The U.S. Food and Drug Administration (“FDA”) draws its authority from the Food Drug & Cosmetic Act (“FD&C Act”), whereas the Alcohol Tobacco Tax and Trade Bureau (“TTB”) is authorized under the Internal Revenue Code (“IRC”). Each of these laws has different definitions of “tobacco products” for different purposes. FDA’s Deeming Rule has no effect on TTB’s jurisdiction over tobacco products, and vice versa. While the FDA has deemed certain products to be “tobacco products” under the FD&C Act, some deemed products do not meet the definition of “tobacco products” under the IRC.
Deeming Regulations: Important Deadlines in 2016
The FDA’s proposed deeming regulations extend the FDA’s regulatory authority to additional tobacco products including e-cigarettes, e-liquids, cigars, hookah tobacco, pipe tobacco and dissolvables, referred to as “covered tobacco products.” The FDA currently regulates cigarette tobacco, roll-your own, cigarettes, and smokeless tobacco.
Tobacco Practice Partner Quoted at Tobacco Merchants Association’s Annual Conference and Meeting
Posted in Articles and Publications, FDA
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a May 13 Convenience Store News article that recapped “tidbits” gleaned from this year’s TMA’s Annual Conference and Meeting, which was held in Williamsburg, Virginia.
Altria Files Suit Against FDA regarding “Black & Mild” Brand Name
Posted in FDA, Significant Cases
On May 26, 2016, Altria Group, Inc. filed suit against the Food & Drug Administration (FDA) in a bid to keep using the Black & Mild brand name for its popular cigars.
Deeming Regulations — Initial Impressions — Warnings
Posted in FDA, Legislation
Nicotine: The deeming regulations promulgated by the Food and Drug Administration contain new warning requirements for certain tobacco products, including cigars, pipe tobacco, e-cigarettes, vapor products, hookah tobacco, dissolvables, and nicotine gel. Effective August 8, 2018, a nicotine health warning is required on packaging and advertisements. The language is:
“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
Alert — FDA Deeming Regulations Issued
Posted in FDA
The FDA issued this morning its long-awaited deeming regulations, which will subject all tobacco products (including e-cigarettes, cigars and pipe tobacco) to the FDA’s regulatory authority. We are currently digesting the regulations and will be posting a series of blog entries regarding various aspects.
Our initial impression is that, notwithstanding…
House Appropriations Committee Seeks to Exempt Premium Cigars, Relax Regulatory Burdens on Vapor Products
Posted in FDA
The House Appropriations Committee recently approved funding language that would exempt traditional large and premium cigars from FDA regulation and substantially lessen the regulatory burden on vapor products.
Troutman Sanders Tobacco Team Quoted in Article on FDA Deeming Regulations
Posted in Articles and Publications, FDA
The Troutman Sanders Tobacco Team was recently quoted in a Tampa Tribune article discussing the potential impact of the FDA’s deeming regulations on the premium cigar industry in general, and one Tampa-area business (J.C. Newman Cigar Company) in particular.
Does FDA Solicitation Signal Imminent Plan to Regulate Cigars?
Posted in FDA
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.
FDA Eyes Regulation of Hookah Tobacco
Posted in FDA, State Regulatory
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.