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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Eleventh Circuit Denies Swisher International’s Request For An Injunction of Further Enforcement by FDA
In August 2021, Swisher International Inc. filed a lawsuit against the Food and Drug Administration (FDA) seeking to have the FDA’s Deeming Rule declared invalid. Swisher followed its lawsuit with a petition for injunction to prevent FDA from taking enforcement action against Swisher while Swisher’s lawsuit against the FDA’s implementation of the Deeming Rule is under consideration and while the FDA processes Swisher’s pending 173 premarket applications. On February 3, 2022, the Eleventh Circuit Court of Appeals upheld a lower court’s denial of a motion for a preliminary injunction finding that Swisher was not likely to suffer “irreparable harm.”
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Troutman Pepper Tobacco Team to attend TPE Show in Las Vegas
Bryan Haynes and Agustin Rodriguez of the Troutman Pepper tobacco team will be attending the Tobacco Plus Expo in Las Vegas on January 26-28, 2022. We look forward to seeing our clients and friends at the show.
For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 – bryan.haynes@troutman.com or Agustin Rodriguez, at 804.697.1381 –
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.
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Five Tips for When State Attorneys General Come Knocking
The scope and scale of state attorneys general investigations has expanded for several reasons, including a perceived lack of enforcement at the federal level. Many state attorneys general are not reticent to fill a perceived regulatory void, and they routinely conduct investigations and bring enforcement actions when they observe a federal agency is not moving fast enough or otherwise has neglected its responsibility.
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US Postal Service Posts PACT Act/POSECCA Field Information Kit and Management Instructions
The U.S. Postal Service (USPS) has made available the Field Information Kit and Management Instructions referenced in its November 4, 2021 Postal Bulletin, correcting hyperlinks in the Postal Bulletin. The Field Information Kit and the Management Instruction are posted to the USPS website, available here and here, respectively.
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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.”
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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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U.S. Postal Service Sets Rule Prohibiting the Mailing of ENDS Products
As of October 20, 2021, the final rule of the U.S. Postal Service (the “USPS”) regarding the treatment of electronic nicotine delivery systems (“ENDS”) in the mail is available for public inspection via the link here. The final rule generally prohibits the mailing of ENDS, subject to certain exceptions, as of the date of its publication in the Federal Register, which we understand will be tomorrow, October 21, 2020. We also expect that as of October 21st, USPS will publish accompanying implementation materials on its websites.
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California Passes CBD Law That Conflicts With FDA Guidance
Governor Gavin Newsome recently signed California Assembly Bill 45 (AB 45) into law, which, among other things, allows hemp-derived cannabidiol (CBD) to be included in any food, beverages, and dietary supplements sold in California. This is not only a break from California’s prior position prohibiting CBD from being included in such products even as the State began to tax and regulate its cannabis industry, but it is also in stark contrast with the U.S. Food and Drug Administration’s (FDA’s) current position on the issue.
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