Archive for July, 2016

DOCKET for NICOPURE LABS, LLC v. FDA et al, Jul 25-28, 2016

Thursday, July 28th, 2016

EXCERPT:
07/25/2016 21 MOTION for Summary Judgment by RIGHT TO BE SMOKE-FREE COALITION
07/27/2016 22 Unopposed MOTION for Leave to File Amicus Curiae Brief in Support of the Defendants by FOOD AND DRUG ADMINISTRATION
07/28/2016 MINUTE ORDER granting the unopposed 22 motion of the Campaign for Tobacco-Free Kids for leave to file an amicus brief. The amicus brief shall be […]

NICOPURE LABS v. FDA: UNOPPOSED MOTION OF THE CAMPAIGN FOR TOBACCO-FREE KIDS FOR LEAVE TO FILE AMICUS CURIAE BRIEF IN SUPPORT OF THE DEFENDANTS, July 27, 2016

Wednesday, July 27th, 2016

The PDF is Here
EXCERPT:
The Campaign has a strong interest in how the courts construe FDA’s authority to advance the public health in connection with these products, given their rapidly increasing use among the nation’s youth, their conceded addictiveness, the wide variations in product types available in the current unregulated market, the detection of hazardous […]

RIGHT TO BE SMOKE-FREE COALITION, et al. v. FDA: MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF PLAINTIFF TRADE ASSOCIATIONS’ MOTION FOR SUMMARY JUDGMENT, July 25, 2016

Tuesday, July 26th, 2016

The PDF is Here
EXCERPT:
the Deeming Rule’s short-comings are several fold. First, FDA has applied a statutory February 15, 2007 grandfather date to vaping products that was intended for traditional tobacco products, like cigarettes. FDA was required under the statute to set a new grandfather date which would have allowed vaping products to take advantage […]

RIGHT TO BE SMOKE-FREE COALITION, et al. v. FDA: PLAINTIFF TRADE ASSOCIATIONS’ MOTION FOR SUMMARY JUDGMENT, July 25, 2016

Tuesday, July 26th, 2016

The PDF is Here
EXCERPT:
The Court should enter summary judgment in favor of Plaintiffs by declaring that: (i) FDA has violated the APA by applying the February 15, 2007 grandfather date and must, therefore, establish a new grandfather date for all vaping products; (ii) FDA failed to comply with the RFA and must therefore, in […]

DOCKET for FORSYTH v MPAA, July 15, 2016

Friday, July 15th, 2016

EXCERPT:
07/15/2016 44 RESPONSE (re 31 MOTION to Strike 1 Complaint, Defendants’ Notice of Motions and 1 Special Motion to Strike Pursuant to California Anti-SLAPP Statute, Cal. Civ. Proc. Code Section 425.16 et seq., or, in the alternative, 2 Motion to Dismiss Pursuant, 33 MOTION to Strike Complaint ) filed byTimothy Forsyth. . . .
07/15/2016 45 Request […]

NICOPURE v FDA: MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF NICOPURE LABS, LLC’S MOTION FOR SUMMARY JUDGMENT, July 8, 2016

Monday, July 11th, 2016

The PDF is Here
EXCERPT:
In the Deeming Rule, FDA has purported to regulate products outside the scope of its statutory authority. It has purported to subject Nicopure and the rest of the vaping industry to crushing regulation in the interest of the public health while conceding that there may not be any public health interest […]

NICOPURE v. FDA: DECLARATION OF JEFF STAMLER, July 8, 2016

Monday, July 11th, 2016

The PDF is Here
EXCERPT:
1. I am the CEO and co-founder of Nicopure Labs, LLC (“Nicopure”). I began working for Nicopure on October 22, 2009. I have personal knowledge of, and am competent to testify regarding, the following.
. . .
13. In total, Nicopure produces over 2,400 types of stock keeping units (“SKUs”), with approximately […]

NICOPURE v. FDA: NICOPURE LABS, LLC’s MOTION FOR SUMMARY JUDGMENT, July 8, 2016

Monday, July 11th, 2016

The PDF is Here
EXCERPT:
The Court should enter summary judgment in Nicopure’s favor; declare that the Deeming Rule exceeds FDA’s statutory authority, is arbitrary, capricious, or an abuse of discretion, was promulgated with an unlawful cost-benefit analysis, and is contrary to the First Amendment; and vacate and set aside the Deeming Rule.
END EXCERPT