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
Tobacco
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
We’re Taking our Talents to South Beach! – Save the Date for Keller and Heckman’s 3rd Annual E-Vapor and Tobacco Law Symposium

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…
FDA and FTC Issue 13 Warning Letters to E-liquid Companies for Misleadingly Marketing to Youth; FDA Investigates Underage Use of JUUL Devices
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…
FDA Inspection Proposal Provides Valuable Insight Into Scope of Investigations; Register for Upcoming SFATA Webinar on May 2, 2018
At yesterday’s meeting with the U.S. House Subcommittee on Agriculture and Rural Development to discuss FDA’s Fiscal Year 2019 budget, Food and Drug Administration (FDA) Commissioner Scott Gottlieb discussed the Agency’s regulation of the tobacco industry and noted, among other things, that when all the requirements for the newly deemed products, including vapor products, went…
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…
Highlights from Keller and Heckman’s 2018 E-Vapor and Tobacco Law Symposium and Survey – Where Should We Host Next Year?
The 2nd Annual Keller and Heckman E-Vapor and Tobacco Law Symposium held on February 6-7, 2018 in Irvine, California was a huge success with over 100 attendees from all over the country and world. Check out the highlight video below. We are in the process of securing a location for next year’s symposium and…
