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Headlines Tagged with FDASuit 444 headlines found

11 Views

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
14 Views

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
10 Views

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
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
4 Views

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
5 Views

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
3 Views

[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
9 Views

[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
20 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
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