FDA Issues Decisions Around Modified Risk & Premarket Applications

U.S. Smokeless Tobacco and R.J. Reynolds are among the companies to receive determinations from the agency.
Logos for the FDA's Center for Tobacco Products

SILVER SPRING, Md. — The Food and Drug Administration (FDA) continues to progress through premarket tobacco product applications (PMTAs) and modified risk tobacco product applications (MRTP), recently issuing both an authorization and multiple denials.

On March 16, the FDA authorized Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product of U.S. Smokeless Tobacco Co. (USSTC), to be marketed as a modified risk product.

USSTC is an Altria Group Inc. company.

Copenhagen Classic Snuff is a pre-existing tobacco product that has been marketed in the United States for years without modified risk information and can now be marketed as a modified risk product with the claim "IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer."

"No tobacco product is safe or 'FDA approved,' so those who do not use tobacco products shouldn't start," said Brian King, director of the FDA's Center for Tobacco Products. "But tobacco products do exist on a spectrum of risk, with those that are smoked having the greatest risk. In this case, the FDA's scientific review found that if an adult smoker completely switched from cigarettes to this smokeless product, it would reduce their risk of getting lung cancer."

The FDA's review of available evidence included recommendations from the Tobacco Products Scientific Advisory Committee, public comments and other available scientific information.

The modified risk granted order will expire in five years, and USSTC must request and receive FDA authorization to continue marketing its moist snuff smokeless tobacco as a modified risk product beyond that time. If the FDA determines at any time that the order no longer benefits public health, it must withdraw the order.

"The ball is now in the company's court to conduct postmarket studies and surveillance on consumer impact, and to submit this information to FDA annually," King said. "If scientific evidence indicates that the net gains of these products no longer outweigh the risks at the population level — or if the company fails to conduct the required postmarket surveillance and studies — the FDA is committed to taking action as appropriate, including withdrawing the order, to protect public health."


On March 17, the FDA issued marketing denial orders (MDOs) for two menthol cigarette products currently marketed by R.J. Reynolds Vapor Co. (RJR Vapor) under the Vuse Solo brand. They are the Vuse Replacement Cartridge Menthol 4.8 percent G1 and the Vuse Replacement Cartridge Menthol 4.8 percent G2.

RJR Vapor must not market or distribute these products in the U.S., or it risks FDA enforcement action, according to the agency. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to the MDOs.

The agency issues decisions on PMTAs based on a public health standard that considers the risks and benefits of the product on the population as a whole. Upon reviewing RJR Vapor's PMTAs, the FDA determined that they lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Specifically, submitted evidence did not demonstrate that the company's menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes, according to the FDA.

"The FDA is a data driven agency and science remains the cornerstone of our tobacco product regulatory activities," King said. "The science has guided — and will always guide — the FDA's decision making on premarket tobacco product applications, including today's marketing denial orders."  

The agency previously issued two MDOs for menthol e-cigarette produtcs marketed by RJR Vapor, the Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent, as Convenience Store News reported. RJR Vapor planned to challenge those MDOs.

Winston-Salem. N.C.-based RJR Vapor is a subsidiary of Reynolds American Inc., which is an indirect subsidiary of British American Tobacco.

More FDA Decisions

The FDA also issued a refuse to accept (RTA) letter on Feb. 21, notifying a company that its PMTAs, which are associated with approximately 17 million individual tobacco products, did not meet acceptance requirements outlined in FDA regulations. The agency did not name the company. 

The applications were for a grouped submissions of e-liquids in varying size, nicotine strength and flavor combinations, each of which was treated as an individual product application according to existing premarket review processes, the agency said.

During the acceptance phase, the FDA reviews applications to ensure they meet a minimum threshold for acceptability for FDA scientific review. If required contents for acceptance are missing, the agency refuses to accept the application.

The agency issued the company an RTA letter because the applications for these products lacking required Environmental Assessments. The company may submit a new application for the products at any time, but it may not be marketed unless the FDA reviews the applications and determines that marketing of the products is appropriate for the protection of the public health.

According to the FDA, it has made determinations on more than 99 percent of the nearly 26 million deemed products for which applications were submitted. This includes authorizing 23 new e-cigarette products and devices, and issuing RTA letters, refuse to file letters or marketing denial orders for millions of products.

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