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Headlines Tagged with FDASuit 429 headlines found

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AUDIO: D.C. COURT RULES AGAINST CIGAR INDUSTRY IN CASE IMPOSING RESTRICTIVE FDA REGULATION

WIBC host Tony Katz spoke with Glynn Loope of the CRA Wednesday to find out how the ruling will impact the cigar industry and what the CRA and its partners are doing to fight back.
WIBC 91.3 FM (Indianapolis, IN)
added May 16, 2018 19:33
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NICOPURE LABS, LLC & RIGHT TO BE SMOKE FREE COALITION v. FDA: BRIEF OF AMICUS CURIAE PUBLIC HEALTH LAW CENTER IN SUPPORT OF DEFENDANTS-APPELLEES (PDF)

I. REQUIRING PRE-APPROVAL OF REDUCED-RISK CLAIMS DOES NOT OFFEND THE FIRST AMENDMENT. / II. DISTRIBUTING FREE SAMPLES OF AN ADDICTIVE, TOXIC PRODUCT IS NOT EXPRESSIVE CONDUCT PROTECTED BY THE FIRST AMENDMENT.
Public Health Law Center (William Mitchell College of Law)
added May 16, 2018 19:02
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CIGAR ASSOCIATION OF AMERICA, et al. v. FDA: BRIEF OF AMICI CURIAE PUBLIC HEALTH ORGANIZATIONS IN SUPPORT OF DEFENDANTS’ CROSS-MOTION FOR PARTIAL SUMMARY JUDGMENT (PDF)

While all of Plaintiffs’ arguments are meritless, amici focus here only on the public health concerns presented by cigars and the Government’s interest in regulating them. According to Plaintiffs, there is no evidence of “aregulatory problem with respe
American Cancer Society Cancer Action Network (ACSCAN)
added May 16, 2018 18:56
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FDA Cigar Warnings Don't Violate 1st Amendment, Judge Says ($$)

since they’re aimed at informing the public of health risks in a suit brought by advocacy groups representing smokers and industry against the U.S. Food and Drug Administration. U.S. District Judge Amit Mehta said that the agency’s rule increasing the s
Law360
added May 16, 2018 04:53
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MINATO: SEVEN THINGS: WHAT’S NEXT FOR CIGAR REGULATION AFTER THE D.C. COURT RULING

In his ruling, much of the fundamental parts of the deeming regulations were upheld, i.e.: the process FDA used to create the regulations was constitutional, warning labels are also constitutional and user fees for cigars are not going away. So now the q
HalfWheel
added May 16, 2018 04:47
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CIGAR ASSOCIATION OF AMERICA, et al., Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION, et al., Defendants. (PDF)

1. The Deeming Rule’s health warning requirements comport with the TCA and the APA (Count VI) and do not violate the First Amendment (Count VII). 2. The User Fee Rule (Counts II and III) is upheld in its entirety. 3. The process by which the agency des
United States District Court for the District of Columbia
added May 16, 2018 04:37
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D.C. COURT RULES IN FAVOR OF FDA IN CIGAR REGULATION LAWSUIT

U.S. District Court Judge Amit P. Mehta ruled in favor the U.S. Food & Drug Administration (FDA) in almost all parts of the lawsuit: upholding the core fo the rule itself, the requirements for warning labels and the payment of user fees. His decision was
HalfWheel
added May 15, 2018 20:03
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FDA's Hand Can't Be Forced On 'Natural' Tobacco Labeling ($$)

dismissed a case challenging the [FDA]’s allowance of the word “natural” in the product packaging and labeling of Natural American Spirit cigarettes. The plaintiff lacked standing to sue under Article III, § 2, of the U.S. Constitution, which limits feder
Law360
added May 10, 2018 17:48
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FDA Tells D.C. Circuit: Deeming Rule Within Agency’s Discretion ($$)

federal judge did not err in rejecting assertions by an e-cigarette manufacturer that the [FDA] should have taken a different approach to the premarket review of new e-cigarettes... in a May 2 brief (Nicopure Labs LLC v. U.S. Food and Drug Administration,
Lexis Nexis
added May 9, 2018 14:20
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NICOPURE LABS, LLC, et al., Plaintiffs-Appellants, v. FOOD & DRUG ADMINISTRATION, et al., Defendants-Appellees: BRIEF FOR APPELLEES (PDF)

The Tobacco Control Act “automatically subjects deemed products to the statutory requirements for ‘tobacco products’ in chapter IX of the [FDCA],” including the requirement of premarket review for new tobacco products.... The prohibition on the distributi
Amazon CloudFront
added May 8, 2018 23:36
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