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Headlines Tagged with FDASuit 444 headlines found

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DOCKET CAA v FDA Nov, 2017-Mar, 2018

01/31/2018 87 NOTICE OF SUPPLEMENTAL AUTHORITY by CIGAR RIGHTS OF AMERICA... 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 ADM
Tobacco On Trial
added Mar 18, 2018 01:49
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Plaintiffs and Amici Curiae File Briefs in Deeming Regulations Challenge

Nicopure Labs and the Right to be Smoke-Free Coalition...argues that the MRTP requirement violates the First Amendment because it prohibits truthful, non-misleading statements (for example, that ENDS do not produce smoke) without the FDA’s advance permiss
Lexology (uk)
added Mar 7, 2018 15:39
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U.S. Smokeless Tobacco Company, a Subsidiary of Altria, Challenges FDA’s Substantial Equivalence Reporting Process in New Lawsuit

The lawsuit explains that the Copenhagen Bold products contain the same loose tobacco that was marketed as loose tobacco as of February 15, 2007, and have the same packaging format (i.e., a mesh pouch) as other grandfathered UST smokeless tobacco products
National Law Review
added Mar 5, 2018 20:10
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Amicus Briefs Filed in Support of Deeming Rule Appeal by Washington Legal Foundation, NJOY, CASAA, the State of Iowa and Clive Bates, et al.

On February 20, 2018 several organizations filed amicus(“friend of the court”) briefs in support of Plaintiff-Appellants Nicopure Labs’ and the Right to be Smoke-Free Coalition’s appeal in the Deeming Rule challenge now pending in the U.S. Court of Appea
National Law Review
added Feb 26, 2018 19:51
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NJOY Joins Fight To Have Unfair FDA Rules Overturned

asked a court to reverse a lower court's decision that blocks e-cigarette companies from truthfully describing their products to consumers, on the grounds that it violates the First Amendment of the U.S. Constitution and prevents the public from obtaining
PR Newswire
added Feb 24, 2018 14:04
3 Views

DC Circuit Urged To Knock Down FDA E-Cig Rule ($$)

a challenge brought by manufacturer Nicopure LLC and trade group The Right to Be Smoke-Free Coalition. Consumer advocates, an e-cigarette maker, the state of Iowa, a nonprofit law center and a host of public policy experts on Tuesday told the court that
Law360
added Feb 22, 2018 18:02
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NICOPURE LABS, LLC, RIGHT TO BE SMOKE FREE COALITION, Plaintiffs-Appellants, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants Appellees: BRIEF OF THE CONSUMER ADVOCATES FOR SMOKE-FREE ALTERNATIVES ASSOCIATION (PDF)

CASAA submits this amicus curiae brief in order to provide helpful information to the Court about the importance of flavors and sampling in connection with consumers (a) receiving information about products and (b) making a successful transition from smo
Amazon CloudFront
added Feb 22, 2018 18:41
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NICOPURE LABS, LLC, RIGHT TO BE SMOKE FREE COALITION, et al., Plaintiffs-Appellants, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants-Appellees: BRIEF OF AMICI CURIAE CLIVE BATES AND ADDITIONAL PUBLIC HEALTH/TOBACCO POLICY AUTHORITIES (PDF)

FDA has failed to account for the likelihood or the risks of harmful unintended consequences arising from its own interventions in the e-cigarette market – what should be a central concern for public health. The costs are likely to overwhelm the claime
Amazon CloudFront
added Feb 22, 2018 18:29
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NICOPURE LABS,LLC,RIGHT TO BE SMOKE FREE COALITION, Plaintiffs-Appellants, v. FOOD AND DRUG ADMINISTRATION,et al., Defendants-Appellees: BRIEF OF NJOY (PDF)

Applying the Tobacco Control Act’s MRTP preclearance requirement to e-cigarette manufacturers is unconstitutional under any potentially applicable standard of First Amendment scrutiny because the FDA lacks any constitutionally sufficient justification
Amazon CloudFront
added Feb 22, 2018 18:23
2 Views

NICOPURE LABS, LLC, RIGHT TO BE SMOKE FREE COALITION, Plaintiffs-Appellants, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants-Appellees: BRIEF OF THE STATE OF IOWA AS AMICUS CURIAE IN SUPPORT OF PLAINTIFFS-APPELLANTS (PDF)

generalized modified risk claims for ENDS are different because they are true—and the MRTPR undermines momentum towards critical harm reduction by effectively silencing them.
Amazon CloudFront
added Feb 22, 2018 18:18
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