In a July 21, 2011 Perspective article published in the New England Journal of Medicine, the authors challenge the U.S. Food & Drug Administration’s decision to regulate electronic cigarettes as tobacco products and invite further regulation.
Troutman Pepper Locke Tobacco Practice
Proposed Legislation Significantly Increases Tobacco Taxes
Posted in Legislation
The Senate Finance Committee is currently considering a bill introduced by Senator Tom Harkin (Iowa) that would dramatically increase the excise tax rates for small cigarettes and cigars, pipe tobacco, roll-your-own tobacco, and smokeless tobacco.
TPSAC Evaluates Dissolvables
Posted in FDA
On the heels of FDA’s surprising determination that dissolvable tobacco products, such as Star Scientific’s Stonewall and Ariva and R.J. Reynolds’ Camel “Orbs,” are not considered smokeless tobacco products currently subject to regulation under the Tobacco Control Act, the FDA’s Tobacco Products Scientific Advisory Committee convened its first meeting to evaluate these products.
States Attempt to Expand Successor Manufacturer Liability
Posted in State Regulatory
Did you know that some states are taking the position that a contract cigarette manufacturer can be held liable for escrow payments as a “successor” manufacturer simply because the manufacturer made the same brand of cigarettes as a prior manufacturer?
The Impact of the “Diligent Enforcement” Arbitration on State Tobacco Taxation
Posted in State Regulatory
We have previously written about New York’s recent effort to collect taxes for cigarette sales on Native American reservations. We have also written about the ongoing arbitration between the states and the major tobacco companies regarding allegations that the states have not “diligently enforced” their state escrow statutes.
Massachusetts Appellate Court Upholds Ban on Sale of Cigar Wraps in Boston
Posted in Significant Cases
On July 26, the Massachusetts Appeals Court upheld a lower court’s dismissal of a lawsuit filed by RYO Cigar Association, Inc. (“RYO”) and New Image Global, Inc. (“New Image”) seeking an injunction against enforcement of a regulation issued by the Boston public commission banning the sale of cigar wraps in Boston.
One Issue Resolved, but Many New Issues Remain
Posted in FDA
At least one issue is resolved. The Food & Drug Administration (“FDA”) will regulate electronic cigarettes (“e-cigarettes”) as tobacco products and not as drug-delivery devices. Yet, many other issues remain unresolved as a result of the FDA’s decision, including the taxation of e-cigarettes.
FTC Releases Reports on Tobacco Advertising and Promotion
Posted in Legislation
The Federal Trade Commission issued a report last week regarding the amounts spent by tobacco companies on advertising and promotion in 2007 and 2008. Perhaps not surprisingly, the amount spent on advertising and promotion by the largest cigarette companies declined by 13% between 2006 and 2007, and another 8% between 2007 and 2008.
FDA Issues Draft Guidance on Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007
Posted in FDA, State Regulatory
FDA recently issued draft guidance regarding how a manufacturer can establish that its tobacco product was commercially marketed in the United States as of February 15, 2007, thus exempting the product from the onerous premarket requirements of the Tobacco Control Act (“TCA”). The guidance first explains that FDA interprets the phrase “as of February 15, 2007” as meaning that a tobacco product was commercially marketed – not in test markets – in the United States on February 15, 2007.
Current Good Manufacturing Practices — An Overlooked Requirement with Far Reaching Consequences
Posted in FDA
A significant provision of the Family Smoking Prevention and Tobacco Control Act is the requirement for tobacco manufacturers to operate in compliance with current good manufacturing practices (cGMP). One good approach to understanding these requirements is to read the underlying regulations. For finished pharmaceuticals this is 21 CFR Part 211.