DOCKET for FORSYTH v MPAA, Sep 15-16, 2016

September 16, 2016 4:32 pm by Gene Borio

The PDF is Here

EXCERPT:

09/15/2016 48 Brief re 47 Stipulation and Order,, Terminate Motions,, Set Deadlines/Hearings, Defendants’ Reply In Support of 1 Special Motion to Strike Pursuant to California Anti-SLAPP Statute . . .

09/15/2016 49 Request for Judicial Notice re 48 Brief,, Defendants Supplemental Request For Judicial Notice In Support Of 1 Special Motion To Strike Pursuant To California Anti-SLAPP Statute . . .

09/16/2016 50 CLERK’S NOTICE CONTINUING MOTION AND CASE MANAGEMENT CONFERENCE. Initial Case Management Conference previously set for 1027/2016 Continued to 10/28/2016 AT 01:30 PM in Courtroom 3, 17th Floor, San Francisco.

END EXCERPT

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DOCKET for NICOPURE LABS v. FDA et al, Sep 9-16, 2016

September 16, 2016 4:10 pm by Gene Borio

EXCERPT:

09/14/2016 Set/Reset Hearings: At the request of the Court and with the consent of counsel for both the plaintiffs and the defendants the Motions Hearing presently scheduled for October 19, 2016, at 10:00 AM is rescheduled for October 11, 2016, at 10:15 AM in Courtroom 3 before Judge Amy Berman Jackson. (jth) (Entered: 09/14/2016)

09/16/2016 49 JOINT APPENDIX by NICOPURE LABS, LLC. (Attachments: # 1 Joint Appendix - Volume II, # 2 Joint Appendix - Volume III, # 3 Joint Appendix - Volume IV, # 4 Joint Appendix - Volume V)(Block, Benjamin) (Entered: 09/16/2016)

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NICOPURE v FDA: REPLY IN SUPPORT OF DEFENDANTS’ CROSS-MOTION FOR SUMMARY JUDGMENT, Sep 9, 2016

September 11, 2016 9:46 am by Gene Borio

The PDF is Here

EXCERPT:

I. E-CIGARETTES—AND THEIR COMPONENTS AND PARTS—ARE PROPERLY REGULATED UNDER THE TOBACCO CONTROL ACT

II. THE FDA’S DEEMING AUTHORITY IS COMMITTED TO AGENCY DISCRETION, AND THE AGENCY’S EXERCISE OF THAT AUTHORITY WAS IN ANY EVENT REASONABLE

III. THERE IS NO BASIS TO SECOND-GUESS THE FDA’S DETERMINATION THAT THE BENEFITS OF THE DEEMING RULE JUSTIFY ITS COSTS

IV. THE FDA FULLY COMPLIED WITH THE REGULATORY FLEXIBILITY ACT

V. THE DEEMING RULE IS CONSISTENT WITH THE FIRST AMENDMENT

INTRODUCTION

Plaintiffs do not deny the many health risks of e-cigarettes—from nicotine addiction, to the inhalation of toxins and carcinogens, to the risk of explosion. Nor do they dispute that e- cigarette use has skyrocketed, particularly among youth. Nevertheless, while they may claim not to oppose “all” regulation of e-cigarettes, that is the obvious consequence of many of their arguments.

Plaintiffs’ rendering of the Tobacco Control Act (“TCA”) bears no relation to its text. Their reading of “tobacco product” to exclude open-system e-cigarettes writes the phrase “any component, part, or accessory” out of the statute. They think it irrelevant that the statute permits the FDA to subject tobacco products to the TCA as the agency “deems” fit. They seek APA review of a cost-benefit analysis that the statute does not require—and then not only cook the books, but ask the Court to examine only one side of the ledger. And they urge the Court to simply delete the statutory premarket review requirement—or at least to amend the grandfather date set by Congress—which would exempt as many as 800 e-cigarette devices and 8,000 e- liquids from premarket review entirely.

