A Ray Of Sunshine for changed PMTA date

As most of you are aware, on August 8th, 2019, SFATA and a coalition of vapor businesses and state associations announced our intent to file a Motion to Intervene on the American Academy of Pediatrics et al (NGO) vs FDA lawsuit in the Maryland court case that resulted in the Pre-Market Tobacco Application (PMTA) deadline change to May 12, 2020. Just yesterday, we received the VERY good news that our Motion to Intervene was granted .



Posted elsewhere but In case there are people that don’t go there:

The suit can be read here: https://clivebates.com/documents/VTAvFDA2019.pdf IMO it is very worthwhile to read but probably more reading than many want to do. However to the issue of why Joinder is very important here are excerpts from the reliefs requested:

G. @para 97

FDA Engaged in Unlawful “Regulation by Litigation” By Superfluously Suggesting a Grossly Accelerated Ten-Month Deadline for the Submission of PMTAs Without Any Advance Notice or Opportunity for Comment by VTA or Industry Stakeholders.

COUNT I (Declaratory Judgment that FDA Violated the Administrative Procedure Act)

Paragraph 125. As a federal agency, FDA is subject to the requirements of the Administrative Procedure Act, including the notice and comment requirements imposed by 5 U.S.C. § 553.

  1. As recently as June of this year, the United States Supreme Court pointedly warned about agency actions that create “unfair surprise” to regulated parties because of the potential for such actions to disrupt expectations. Kisor v. Wilkie, 139 S. Ct. 2400, 2417-18 (June 26, 2019). By proposing an abbreviated ten-month deadline for the filing of PMTAs for Newly Deemed Products, including vapor products, when it had previously established a deadline some 27 months longer upon which industry stakeholders had relied and had (and still has) failed to publish long promised and necessary rules setting forth the requirements for the preparation of PMTAs, FDA engaged in arbitrary and capricious agency action that this Court should declare unlawful pursuant to 5 U.S.C. § 706(2)(A) and set aside.

COUNT II (Declaratory Judgment that FDA Violated the Fifth Amendment’s Due Process Clause)

  1. The Fifth Amendment’s Due Process Clause protects, inter alia, (among other things) against the deprivation of property without due process of law.
  2. A violation of a person’s procedural due process rights occurs when the person is deprived of a property interest without sufficient procedural protections.
  3. The VTA’s members have constitutionally protected property interests in their continued ability to operate their businesses of manufacturing and selling vapor products in interstate commerce. Indeed, Congress has generally recognized this right by forbidding FDA from banning the sale of such products as a class. 21 U.S.C. § 387g(d)(3)(A)-(B).
  4. As regards the procedural protections that were due the VTA’s members in conjunction with the Maryland District Court litigation and FDA’s remedy proposal therein, “t here is a ‘failure of due process’ where ‘it cannot be said that the procedure adopted, fairly insures the protection of the interests of absent parties who are to be bound by it.’ ” Hansberry v. Lee, 311 U.S. 32, 42-43 (1940)).

PMTA has recently been pushed out 120 days …Notnl sure it will make a difference we shall see