26 TOBACCO BUSINESS | NOVEMBER / DECEMBER | 22 Federal law and U.S. Food and Drug Administration (FDA) regulations require that tobacco products that were introduced into the market after Feb. 15, 2007, must have a premarket tobacco product application (PMTA) submitted for review by the FDA. In order to receive marketing authorization from the agency to allow a product to continue to be sold, the law states that the FDA must determine that a tobacco product is “appropriate for the protection of the public health.” The products that require PMTAs include cigars, pipe tobacco, electronic cigarettes, hookah tobacco and modern oral products. There were two deadlines for filing PMTAs with the agency. For products made or derived from tobacco itself, the FDA deadline was Sept. 9, 2020. Under a law passed earlier this year, for products with nicotine made or derived from a source other than tobacco itself, for example synthetic nicotine, the PMTAs were due by May 14, 2022. The FDA has updated its website with metrics and reporting for PMTAs through July 31, 2022. Below is a summary of the updated PMTAmetrics. Tobacco-DerivedNicotine Product PMTAUpdate The agency received PMTA applications by Sept. 9, 2020, for more than 8 million products that have nicotine derived from the tobacco leaf itself, the vast majority of which were electronic nicotine or vapor products. Specifically, the agency received PMTAs for 8,013,850 e-cigarette and vapor products, 2,310 cigar products, 1,356 hookah tobacco products, 579 pipe tobacco products, 76 roll-your-own products and 61 smokeless tobacco products. However, through its PMTA review process, and as of July 31, 2022, the FDA has refused to allow or denied marketing authorization for some 7,746,047 e-cigarette and nicotine vapor products, whichmeans the products need to be removed from the market. This leaves approximately 267,000 e-cigarette and nicotine vapor products under pending PMTAs. The agency has stated in a report that it expects to finalize the review of these remaining PMTAs by June 30, 2023. These remaining PMTAs include applications for Juul, Vuse, Njoy, Logic, Blu, Smok and Puff Bar. Besides these PMTA refusals and denials, the FDA has issued orders authorizing the sale of 23 electronic cigarette devices and nicotine e-liquids sold by R.J. Reynolds Vapor Company, Njoy and Logic. However, of the 23 products authorized, the only flavor allowed is tobacco-flavored nicotine e-liquids. To date, the FDA has not authorized any flavor other than tobacco flavor for electronic cigarette and nicotine liquid products. Synthetic Nicotine PMTAUpdate The FDA received PMTAs for almost 1 million synthetic nicotine products, the vast majority being vapor products. As of September 6, 2022, the FDA has refused to accept PMTAs for more than 800,000 products containing synthetic nicotine. At the same time, the agency has accepted PMTAs covering 350 synthetic nicotine products for agency review and is still processing more PMTAs for products with synthetic nicotine. The new law passed by the U.S. Congress provides that a product with synthetic nicotine can remain on the market if the FDA issued a marketing granted order (MGO) by July 13, 2022. If an MGO was not issued by July 13, 2022, the product is illegal to market. At this point in time, the FDA has not issued any MGOs for products that contain synthetic nicotine. The FDA issued an announcement in early August 2022 stating that manufacturers, distributors and retailers may be subject to FDA enforcement if products continue to be sold without first receiving an MGO. Generally, FDA enforcement actions are first targeted at manufacturers, and a warning letter is issued to the company informing them that their products are illegal to market. If the company continues to sell its products, then the FDA can pursue further action, including assessing fines, seizing products and seeking an injunction in the courts. Menthol Cigarettes and Flavored Cigars On April 28, 2022, the FDA published two new proposed regulations. These regulations are known as product standards. A product standard is the power that Congress gave to the FDA to reduce or eliminate an ingredient in a tobacco product or a constituent in tobacco smoke. This is a very significant power because it can result in products being removed from the market. One of the proposed regulations would prohibit menthol as a flavor in cigarettes, roll-your-own cigarette tobacco and heated tobacco products. The second regulation would also prohibit any flavors in cigars. Federal law requires that an agency request comments from the public about proposed regulations. The FDA receivedmore than 175,000 comments on thementhol cigarette ban and almost 72,000 comments on the flavored cigar ban by theAugust 2, 2022, submission deadline. In addition, a Gallup poll conducted in August 2022 found that less than a majority of Americans, only 42 percent, are in support of banningmenthol cigarettes. In response to this significant number of comments, the FDA issued an announcement that it “will need ample time to comprehensively review and analyze all of the comments.” In addition, a Gallup poll conducted in August 2022 found that less than amajority of Americans, only 42 percent, both Democrats and Republicans, are in support of banning menthol cigarettes. Because the FDA announced it will need “ample” time to read all of the comments, it could take nine to 12 months—or possibly longer—for the agency to read through the comments on the menthol ban and flavored cigar ban. The FDA will then decide whether to draft any changes to the proposed regulations, and if it does, that process may take up to three months. After any changes are made, the FDA will need to send the final proposed regulations to the White House Office of Management and Budget (OMB) for its final review and decision on whether the FDA can proceed with implementing the regulations. During this time, the OMB will meet with members of the public for their input on the final regulations. This processmay take up to twomonths or longer. Also, in the proposed regulations, the FDA asked for the public’s feedback on making the effective date of the regulations two years after the final regulations are published instead of the usual one-year time period before the regulation takes effect. Some manufacturers recommended in their comments that the FDA consider making the regulations effective six years after the final regulations are published. Then, there is also the possibility that lawsuits could be brought against the FDA regarding the proposed regulations, which may further delay an effective date. So, by adding up the estimated time periods for the FDA to read comments, make changes and obtain OMB final approval, it could take almost a year and a half before the final regulations would be published. Then, when publishing the final regulations, the FDA will need to determine if the regulations will actually go into effect in one year or two years.When adding up all of these time periods, the estimated timewhen the menthol cigarette ban and flavored cigar ban may go into effect is approximately two and a half to possibly three and a half years from now. TB F ASSOC I AT I ONS : NAT I ONAL ASSOC I AT I ON OF TOBACCO OUTLETS AN UPDATE ON FDA REGULATIONS Thomas A. Briant, Executive Director, National Association of Tobacco Outlets From premarket tobacco product applications to the ban on menthol cigarettes and flavored cigars
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