Archive for the 'FDA Suit' Category

CIGAR ASSOCIATION OF AMERICA v. FDA: JOINT STATUS REPORT, Dec. 13, 2018

Friday, December 14th, 2018

The PDF is Here
EXCERPT:
Plaintiffs are concerned about the impending November 8, 2019 deadline for reporting of harmful and potentially harmful constituent (“HPHC”) testing for all cigars and pipe tobacco. . . .
With regard to the substantial equivalence and premarket review process and the arbitrary
failure to appropriately treat the category of the premium cigars […]

DOCKET CAA v FDA MAR-DEC, 2018

Friday, December 14th, 2018

EXCERPT:
MINUTE ORDER. Briefing on the unresolved counts in this matter is deferred until at least January 14, 2019, on which date the parties shall file an additional Joint Status Report that proposes a schedule for further proceedings, if appropriate.
END EXCERPT

DOCKET CAA v FDA Nov, 2017-Mar, 2018

Saturday, March 17th, 2018

EXCERPT:
01/31/2018
87 
NOTICE OF SUPPLEMENTAL AUTHORITY by CIGAR RIGHTS OF AMERICA, INTERNATIONAL PREMIUM CIGAR AND PIPE RETAILERS ASSOCIATION (Attachments: # 1Exhibit A)(Edney, Michael) (Entered: 01/31/2018)
01/31/2018
88 
NOTICE OF SUPPLEMENTAL AUTHORITY by SYLVIA MATHEWS BURWELL, ROBERT CALIFF, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND DRUG ADMINISTRATION (Beckenhauer, Eric) (Entered: 01/31/2018)
END EXCERPT

CIGAR ASSOCIATION OF AMERICA v. FDA: REPLY IN SUPPORT OF DEFENDANTS‘ CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT, Dec 4, 2017

Monday, December 4th, 2017

The PDF is Here
EXCERPT:
The government has long required commercial disclosures related to consumer health and safety. Those interests explain and justify disclosures that are now ubiquitous, from “Drug Facts“ labels on over-the-counter drugs, to “Nutrition Facts“ labels on food, to country-of-origin labels on meat. In this case, Plaintiffs neither dispute that their cigar and […]

CAA v FDA: MEMORANDUM OPINION re Intervenors, Oct 16, 2017

Thursday, October 19th, 2017

The PDF is Here
EXCERPT:
the court concludes that Proposed Intervenors have not established that they would suffer a legally sufficient injury-in-fact if Plaintiffs were to prevail in this litigation. Therefore, they lack standing to intervene as of right, and the court declines to allow Proposed Intervenors to intervene permissively. Accordingly, the court denies Proposed Intervenors’ […]

DOCKET CAA v FDA Oct, 2017

Wednesday, October 18th, 2017

EXCERPT:
10/12/2017 67  AMICUS BRIEF by CAUSE OF ACTION INSTITUTE. (znmw) (Entered: 10/13/2017)
10/16/2017 68  MEMORANDUM OPINION re: 36 Proposed Intervenors’ Motion to Intervene. Signed by Judge Amit P. Mehta on 10/16/2017. (lcapm3) (Entered: 10/16/2017)
10/16/2017 69  ORDER. For the reasons stated in 68 the court’s Memorandum Opinion, the court denies 36 Proposed Intervenors’ Motion to Intervene. See attached Order for additional details. Signed by Judge Amit P. Mehta on […]

NICOPURE v. FDA: NOTICE (Joint) by SYLVIA MATHEWS BURWELL, ROBERT CALIFF, FOOD AND DRUG ADMINISTRATION, Jun 8, 2017

Tuesday, June 13th, 2017

The PDF is Here
EXCERPT:
The parties respectfully notify the Court that the Food and Drug Administration (“FDA”) has announced that it is deferring enforcement of all future compliance deadlines under the Deeming Rule for three months . . .
Plaintiff Nicopure Labs, LLC believes that this deferral is not a reason for the Court to […]

CIGAR ASSOCIATION OF AMERICA, et al. v FDA: NOTICE OF AMICUS CURIAE CAMPAIGN FOR TOBACCO-FREE KIDS IN RESPONSE TO THE COURT’S NOTICE TO PARTIES

Wednesday, April 5th, 2017

The PDF is Here
NOTICE OF AMICUS CURIAE CAMPAIGN FOR TOBACCO-FREE KIDS IN RESPONSE TO THE COURT’S NOTICE TO PARTIES
EXCERPT:
Lawyers with the law firm, Zuckerman Spaeder LLP, have been representing Tobacco-Free Kids and other public health and medical organizations in connection with amicus curiae briefs either filed, or to be filed, in various lawsuits […]

CIGAR ASSOCIATION OF AMERICA, et al. v FDA: NOTICE TO PARTIES, Apr 3, 2017

Monday, April 3rd, 2017

The PDF is Here
EXCERPT:
I hereby provide notice to the parties that my former law firm, Zuckerman Spaeder LLP, has, from time to time, and still may, represent the Campaign for Tobacco-Free Kids (“CTFK”). When I was a lawyer at the firm, I did not work on any matter on behalf of CTFK. Additionally, my […]

CIGAR ASSOCIATION OF AMERICA, et al. v FDA: BRIEF OF AMICUS CURIAE CAUSE OF ACTION INSTITUTE, Apr 3, 2017

Monday, April 3rd, 2017

The PDF is Here
EXCERPT:
To Those Courageous Men And Women Who Came To This Country In Search Of Personal Freedom, Economic Opportunity And A Future Of Hope For their Families
These words, etched on the Immigrant Statue in historic Ybor City, ring hollow in the face of regulatory onslaught by the Food and Drug Administration’s (“FDA”) […]