” treating electronic nicotine-delivery systems (ENDS) and e-liquids as “tobacco products” regulated under the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA).
- The rule subjected ENDS to the TCA’s requirements for “new tobacco products,” including premarket authorization based on whether marketing the product would be “appropriate for the protection of public health.”
- Nicopure Labs, an ENDS manufacturer, and an industry coalition sued in federal district court, alleging the rule exceeded statutory authority and violated the APA, the First Amendment, and other constitutional provisions.
- The district court granted summary judgment for FDA and upheld the Deeming Rule.
- On appeal, the plaintiffs did not dispute that ENDS fit within the statutory definition of “tobacco product,” but challenged: (1) applying the full premarket regime to ENDS without a more tailored pathway, (2) the TCA’s modified-risk tobacco product (MRTP) authorization requirement for “reduced-risk” marketing claims, and (3) the statutory ban on distributing free samples as applied to ENDS.
- FDA relied on evidence of nicotine’s addictiveness, chemicals in vapor, rising youth use, uncertainty about long-term effects, and concerns about dual use with combustible products.

## Issues

1. Whether applying the TCA’s full premarket authorization regime to ENDS, without creating a more lenient pathway, violated the TCA or was arbitrary and capricious under the APA.
2. Whether the TCA’s MRTP provisions requiring prior FDA authorization for “reduced-risk” marketing claims violated the First Amendment as applied to truthful, non-misleading commercial speech.
3. Whether the TCA’s ban on distributing free tobacco-product samples violated the First Amendment.

## Decision

- The D.C. Circuit affirmed the district court and upheld the Deeming Rule and the challenged TCA provisions as applied to ENDS.
- The court held FDA acted within its discretion and did not act arbitrarily or capriciously by subjecting ENDS to the same premarket review standards as other new tobacco products.
- The court held the MRTP prior-authorization requirement for modified-risk claims did not violate the First Amendment.
- The court held the free-sample ban was constitutional because it regulated conduct, not expression; even if treated as speech-related, it would survive intermediate scrutiny.

## Legal Principles

- When a statute assigns an agency a public-health standard for product marketing (e.g., “appropriate for the protection of public health”), the agency may apply a uniform premarket review framework so long as its decision is reasonable and supported by the administrative record.
- The APA does not require an agency to create a product-specific, more lenient regulatory pathway absent a statutory command; alleged compliance burdens do not alone make a rule arbitrary and capricious.
- Restrictions requiring prior authorization for health- or risk-reduction marketing claims about regulated products are assessed under commercial-speech doctrine and may be upheld under intermediate scrutiny when they directly advance substantial governmental interests and are reasonably fitted to those interests.
- A requirement that manufacturers substantiate “reduced-risk” claims before marketing them is a permissible method to prevent misleading representations about health risks.
- A ban on distributing free product samples is generally a regulation of commercial conduct (product distribution), not protected expressive conduct, and may be upheld where it targets public-health concerns such as youth initiation.

## Conclusion

The D.C. Circuit sustained FDA’s regulation of e-cigarettes under the TCA, holding that applying full premarket review to ENDS was neither unlawful nor arbitrary, that prior authorization for modified-risk claims permissibly regulates commercial speech, and that the free-sample ban constitutionally regulates conduct in service of public-health objectives.


Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019)