Posts by admin

FDA and Right to Be Smoke-Free Coalition File Briefs Opposing Summary Judgment Motion in Public Health NGOs’ Lawsuit Seeking to Nullify FDA’s PMTA Filing Deadline Extension

Defendant U.S. Food and Drug Administration (FDA) and the Right to Be Smoke-Free Coalition (RSF) recently submitted briefs to the federal district court of Maryland opposing a motion for summary judgment filed by various public health NGOs in American Academy of Pediatrics v. FDA.[1]The NGOs are challenging various extensions to premarket application compliance deadlines for deemed tobacco products…

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NGOs File Motion for Summary Judgment in Lawsuit Challenging FDA’s Guidance Extending Deeming Rule Compliance Policy Deadlines

On March 27, 2018, a coalition of public health organizations including the Campaign for Tobacco-Free Kids, the Truth Initiative, the American Cancer Societyand the American Academy of Pediatrics, among others, as well as several individual physicians (collectively the “NGOs”) filed a lawsuit in the United States District Court for the District of Maryland challenging the Food and Drug…

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FDA Commissioner Dr. Scott Gottlieb’s Recent Remarks on Vapor Products and the Continuum of Risk; Update on Deeming Rule Appeal

On June 18, 2018, U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb delivered remarks on “FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science” at the Tobacco Regulatory Science Program Meeting.[1] While addressing the importance of regulatory science to inform FDA’s Center for Tobacco Products (CTP) regulatory efforts, Commissioner Gottlieb focused…

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Opening Brief Filed in Deeming Rule Appeal by Nicopure Labs and the Right to be Smoke-Free Coalition

On February 12, 2018, Nicopure Labs, LLCand the Right to be Smoke-Free Coalition[i] (the Appellants) filed their opening brief in the appeal of last year’s decision from the U.S. District Court for the District of Columbia, which ruled in favor of FDA in the first lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) Deeming…

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Notice of Appeal Filed in Deeming Rule Challenge by Right to be Smoke-Free Coalition and Nicopure Labs

On August 30, 2017, the Right to be Smoke-Free (RSF) Coalition, a non-profit, industry-led trade association of vapor businesses dedicated to advocating for reasonable and responsible laws and regulations, joined Nicopure Labs LLC in appealing the recent decision in Nicopure Labs, LLC and Right to be Smoke-Free Coalition et al. v. Food and Drug Administration…

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New E-Liquid Law in Indiana

Great news!  Our long and hard fought battle in Indiana is on the verge of coming to an end.  On Friday, April 21, 2017, the Indiana General Assembly passed Senate Enrolled Act (SEA) 1, which hammered the final nail in the coffin of Indiana’s Vapor Pens and E-Liquid Act (the Act) by removing the provisions…

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