Am. Acad. Pediatrics v. Food & Drug Admin.
379 F. Supp. 3d 461
| D. Maryland | 2019Background
- In May 2016 FDA adopted the Deeming Rule bringing e-cigarettes and other products within the Tobacco Control Act’s premarket-review regime; the Rule established staggered compliance periods and a continuing compliance period for timely-submitted applications.
- FDA issued subsequent guidances (May 2017; August 2017) extending/defering enforcement; the August 2017 Guidance allowed many newly deemed products (notably flavored e-cigarettes) to remain on the market until 2021–2022 or longer and stated FDA would not enforce premarket submission requirements during that period and would continue compliance while applications remained pending.
- Public-health organizations (AAP, ACS CAN, AHA, ALA, Campaign for Tobacco‑Free Kids, Truth Initiative, and individual physicians) sued under the APA to vacate the August 2017 Guidance, arguing it exceeded statutory authority, was issued without required notice-and-comment, and was arbitrary and capricious.
- Defendants (FDA and HHS officials) moved to dismiss or for summary judgment, arguing lack of standing, that the Guidance is an unreviewable enforcement discretion decision and not final agency action, and alternatively that it was a permissible policy statement.
- The Court found organizational plaintiffs have standing (informational injury and diversion of resources), held the Guidance is reviewable final agency action, concluded the Guidance unlawfully exceeded FDA authority and effectively amended statutory obligations, and granted plaintiffs’ summary judgment vacating the August 2017 Guidance.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing | Organizations suffer concrete informational injury and diversion of resources because FDA’s deferral deprives them of statutorily required premarket data. | No cognizable injury; speculative and attributable to third parties. | Organizational plaintiffs have standing: informational injury, traceability to Guidance, and redressability. |
| Reviewability of enforcement decision | The Guidance is not a mere case-by-case refusal to enforce but a wholesale suspension that conflicts with statutory mandates and thus is reviewable. | The Guidance is an exercise of enforcement discretion (Chaney), presumptively unreviewable. | Guidance is reviewable: statute provides mandatory standards that cabin FDA discretion; the presumption of unreviewability is rebutted. |
| Final agency action | Guidance is nonbinding boilerplate; not final because it does not itself create legal obligations. | Guidance effectuated binding legal consequences and consummated agency decisionmaking—final. | Guidance is final agency action: it consummated FDA decisionmaking and produced immediate legal/practical effects. |
| APA notice-and-comment | August 2017 Guidance is a substantive legislative rule (effectively amending statutory deadlines) and required notice-and-comment. | Guidance is interpretive/policy statement exempt from notice-and-comment. | Guidance is a legislative rule/amendment to the statutory scheme; FDA violated APA by not using notice-and-comment; Guidance vacated. |
Key Cases Cited
- Heckler v. Chaney, 470 U.S. 821 (Sup. Ct.) (agency refusal to enforce generally presumptively unreviewable)
- Bennett v. Spear, 520 U.S. 154 (Sup. Ct.) (two-part test for final agency action)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (Sup. Ct.) (standing burden and informational injury principles)
- Brown & Williamson Tobacco Corp. v. FDA, 153 F.3d 155 (4th Cir.) (limits on agency authority over tobacco; ultra vires doctrine)
- Brown & Williamson Tobacco Corp. v. FDA, 529 U.S. 120 (Sup. Ct.) (affirming limits on FDA authority over tobacco regulation)
- Pub. Citizen Health Research Group v. Acosta, 363 F. Supp. 3d 1 (D.D.C.) (agency suspension of reporting treated as rulemaking; reviewable)
- National Mining Ass'n v. Jackson, 768 F. Supp. 2d 34 (D.D.C.) (guidance that changes statutorily prescribed process is legislative rule)
- National Family Planning & Reproductive Health Ass'n v. Sullivan, 979 F.2d 227 (D.C. Cir.) (directive that repudiates prior regulation is legislative rule requiring notice-and-comment)
- Philip Morris USA Inc. v. FDA, 202 F. Supp. 3d 31 (D.D.C.) (guidance can be final where agency takes definitive legal position and imposes practical effects)