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

July 28, 2016 1:30 pm by Gene Borio

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 filed by August 19, 2016. The Court notes that the amicus will be most helpful to the Court if it does not repeat the arguments made by the government.

END EXCERPT

(more…)

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

July 27, 2016 5:02 pm by Gene Borio

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 constituents in some e-cigarette products, the reports of adverse events relating to these products, and the continuing uncertainty over whether e-cigarettes contribute to smoking cessation or abstinence, or instead encourage “dual use” of e-cigarettes and traditional, deadly tobacco products..

We believe the Campaign’s perspective on these issues as a non-governmental public health advocacy group is distinct from that provided by the government Defendants, and that the Court will benefit from this additional perspective. We also anticipate that several other public health groups will join the Campaign as signatories to this brief, such that the Court will not be burdened by multiple amicus briefs from similar public health advocacy orientations.

END EXCERPT

(more…)

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

July 26, 2016 11:29 pm by Gene Borio

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 of the more flexible SE pathway. Second, FDA did not consider, as required under the Regulatory Flexibility Act (“RFA”), 5 U.S.C. §§ 601, et seq., any significant alternatives that, in the absence of a new grandfather date, would have allowed vaping product manufacturers sufficient time to develop the extensive information, including long-term clinical studies, necessary to successfully navigate the more stringent PMTA process. As it stands now, such data cannot be generated by the PMTA deadline of August 2018. Third, even if FDA is correct in that it must apply the February 15, 2007 grandfather date to vaping products, this means that the TCA itself violates substantive due process and is unconstitutional. Under this scenario, there would be no rational relationship between the TCA’s underlying purposes and the means chosen by Congress to accomplish such goals. Indeed, as FDA conceded during the rulemaking, virtually all manufacturers will exit the vaping market, thus depriving adults of a relatively safer tobacco product and a chance to reduce or, better yet, quit their smoking habits.

END EXCERPT

(more…)

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

July 26, 2016 11:23 pm by Gene Borio

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 the absence of a new grandfather date, consider significant regulatory alternatives, including the extension of the two year compliance period for all vaping products regarding the filing of pre-market applications; and/or (iii) the TCA is unconstitutional to the extent that it requires application of the February 15, 2007 date to vaping products.

END EXCERPT

(more…)

DOCKET for FORSYTH v MPAA

July 15, 2016 9:01 pm by Gene Borio

Date Filed: 02/25/2016
Jury Demand: Plaintiff
Nature of Suit: 370 Other Fraud
Jurisdiction: Diversity

Date Filed # Docket Text

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. (Attachments: # 1 Declaration Declaration of David Schachman)(Schachman, David) (Filed on 7/15/2016) (Entered: 07/15/2016)

07/15/2016 45 Request for Judicial Notice re 44 Opposition/Response to Motion, filed byTimothy Forsyth. (Related document(s) 44 ) (Schachman, David) (Filed on 7/15/2016) (Entered: 07/15/2016)

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

July 11, 2016 6:03 pm by Gene Borio

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 in the regulation. FDA compounded this improper approach by ignoring reasonable, more flexible alternatives to the “all-or-nothing” approach taken with respect to vaping products. The agency also abdicated its obligation to conduct a reasoned cost-benefit analysis. And it has violated Nicopure’s First Amendment rights. This Court should set aside the Deeming Rule’s regulation of vaping devices and e-liquids.

END EXCERPT

(more…)

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

July 11, 2016 5:46 pm by Gene Borio

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 40% of those consisting of e-liquid. The remaining 60% of Nicopure’s SKUs are for vaporizers and related parts such as batteries, replacement tanks, empty cartridges, heating coils, wall chargers and adapters, mouthpieces, and USB chargers, none of which contains or is derived from tobacco, and none of which is intended for human consumption. For example, SKU #XG6XPASS- MANU-BLCK is a rechargeable battery, which is not made or derived from tobacco, and which is not intended for human consumption.

14. Of Nicopure’s approximately 950 e-liquid SKUs, 83% contain nicotine.

. . .

21. In contrast to the uncertainty of approval, the immense cost of filing a PMTA for a single product (let alone a product portfolio) is definite. FDA itself estimates that the average cost per e-liquid PMTA will be $131,643, and that the average cost of a vaporizer PMTA will be $440,725.

. . .

32. In other words, as of August 8, 2016, Nicopure cannot continue to bring innovative new products to market without (i) investing the substantial time and money required to prepare a PMTA, and (ii) waiting for FDA to adjudicate the PMTA. That process is likely to take years to complete

. . .

33. But for the Deeming Rule, Nicopure would continue to work to improve the variety, quality, and performance of its e-liquids and vaping devices by researching, developing, and introducing new products.

. . .

44. The Deeming Rule will also restrict Nicopure’s ability to make truthful, nonmisleading statements to consumers. Beginning on the Rule’s effective date, Nicopure will not be able to inform consumers that its products are free of, or contain reduced levels of, any substance, without an order of approval from FDA. These restrictions cover, among other things, truthful, nonmisleading statements that Nicopure’s products are free of smoke, ash, tar, and certain chemicals.

END EXCERPT

(more…)

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

July 11, 2016 5:39 pm by Gene Borio

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

(more…)

DOCKET for NICOPURE LABS, LLC v. FDA et al, Jun 23-28, 2016

June 26, 2016 7:28 pm by Gene Borio

EXCERPT:

All further filings with this Court shall be filed only in Nicopure Labs v. FDA, Civil Action No. 16-878. Nicopure Labs’ motion for summary judgment shall be filed by July 8, 2016. The Right to Be Smoke-Free motion for summary judgment, which must be focused on the claims unique to those plaintiffs, shall be filed on July 25, 2016. Defendants’ opposition to both motions and cross-motion for summary judgment, which shall be supported by a single memorandum of points and authorities, shall be filed by August 16, 2016. Nicopure and Right to Be Smoke-Free shall file a consolidated reply in support of their motions for summary judgment, and in opposition to defendants’ cross-motion for summary judgment, by August 26, 2016. Defendants’ reply in support of their cross-motion shall be filed by September 9, 2016. The hearing on the motions currently set for September 8, 2016 is hereby vacated, and a motions hearing will be held on October 19, 2016 at 10:00 a.m. in Courtroom 3. Defendants’ obligation to answer the complaints in both cases shall be held in abeyance pending the resolution of the parties’ cross-motions for summary judgment. See Order for complete details. SO ORDERED. Signed by Judge Amy Berman Jackson on 6/28/2016. (lcabj3) (Entered: 06/28/2016)

END EXCERPT

(more…)

CIVIL DOCKET FOR PHILIP MORRIS USA INC. et al v. FDA, Jun 20, 2016

June 23, 2016 5:09 pm by Gene Borio

EXCERPT:

06/20/2016 42 TRANSCRIPT OF MOTION HEARING PROCEEDINGS before Judge Amit P. Mehta held on June 9, 2016; Page Numbers: 1-94. Date of Issuance: June 20, 2016. Court Reporter/Transcriber: William Zaremba; Telephone number: (202) 354-3249. Transcripts may be ordered by submitting the Transcript Order Form.

END EXCERPT

(more…)