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”…

Although we are still waiting for an official announcement, FDA’s Stakeholder Relations Office recently indicated that the Agency will be delaying enforcement of all future Deeming Regulation compliance deadlines set for May 10, 2017 or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence

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The U.S. Seventh Circuit Court of Appeals ruled in favor of the Right to be Smoke-Free Coalition holding that portions of Indiana’s E-Liquid Law are unconstitutional as applied to out-of-state manufacturers

On January 30, 2017, the U.S. Court of Appeals for the Seventh Circuit issued its decision in Legato Vapors LLC et al. v. David…

The U.S. Food and Drug Administration’s (FDA’s) “Deeming Regulation” became effective on August 8, 2016, extending the Agency’s regulatory authority over tobacco products beyond traditional cigarettes, smokeless tobacco and roll-your-own tobacco products to include “other” tobacco product categories such as cigars, pipe tobacco, hookah/shisha, electronic vapor and e-liquid products, and components and parts

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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…

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…

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

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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.

  1. 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),…

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…

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…