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Headlines Tagged with FDASuit 444 headlines found

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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
5 Views

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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FDA Fights Challenges To E-Cig Regulations In DC Circ. ($$)

defended its regulation of electronic cigarettes under the scope of the Tobacco Control Act, telling the D.C. Circuit that it’s not unconstitutional to require such products to be reviewed before hitting the market. Under the agency's 2016 rule for modif
Law360
added May 6, 2018 18:06
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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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[UK] Plaintiff Lacks Standing to Force FDA Action Against Tobacco Company

A federal court has dismissed a case challenging the FDA’s allowance of the word “natural” in Natural American Spirit’s (“NAS”) product packaging and labeling. The Plaintiff lacks standing to sue under Article III, § 2, of the U.S. Constitution, which li
Lexology (uk)
added May 4, 2018 17:20
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[UK] FDA Moves to Dismiss Suit Regarding SE Standards

a lawsuit filed by U.S. Smokeless Tobacco Company (UST) challenging the FDA’s issuance of Not Substantially Equivalent Orders for a smokeless tobacco product. The FDA has now moved to dismiss the lawsuit for lack of subject matter jurisdiction after resci
Lexology (uk)
added May 1, 2018 04:51
19 Views

juul e-cigarette craze highlights why flavored tobacco products are so dangerous

The groups are also calling on the FDA to take immediate action to address the rising popularity of JUUL among youth. Demands include removing any JUUL flavors, such as the highly popular mango and cool cucumber flavors, which violate FDA rules. Those fl
Truth Initiative (American Legacy Foundation)
added Apr 23, 2018 17:14
2 Views

Florida Federal Judge Dismisses Complaint Over Cigarette Advertisements ($$)

dismissed without prejudice a complaint against the [FDA] in which the plaintiff claimed that the agency violated the Administrative Procedure Act (APA) by allowing a cigarette company to advertise its cigarettes as natural because the plaintiff failed t
Lexis Nexis
added Apr 16, 2018 21:55
5 Views

Cigar News: Texas Cigar Groups Petition Court to Throw Out Warning Label Requirements while FDA Seeks to Combine Cases

the Texas Group believes they are entitled to a preliminary injunction against the enforcement of the FDA’s regulations on Warning Labels. The group points out: “Plaintiffs already have begun to incur significant compliance costs, which will only mount
Cigar Coop
added Apr 6, 2018 19:09
8 Views

EDITORIAL: Crack Down on E-Cigarettes

Litigation shouldn't have been necessary. The agency ought to move quickly to restrict e-cigarette advertising and online sales, and to impose testing and labeling rules so consumers know what dangerous ingredients e-cigarettes contain. Further delay wil
Bloomberg News
added Mar 29, 2018 18:09
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