On January 26, the Food and Drug Administration essentially threw up its hands and announced that Congress needs to create a new regulatory pathway for cannabidiol (CBD) products because the existing pathways are inadequate to mitigate possible health risks. The agency simultaneously denied three long-pending requests to allow marketing of CBD products as dietary supplements. The move came as a major setback to industry stakeholders that have waited years for clear guidelines on CBD from FDA.

Continue Reading FDA Won’t Use Its Existing Authority to Regulate CBD After All

The Reagan-Udall Foundation, an independent nonprofit created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety” recently released its report Operational Evaluation of Certain Components of FDA’s Tobacco Program. The report was commissioned by FDA Commissioner Robert Califf in July, 2022 amid ongoing controversy over the agency’s handling of premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) and a lack of enforcement against unlawful ENDS.

Continue Reading Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products

Dealing in goods subject to cigarette and other tobacco products (OTP) taxes presents considerable administrative burdens. The sale of cigarettes and other tobacco products, on which all 50 states impose an excise tax, requires accurate bookkeeping, regular reporting, and tax remittance practices. In addition, manufacturers, distributors, and wholesalers of these highly-regulated products will be the subject of audits by state revenue departments.

Continue Reading Practical Tips for Avoiding and Contesting Tobacco Tax Assessments

The Department has issued updated guidance addressing remote sellers’ cigarette and tobacco tax responsibilities after the Minnesota Legislature’s mid-2021 amendments to the State’s cigarette and tobacco tax and tobacco product delivery sales statutes, Congress’ late-2020 amendment of the Jenkins Act, and a 2018 decision of the U.S. Supreme Court on permissible state taxation of remote sales.

On May 9, 2022, the Minnesota Department of Revenue (the “Department”) issued Revenue Notice # 22‑02 on remote sellers’ tax payment responsibilities under the State’s cigarette and tobacco tax and tobacco product delivery sales statutes. The notice applies to all delivery sales after December 31, 2021, and it revokes and replaces the Department’s earlier notice on these subjects.
Continue Reading Minnesota Department of Revenue Revokes and Replaces Guidance on Remote Sellers’ Tobacco Tax Responsibilities

Bryan Haynes of Troutman Pepper’s Tobacco Team was quoted in a recent article in Bloomberg Law discussing FDA’s recent proposals to ban menthol in cigarettes and “characterizing flavors” in cigars.

Haynes noted that FDA “has authority to implement tobacco product standards,” but that this authority is “not without limits.”  Haynes also noted that bans on

Bryan Haynes of Troutman Pepper’s Tobacco Team was quoted in a recent article by Emily Field of Law360 discussing FDA’s recently-announced proposal that would limit nicotine levels in combusted tobacco products.

Haynes noted that this proposal, along with FDA’s other recent proposals to ban menthol in cigarettes and flavors in cigars can be summed up

The US Food and Drug Administration (FDA) recently announced plans to publish a proposed rule that would establish a maximum nicotine level in cigarettes and certain “other combusted tobacco products.” At the moment, it is not clear what “other combusted products” FDA might have in mind. According to the Spring 2022 Unified Agenda of Regulatory and Deregulatory Actions, FDA is targeting May 2023 to issue the proposed rule, but that could always change.
Continue Reading FDA Set to Propose Maximum Nicotine Level in Cigarettes

Status report concerns FDA’s review of 240 PMTAs submitted on or before September 9, 2020, for vapor products with larger market shares.  FDA estimates that it will resolve most of these in the periods before July 2022 and from April through June 2023.

Pursuant to an order entered by Judge Paul W. Grimm in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), on May 13, 2022, FDA filed its first status report regarding its review of pending premarket tobacco applications (“PMTAs”) for certain popular vapor products.
Continue Reading Deeming Regulations Litigation Update – FDA Files Status Report on Pending PMTAs for Popular Vapor Products

Retailers should take note that Philip Morris USA Inc., Altria Group, Inc, R.J. Reynolds Tobacco Company have reached an agreement with the United States Department of Justice on warnings to be placed in retail stores carrying the manufacturers’ cigarettes to warn consumers about the health effects of tobacco. These are referred to as “corrective-statement signs” because they are meant as “corrections” to the manufacturers’ alleged deliberate misleading of consumers as to the dangers of smoking from the 1950s until the early 2000s.
Continue Reading Cigarette Companies and Federal Government Reach Agreement on Warnings to be Displayed in Retail Stores

New Virginia law addresses excise taxation and other requirements regarding remote retail sales of cigars and pipe tobacco to consumers in the Commonwealth.

On April 27, 2022, the Virginia General Assembly passed House Bill 1199 and Senate Bill 748 regarding the application of the Commonwealth’s tobacco products tax on “remote retail sales” of cigars and pipe tobacco and related requirements.
Continue Reading Virginia Enacts Tobacco Products Tax Law Applicable to Remote Retail Sales of Cigars and Pipe Tobacco