Just two weeks before the September 30, 2017 registration deadline for U.S. tobacco product manufacturing establishments, on Friday, September 15, 2017, the U.S. Food and Drug Administration (FDA) published a Revised Guidance for Industry on Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments .See our original Client Alert summarizing the
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
10 Business, Advertising, and IP Considerations for E-Vapor Companies
As the e-vapor industry evolves, manufacturers must keep up with an expanding legal and regulatory landscape. In addition to designing their products and services to comply, it is important for e-vapor companies to carefully assess their business practices and relationships with employees and business partners so as to best protect their confidential information and intellectual
Azim Chowdhury and Eric Gotting Featured in Vapor Voice Article “Indiana’s Vapor Revamp: Following a rebuke in court, Indiana fixes its vapor rules”
Read about Azim Chowdhury and Eric Gotting’s role in this pivotal decision here.
Azim Chowdhury and Eric Gotting Featured in Vapor Voice Article “Indiana’s Vapor Revamp: Following a rebuke in court, Indiana fixes its vapor rules”
Read about Azim Chowdhury and Eric Gotting’s role in this pivotal decision here.
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
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
Keller and Heckman LLP Victory for the Right to be Smoke-Free Coalition and E-Vapor Industry in Indiana
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
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