On February 12, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition[i] (the Appellants) filed their opening brief in the appeal of last year’s decision from the U.S. District Court for the District of Columbia, which ruled in favor of FDA in the first lawsuit challenging aspects of the Tobacco Control Act
Deeming Rule
Azim Chowdhury and Adam Susser to Participate in the FDLI Tobacco Products and Regulation and Policy Conference
Azim Chowdhury and Adam Susser will participate in the FDLI Tobacco Products and Regulation and Policy Conference, which will take place October 26-27, 2017 in Washington, DC.
This KH sponsored event will bring together public health advocates, researchers, manufacturers, lawyers, consumer interests, entrepreneurs, governmental agencies and others to effectively regulate the broad spectrum of tobacco…
Notice of Appeal Filed in Deeming Rule Challenge by Right to be Smoke-Free Coalition and Nicopure Labs
On August 30, 2017, the Right to be Smoke-Free (RSF) Coalition, a non-profit, industry-led trade association of vapor businesses dedicated to advocating for reasonable and responsible laws and regulations, joined Nicopure Labs LLC in appealing the recent decision in Nicopure Labs, LLC and Right to be Smoke-Free Coalition et al. v. Food and Drug…
FDA’s New Tobacco Strategy: What Does It Mean for Your Vape Business?
On Friday July 28, 2017, the U.S. Food and Drug Administration (FDA) announced its new “comprehensive regulatory plan to shift trajectory of tobacco-related disease, death” that refocuses the Agency’s implementation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Deeming Rule. FDA’s new strategy appears to be moving away from its “one-size-fits-all”…
FDA Delays Upcoming Deeming Compliance Deadlines by Three Months
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FDA Finalizes New Rule “Clarifying” When a Tobacco Product is Actually a Medical Product
FDA’s Ingredient Listing Deadline Rapidly Approaching for Manufacturers of E-Vapor, E-Liquid and Other Deemed Tobacco Products
UPDATE – FDA’s Ingredient Listing Deadline For Deemed Products Extended by Six Months
On December 28, 2016, FDA finalized its Guidance for Industry, “Listing of Ingredients in Tobacco Products” which is available here. In the new guidance FDA states that, “considering that some manufacturers of newly deemed products are not familiar with the forms…
Revisions to Industry Guidance Regarding FDA Health Document Submission Requirements for Tobacco Products
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…
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
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