Renewable Energy Insights > Troutman Sanders LLP

Category — FDA

Tobacco Practice Partner Quoted in Law360 Article

Troutman Sanders tobacco team partner Bryan Haynes was quoted in a January 2nd Law360 article titled “Product Liability Legislation and Regulation to Watch In 2015.” [Read more →]

January 22, 2015   Comments Off

Troutman Sanders Tobacco Practice Publishes Article on Vapor Product Regulatory Predictions in Vapor Digest Magazine

An article by Bryan Haynes of the Troutman Sanders Tobacco practice appears in the January issue of Vapor Digest Magazine. The article, titled “Vapor Industry Regulation – Predications for 2015” discusses the regulatory landscape that could be facing the vapor industry during the upcoming year.  Aside from the FDA’s deeming regulations, which may become finalized during the coming year, Bryan speculates on the likelihood of additional regulations, primarily on a state level. [Read more →]

January 21, 2015   Comments Off

The Tricky World of Online Tobacco Sales – the FDA Issues Warning Letters to Retailers for Sales of NSE-Products

On December 16, the FDA issued warning letters to six online retailers for selling “across state lines a tobacco product subject to a Not Substantially Equivalent (NSE) Order.”  Once an NSE order has been issued for a particular tobacco product by the FDA’s Center for Tobacco Products, the products are considered “misbranded and adulterated” and therefore cannot be sold, marketed, or distributed.  [Read more →]

December 19, 2014   Comments Off

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. [Read more →]

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

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

Altria Argues Against Applicability of Modified Risk Descriptor Ban to Cigars

The Food and Drug Administration’s (“FDA”) proposed deeming regulations raise concerns for cigar manufacturers with product labels that include descriptors such as “light,” “mild,” “medium” or “low.”  In 2009, the Tobacco Control Act banned these descriptors for cigarettes.  The stated rationale for the ban was the assertion that many consumers believed that descriptors such as “light” or “mild” meant that certain cigarettes were less harmful than other cigarettes. [Read more →]

August 14, 2014   Comments Off

FDA-Backed Research is Too Little, Too Late

Troutman Sanders tobacco team partner Bryan Haynes was quoted in a July 7th Reuters article titled “INSIGHT – As millions vape, e-cigarette researchers count puffs, scour Facebook.” [Read more →]

July 8, 2014   Comments Off

TMA Hosts Conference on Deeming Regulations

Earlier this week, the Tobacco Merchants Association hosted a conference on the FDA’s proposed tobacco product deeming regulations, which would subject a host of new products — including e-cigarettes, cigars and pipe tobacco — to the FDA’s regulatory authority.  The Troutman Sanders tobacco team participated in the discussion regarding how the industry can best contribute to the ongoing debate as to how these products should be regulated, if at all. [Read more →]

June 19, 2014   Comments Off

Testing E-Cigarettes

The FDA’s proposed deeming regulations call for testing of harmful and potentially harmful constituents in electronic cigarettes.  Those requirements would not be triggered until three years after the regulations become effective, and in the meantime the FDA presumably would need to establish protocols for e-cigarette testing and a list of constituents to be reported. [Read more →]

May 10, 2014   Comments Off