Convenience store retailers could be waiting until mid-2023 for decisions on remaining pre-market tobacco applications and potentially up to a year for the Food and Drug Administration (FDA) to review all comments related to the proposed menthol cigarette and flavored cigar ban and to decide whether to draft any changes to the guidance.
Federal law and FDA regulations require that tobacco products introduced into the market after Feb. 15, 2007, must have a 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 requires 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.
Tobacco Product PMTA Update
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 more than 8.01 million 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 to some 7.75 million e-cigarette and nicotine vapor products, which means the products need to be removed from the market. This leaves approximately 267,000 e-cigarette and nicotine vapor products under pending PMTA applications. The agency has stated in a report that it expects to finalize the review of these remaining PMTA applications, which include applications for JUUL, Vuse, NJOY, Logic, Blu, Smok and Puff Bar, by June 30, 2023.
Besides these PMTA refusal and denials, the FDA has issued orders authorizing the sale of only 23 electronic cigarette devices and nicotine e-liquids sold by R.J. Reynolds Vapor Co., 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 PMTA Update
The FDA received PMTAs for almost 1 million synthetic nicotine products, the vast majority being vapor products. As of Sept. 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 products for agency review and is still processing more PMTAs for products with synthetic nicotine.
The new law passed by 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, then 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, which states 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 actions including assessing fines, seizing product and seeking an injunction in the courts.
Menthol Cigarettes & 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, in roll-your-own cigarette tobacco and in 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 received more than 175,000 comments on the menthol cigarette ban and almost 72,000 on the flavored cigar ban by the Aug. 2, 2022 submission deadline.
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 of 2022 found less than a majority of Americans, only 42%, both Democrats and Republicans, are in support of banning menthol cigarettes.
Since 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. Then, the FDA will decide whether to draft any changes to the proposed regulations and, if it does so, that 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 process may take up to two months or longer.
Also, in the proposed regulations, the FDA asked for public 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 one-and-a-half years 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 time when the menthol cigarette ban and flavored cigar ban may go into effect is approximately two-and-a-half years to possibly three-and-a-half years from now.
Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATO’s mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco segment in a responsible manner.