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Tobacco’s Ever-Evolving Legislative Landscape

The tobacco/nicotine category continues to face significant regulatory challenges.

By Anne Baye Ericksen | May 23, 2022

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There have been several landmark decisions shaping the tobacco/nicotine category for convenience stores.

The 2007 Tobacco Control Act granted the Food and Drug Administration (FDA) market authority over tobacco products. In 2016, the agency deemed vape products as tobacco products. 

And with the passage of the omnibus budget bill in mid-March, Congress amended the definition of tobacco products as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.” The language “containing nicotine from any source” now places synthetic nicotine products under the FDA’s authority. 

“It was always a matter of when, and not if, the FDA would gain regulatory authority over synthetic nicotine. Without enforcement discretion or court injunctions, the effect on c-stores will be felt most in synthetic nicotine pouches and disposable vaping devices,” said Gregory Conley, president of the American Vaping Association. 

What’s more, the timeline for manufacturers to apply for and gain authorization is limited. Manufacturers of synthetic nicotine products on store shelves as of April 14 have until May 14 to submit pre-market tobacco applications (PMTAs). 

“NACS is advising any retailers who sell synthetic nicotine products to verify with the manufacturers of those products that they have submitted PMTAs by the May 14 deadline. If they have not submitted PMTAs, any retailers selling the products must remove them from shelves by May 14 or possibly face enforcement from the FDA,” cautioned Anna Ready Blom, director of government relations for the National Association of Convenience Stores (NACS).

Items with an accepted PMTA can remain on sale until July 13. Eligibility beyond that depends on the FDA’s final ruling.

Additionally, any product that had already been through the PMTA process, but denied market approval, cannot reapply. Nor can any tobacco-derived product that was modified to use synthetic nicotine after receiving a market denial order. 

Menthol Makeover

Meanwhile, the industry still awaits the FDA’s decision on a nationwide menthol ban.

“NACS strongly opposes a ban on menthol cigarettes and flavored cigars because it will push users to the illicit market, undermining the efforts and investments of responsible retailers in our industry,” said Ready Blom. “If the FDA moves forward with the rulemaking, NACS plans to file comments on behalf of the industry, and we are also planning to organize a comment campaign where retailers can file individual comment letters.”

However, not all stores will be impacted equally. Some retailers may experience minimum change. 

“The proposed menthol ban does not affect us as most of our locations are rural, and menthol cigarettes are a very small percentage of our overall cigarette sales,” said Sean Bumgarner, vice president at Scrivener Oil Co., which operates 12 Signal Food Stores in southwest Missouri.

City Limits

Conley said flavor bans remain a hot topic, with state proposals in Illinois, Connecticut, Maine and Hawaii. However, he believes the movement for bans has slowed. 

“Thus far, we have been pleasantly surprised at the reticence displayed by some state legislators to target tobacco and nicotine products. After two years of pandemic-related business interruptions, youth vaping on the decline and news of FDA actions, some are understanding that this issue can’t be properly addressed with new prohibitions,” he said.

In California, a statewide flavor ban was postponed during a petition drive to turn it into a ballot issue, for which it qualified. This fall, voters will make the decision.

Perhaps the most assertive local regulation is the birth date cutoff, instead of a minimum age, in Brookline, Mass. No one born later than Jan. 1, 2000, can buy any tobacco/nicotine product within the city. Local c-stores immediately filed a lawsuit claiming the ordinance unfairly penalizes their businesses and denies some adults access to the lawful products. At this time, no additional action has been taken.

On a more encouraging note, the FDA granted a few market approvals last year, including Vuse Solo and two of its tobacco-flavored replacement pods. In December it granted a modified-risk market order for 22nd Century Group’s VLN King and VLN Menthol King combustible cigarettes, a first for the category. This year, it is expected to decide on the outstanding PMTAs.

“We are watching the news one day at a time while monitoring our inventory conditions to ensure we avoid any large on-hand situations,” said Ben Brooks, category manager for Nouria Energy. The Worcester, Mass.-based company operates 146 convenience stores across five states. “We are also ensuring with our vendor partners that if a product needs to be removed from the shelf, we will have an avenue to return the product.”

Related Articles Read More >

FDA Plans Proposed Rule to Establish Maximum Level of Nicotine in Cigarettes
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