In the wake of recent reports tying health issues to vaping, a number of States have moved to ban non-tobacco flavored vapes, with one banning all vaping products. These actions may prove to be precipitous, with evidence emerging that THC products with specific ingredients are causing the problems.
Massachusetts Orders Four-Month Moratorium on Vaping Products
On September 24, 2019, Massachusetts Governor Charlie Baker declared a public health emergency, and Public Health Commissioner Monica Bharel ordered the sale or display of vaping products in retail establishments, online, or through other means, to be prohibited in the Commonwealth. The moratorium “takes effect immediately and shall remain in effect, unless extended with the approval of the Governor and the Public Health Council, through January 25, 2020, or until the declared public health emergency is terminated, or the Order is otherwise rescinded by [the Commissioner], whichever happens first.”
FDA Announces Proposed Rule for PMTAs Amid Threat to Advance Enforcement Against Flavored ENDS
On September 20, 2019, the Food and Drug Administration announced that it will issue a proposed rule governing the process for premarket tobacco applications, including for electronic nicotine delivery systems. The rule (when finalized) would establish binding procedures for PMTAs, as opposed to the current non-binding procedures reflected in FDA guidance.
California Issues New Rule Raising Cost Base of Other Tobacco Products for Shipments by Out-of-State Distributors
California recently issued a Special Notice, which changes how the California Department of Tax and Fee Administration (CDTFA) will apply the OTP excise tax to the wholesaler’s cost basis when an out-of-state California licensed tobacco products distributor sells tobacco products to wholesalers, retailers, or consumers located in California.
Trump Administration Instructs FDA to “Clear Market” of Flavored ENDS Products (including Menthol and Mint)
Today, the Trump Administration announced that it is instructing the Food and Drug Administration to “finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products.”
Michigan Moves to Crack Down on the Sale and Advertising of Vapor Products
In a press release dated September 3, 2019, Michigan Governor Gretchen Whitmer announced her administration would be introducing emergency rules to ban the sale of “flavored vaping products” in retail stores and online, and ban “misleading” marketing of vaping products, including the use of terms like “clean,” “safe,” and “healthy.”
Troutman Sanders to Host TMA Conference on the FDA Premarket Tobacco Application Process
On August 22, 2019, Troutman Sanders will host the Tobacco Merchants Association “(TMA”) / Vapor Voice conference entitled “Finding Direction – Navigating PMTAs.” The conference will address the FDA premarket tobacco application process for electronic nicotine delivery systems (ENDS). The conference will be held in our Richmond office and Bryan …
FDA Announces New Proposed Rule re Graphic Cigarette Warnings for Packaging and Advertisements
On Thursday, August 15, 2019, the Food & Drug Administration published for public comment a new proposed rule covering cigarette labeling and advertising. The proposed rule, Required Warnings for Cigarette Packages and Advertisements, would require, once finalized, new health warnings on cigarette packages and in advertisements to promote greater public…
U.S. Food and Drug Administration Expresses Concerns About Therapeutically Marketed CBD Products
The U.S. Food and Drug Administration continues to be concerned about the proliferation of products containing CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA. On Tuesday, July 23, 2019, FDA issued a press release announcing it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, alleging the company illegally sold unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.
Public Health Advocates Urge FDA to Revamp ENDS Premarket Review Process and Appeal Maryland Ruling
On the heels of a Maryland federal judge’s order advancing to May 2020 the deadline for premarket review submissions (discussed here), a group of public health advocates (led by Iowa Attorney General Tom Miller) has petitioned the Secretary of Health and Human Services to appeal the court’s decision and to revamp the premarket review process for electronic nicotine delivery systems (ENDS).