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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 […]
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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.
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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)
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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 […]
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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’ […]
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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 […]
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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 […]
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NOTICE OF AMICUS CURIAE CAMPAIGN FOR TOBACCO-FREE KIDS IN RESPONSE TO THE COURT’S NOTICE TO PARTIES
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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 […]
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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 […]
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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”) […]