Archive for the 'FDA Suit' Category

DOCKET for CIGAR ASSOCIATION v FDA, Feb 21-Mar 22, 2017

Wednesday, March 22nd, 2017

EXCERPT:
MINUTE ORDER granting 27 the parties’ Joint Motion to Amend Scheduling Order. The revised schedule is as follows: Defendants’ Opposition to Plaintiffs’ Motion for Summary Judgment and Cross-Motion for Summary Judgment shall be filed on or before May 1, 2017; briefs of any amici granted leave to file in support of Defendants shall be filed […]

CIGAR ASSOCIATION OF AMERICA, et al. v FDA: BRIEF OF THE STATES OF AZ, LA, MI AND TX AS AMICI CURIAE IN SUPPORT OF PLAINTIFFS, Feb 21, 2016

Friday, March 17th, 2017

The PDF is Here
EXCERPT:
First, the FDA failed to provide an adequate cost-benefit analysis determining that the benefits of deeming premium cigars to be regulated tobacco products outweigh the undeniably severe costs, particularly to thousands of small businesses. In doing so, the agency ignored the principles that Congress set for balancing the costs of regulation […]

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 […]