Archive for the 'FDA Suit' Category

CIGAR ASSOCIATION OF AMERICA, et al. v FDA: PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT, Feb 13, 2017

Wednesday, February 15th, 2017

The PDF is Here
EXCERPT:
For these reasons and those set out in the accompanying Memorandum of Law, Plaintiffs request that the Court grant their motion for summary judgment on all claims and: (1) vacate and set aside the Deeming Rule; (2) vacate and set aside the User Fee Rule; (3) declare that the User Fee […]

DOCKET for CIGAR ASSOCIATION v FDA, Jul 15, 2016-Feb 16, 2017

Wednesday, February 15th, 2017

The PDF is Here
EXCERPT:
07/15/2016 1 COMPLAINT against SYLVIA M. BURWELL, in her official capacity as Secretary of Health and Human Services, Robert Califf, M.D., in his official capacity as Commissioner of Food and Drugs, UNITED STATES FOOD AND DRUG ADMINISTRATION, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES filed by CIGAR ASSOCIATION OF AMERICA, CIGAR […]

NICOPURE v FDA: SUPPLEMENTAL MEMORANDUM to Respond to the Court’s October 26, 2016 by FDA, Nov 1, 2016

Wednesday, November 2nd, 2016

The PDF is Here
EXCERPT:
“[W]hat is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule . . . at this time?”
Perhaps nothing. Not all nicotine-free e-liquids (“NFLs”) are subject to the deeming rule. Assuming an NFL is not made or derived from tobacco, it is subject […]

NICOPURE v FDA: SUPPLEMENTAL MEMORANDUM re Minute Order by AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION, et. al. Nov 1, 2016

Wednesday, November 2nd, 2016

The PDF is Here
EXCERPT:
Pursuant to the Court’s October 26, 2016 order, Plaintiffs Nicopure Labs, LLC and the Right To Be Smoke-Free Coalition, et al. submit this memorandum concerning the ripeness of their challenge to FDA’s statutory authority to regulate e-liquids that do not contain nicotine and are not derived from tobacco (“Non-Tobacco E-liquids”).1 Plaintiffs’ […]

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 […]