Keller and Heckman Associate Neelam Gill will present, “Remote Regulatory Assessments for Vapor Product Manufacturers in PMTA Review: What to Expect and How to Prepare,” at the Next Generation Nicotine Delivery USA 2021 event, June 9, 2021. This virtual event will bring together business leaders from the ENDS and tobacco industry together with other experts
FDA Issues Warning Letters to Vape Companies that Did Not Submit Premarket Tobacco Product Applications (PMTAs)
Reposted from Keller and Heckman’s Blog, The Daily Intake
- On January 15, 2021, the U.S. Food and Drug Administration (FDA) issued warning lettersto ten companies that sell electronic nicotine delivery system (ENDS) products, including e-liquids. FDA’s letters warned that any new tobacco product not in compliance with the premarket authorization requirements of the Federal
Agenda and Speakers Announced: 2021 E-Vapor and Tobacco Law Symposium
Keller and Heckman is pleased to announce the agenda for our 5th Annual E-Vapor and Tobacco Law Symposium.
This year’s virtual program will feature new, timely topics specifically designed to help vapor and deemed tobacco product manufacturers stay in compliance with rapidly evolving laws and policies. Topics that will be discussed include:
- FDA’s new guidance
E-Vapor and Tobacco Law Symposium – Registration Is Now Open
Registration is now open for Keller and Heckman’s 5th annual E-Vapor and Tobacco Law Symposium! This comprehensive three-day seminar will address legal, scientific, and public health issues relevant to the e-vapor and tobacco industries as we move forward in a post-PMTA world.
This year’s program will be taking place virtually February 9 – 11, 2021.
A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules
Reposted from Keller and Heckman’s Blog, The Daily Intake
- The Food and Drug Administration (FDA) is one of 27 agencies and offices within the U.S. Department of Health and Humans Services (HHS). FDA’s final rules have typically been signed by the FDA Commissioner, or more often a lower appointed officer within the agency. FDA’s rules
In the Wake of Heightened Regulatory Scrutiny of Vaping Products, Nicotine-Containing Toothpicks are Next to Come Under Fire by FDA
Reposted from Keller and Heckman’s Blog, The Daily Intake
- The U.S. Food and Drug Administration recently issued a warning letter to Smart Toothpicks LLC, of Tempe, Arizona, for several violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. Smart Toothpicks sells nicotine-infused
FDA Will Seek to Remove Flavored E-Cigarettes from the Market
Reposted from Keller and Heckman’s Blog, The Daily Intake
- On September 11, 2019 President Trump, along with HHS Secretary Azar and FDA Commissioner Sharpless, announced that the Food and Drug Administration (FDA) intends to soon finalize a compliance policy to prioritize enforcement of the premarket authorization requirements against non-tobacco flavored e-cigarettes. E-cigarettes on the market
China Is Drafting First E-Cigarette Standard
Electronic cigarettes may soon become much more widely available in the world’s largest tobacco market: The People’s Republic of China. With over 300 million smokers, China has the world’s largest smoking population – which directly results in approximately 1 million deaths annually. [1] While the global e-cigarette market has experienced rapid growth over the last
FDA Reiterates That Scientific Data and Safety Information are Required to Support a Regulation or Formal Enforcement Discretion Policy on the Use of CBD in Foods
Reposted from Keller and Heckman’s Blog, The Daily Intake
- Many businesses are already capitalizing on a surge in the popularity of cannabidiol (CBD) products and are pressuring the Food and Drug Administration (FDA) for a regulatory path to enable the lawful use of CBD in foods and dietary supplements under the Federal Food, Drug, and
FDA Announces New Steps to Advance Regulatory Framework for CBD Products
Reposted from Keller and Heckman’s Blog, The Daily Intake
- Interest in products derived from cannabis (Cannabis sativa L.) and its components, including cannabidiol (CBD) has been high for the past couple of years and only increased when Congress passed the 2018 Farm Bill in December 2018. Among other things, the law established a category for