FDA Issues New Rules For Approving Tobacco Products For The Market

Two new rules have been issued regarding the approval of tobacco products in the U.S., such as e-cigarettes and traditional cigarettes, one of which requires federal regulators to consider the benefits and risks to the population as a whole.

The Food and Drug Administration (FDA) issued the two final rules for the premarket review of new tobacco products on October 4, which will help establish new requirements for how tobacco products, including e-cigarettes, are approved by the agency.

One of the new rules includes a requirement that additional information be provided for Premarket Tobacco product Applications (PMTAs) and the other for Substantial Equivalence Reports (SERs). These are the two most common avenues manufacturers use to receive approval for new tobacco products from the FDA.

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The PMTA rule requires manufacturers and importers of tobacco products to prove the new product is “appropriate for the protection of the public health.”

The new rule calls for the FDA to consider the risks and benefits of the population as a whole. The evaluation of risk versus benefit includes reviewing the products’ components, ingredients, additives, toxicological profile, and overall health impact. It also focuses on how the product is manufactured, packaged, and labeled.

The PMTA rule is supposedly designed to ensure there is enough evidence for the FDA to evaluate the product appropriately. The rule also includes information on how a manufacturer can submit a supplemental PMTA or a resubmission, such as for a modified version of a product that has already been reviewed or approved.

The SER is the most common pathway for most tobacco products including vapes, cigarettes, hookah, rolled tobacco, and cigars.

This new SER rule requires the FDA to find a new product to be “substantially equivalent” to an existing product before it is approved. This means it must have the same characteristics as a prior tobacco product which was approved; or it has different characteristics, but the differences do not cause the new product to raise different concerns regarding public health.

This means that if a tobacco product manufacturer does not want to go through the PMTA process and show their product is not a liability to public health, they must take the SER track and show their product is essentially the same as something else already on the market.

“These final rules are important components of the FDA’s comprehensive approach to tobacco product regulation, which includes premarket application review, science-based use of the product standard authority and prioritized compliance and enforcement actions,” Acting FDA Commissioner Dr. Janet Woodcock, said in the press release. “The FDA is committed to protecting Americans from tobacco-related disease and death by ensuring that new tobacco products undergo appropriate regulatory review to determine if they meet the public health standards set by law. If new tobacco products do not meet the standards for these pathways, they cannot be marketed or sold in the United States.”

The new rules are scheduled to be published October 5 and November 4.

FDA Premarket Review of Tobacco Products Continues

The FDA is currently conducting premarket review of thousands of tobacco products, which represent more than 6.5 million products overall. So far, the agency has taken action on 96% of the applications submitted before a deadline last month, including denials for more than one million flavored e-cigarettes.

The move is part of the agency’s response to growing youth nicotine addiction rates. The FDA used its oversight authority under section 910 of the Federal Food, Drug, and Cosmetic Act to claim regulatory responsibility of all Electronic Nicotine Delivery Systems (ENDS) in 2016, which includes e-cigarettes, vaping products, and all liquids used with the devices.

As a result of the action, the FDA mandated that all new and existing nicotine based e-cigarette and vaping products go through premarket tobacco product applications (PMTAs). Under the new rules, manufacturers must provide evidence their vaping products benefit adult smokers enough to overcome the public health threat they represent to youth,  as well as how they intended to prevent the lithium ion batteries from exploding. Failure to do so means the products will likely be banned from the market.

However, the FDA has yet to issue a final ruling regarding JUUL products, which studies have shown are as addictive as smoking Marlboro cigarettes and have higher nicotine delivery rates than other e-cigarettes. Given JUUL’s massive share of the vaping market, it is probably the most highly anticipated of the rulings.

Currently, more than 4,500 JUUL lawsuits are being pursued against the company by individuals, school districts and municipalities, each involving similar allegations that the e-cigarette manufacturer caused a new generation of teens and young adults to become addicted to nicotine by encouraging minors or prior non-smokers to use their vaping products.

JUUL is currently facing allegations claiming the manufacturer mined the middle and high school environments with easily concealable USB-like vaping products containing a highly addictive nicotine salt formulation in an effort to make life-long customers out of children.


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