Summary - with extraneous stuff omitted :- ) Although it's worth reading the whole thing - many good points made....
FIRST CLAIM FOR RELIEF Violation of APA—Unlawful Statutory Interpretations
32. The above paragraphs are incorporated herein by reference.
33.The APA, 5 U.S.C. § 706(2)(A), (C), provides that a reviewing court shall hold unlawful and set aside agency action that is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,” and that is “in excess of statutory jurisdiction, authority, or limitations, or short of statutory right.”
34.The Deeming Rule violates those provisions because,
inter alia, its definition of “
tobacco product” and attendant proposed reach of its provisions is unambiguously foreclosed by, and is an unreasonable construction of, the text of the Act.
SECOND CLAIM FOR RELIEF Violation of APA—Arbitrary and Capricious Agency Action
(snip)
45. The net effect of the Deeming Rule is a regime that arbitrarily frustrates innovations and advances in public health while preserving the status quo that existed in 2007, i.e., a market dominated by cigarettes. The Deeming Rule does not explain how this result serves the public interest or the Act’s goals of “pro-mot[ing] cessation” of
tobacco use and “reduc[ing] … the social costs associated with
tobacco-related diseases.” Act § 3(9).
THIRD CLAIM FOR RELIEF Violation of APA—Unlawful Cost-Benefit Analysis
(snip)
49. Among other things, the Deeming Rule grossly underestimates the number of PMTAs that manufacturers will be required to file, and that FDA will be required to review. Although the Deeming Rule estimates that 750 PMTAs will be filed annually, Nicopure alone will need to file many hundreds of PMTAs just to cover its existing product offerings. Countless other manufacturers will also have to comply.
50. A proper cost-benefit analysis, as required by law, would demonstrate that the Deeming Rule
imposes severe regulatory burdens on manufacturers, including small businesses such as Nicopure, by requiring compliance with extensive premarket approval, reporting, recordkeeping, inspection, labeling, manufacturing, testing, and other requirements. These costs vastly outweigh the benefits generated by the Deeming Rule, particularly given that vaping devices and e-liquids do not contain tobacco and/or do not pose the public-health risks associated with products that contain tobacco.
51.The Deeming Rule’s flawed cost-benefit analysis infects the entirety of the Rule, and therefore requires the Rule to be vacated and set aside, because FDA could not rationally have adopted the same regulatory scheme if it had performed a reasonable cost-benefit analysis.
FOURTH CLAIM FOR RELIEF Violation of First Amendment
(snip)
54.The Deeming Rule violates the First Amendment by prohibiting manu-facturers, including Nicopure, from making truthful and nonmisleading statements regarding vaping devices, e-liquids, and related products.
55.The Deeming Rule violates the First Amendment by prohibiting manu-facturers, including Nicopure, from engaging in other forms of protected expression, including by distributing free samples of vaping devices or e-liquids.
RELIEF REQUESTED
WHEREFORE, Nicopure asks this Court issue judgment in its favor and against Defendants, and to grant the following relief:
A. Vacate and set aside the Deeming Rule;
B. Declare that:
i. the Deeming Rule is contrary to and exceeds FDA’s statutory authority under the Act and the FDCA;
ii. the Deeming Rule is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law;
iii. the Deeming Rul
e’s cost-benefit analysis is unlawful; and
iv. the Deeming Rule is contrary to the First Amendment.
C. Issue a preliminary injunction enjoining enforcement of the Deeming Rule and prohibiting FDA from taking any action under the Deeming Rule pending resolution of this action on the merits;
D. Expedite resolution of this action on the merits;
F. Grant Nicopure reasonable attorney’s fees and expenses; and
G. Award such further relief as this Court deems just and proper.