This is not the statute that Congress wrote. More than enough is already known about the health risks of e-cigarettes to warrant regulatory oversight. And Congress’s choice to ban free sampling and to require premarket review of “modified risk” products is fully consistent with binding precedent, and would in any event survive First Amendment scrutiny. Those provisions are reasonably tailored to protect the public—especially youth—from the harms of addictive products. The Court should not require the FDA to turn a blind eye to those risks.

. . .

Plaintiffs also argue that the addictive nature of their products is irrelevant because they have an interest in “communicating information” about “legal” products. But the addictive nature of e-cigarettes underscores the importance of verifying at the outset that they present a modified risk, rather than waiting until potentially misled consumers are thoroughly addicted to them. Premarket review protects those who would find it hard to stop using an addictive product upon learning that they were misled, and is thus an effective and narrowly tailored means of promoting government interests.

END EXCERPT

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USA v. MO APPEAL: PER CURIAM ORDER allocating oral argument time, Aug 31, 2016

September 1, 2016 8:02 pm by Gene Borio

The PDF is Here

EXCERPT:

It is ORDERED, on the court’s own motion, that the following times are allotted for the oral argument of this case scheduled for September 13, 2016, at 9:30 A.M.:

Appellant - 15 Minutes

Appellee United States of America - 15 Minutes

One counsel per side to argue. The panel considering this case will consist of Circuit Judge Tatel, and Senior Circuit Judges Edwards and Sentelle.

END EXCERPT

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USA v. MO APPEAL: DOCKET Aug 31-Sep 1, 2016

September 1, 2016 3:21 pm by Gene Borio

EXCERPT:

08/31/2016 Open Document PER CURIAM ORDER [1633033] filed allocating oral argument time as follows: Appellant - 15 Minutes, Appellee United States of America - 15 Minutes. One counsel per side to argue; directing party to file Form 72 notice of arguing attorney by 09/06/2016 [15-5210]

09/01/2016 FORM 72 submitted by arguing attorney, Jeffrey A. Mandell, on behalf of Appellant R.J. Reynolds Tobacco Company (For Internal Use Only: Form is restricted to protect counsel’s personal contact information). [15-5210] (Mandell, Jeffrey)

09/01/2016 FORM 72 submitted by arguing attorney, Lewis S. Yelin, on behalf of Appellee USA (For Internal Use Only: Form is restricted to protect counsel’s personal contact information). [15-5210] (Yelin, Lewis)

END EXCERPT

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NICOPURE v FDA: PLAINTIFFS’ JOINT MEMORANDUM IN OPPOSITION TO DEFENDANTS’ CROSS-MOTION FOR SUMMARY JUDGMENT AND REPLY…, Aug 29, 2016

August 29, 2016 4:53 pm by Gene Borio

The PDF is Here

EXCERPT:

FDA argues that this Court has no business scrutinizing the Deeming Rule, a regulation that governs thousands of products, affects billions of dollars in commerce, and spans over 130 pages in the Federal Register. On issue after issue, FDA insists that this Court must blindly defer to the agency’s conclusions, going so far as to argue that its rulemaking is, in effect, subject to no judicial review whatsoever. But this is not the law. Rather, this Court should review the Deeming Rule for adherence to the Tobacco Control Act (“TCA”), the Administrative Procedure Act (“APA”), and the First Amendment. When it does so, this Court should vacate the Rule for several reasons.

. . .

The Deeming Rule purports to regulate products outside the scope of FDA’s statutory authority. Moreover, the Rule purports to subject Nicopure and the rest of the vaping industry to crushing regulation in the interest of the public health, while conceding that the Rule may produce no public health benefits at all. FDA compounded this improper approach by ignoring reasonable, more flexible alternatives to the “all-or-nothing” approach taken with respect to vaping products, and by failing to explain the choices made in the Rule. FDA also abdicated its obligation to conduct a reasoned cost-benefit analysis. And it has violated Plaintiffs’ First Amendment rights. This Court should hold unlawful and set aside the Deeming Rule’s regulation of vaping devices and e-liquids.

