Azim Chowdhury Interviewed by Regulator Watch on Fake Comments Submitted to FDA Advance Notice on Flavored Tobacco Products and Public Health NGO Lawsuit Challenging FDA Tobacco Compliance Deadlines
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
FDA Retrospective: The Comprehensive Plan for Tobacco and Nicotine Regulation at One Year
On August 2, 2018, just over one year since FDA announced its “Comprehensive Plan for Tobacco and Nicotine Regulation”[1] (hereinafter, the “Comprehensive Plan”), FDA Commissioner, Scott Gottlieb, M.D., and Center for Tobacco Products (CTP) Director, Mitch Zeller, J.D., authored a post on the Agency’s FDA Voice blog, which reviewed the progress made to date
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 Society and 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
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
Tobacco Product Listing Update Due by June 30, 2018 for U.S. Manufacturing Establishments
Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product). As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along
American Cancer Society Acknowledges Reduced Harm for Electronic Nicotine Delivery Systems and Warns About the Dangers of Misleading Consumers
On June 11, 2018, the American Cancer Society (“ACS”) released a statement entitled, “The American Cancer Society Public Health Statement on Eliminating Combustible Tobacco Use in the United States’ (“Statement”).[1] The Statement sets forth the ACS’s goal of eliminating exposure to combustible tobacco smoke and provides three strategies for the ACS to enhance its approach in tobacco prevention and control.
Continue Reading American Cancer Society Acknowledges Reduced Harm for Electronic Nicotine Delivery Systems and Warns About the Dangers of Misleading Consumers
Preparing for the EU General Data Protection Regulation: A Checklist for Vapor Product Retailers and Businesses
The new European Union (EU) General Data Protection Regulation (GDPR) replaces the Data Protection Directive on May 25, 2018 and will directly impact all companies, including vapor product retailers and businesses, that market and sell products to consumers in the EU and/or employ residents of the EU. The reforms will give European consumers new rights
Revised FDA Ingredient Listing Guidance for Tobacco Products Published, Exempts Non-Consumable Product Hardware and Components and Parts From Section 904(a)(1) Listing Requirement
The vapor device industry has been requesting FDA for years to exempt devices from the Tobacco Control Act Section 904(a)(1) ingredient listing requirement, respectfully arguing, among other things, that the information required for non-consumable hardware products and components provides no meaningful information to FDA that would help it protect the public health.[1] On April
FDA’s May 8, 2018 Ingredient Listing Deadline Approaching for Large Manufacturers of Deemed Tobacco Products; New FDA eSubmitter Instructions and Ingredient Spreadsheets Now Available
Per Section 904(a)(1) of the Tobacco Control Act (TCA), one of the core requirements for manufacturers, including manufacturers of deemed tobacco products such as e-liquid, vapor devices, cigars and hookah, is the requirement to submit to the Food and Drug Administration (FDA) a list of all ingredients that are “added by the manufacturer to the