FDA

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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Right to be Smoke-Free Coalition and E-Vapor Industry Trade Associations file Motion for Summary Judgment in Lawsuit Challenging FDA’s Deeming Regulation and the Tobacco Control Act

On July 25, 2016, Keller and Heckman LLP, on behalf of the Right to be Smoke Free Coalition and ten national and state e-vapor industry trade associations (the “E-Vapor Coalition”), filed a Motion for Summary Judgement in a lawsuit challenging parts of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) recently…

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Fight for your right to vape Support HB 2058

Hello Vape Fans everywhere! As most of you are aware, the Food and Drug Administration (FDA) has put new regulations into effect that have impacted the whole vaping industry. Some states have taken this as a sign to make their own laws against vaping such as California and Indiana. We have seen companies close, people…

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Right To Be Smoke Free Coalition and E-Vapor Industry Trade Associations File Lawsuit Challenging FDA’s Deeming Regulation and the Tobacco Control Act

On behalf of the Right To Be Smoke Free Coalition and the entire e-vapor industry, yesterday Keller and Heckman LLP filed a Complaint in the U.S. District Court for the District of Columbia challenging portions of FDA’s Deeming Regulation and the Tobacco Control Act on various constitutional and administrative grounds. The named Plaintiffs in the…

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