The FDA has extended their upcoming deeming regulations deadlines. This includes the May 10, 2017 deadline, or later, including deadlines for cigar warning label plans, registration and listing, ingredient submissions, health documents, and others. The extension gives the FDA and Department of Health and Human Services’ new leadership time to
Lawsuits Being Filed Against the FDA Regarding Deeming Regulations
Posted in FDA, State Regulatory
In May through July several groups have filed lawsuits against the US Food and Drug Administration alleging that the deeming regulations that expand the regulation by FDA of additional tobacco products violate the law.
Currently there are eight lawsuits pending, of which 5 pertain to the vapor industry. Two of these five have been consolidated because they address similar claims.
Tobacco Practice Partner Quoted in Vapor Voice Magazine
Posted in Articles and Publications, FDA
Troutman Sanders tobacco team partner Bryan Haynes was interviewed for a June 21 Vapor Voice Magazine article titled “Dark Vapor.” The article deals with the huge propensity for black-market growth in the vapor industry as the FDA’s deeming regulations force many companies to cease their innovative efforts – or even shut their doors.
Deeming Regulations: Effects of Different Definitions of Tobacco Products
Posted in FDA
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.