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Category — Tobacco Products

Troutman Sanders Tobacco Practice Publishes Article on Premium Cigars in Smokeshop Magazine

An article by the Troutman Sanders Tobacco practice appears in the October issue of Smokeshop Magazine. The article, titled “Premium Cigars Face Regulations Strangulation under FDA”, discusses the anticipated impact of FDA’s pre-market review requirements on the premium cigar market.

The article discusses the unique challenges faced by the premium cigar industry under the current premarket review scheme due to the fact that cigars are “artisanal and not homogeneous” and that there is the possibility for a many similar products with only slight variations. Under the current FDA policy, even slight changes would be enough to trigger the need for a new product application. This requirement will impede manufacturers from improving their products in ways such as sourcing better materials or improving their packaging, as either of those changes would apparently result in the need for premarket review.

Additionally, the grandfather date of February 15, 2007 poses another challenge – cigars that are unable to be proven as being sold “in market” before this date would automatically be subject to premarket review. Manufacturers that either added products after this date, or were not in business before this date, would have to undertake the costly task of acquiring data and product specifications from a pre-February 15, 2007 product to serve as a “predicate” product, as is required for the submission of a Substantial Equivalence report. Submission of this report would allow for the continued to manufacture of the cigar until the FDA either approves or denies the application.

Cigar manufactures can take steps now to lessen the potential impact on their businesses.  Feel free to contact us for help in this area.

The full text of the article can be found here.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.

December 5, 2014   Comments Off

Troutman Sanders Tobacco Practice Publishes Article on E-Cigarettes in Smokeshop Magazine

An article by the Troutman Sanders Tobacco practice appears in the December issue of Smokeshop Magazine. The article, titled “Hey Legislators: Vaping Products Don’t Belong in the MSA!” discusses the “longshot” bid by congressmen to have e-cigarettes included in the Master Settlement Agreement (“MSA”).

The article discusses letters sent earlier this year by three Congressmen – Representatives Henry Waxman of California and Peter Welch of Vermont as well as Senator Tom Harkin of Iowa – to their respective state Attorneys General calling for the inclusion of e-cigarettes in the MSA.  In their letters, they state that this addition would help curb the trend of youth use of the products due to the advertising restrictions inherent in the agreement, and that e-cigarettes meet the MSA’s definition of a “cigarette” due to their appearance, vapor production, and nicotine content.

However, the premise behind the addition of e-cigarettes to the MSA is inherently flawed.  The MSA was established in response to state’s claims for monetary relief related to expenses incurred by smoking-related illnesses. E-cigarette companies were not even in operation at the time the MSA was signed, and therefore could not have participated in the conduct that lead to the agreement.

Although this particular regulation is highly unlikely, it’s another example of the inventive measures being considered by lawmakers regarding regulation of the e-cigarette market.

The full text of the article can be found here.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.

December 5, 2014   Comments Off

Congressional Letter Casts Doubts on Applicability of 2007 Grandfather Date for Recently Deemed Tobacco Products

On November 24, the Speaker of the House John Boehner, House Majority Leader Kevin McCarthy, and Fred Upton, the Chairman of the Energy and Commerce Committee, wrote to the Secretary of the Department of Health and Human Services challenging the proposed “grandfather” date for premarket review of the newly “deemed” tobacco products.  According to the proposed regulation, the grandfather date for purposes of premarket review of e-cigarettes, cigars and pipe tobacco would remain at February 15, 2007 – which is the date for other currently regulated tobacco products such as cigarettes, smokeless, and roll-your-own tobacco. These products have been regulated since the Tobacco Control Act was enacted in 2009. [Read more →]

December 3, 2014   Comments Off

California Legislature Seeks to Extend STAKE Act to E-Cigarettes

On December 1, Senator Jerry Hill of the California legislature introduced a bill that would extend the Stop Tobacco Access to Kids Enforcement Act (“STAKE Act”) to ban sales of electronic cigarettes to minors.  [Read more →]

December 3, 2014   Comments Off

Troutman Sanders Tobacco Practice Partner to Speak at FDLI Tobacco Regulation Conference

Bryan Haynes, Troutman Sanders tobacco practice partner, will be attending the Food and Drug Law Institute Tobacco Conference on October 21 in Washington, D.C. Bryan will be a panelist during the morning panel entitled “Post Market Considerations: Advertising and Promotion of Tobacco Products.” [Read more →]

October 13, 2014   Comments Off

Class Action Suit Filed Against E-Cigarette Importer

A California consumer has filed a class action lawsuit against Fumizer, LLC alleging the company made false claims that their e-cigarettes can aid smokers in quitting cigarettes, while neglecting to inform consumers of other alleged health risks. [Read more →]

September 26, 2014   Comments Off

DC Increases Tobacco Tax But Exempts E-Cigarettes

The District of Columbia Mayor recently approved a proposal to increase the tobacco products tax, although the new law exempts e-cigarettes from the tax. [Read more →]

September 24, 2014   Comments Off

FDA Announces E-Cigarette Workshop

In a notice to be published September 17th in the Federal Register, the FDA Center for Tobacco Products announced that it will conduct a public workshop to discuss e-cigarettes, including product science, packaging and labeling, risks and benefits of product characteristics, strategies to mitigate consumer risks, and methods for evaluating product performance.  The notice further indicates that the FDA intends to conduct future workshops addressing both individual- and population-level health impacts of e-cigarettes.  The workshops will be held on December 10 and 11, 2014 in Silver Spring, Maryland. [Read more →]

September 16, 2014   Comments Off

Utah Regulators Take Enforcement Action Against Three E-Cigarette Companies

The Utah Department of Commerce recently announced enforcement action against three e-cigarette companies for alleged violations of state consumer protection laws.  A copy of the Department’s press release is attached here:  14-08-27_dcp-e-cigarette [Read more →]

September 15, 2014   Comments Off

Troutman Sanders Tobacco Practice Partner to Speak at ECIG Vegas Industry Conference

Bryan Haynes, Troutman Sanders tobacco practice partner, will be attending the ECIG Vegas Industry Conference from September 24-25 in Las Vegas, Nevada. Bryan will be a panelist during the September 24th morning session entitled “The Deeming Regulations: Expectation vs. Reality.” [Read more →]

September 10, 2014   Comments Off