Keller and Heckman Associate Neelam Gill will be a panelist at the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation, and Compliance Conference, to be held virtually on December 9 – 10, 2021. Neelam will be participating in the panel on “Preparing for Tobacco Product Standards and cGMPs,” which will focus on pending Tobacco Product

Please be sure to join us for a two-day comprehensive seminar focused on legal and regulatory issues critical to e-vapor, tobacco, and CBD industries following the aftermath of FDA’s decisions on millions of premarket applications. Topics that will be covered include PMTA marketing denial order (MDO) challenges, new requirements for PMTAs and Substantial Equivalence reports,

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

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

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.

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

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

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

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