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Category — FDA

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

Troutman Sanders Tobacco Practice Quoted on FDA Deeming Regulations

The Troutman Sanders tobacco practice has been quoted in two recent articles regarding the FDA’s recent move to extend regulatory oversight to e-cigarettes, cigars, pipe tobacco and other tobacco products.  [Read more →]

April 25, 2014   Comments Off

The FDA’s New Deeming Regulations — Get Your Comments In!

The FDA issued proposed regulations yesterday that would extend the FDA’s regulatory authority under the Tobacco Control Act to all tobacco products, including e-cigarettes, cigars and pipe tobacco.  It is important to note that this is a proposal only, and the regulations could become more reasonable or more onerous after a public comment period. [Read more →]

April 25, 2014   Comments Off

The FDA’s New Deeming Regulations– Preliminary Observations — Electronic Cigarettes

FDA’s proposed deeming regulation issued earlier today would cover a variety of products that meet the statutory definition of a “tobacco product,” including electronic cigarettes, cigars and pipe tobacco.  This blog entry discusses three provisions that would apply to the tobacco products “deemed” to be subject to FDA regulation.  [Read more →]

April 24, 2014   Comments Off

The FDA’s New Deeming Regulations — Preliminary Observations — Premarket Review / Substantial Equivalence

The FDA’s proposed deeming regulations issued earlier today purport to contain a number of relatively modest proposals for regulation of the newly “deemed” products — generally e-cigarettes, cigars and pipe tobacco.  However, lost in the shuffle of the media commentary thus far is the proposal’s impact on tobacco companies’ ability to market new products, or even to continue to market products that are currently being sold.

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April 24, 2014   Comments Off

The FDA’s New Deeming Regulations — Preliminary Observations — Potential Exemption for Premium Cigars

FDA issued the long-awaited deeming regulation this morning.  With respect to cigars, FDA proposed two options for the scope of the rule.  FDA is requesting comments on the two options, and comments must be submitted within 75 days of the issuance of the proposed rule. [Read more →]

April 24, 2014   Comments Off