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FDA recently revised its draft guidance on the “Use of Investigational Tobacco Products.” This draft guidance was originally issued in September 2015; however, after receiving numerous comments, FDA decided to revise the guidance to clarify certain information.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 Continue Reading FDA Revises Draft Guidance on Investigational Tobacco Products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
An Oregon vape shop owner filed a complaint this month against the State of Oregon over rules that prohibit the packaging of vaping products in a manner that appeals to minors. The plaintiffs, Paul Bates and No Moke Daddy LLC, doing business as Division Vapor, allege that the Oregon Health Authority’s regulations’ standard of being packaged in a manner that is attractive to minors is “vague, incomprehensible, and overbroad” and hinders freedom of expression and the ability of adult consumers to make informed purchasing decisions by preventing otherwise accurate product descriptors in labeling. Continue Reading Vape Shop Sues State of Oregon Over Labeling Rules for Vaping Products
In a Joint Status Report filed in federal court on December 13, Plaintiffs Cigar Association of America, Cigar Rights of America, and International Premium Cigar and Pipe Retailers Association requested the extension of the Food and Drug Administration’s harmful and potentially harmful constituent (HPHC) reporting deadline. The Plaintiffs have already obtained a delay of the cigar and pipe tobacco warning labeling requirements until after the resolution of the lawsuit. Now, Plaintiffs seek an extension of the approaching November 8, 2019 deadline for HPHC reporting for cigar and pipe tobacco products. Continue Reading Cigar and Pipe Industries Request Extension of November 2019 HPHC Reporting Deadline
Bryan Haynes of the Troutman Sanders Tobacco Team will be at the Food and Drug Law Institute Enforcement Conference on December 12-13, 2018 in Washington, DC. Of note, both FDA Commissioner Scott Gottlieb and FDA Center for Tobacco Products Director of the Office of Compliance and Enforcement Ann Simoneau will be presenting at the conference. Perhaps the FDA will elaborate on its recently-announced policy changes with the stated intention of deterring youth access to flavored tobacco products. Continue Reading Troutman Sanders Tobacco Team to Attend FDLI Enforcement Conference – Will the FDA Elaborate on its Recently-Announced Enforcement and Compliance Policies?
On November 29, the Food and Drug Administration issued a warning letter to an e-liquid company for allegedly selling products with labeling and advertising causing the products to resemble kid-friendly products, including cereal and candy. The products are alleged to be misbranded under Section 903 of the Food, Drug and Cosmetic Act because their labeling and/or advertising are false and misleading. Continue Reading FDA Takes Enforcement Action Against ENDS Company for Selling Products Alleged to Be Kid-Friendly