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
Dr. Califf Takes the Reins at FDA: Five Takeaways for the Tobacco Industry
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
In a First, FDA Authorizes Marketing of Low-Nicotine Cigarette as “Modified Risk Tobacco Product”
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”
New Regulations Potentially on the Horizon for Synthetic Nicotine in 2022
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
North Carolina AG Opens Investigation Into E-Cigarette Maker Puff Bar
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
When Might FDA’s Graphic Warning Rule for Cigarettes Take Effect?
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?
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Massachusetts Supreme Judicial Court Affirms Punitive Damages Award Against Philip Morris USA Inc. In Spite of Master Settlement Agreement Release
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.[1]
Continue Reading Massachusetts Supreme Judicial Court Affirms Punitive Damages Award Against Philip Morris USA Inc. In Spite of Master Settlement Agreement Release