END EXCERPT

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DOCKET for NICOPURE LABS v. FDA et al, Aug 26-29, 2016

August 29, 2016 4:22 pm by Gene Borio

EXCERPT:

08/26/2016 46 Memorandum in opposition to re 44 MOTION for Summary Judgment and Reply in support of Plaintiffs’ Motions for Summary Judgment filed by AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION, . . .

08/29/2016 47 REPLY to opposition to motion re 21 MOTION for Summary Judgment , 20 MOTION for Summary Judgment filed by AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION, AMERICAN VAPING ASSOCIATION, ELECTRONIC VAPING COALITION OF AMERICA, . . .

END EXCERPT

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NICOPURE v FDA: Brief of Amici Curiae Public Health Organizations, Aug 19, 2016

August 23, 2016 6:33 pm by Gene Borio

The PDF is Here

EXCERPT:

This brief is focused on a single issue that amici are particularly well-suited to address: whether the Deeming Rule advances the public health. The answer is indisputably yes.

Absent the Deeming Rule, the e-cigarette industry will continue to be the “Wild West.“ Currently, hundreds if not thousands of companies market many thousands of e-cigarette products that deliver nicotine in unregulated doses that can create and sustain addiction. These products present risks to the public health that may vary significantly in type and degree. The use of these products increased significantly between 2011 and 2014, especially among the young; because the industry is relatively new, information about the long-term effects of these products is limited. Yet, prior to the Deeming Rule, anyone could put such products on the market without meeting any regulatory requirement. In the Deeming Rule, FDA has identified numerous significant specific public health concerns about e-cigarettes and established a regulatory framework to ensure, for the first time, that these products do not expose their users to unnecessarily high levels of risk or increase the risk of youth tobacco initiation. The Deeming Rule will also enable FDA to acquire the information needed to answer the many unanswered questions about the health effects of these products and develop standards of product identity, design, manufacturing, packaging, and advertising. The stakes for the next generation are simply too high to allow the unregulated market to continue. The core of Plaintiffs‘ argument is that FDA‘s application of the Deeming Rule to e- cigarettes is arbitrary and capricious because: (1) there is evidence that exclusive e-cigarette use is less harmful to the individual than smoking cigarettes; and (2) FDA acknowledges that the long-term public health effects of e-cigarettes cannot currently be determined with certainty.

END EXCERPT

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DOCKET for NICOPURE LABS v. FDA et al, Aug 19-24, 2016

August 23, 2016 5:43 pm by Gene Borio

Date Filed # Docket Text

08/19/2016 45 AMICUS BRIEF by CAMPAIGN FOR TOBACCO-FREE KIDS, AMERICAN ACADEMY OF PEDIATRICS, AMERICAN CANCER SOCIETY CANCER ACTION NETWORK, AMERICAN HEART ASSOCIATION, AMERICAN LUNG ASSOCAITION, AMERICAN THORACIC SOCIETY, TOBACCO CONTROL LEGAL CONSORTIUM, TRUTH INITIATIVE. (Angulo, Carlos) Modified text on 8/19/2016 (td). Modified to add filers on 8/22/2016 (znmw). (Entered: 08/19/2016)

08/22/2016 MINUTE ORDER. The Clerk of Court is directed to add to the docket as additional amici the seven parties who have joined in the brief of the Campaign for Tobacco-Free Kids. See 45 Amicus Brief at iii n.1; see also Appendix A to 45 Amicus Brief. Signed by Judge Amy Berman Jackson on 8/22/2016. (lcabj3) (Entered: 08/22/2016)

08/24/2016 MINUTE ORDER. The parties shall file a joint appendix by September 16, 2016. See LCvR 7(n). SO ORDERED. Signed by Judge Amy Berman Jackson on 8/24/2016. (lcabj3) (Entered: 08/24/2016)

NICOPURE v FDA: DEFENDANTS’ CROSS-MOTION FOR SUMMARY JUDGMENT, Aug 17, 2016

August 18, 2016 3:50 pm by Gene Borio

The PDF is Here

EXCERPT:

Plaintiffs acknowledge none of these risks. Their briefs give no inkling that nicotine is highly addictive, that e-liquids often contain toxic chemicals, or that e-cigarettes can explode. Instead, Plaintiffs contend that e-cigarettes should not be regulated at all, because they are generally “safer” than conventional cigarettes—one of the deadliest products ever brought to market. But that is rather like saying that cars should not be regulated because they are safer than motorcycles. And it is no answer to the many risks of e-cigarettes that are known now, and that could be mitigated through FDA oversight.

