Since the start of 2014, the FDA Center for Tobacco Products (CTP) has issued four Not Substantially Equivalent (NSE) Orders, 13 Refusals to Accept Exemptions from Substantial Equivalence (SE), four Refusals to File (RTF) submissions for Premarket Tobacco Applications (PMTAs), and 43 Withdrawals of SE Reports.
European Union Tobacco Products Directive Cracks Down on Electronic Cigarettes
Posted in Legislation
On February 26, 2014, the European Parliament approved the revised Tobacco Products Directive (the “Revised Directive”), which governs the manufacture, presentation and sale of tobacco and related products in the European Union. This Revised Directive was passed by the European Parliament more than ten years after approval of the Tobacco Products Directive (the “Directive”). Prior to approval by the European Parliament, the Revised Directive was recommended by the European Union Member States. The Revised Directive will now be reviewed by the European Council, and is scheduled to take effect in 2016.
New Federal Legislation Would Regulate E-Cigarette Advertising and Marketing
Posted in Legislation
On February 26, 2014, legislators from California, Connecticut, Illinois, Iowa and Massachusetts introduced the federal “Protecting Children from Electronic Cigarette Advertising Act.” The legislation would prohibit marketing electronic cigarettes to children.
The FDA’s Regulatory Quagmire – and What it Could Mean for E-Cigarettes and Cigars
Posted in FDA
Troutman Sanders tobacco practice partner Bryan Haynes was quoted in a February 27th Reason article titled “FDA Cigarette Regulations Protect Big Tobacco, Not Public Health.”
Missouri Reintroduces the Allocable Share Bill After the Arbitration Panel’s Decision on MSA “Diligent Enforcement” Disputes
Posted in Legislation, State Regulatory
Missouri, the last remaining state in which nonparticipating manufacturers (“NPMs”) can obtain allocable share releases from their escrow payments, has again introduced legislation to repeal the release mechanism. The bill, House Bill 1242, was introduced on January 8, 2014 and has been referred to and is pending before the House Budget Committee.
Pending FDA Regulation, Lobbyists Push for E-Cigarette Clarity in Washington
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a February 26th NPR article titled “Lobbyists Amp Up Efforts To Sell Washington On E-Cigarettes.”
States Seek to Increase Tobacco Tax Revenue by Taxing E-Cigarettes
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a February 24th Law360 article titled “States Acting Hastily In Pushing E-Cigarette Taxes.”
FDA’s First Order of Not-Substantially-Equivalent for Four Currently Marketed Tobacco Products.
Posted in FDA
On February 21, 2014, the FDA issued it’s first orders to stop the sale & distribution of tobacco products that are currently on the market, as they were found not substantially equivalent (NSE). FDA’s press release on the subject can be found here.
Troutman Sanders Tobacco Practice Comments on Applicability of FDA New Product Requirements to E-Cigarettes
Posted in Articles and Publications, FDA
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a February 20th article titled “E-cig industry on tenterhooks ahead of U.S. regulation.”
The article discusses the heavy cloud of speculation hanging over the rapidly expanding e-cigarette industry as it awaits the release of deeming regulations by the FDA. In addition to concerns over potential advertising restrictions, flavoring bans, and the regulation of internet sales, the article also discusses how regulations could affect this relatively new segment of the tobacco industry when it comes to its rapidly changing product dynamic.
Lawmakers Attempt to Force Electronic Cigarettes into the MSA
Posted in Legislation, State Regulatory
On February 12, 2014, congressmen from California, Iowa and Vermont sent a joint letter to the Attorneys General in those states, urging them to classify electronic cigarettes as cigarettes under the Master Settlement Agreement (“MSA”). The MSA was adopted in 1998 and applies to cigarette and roll-your-own tobacco manufacturers. In the letter, the lawmakers stated that classifying electronic cigarettes as cigarettes would be a “bold step” in the battle against tobacco use.