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. 

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.

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.

Nonparticipating manufacturers, wholesalers, and distributors that do business in Oklahoma will be subject to substantial additional requirements if House Bill 2363 currently pending in the Oklahoma State Legislature is enacted.   The bill has passed both houses of the Legislature and appears to be headed toward approval.

The television arm of the Washington Post, Post TV, recently ran a news report on electronic cigarettes titled “E-cigs: The battle happening on nicotine’s next front”. The report discusses the recent popularity of e-cigarettes, and speaks of concerns regarding both the impending regulation of the product by the FDA as well as the restrictions that are already beginning to be imposed by major cities on the product. 

The Troutman Sanders tobacco practice is excited to participate in the upcoming 2014 Tobacco Merchants Association (“TMA”) Annual Meeting held May 19-22 in Williamsburg, Virginia.  The year’s theme is, “Evidence-Based Science, Electronic Cigarettes, & Tobacco Harm Reduction”. Cigarette company executives and other representatives from both the tobacco and e-cigarette industries will also be present at the conference.

Many observers assume the FDA will deem little cigars to be within its jurisdictional purview once the so-called “deeming regulations” are issued.  Given the physical similarity to cigarettes, one would also assume that the FDA will require reporting of harmful and potentially harmful constituents (HPHCs) on the products. 

On April 7, 2014, legislators from California, Connecticut, Illinois, Iowa and Massachusetts wrote joint letters to the head of the Federal Trade Commission (the “FTC”) and the Food and Drug Administration (the “FDA”).  The legislators’ letters urged the FTC and FDA to take action against manufacturers of electronic cigarettes that purportedly make false or unsubstantiated claims in their advertising and marketing.