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.
Michael Jordan is an associate in Troutman Pepper's Richmond office. Michael draws on a diverse range of experiences in government and private practice to help clients navigate complex regulatory issues. He focuses primarily on heavily regulated industries, such as tobacco and cannabis.
On November 3, Judge Gary L. Sharpe of the U.S. District Court for the Northern District of New York issued a preliminary injunction, blocking cannabis regulators from issuing marijuana retail licenses for five geographic regions across the state, while a constitutional challenge to the program proceeds.…
On July 5, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like cigarettes was “arbitrary and capricious.” In reaching this conclusion, Judge Amit Mehta relied heavily on industry comments regarding the relative public health risks and negligible youth use of premium cigars, as well as related studies — which the court said FDA either ignored or glossed over. The opinion underscores the importance of the role of public comments in agency rulemaking.
Continue Reading Industry Comments Loom Large in DC Court, Finding FDA Regulation of Premium Cigars “Arbitrary and Capricious”
On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to reject premarket tobacco product applications (PMTAs) for all products that contain nicotine not derived from tobacco, also known as non-tobacco nicotine (NTN) or synthetic nicotine. …
Continue Reading Bipartisan Coalition of 31 State AGs Urge FDA to Deny Marketing Authorization for Non-Tobacco Nicotine Products
On February 15, the Senate confirmed cardiologist Robert M. Califf, M.D., to lead the U.S. Food and Drug Administration (FDA). He’s no stranger to the agency. Dr. Califf served a brief stint as FDA’s commissioner of food and drugs from February 2016 to January 2017, and before that, he was deputy commissioner for medical products and tobacco from February 2015 until February 2016. So what might his appointment mean for the tobacco industry? We have five takeaways.
Continue Reading Dr. Califf Takes the Reins at FDA: Five Takeaways for the Tobacco Industry
Some cigarette pack labels may soon feature the phrases “95% less nicotine,” “helps reduce your nicotine consumption,” and “… greatly reduces your nicotine consumption.” On December 23, 2021, the Food and Drug Administration (FDA) issued modified risk granted orders to 22nd Century Group, Inc.’s VLN King and VLN Menthol King cigarettes, allowing the company to market the low-nicotine cigarettes with these proposed reduced exposure claims if the company adds the phrase “Helps you smoke less.” Of course, the company’s products will continue to be required to bear one of four Surgeon General’s warnings for cigarettes.
Continue Reading In a First, FDA Authorizes Marketing of Low-Nicotine Cigarette as “Modified Risk Tobacco Product”
On December 15, New Jersey Congresswoman Mikie Sherrill introduced the Clarifying Authority Over Nicotine Act of 2021 — a bipartisan bill designed to give the U.S. Food and Drug Administration (FDA) the authority to regulate synthetic nicotine products just as it regulates nicotine products made or derived from tobacco. In a press release, Rep. Sherrill stated, “This bill will ensure all tobacco products, including products made with synthetic nicotine, are regulated by the FDA in order to protect kids in our communities and those who may seek to use these products.”…
Continue Reading New Regulations Potentially on the Horizon for Synthetic Nicotine in 2022
On November 16, North Carolina Attorney General Josh Stein launched a probe into e-cigarette maker Puff Bar and others, citing concerns of youth-appealing flavors, youth marketing, and poor age verification. In a statement, Stein announced, “We are actively investigating Puff Bar and other companies at all stages of the distribution chain, from manufacturers to retailers and everything in between to ensure they are not profiting off kids.”…
Continue Reading North Carolina AG Opens Investigation Into E-Cigarette Maker Puff Bar
More than a year and a half ago, in March 2020, the U.S. Food and Drug Administration (FDA) issued its final rule on a graphic-warning requirement for cigarettes. The rule—initially slated to take effect June 18, 2021—would require 11 new textual, health warning statements accompanied by color, “photorealistic” images displayed on the top 50% of the front and rear panels of cigarette packs and top 20% of cigarette ads. The rule’s effective date, however, has been extended multiple times by court order and is currently set for October 11, 2022. So when might tobacco manufacturers need to start producing new cigarette packs and ads?
Continue Reading When Might FDA’s Graphic Warning Rule for Cigarettes Take Effect?
On Wednesday, the Massachusetts Supreme Judicial Court upheld a jury’s award of $10 million in punitive damages in a wrongful-death case against Philip Morris USA Inc. (“PM USA”), rejecting the tobacco company’s argument that such relief was precluded by the 1998 master settlement agreement between the Massachusetts Attorney General, PM USA, and other attorneys general and tobacco manufacturers.
Continue Reading Massachusetts Supreme Judicial Court Affirms Punitive Damages Award Against Philip Morris USA Inc. In Spite of Master Settlement Agreement Release