480 F.Supp.3d 256
D.D.C.2020Background
- In May 2016 the FDA issued the Final Deeming Rule, bringing cigars and pipe tobacco within the Family Smoking Prevention and Tobacco Control Act (TCA) and triggering premarket review requirements for “new tobacco products.”
- The TCA defines a “grandfather” (predicate) date of February 15, 2007 for substantial equivalence reviews and creates three pathways for premarket authorization (substantial equivalence, minor-modification exemption, PMTA).
- The FDA’s 2014 Proposed Deeming Rule solicited comment on whether to exclude or treat “premium cigars” differently and proposed a detailed premium cigar definition; the Final Rule adopted Option 1 and regulated all cigars.
- The Final Rule announced staggered compliance periods (e.g., 18 months to submit substantial equivalence reports plus up to 12 months for review); later FDA guidance sought to extend deadlines but was vacated in Am. Acad. of Pediatrics v. FDA, which set an application deadline ultimately extended to September 9, 2020.
- Commenters asked the FDA to create a streamlined substantial equivalence process for premium cigars; the FDA did not meaningfully address those suggestions in the Final Rule.
- The district court granted in part and denied in part summary judgment: it upheld most challenges to the Final Rule but found the FDA acted arbitrarily by failing to respond to comments about a streamlined substantial equivalence process for premium cigars, remanded on that narrow issue, and enjoined enforcement of premarket review against premium cigars as defined in the FDA’s August 2020 notice until the agency completes its review.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA could adjust the TCA’s Feb. 15, 2007 grandfather date (Count I) | FDA has statutory authority to alter or tailor the grandfather date or otherwise avoid its burdens on newly deemed cigars | Statute fixes the date; FDA lacks authority to change it by regulation | FDA correctly concluded it cannot change the 2007 date; challenge denied |
| Whether the Final Rule’s August 8, 2016 effective date was premised on legal error about compliance-date discretion (Count XIII) | Effective date was legally flawed because FDA assumed it could set or later adjust compliance dates without notice-and-comment | FDA had discretion to set compliance periods; AAP addressed a later guidance, not the original Rule | Plaintiffs failed to show the effective date was based on legal error; challenge denied |
| Whether FDA unlawfully enforced substantial equivalence without issuing product-specific rules (Count XI) | FDA promised implementing rules/guidance and cannot compel submissions without specifying form and content | FDA had time under the compliance periods to issue rules; post-Rule developments are not in the administrative record | Challenge to the Final Rule fails because subsequent developments do not render the Rule arbitrary; challenge denied |
| Whether FDA’s cost-benefit analysis was arbitrary (Count XV) | FDA failed to quantify benefits for cigars and pipe tobacco and should have done a product-specific analysis | Analysis was reasonable; benefits were qualitative where quantification was infeasible; review is deferential | Cost-benefit analysis was reasonable and adequately explained; challenge denied |
| Whether FDA arbitrarily ignored requests to create a streamlined substantial equivalence pathway for premium cigars (Count XIV) | FDA failed to address detailed commenter proposals for a tailored, expedited SE process for premium cigars | Substantial equivalence is an automatic statutory consequence of deeming; FDA’s discretion is limited | FDA’s response was conclusory and mischaracterized comments; agency failed to meaningfully respond; remand ordered and enforcement against premium cigars enjoined until review completed |
Key Cases Cited
- Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019) (addresses scope of FDA authority under the TCA and limits on tailoring PMTA obligations)
- Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (sets the APA arbitrary and capricious standard)
- Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461 (D. Md. 2019) (vacated FDA guidance extending premarket compliance deadlines)
- CTS Corp. v. EPA, 759 F.3d 52 (D.C. Cir. 2014) (limits review to the administrative record)
- Pub. Citizen, Inc. v. FAA, 988 F.2d 186 (D.C. Cir. 1993) (agency must respond meaningfully to significant public comments)
- Inv. Co. Inst. v. Commodity Futures Trading Comm’n, 720 F.3d 370 (D.C. Cir. 2013) (recognizes that agencies need not quantify benefits that cannot reasonably be quantified)