Sottera, Inc. v. Food & Drug Administration
393 U.S. App. D.C. 257
| D.C. Cir. | 2010Background
- NJOY imports electronic cigarettes that vaporize nicotine; FDA treated shipments as adulterated/misbranded or unapproved drug/device combinations under the FDCA.
- In April 2009, FDA denied entry of NJOY’s e-cigarettes; Smoking Everywhere sought injunctive relief, NJOY joined as intervenor-plaintiff.
- Parties argued whether FDA authority over e-cigarettes rests under the FDCA’s drug/device provisions or under the Tobacco Act.
- District court granted a preliminary injunction in NJOY’s favor; issue on appeal is whether FDCA or Tobacco Act governs.
- Brown & Williamson held FDA lacks FDCA authority to regulate tobacco products as customarily marketed absent therapeutic claims.
- The Tobacco Control Act (2009) regulates tobacco products under its own framework and defines tobacco product as derived from tobacco, not subject to FDCA drug/device provisions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| FDCA jurisdiction over e-cigarettes as drugs/devices | NJOY argues FDCA authorizes regulation as drug/device. | FDA contends Brown & Williamson precludes FDCA regulation for tobacco products marketed without claims. | FDCA cannot regulate customarily marketed tobacco products. |
| Brown & Williamson scope for all tobacco products | Brown & Williamson does not categorically bar regulation of nicotine-delivery products lacking tobacco. | Brown & Williamson forecloses FDCA regulation of tobacco products marketed without therapeutic claims. | Brown & Williamson bars FDCA regulation of customarily marketed tobacco products. |
| Tobacco Act vs FDCA for derived-from-tobacco products | Tobacco Act may not narrow FDCA authority; derived-from-tobacco products could still fall under FDCA. | Tobacco Act provides exclusive regulation for tobacco products; FDCA does not apply to those products. | Tobacco Act governs derived-from-tobacco products; not subject to FDCA drug/device provisions unless therapeutic. |
Key Cases Cited
- FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (Supreme Court 2000) (FDA lacks FDCA authority to regulate tobacco products as customarily marketed)
- Ark. Dairy Coop. Ass'n., Inc. v. U.S. Dep't of Agric., 573 F.3d 815 (D.C. Cir. 2009) (preliminary injunction factors; abuse of discretion standard applied)
- Serono Labs., Inc. v. Shalala, 158 F.3d 1313 (D.C. Cir. 1998) (preliminary injunction considerations and evidentiary standards)
- MCI Telecommunications Corp. v. AT&T Co., 512 U.S. 218 (Supreme Court 1994) (economic and regulatory considerations in statutory interpretation)
- United States v. Mead Corp., 533 U.S. 218 (Supreme Court 2001) (Chevron deference applicability to agency interpretations)
- Nat'l Cable & Telecomm. Ass'n v. Brand X Internet Servs., 545 U.S. 967 (Supreme Court 2005) (Mead/Brand X: deference framework for agency statutory interpretations)