## Facts

- Sottera, Inc. (NJOY) imported and distributed electronic cigarettes designed to resemble traditional cigarettes and to deliver inhaled nicotine vapor.
- The products used liquid nicotine derived from tobacco and were marketed for “smoking pleasure,” not for smoking cessation or other therapeutic purposes.
- In 2009, the FDA detained and refused admission of Sottera’s shipments, asserting the products were “adulterated and misbranded” drug-device combination products under the Federal Food, Drug, and Cosmetic Act (FDCA).
- Sottera contended the products were not “drugs” or “devices” under the FDCA absent therapeutic marketing claims and instead could be regulated, if at all, only as “tobacco products” under the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Act).
- The district court issued a preliminary injunction barring the FDA from regulating such non-therapeutically marketed tobacco-derived e-cigarettes under the FDCA drug/device provisions.
- The FDA appealed the preliminary injunction to the D.C. Circuit.

## Issues

1. Whether the FDA may regulate tobacco-derived e-cigarettes marketed for recreational use as “drugs,” “devices,” or combination products under the FDCA.
2. Whether, absent therapeutic claims, such products fall within the Tobacco Act’s “tobacco product” framework rather than the FDCA drug/device regime.
3. Whether the preliminary injunction was proper under the standards for likelihood of success, irreparable harm, and the balance of equities/public interest.

## Decision

- The D.C. Circuit affirmed the preliminary injunction.
- The court held the FDA may not regulate Sottera’s e-cigarettes as FDCA drugs/devices or drug-device combinations when they are not marketed for therapeutic purposes.
- The court held tobacco-derived e-cigarettes customarily marketed for recreational use are subject to regulation under the Tobacco Act, not the FDCA drug/device provisions.
- The court agreed Sottera showed a likelihood of success on the merits and irreparable harm from continued detention/seizure and market exclusion, and that the balance of harms and public interest did not favor FDCA-based enforcement given available Tobacco Act authority.

## Legal Principles

- Statutes addressing the same subject should be read together; the FDCA and Tobacco Act must be harmonized to avoid conflict between regulatory schemes.
- A tobacco-derived product intended for human consumption fits the Tobacco Act’s definition of “tobacco product,” unless it is marketed as a “drug,” “device,” or combination product under the FDCA.
- Under the FDCA, “intended use” turns on therapeutic claims or objective evidence that the product is intended to diagnose, cure, mitigate, treat, or prevent disease (or otherwise serve a therapeutic function affecting body structure/function).
- Tobacco-derived nicotine products are regulated under the Tobacco Act when customarily marketed for recreational use; they may be regulated under the FDCA drug/device provisions only when marketed for therapeutic purposes.
- Preliminary injunctive relief is supported where unlawful enforcement is likely, continued seizures or destruction of inventory and exclusion from the market constitute irreparable harm, and the agency retains alternative regulatory authority addressing public health concerns.

## Conclusion

The D.C. Circuit held that tobacco-derived e-cigarettes marketed for recreational “smoking pleasure,” without therapeutic claims, cannot be regulated as FDCA drugs/devices and instead fall within the Tobacco Act’s tobacco-product regime, justifying injunctive relief against FDCA-based import detention and enforcement.


Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891 (D.C. Cir. 2010)