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The Food and Drug Administration recently issued a solicitation for proposals for a 10 port cigar smoking machine that will simulate human cigar smoking under a variety of conditions and collect smoke residue for chemical analysis.  The stated purpose of the solicitation is to increase the FDA’s capability to analyze cigar smoke products and support regulatory work for the Center for Tobacco Products.  The machine must analyze smoke under a variety of testing regimes, including ISO, CORESTA, Canadian Intense and Massachusetts Intense.

Much attention has been given to the impact of the FDA’s proposed deeming regulations on the e-cigarette and cigar industries.  But the deeming regulations almost certainly will give the FDA the authority to regulate much more — any product that is made or derived from tobacco and intended for human consumption.  This includes tobacco used in a waterpipe (known as a hookah).  The tobacco, known as shisha (which is usually flavored), is vaporized through the hookah pipe.

We are pleased to announce that Bryan Haynes, Partner at Troutman Sanders LLP, will moderate a panel entitled, “E-cigarettes post deeming—an outlook for ENDS products,” on Wednesday, October 21, 2015 from 12:10-12:40 p.m., at the 2015 FDA Regulation of Tobacco Products conference put on by The Food and Drug Law Institute.  The panelists will discuss the potential impact of the finalized deeming regulations on the spectrum of products on the market, and the public health.

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.

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. 

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.

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.