981 F.3d 26
D.C. Cir.2020Background
- The FDA promulgated the 2016 Deeming Rule, classifying e-cigarettes as "tobacco products" under the Family Smoking Prevention and Tobacco Control Act, which subjects them to the Act's premarket and modified-risk (preclearance) requirements.
- The Deeming Rule was issued by FDA Associate Commissioner for Policy Leslie Kux pursuant to delegated rulemaking authority; plaintiffs sued alleging that Kux was not properly appointed under the Appointments Clause.
- After litigation began, FDA Commissioner Scott Gottlieb (and earlier Commissioner Califf) ratified the Deeming Rule; the FDA contends ratification cures any Appointments Clause defect.
- Plaintiffs also challenged the Rule under the First Amendment, arguing the Act's preclearance requirement unlawfully burdens truthful, non-misleading modified-risk commercial speech by forcing manufacturers to obtain FDA approval before marketing certain claims.
- The district court granted summary judgment to the FDA; the D.C. Circuit reviewed the Appointments Clause and First Amendment claims de novo.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Appointments Clause validity of Kux's issuance of the Deeming Rule | Kux was not a properly appointed officer; her issuance of the Rule violated the Appointments Clause and is void | Kux acted pursuant to delegation; Commissioners Califf and Gottlieb ratified the Rule, curing any defect | Ratification by Commissioner Gottlieb cured any Appointments Clause defect; summary judgment for FDA |
| Timeliness/effectiveness of post-suit ratification | Ratification after suit and without considering new evidence is invalid/arbitrary | Post-suit ratification is effective; no obligation to consider post-rulemaking evidence once record closed | Ratification after suit was effective; Gottlieb reasonably reviewed and independently evaluated the Rule |
| Whether Appointments Clause defects are presumptively incurable / cause continuing prejudice | Appointments Clause violations are per se harmful and cannot be cured; plaintiffs suffer continuing prejudice that could affect future rulemaking | Appointments Clause defects can be remedied by ratification; plaintiffs show no concrete continuing prejudice | No continuing prejudice shown; ratification resolves the claim on the merits |
| First Amendment challenge to modified-risk preclearance for e-cigarettes | Preclearance unconstitutionally burdens truthful, non-misleading commercial speech by requiring preapproval of modified-risk claims | Preclearance is permissible because claims can be misleading in context; Nicopure governs and upholds the requirement | First Amendment challenge foreclosed by Nicopure; preclearance sustained as constitutional |
Key Cases Cited
- Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019) (upheld application of preclearance requirement to e-cigarettes and rejected related First Amendment challenges)
- Guedes v. Bureau of Alcohol, Tobacco, Firearms & Explosives, 920 F.3d 1 (D.C. Cir. 2019) (discusses Appointments Clause and ratification principles)
- FEC v. Legi-Tech, Inc., 75 F.3d 704 (D.C. Cir. 1996) (post-suit ratification can validate prior agency action)
- Intercollegiate Broad. Sys., Inc. v. Copyright Royalty Bd., 796 F.3d 111 (D.C. Cir. 2015) (ratification and standards for agency reconsideration)
- Wilkes-Barre Hosp. Co., LLC v. NLRB, 857 F.3d 364 (D.C. Cir. 2017) (ratification can remedy defects from improperly appointed officials)
- Doolin Sec. Sav. Bank, F.S.B. v. Office of Thrift Supervision, 139 F.3d 203 (D.C. Cir. 1998) (explains agency ratification under Restatement of Agency)
- Butte County v. Hogen, 613 F.3d 190 (D.C. Cir. 2010) (agency must consider new evidence if issue remained pending during decision-making)