The Court need not sift through this evidence, however, because Congress entrusted the decision whether to supervise tobacco products, including e-cigarettes, to the expert judgment of the FDA. There can be no doubt that “the FDA has authority under the Tobacco [Control] Act to regulate e-cigarettes,” as the D.C. Circuit held in Sottera, Inc. v. FDA, 627 F.3d 891, 897 (D.C. Cir. 2010), and Plaintiffs cannot escape that conclusion simply because their “open-system” e- cigarettes are refillable. It is equally clear that the FDA’s exercise of the deeming authority is committed to agency discretion, given that Congress authorized it to subject “any” tobacco product (except certain raw tobacco leaf) to the Tobacco Control Act as it “deems” fit. 21 U.S.C. § 387a(b). In any event, the FDA rationally explained why it deemed e-cigarettes subject to the Tobacco Control Act, given their many known risks, as well as why it rejected the regulatory alternatives that Plaintiffs prefer. While Plaintiffs fault the FDA for adopting a “onesize- fits-all” approach, the Tobacco Control Act makes deeming a necessary precondition to any regulation of e-cigarettes—including the age restrictions that Plaintiffs profess to support, Stamler Decl. ¶ 41—and Plaintiffs offer no statutory support for their alternative, à-la-carte approach.

There is likewise no basis to review the FDA’s cost-benefit analysis, as the Tobacco Control Act requires no such analysis, and the Executive Orders under which the agency acted expressly preclude judicial review of its conclusions. Regardless, the FDA reasonably found that the costs of the deeming rule—an estimated $2 per beneficiary per year—were justified by its benefits, including more accurate labels, effective health warnings, and improved product consistency. Similarly misplaced are Plaintiffs’ criticisms of the FDA’s regulatory flexibility analysis, as the agency fully complied with the purely procedural requirements of the Regulatory Flexibility Act.

Plaintiffs’ two First Amendment challenges—to the ban on the distribution of free samples, and to the premarket review of “modified risk” products—also lack merit. The free sample ban regulates conduct, not speech, and thus does not even implicate free speech concerns. And the premarket review of “modified risk” tobacco products is modeled after the premarket review of therapeutic drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), which the D.C. Circuit has already upheld against First Amendment challenge. Moreover, both provisions would easily pass muster even if scrutinized as commercial speech, as they are narrowly tailored to prevent the harms that Congress foresaw.

Absent the deeming rule, the FDA cannot require e-cigarettes and e-liquids to have accurate labels. It cannot require warnings about their addictive potential. It cannot require that toxic and carcinogenic chemicals be reduced or eliminated. It cannot require that these products be made in accordance with good manufacturing practices. It cannot verify that purportedly “modified risk” products do, in fact, reduce risk. And it can do nothing to prevent risky products from falling into the hands of youth. The Court should reject Plaintiffs’ suggestion that e- cigarettes are somehow so unique among tobacco products that they should escape regulation of these known risks.

. . .

Indeed, cigarette companies have long manipulated these components or parts to affect the performance of their products. See, e.g., United States v. Philip Morris USA Inc.,

. . .

Even if the tobacco industry had no history of false and misleading statements about the relative health risk of their products, Congress’s determination that the government should ensure the accuracy and completeness of a manufacturer’s modified-risk claims through premarket FDA review when an addictive substance is at issue clearly advances the government’s substantial interest in protecting the public health. After-the-fact enforcement comes too late for the addicted consumer.

END EXCERPT

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