In an August 2017 Guidance, the FDA gave companies an extension to comply with certain deadlines for premarket review submissions, including “substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product applications (PMTAs).” Continue Reading Deeming Regulations Litigation Update–Challenge to Premarket Review Submission Deadlines in Limbo After FDA Issues Draft Guidance

In a March 2019 update to its guidance regarding “Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,” the FDA has extended the deadline for manufacturers of “Deemed Products” to report harmful and potentially harmful constituents (“HPHCs”) in their products.  “Deemed Products” are those that were first regulated by the FDA under the Deeming Regulations, and generally include e-cigarettes and other electronic nicotine delivery systems, cigars, pipe tobacco and hookah tobacco. Continue Reading FDA Extends HPHC Reporting Deadline for Deemed Products

Bryan Haynes of the Troutman Sanders Tobacco Team participated in a panel discussion entitled “How Innovation is Changing the Vape Category” at the Tobacco Plus Expo on February 12.  A video of the panel discussion can be found here. Continue Reading Troutman Sanders Tobacco Team Participates in Panel Discussion – “How Innovation is Changing the Vape Category”

A March 1 article on Axios indicates that the FDA is poised to formally implement a policy that would severely restrict the sale of flavored e-cigarettes in retail environments.  In a November 15, 2018 statement, FDA Commissioner Scott Gottlieb had announced a plan to prohibit flavored ENDS products (other than tobacco, mint and menthol or non-flavored products) that are not sold in an age-restricted, in-person location.  At the time, Commissioner Gottlieb indicated that the FDA would provide additional details “soon,” and suggested that in the interim manufacturers voluntarily remove flavored ENDS from convenience stores.  Some manufacturers did just that. Continue Reading FDA Appears Poised to Restrict the Sale of Flavored E-Cigarettes

FDA recently revised its draft guidance on the “Use of Investigational Tobacco Products.” This draft guidance was originally issued in September 2015; however, after receiving numerous comments, FDA decided to revise the guidance to clarify certain information. FDA also regards the revision to be in furtherance of its commitments under the Agency’s comprehensive plan for tobacco and nicotine regulation. Continue Reading FDA Revises Draft Guidance on Investigational Tobacco Products

A bill, H.R.7337 – the Stop Tobacco Sales to Youth Act of 2018, was introduced in Congress recently to amend the Prevent All Cigarette Trafficking (“PACT”) Act to include electronic cigarettes and pipe tobacco. The PACT Act currently requires Internet sellers of cigarettes and smokeless tobacco to pay applicable excise and sales taxes as if the sale were a face-to-face transaction, prohibits using U.S. Mail for these sales, and requires age verification. Continue Reading Bill to Restrict Internet Sales of E-Cigarettes and Other Tobacco Products Introduced in Congress

The Troutman Sanders tobacco team will attend the Tobacco Plus Expo trade show on February 11-13.  The trade show features a number of education sessions addressing regulatory topics and other areas of interest to the tobacco industry.  Bryan Haynes will participate in a February 12 panel discussion entitled “How Innovation is Changing the Vape Category.”  We look forward to seeing our clients and friends at the show.

 

As the partial shutdown of the U.S. government reaches a month (the longest in U.S. history), and thousands of federal workers furloughed or working without pay, regulated industry and stakeholders are asking: How long will the shutdown continue? And, what is the impact of the shutdown on federal agencies and regulatory matters? In addressing the first question, there does not appear to be an immediate end in sight as President Trump’s standoff with Congress over a border wall continues. Continue Reading The Federal Government Shutdown’s Impact on Tobacco Regulators

As we previously reported here, on September 5, 2018, the U.S. District Court for the District of Massachusetts found that FDA “unlawfully withheld” and “unreasonably delayed” the promulgation of a rule mandating color graphic warnings for cigarettes, as set forth in the 2009 Tobacco Control Act. The Court ordered FDA to provide an accelerated timeline for the completion of its rulemaking. On October 5, 2018, FDA provided the Court an accelerated schedule that would result in the submission of the final rule for publication in the Federal Register by May 2021 (six months sooner than FDA’s initial, estimated timeline of November 2021). Continue Reading Public Health Groups File Renewed Request for Urgent Action, Again Urging Court to Mandate an Expedited Schedule for Graphic Health Warnings Rule