UPDATE: On December 5, 2016, FDA finalized its Guidance for Industry, “Health Document Submission Requirements for Tobacco Products” which is available here. As noted above, manufacturers and importers of newly deemed tobacco products (such as e-vapor products) that were on the market on the August 8, 2016 effective date of the Deeming Regulation
FDA’s Establishment Registration and Product Listing Deadline is Fast Approaching – Are You Prepared?
UPDATE: On December 9, 2016, FDA issued a revised guidance for industry, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments,” extending the December 31, 2016 deadline for registration and product listing for U.S. manufacturers by six months by June 30, 2017. According to FDA, the guidance has been
Azim Chowdhury Interviewed in VB2B Winter Edition
Azim Chowdhury was interviewed in VB2B’s Winter Edition. Azim discussed current events in the e-vapor industry and what companies need to do in the face of rapid regulatory change.
- What are the different services Keller Heckman offers the business owners?
We are a regulatory law firm specializing in the U.S. Food and Drug Administration (FDA),
Right to be Smoke-Free Coalition and E-Vapor Industry Trade Associations file Motion for Summary Judgment in Lawsuit Challenging FDA’s Deeming Regulation and the Tobacco Control Act
On July 25, 2016, Keller and Heckman LLP, on behalf of the Right to be Smoke Free Coalitionand ten national and state e-vapor industry trade associations (the “E-Vapor Coalition”), filed a Motion for Summary Judgement in a lawsuitchallenging parts of the Tobacco Control Act (TCA) and the Food and Drug Administration’s (FDA’s) recently published “Deeming
Right To Be Smoke Free Coalition and E-Vapor Industry Trade Associations File Lawsuit Challenging FDA’s Deeming Regulation and the Tobacco Control Act
On behalf of the Right To Be Smoke Free Coalition and the entire e-vapor industry, yesterday Keller and Heckman LLP filed a Complaint in the U.S. District Court for the District of Columbia challenging portions of FDA’s Deeming Regulation and the Tobacco Control Act on various constitutional and administrative grounds. The named Plaintiffs in the
The Cole-Bishop Amendment to the Agricultural Appropriations Bill Amending the Grandfather Date for “Deemed” Tobacco Products Passes House Committee – What Next?
On April 19, 2016, the House Appropriations Committee voted to include a bipartisan amendment, sponsored by Rep. Tom Cole (R – OK) and Rep. Sanford Bishop (D – GA), to the 2017 fiscal year Agricultural Appropriations bill that would amend the February 15, 2007 “grandfather date” for currently unregulated tobacco product categories, including nicotine-containing
CPSC Likely to Gain New Authority Over Some Nicotine-Containing E-Liquid Packages
With the passage of the Child Nicotine Poisoning Prevention Act (S. 142) by both houses of Congress, the U.S. Consumer Product Safety Commission (CPSC) will likely soon get new authority to require child-resistant (CR) packaging (“special packaging”) over certain packages of nicotine-containing “e-liquid.” Assuming the President signs the bill, as expected, covered products