FDA Withdraws Notice Of Proposed Rulemaking For Premium Cigars – Food, Drugs, Healthcare, Life Sciences

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FDA Withdraws Notice of Proposed Rulebook for Premium Cigars

June 21, 2021

Troutman Pepper Hamilton Sanders

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On June 11, 2021, the US Food and Drug Administration (FDA) issued a preliminary notification on the proposed regulation (ANPRM) for premium cigars issued in March 2018 as part of the Unified Agenda of Regulatory and Deregulatory Actions of spring 2021, which was published twice is retired a year. Nonetheless, the FDA commissioned a study to obtain information similar to that sought in the ANPRM. The study is expected to be completed in spring 2022. So there is still a chance the FDA will take a modified approach to premium cigars in the future.

As you may recall, the FDA issued the ANPRM to “provide information related to the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the Family Smoking Prevention and Tobacco Control Act (Tabacco Control Act) “as amended) and regulations relating to the sale and distribution of tobacco products. Specifically, this ANPRM seeks comments, data, research, or other information that may aid FDA regulatory action in relation to premium cigars. “83 Reg. No. 12,901 (March 26, 2018). According to the file, 32,729 comments were received , including from organizations such as Cigar Rights of America, Altria Client Services, the Cigar Association of America, Inc., the National Association of Tobacco Outlets, Inc., Davidoff of Geneva USA, the International Premium Cigar and Pipe Retailers Association, and The Heritage Foundation Despite the comments received, the FDA claimed in a court motion in August 2020 that the comments “did not provide new data sufficient to answer the question of whether the properties of premium cigars or their consumption patterns may lead to other health effects than other tobacco products. “Akad. of Pediatrics v. FDA, No. 8: 18-cv-883-PWG, ECF No. 188, 2 (August 5, 2020). So it is not surprising that the FDA has decided to withdraw the ANPRM.

You may also recall that in August 2020 the U.S. District Court for the District of Columbia prohibited the FDA from enforcing the Tobacco Control Act’s licensing requirement for premium cigars until the agency streamlined a substantial equivalence process specifically for premium cigars in Considering. Cigar assoc. of America, et al., v. FDA, Case No. 1: 16-cv-01460 (APM), 38 (DDC August 19, 2020). For the purposes of the order, the court defined a premium cigar as any cigar that met the following criteria:

• Is wrapped in whole tobacco leaf;
• Contains a 100% leaf tobacco binder;
• Contains at least 50 percent (by weight of the filler) long filler tobacco (ie whole tobacco leaves that extend the entire length of the cigar);
• is handmade or hand-rolled (i.e. no machines other than simple tools such as scissors have been used to cut the tobacco before rolling);
• Has no filter, tobacco-free tip, or tobacco-free mouthpiece;
• Has no characteristic taste other than tobacco;
• Contains only tobacco, water and vegetable gum with no other ingredients or additives; and
• Weighs more than 6 pounds per 1,000 units.

Despite the withdrawal of the ANPRM, there is still an opportunity for the FDA to develop a modified approach to premium cigars. According to the withdrawal notice, “The FDA has entered into an agreement with the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a comprehensive and systematic assessment and review of the scientific literature and to provide a final report on the study results. The review will include the Analysis of data on short- and long-term health effects of “premium” cigars. The NASEM review has started and is expected to complete in spring 2022. “The FDA plans to provide a public update after receiving the results of the NASEM review Of course, it remains to be seen when and how the FDA will reconsider its approach to pre-market screening of premium cigars in light of the August 2020 court order.

The content of this article is intended to provide general guidance on the subject. Expert advice should be sought regarding your specific circumstances.

The content of this article is intended to provide general guidance on the subject. You should seek expert advice regarding your specific circumstances.

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