What Tobacco Products Are Legal to Sell?
By Hannah Hammond on Apr. 04, 2023The Food and Drug Administration has issued 45 marketing granted orders (MGOs) for tobacco products submitted through the premarket tobacco product application (PMTA) process. Authorizations so far have been for tobacco-flavored products only, although some flavored products remain under review.
The FDA said it will need through the end of this year to complete its review on e-cigarette products that hold more than 2% share of the market.
So what can retailers sell now?
Thomas Briant, the National Association of Tobacco Outlets (NATO) executive director and legal counsel, presented a webinar in March that gave an overview of what tobacco products are lawful and unlawful according to federal law and FDA guidance. Here’s what retailers should know:
Products That Can Be Lawfully Sold
Products that can be lawfully marketed under the Family Smoking Prevention and Tobacco Control Act and FDA guidance include: products on the market before Feb. 15, 2007, or grandfathered products; products for which the FDA has issued an order for being substantially equivalent (SE) or which received a substantially equivalent exemption; and products that are the subject of a PMTA and the FDA has issued them a MGO, Briant said.
A list of MGO’s can be found on NATO’s website and the FDA’s Premarket Tobacco Product Marketing Granted Orders page. A breakdown of MGOs issued since 2015 includes:
- 2015: Eight for Swedish Match General products
- 2019: Six for 22nd Century VLN Cigarettes and Marlboro Heatstick products
- 2020: One Marlboro Heatstick product
- 2021: Seven for U.S. Smokeless tobacco and R.J. Reynolds Vapor
- 2022: 20 for Logic, Njoy and R.J. Reynolds Vapor products
- 2023: Three Marlboro Heatstick products
Unlawfully Marketed Products
Unlawfully marketed products include:
- All new products on the market after Feb. 15, 2007, without a SE or MGO
- Products that were required to have a PMTA but did not file one
- Products with a PMTA submitted but the FDA issued a refuse-to-accept, refuse-to-file or marketing denial order (MDO)
- Pending PMTAs under review by FDA, including all synthetic nicotine products
“Regardless of whether these products have tobacco-derived nicotine or synthetic nicotine, they are treated the same, and all are unlawful to market unless that marketing granted order has been issued,” Briant said.
Some MDOs also have court- or FDA-granted stays, which would allow them to remain on the market pending further review.
FDA Enforcement Priorities
Some may be thinking: "‘But many of these products are on the market when legally they are not supposed to be.’ That would be a true statement,” Briant said. Here’s why that is the case.
The FDA has enforcement discretion for the tobacco products on the market. If a product is sold illegally, the agency can issue a warning letter and seek fines or civil and criminal penalties against the manufacturers, wholesalers and retailers selling that product, Briant said.
The FDA is only now beginning a new level of enforcement, especially against manufacturers, he said.
“Why now? Because the agency has, quite rightly, been overwhelmed with the sheer number of PMTAs and products that require agency authorization to be marketed, and they have limited resources and limited personnel,” Briant said.
Therefore, the agency has priorities in what it chooses to enforce. The focus is on unlawfully marketed products, and:
- Products with no PMTA submitted
- Products with a MDO
- Flavored cartridge e-cigarettes (not including tobacco and menthol)
- E-cigarette manufacturers not preventing youth access
- E-cigarettes targeted to youth
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