Archive for the 'FDA Suit' Category

DOCKET for NICOPURE LABS v. FDA et al, Nov 1, 2016

Wednesday, November 2nd, 2016

EXCERPT:
MEMORANDUM re Order,,,,,,,,,,,,, Set Deadlines,,,,,,,,,,,, by AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION, AMERICAN VAPING ASSOCIATION, ELECTRONIC VAPING COALITION OF AMERICA, GEORGIA SMOKE FREE ASSOCIATION, KENTUCKY VAPING RETAILERS ASSOCIATION, INC., LOUISIANA VAPING ASSOCIATION, MARYLAND VAPE PROFESSIONALS, LLC, NEW JERSEY VAPOR RETAILERS COALITION, NICOPURE LABS, LLC, OHIO VAPOR TRADE ASSOCIATION, RIGHT TO BE SMOKE-FREE COALITION, TENNESSEE SMOKE FREE […]

DOCKET for NICOPURE LABS v. FDA et al, Oct 17-26, 2016

Wednesday, October 26th, 2016

EXCERPT:
MINUTE ORDER. By Tuesday, November 1, 2016, each side in this case shall file one supplemental memorandum . . . defendants’ memorandum must explain to the Court: what is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule (which is in effect, and assuming it is […]

DOCKET for NICOPURE LABS v. FDA et al, Oct 11, 2016

Tuesday, October 11th, 2016

Date Filed # Docket Text
10/11/2016 Minute Entry for Proceedings held before Judge Amy Berman Jackson: Motions Hearing held on 10/11/2016 re: 20 Motion for Summary Judgment filed by NICOPURE LABS, LLC; 21 Motion for Summary Judgment filed by RIGHT TO BE SMOKE-FREE COALITION, ET AL., 44 MOTION for Summary Judgment filed by FOOD AND DRUG ADMINISTRATION, ET […]

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

Friday, September 16th, 2016

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 […]

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

Sunday, September 11th, 2016

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 […]

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

Monday, August 29th, 2016

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 […]

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

Monday, August 29th, 2016

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 […]

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

Tuesday, August 23rd, 2016

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 […]

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

Tuesday, August 23rd, 2016

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 […]

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

Thursday, August 18th, 2016

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 […]