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
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
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
Under Judge Grimm’s Revised Remedial Order, FDA must submit quarterly status reports regarding its review of pending PMTAs for certain popular vapor products.
On April 15, 2022, Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ordered FDA to submit status reports to the Court and to the Plaintiffs in the case every ninety days, beginning on April 29th.
Continue Reading Deeming Regulations Litigation Update—Federal Court Exercises Even More Oversight over FDA’s PMTA Review
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.
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Continue Reading Dr. Califf Takes the Reins at FDA: Five Takeaways for the Tobacco Industry
As part of a federal funding bill, language giving the Food and Drug Administration authority over synthetic nicotine, and any other nicotine that is not derived from tobacco, was passed by Congress on March 11. President Biden is expected to sign the bill into law soon.
Continue Reading Bill Regulating Synthetic Nicotine Clears Congress
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
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