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
Today, August 10, 2018, is the compliance date for the health warnings contained in the FDA’s Deeming Rule and codified in 21 C.F.R. Part 1143. In particular, as of today, roll-your-own (RYO) tobacco, cigarette tobacco, or covered tobacco products (except cigars and pipe tobacco) such as e-liquids that contain tobacco-derived nicotine manufactured, packaged, sold, offered
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
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
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 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
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
The 3rd Annual Keller and Heckman E-Vapor and Tobacco Law Symposium will be held on January 29th-30th, 2019.
Registration for this program will be launching in late September 2018.
Seminar Details
Dates:
January 29 – January 30, 2019
Location:
Miami Marriott Biscayne Bay
Price:
$899 early rate
$1,099 regular rate
More information on
On May 2, 2018, the U.S. Food and Drug Administration (FDA) filed its brief in response to Appellants Nicopure and Right to be Smoke-Free Coalition’s appeal in the lawsuit challenging aspects of the Tobacco Control Act (TCA) and the Deeming Rule now pending before the U.S. Court of Appeals for the D.C. Circuit. FDA’s brief
On May 1, 2018 the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued 13 warning letters to companies that they claim misleadingly labeled or advertised nicotine-containing e-liquids as kid-friendly food products such as juice boxes, candies, and cookies. Warning letters were issued to manufacturers, distributors, and retailers of eight products.
All
