Search manufacturing rule

On March 8, the Food and Drug Administration announced that it is proposing a long-awaited rule on so-called “tobacco product manufacturing practices.”  Here are some preliminary thoughts on the proposed rule:

  • The timing of the proposed rule was a bit of a surprise. Although the proposed rule had been listed as a priority on FDA’s regulatory agenda for some time, nothing indicated that this proposal was imminent. And FDA has identified a number of other rulemaking priorities for 2023, including the proposed ban on menthol cigarettes, the proposed ban on characterizing flavors in cigars and a proposed standard on nicotine levels in cigarettes. It is becoming more and more clear that new leadership at FDA and the Center for Tobacco Products will be working aggressively to impose new requirements on industry.
Continue Reading FDA Announces New Proposed Rule on “Tobacco Product Manufacturing Practices”

Yesterday, August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016 rule that swept all tobacco products under the same set of regulations.  In previous decisions, the District Court already had vacated the portions of the Deeming Rule that required premium cigars to display health warnings on packaging and advertising and to engage in the burdensome premarket authorization process. 

Continue Reading U.S. District Court Vacates FDA Deeming Rule With Respect To Premium Cigars

The Troutman Pepper Tobacco + Nicotine Team will attend a TMA workshop on FDA’s proposed rule on tobacco product manufacturing practices.  Bryan Haynes will participate in a panel discussion of the legal implications of the proposed rule.  The workshop is on Tuesday, June 13 at the Hyatt Regency at Reagan National Airport. We hope you will join us!

To mark the nine-year anniversary of the Family Smoking Prevention and Tobacco Control Act and the one-year anniversary of FDA’s Comprehensive Plan for Nicotine, FDA recently provided updates on efforts to improve its tobacco regulatory programs. In addition, FDA announced new initiatives that are designed to help industry have a better understanding of what is needed to submit complete and robust tobacco product applications. The stated objective of these efforts is to improve the transparency and efficiency of the premarket review process. Continue Reading FDA Announces its Plans to Issue Tobacco Product Application “Foundational” Rules

This is the second post in our multipart series evaluating the Food and Drug Administration’s response to the Regan-Udall Foundation report on the operations of the Center for Tobacco Products. If you missed our first post, check it out here.

There is a common refrain that appears throughout the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) — lack of transparency. The report found that stakeholders generally perceived premarket tobacco product applications (PMTAs) — required for all electronic nicotine delivery systems (ENDS) on the market — as “ineffective and problematic” due in part to a “lack of adequate guidance and transparency regarding CTP expectations,” as well as a “lack of clarity regarding review standards.”

Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force

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 term tetrahydrocannabinol (THC) is most often associated with the delta-9 THC cannabinoid, which is one of over 100 cannabinoids found in both high-THC marijuana and low-THC hemp. Delta-9 THC is also the cannabinoid most often responsible for getting cannabis users “high” and is the cannabinoid that has been explicitly prohibited by the federal Controlled Substances Act (CSA). Continue Reading Delta-8’s 2018 Farm Bill Honeymoon May Be Slowly Coming to an End

Did you know that there are special environmental requirements for businesses manufacturing, distributing and selling electronic nicotine delivery systems (ENDS)?  Late last year, the Environmental Protection Agency added e-cigarettes, vape pens and certain e-liquids as hazardous waste pharmaceuticals under a final rule entitled “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine.” The rule requires companies to provide certain training, complete reporting, and maintain recordkeeping, among other obligations. Failure to comply can result in enforcement and penalties.

If you manufacture or distribute ENDS products, please let us know how we can help you comply with these regulations.

 

Agustin Rodriguez

Agustin is Counsel in the firm’s Government Investigations, Compliance and Enforcement practice. He leverages his extensive background to assist clients in navigating federal, state and local regulation of tobacco, alcohol and other consumer products. He has unique experience advising on global supply chain risk management issues, specifically in Asia and Latin America. Continue Reading Troutman Sanders Welcomes Agustin Rodriguez

The federal government is attempting to intervene in a lawsuit between a tribal tobacco manufacturer and the State of Nebraska.

HCI Distribution Inc. (“HCI”) and Rock River Manufacturing (“Rock River”) filed a lawsuit against the State of Nebraska alleging that Nebraska was attempting to regulate the companies’ tobacco production in violation of the U.S. Constitution. HCI and Rock River are subsidiaries of Ho-Chunk Incorporated (“Ho-Chunk”), which is the economic development arm of the Winnebago Tribe. Continue Reading Federal Government Seeks to Intervene in Tribal Lawsuit Against the State of Nebraska