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.”
This will be the first part in our continuing series of posts discussing certain aspects of the FDA’s proposed deeming regulations, which were issued today.
This part focuses on the premarket review process that will be applicable to the newly deemed products — principally e-cigarettes, cigars, and pipe tobacco. The FDA contemplates that the premarket review process applicable to currently regulated tobacco products (cigarettes, smokeless tobacco and cigarette tobacco) will be equally applicable to the newly deemed products. Significantly, the statutory grandfather date of February 15, 2007 applies to the newly deemed products. This means that any product that has been introduced or changed in any way since that date will be subject to the premarket review process. This means that all or almost all e-cigarettes will be subject to premarket review.
On January 28, 2016, President Obama signed the Child Nicotine Poisoning Prevention Act of 2015 (the Act) into law which requires liquid nicotine containers to be packaged in child-resistant packaging. The Act takes effect on July 26, 2016. Liquid nicotine containers are defined as packages containing nicotine in a solution or other form, including soluble nicotine in any concentration, and that are accessible by a consumer; but excludes sealed, pre-filled and disposable containers which are inserted into e-cigarettes, ENDS or similar products, and any product where the nicotine is not accessible by a consumer. The Act also provides effectiveness and testing standards as set forth in the federal Poison Prevention Packaging Act.
An article by the Troutman Sanders Tobacco practice appears in the February issue of Smokeshop Magazine. The article, titled “Pennsylvania’s Legal Battle Over MSA Payments Keeps Twisting” discusses the ongoing battle between Pennsylvania and major tobacco manufacturers regarding disputed 2003 Master Settlement Agreement (“MSA”) escrow payments.
An article by Bryan Haynes of the Troutman Sanders Tobacco practice appears in the January issue of Vapor Digest Magazine. The article, titled “Vapor Industry Regulation – Predications for 2015” discusses the regulatory landscape that could be facing the vapor industry during the upcoming year. Aside from the FDA’s deeming regulations, which may become finalized during the coming year, Bryan speculates on the likelihood of additional regulations, primarily on a state level.
Indiana Attorney General Greg Zoeller and the Indiana legislature are working closely to pass legislation that would increase state regulation of electronic cigarettes and vaping products.
Two bills recently introduced in the New York State Assembly would regulate vapor products.
One bill, A 635, would ban the sale of e-liquid refill bottles. Another bill, A 296, would tax vapor product cartridges at 75% of the wholesale price. The products would therefore need to be sold through…
Parallel bills pending in the New York State Assembly and Senate (A 128 and S 1825) would ban characterizing flavors in most tobacco products.
Parallel bills (H 646 and SB 97) in the Texas legislature would regulate vapor products in the same manner as tobacco products by including vapor products within the same restrictions applicable to tobacco products.
A number of bills have been introduced in the Virginia legislature that would restrict sales and marketing of vapor products.
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