So far, all of the Food and Drug Administration (FDA) decisions regarding millions of tobacco pre-market applications (PMTAs) for electronic nicotine delivery systems (ENDS) and e-liquids have resulted in refusal of marketing orders (MDO).
The number of denial orders was expected in 2014, when consumer advocates for the Association of Smoke-Free Alternatives (CASAA) and other experts warned the FDA that subjecting new nicotine products to the same hurdles authorization for cigarettes would exclude 98% of manufacturers, âsaid Alex Clark, managing director, CASAA.
It wasn’t until mid-October that the agency announced its first PMTA approval, authorizing the continued sale of RJ Reynolds Vapor Co.’s Vuse Solo, a closed-system e-cigarette, and two of its capsules. tobacco flavored replacement. However, the FDA rejected requests for 10 flavored Vuse Solo cartridges, but failed to publicly identify them. The National Association of Convenience Stores (NACS) has joined with other organizations in the retail industry in speaking out against the oversight, especially as MDOs demand that items be immediately removed from store shelves.
âOur members don’t need any confidential or detailed product information, they just need to know the names of the products, so that they can be identified and taken off the market,â the NACS letter reads.
As of early November, the FDA still had not released PMTA decisions for other major vape brands, such as JUUL.
Despite all the segment that has changed in recent months, business continued as usual for the more than 80 Crosby’s convenience stores in New York and Pennsylvania.
âThe category has always had a bit of uncertainty, but because we weren’t offering these MDO products, it didn’t impact our vaping category. If anything, the flavor ban a few months ago had a bigger impact on the business, âsaid Doug Galli, former vice president / general manager of the convenience store chain, which is part of Reid Petroleum, based in Lockport, NY. moved to a special projects position.
In fact, Galli noted that vape sales are more than just keeping pace.
âOther tobacco products, vapers and nicotine replacement products have done us good, and it continues to grow,â he said.
NielsenIQ Total US Convenience data for the 52 weeks ending October 23, 2021, recorded a 13.8% dollar sales increase for vapor tobacco alternatives and e-cigarettes. This is consistent with the same period last year, which landed at 14.0% for each. Additionally, the research firm reported that Vuse gained one point in market share for the four weeks ending October 23, 2021, and dollar sales have jumped over 54%.
What to watch
FDA actions aren’t the only regulations affecting the category through 2022. In Massachusetts, the first state to pass a comprehensive ban on flavors and menthol tobacco, lawmakers have proposed to repeal parts of the law. . A bill, for example, would exempt products with FDA marketing authorization or modified risk status.
âThe data shows the ban didn’t work. Increased sales in New Hampshire and Rhode Island coupled with the conversion to traditional tobacco-flavored cigarettes in Massachusetts prove it, âsaid Jon Shaer, Director
Director, New England Convenience Store & Energy Marketers Association. âIt’s hard for retailers to watch sales happen, but not in their stores. “
“One of my problems is that when they put the ban into effect, it didn’t allow PMTA or the FDA’s modified risk,” added Anna Bettencourt, senior category manager for the chain. Haffner’s stores, owned by Lawrence, Mass. – based at Energy North Inc. âIf the FDA allows products to be marketed, then states would have to authorize their sale. “
Another development that could benefit the vape category for convenience stores is the final decision on the Prevention of Online Sales of Electronic Cigarettes to Children Act (POSECCA). The law prohibits the delivery of vaping products to residences in the continental United States through the United States Postal Service. Several delivery services, including FedEx, have also said they will no longer ship home vape items.
âConsumer access is being tested with the new regulations,â Clark said.
Perhaps the most intriguing part of this legislation is that Congress failed to distinguish between tobacco products and synthetic nicotine products. At this time, it is not clear whether synthetic nicotine falls under the jurisdiction of the FDA. It’s definitely a product line to watch for its potential to replenish the back bars of convenience stores after so much MDO.