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.
Should Vapers be Subject to Higher Insurance Premiums Applicable to “Smokers” and “Tobacco Users”?
Posted in FDA, Legislation
Under the Patient Protection and Affordable Care Act (the “Affordable Care Act”) (also known as “ObamaCare”), which became law in 2010, health insurance companies may charge smokers and tobacco users more than those who do not smoke or use tobacco. Specifically, smokers and tobacco users may be charged up to 50 percent more.
Testing E-Cigarettes
Posted in FDA
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.
Troutman Sanders Tobacco Practice Quoted on FDA Deeming Regulations
Posted in FDA
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.
The FDA’s New Deeming Regulations — Get Your Comments In!
Posted in FDA
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.
The FDA’s New Deeming Regulations– Preliminary Observations — Electronic Cigarettes
Posted in FDA
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 New Deeming Regulations — Preliminary Observations — Premarket Review / Substantial Equivalence
Posted in FDA
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.
The FDA’s New Deeming Regulations — Preliminary Observations — Potential Exemption for Premium Cigars
Posted in FDA
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.
Potential Testing Requirements for Little Cigars
Posted in FDA
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.
Legislators Pressure the FTC and FDA to Regulate E-Cigarette Advertising and Marketing
Posted in FDA, Legislation
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.