The ABCs of FDA Tobacco Product Review Applications

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    The ABCs of FDA Tobacco Product Review Applications

    In 2009, the Family Smoking Prevention and Tobacco Control Act authorized the U.S. Food and Drug Administration (FDA) to regulate cigarettes, smokeless tobacco and roll-your-own (RYO) tobacco products. This federal law required cigarettes, smokeless and RYO tobacco first introduced into the marketplace or modified after Feb. 15, 2007, to receive marketing authorization from the FDA prior to being offered for sale. This same marketing authorization requirement was later extended by the FDA to cigars, pipe tobaccos, electronic cigarettes, vapor products, hookah products and alternative nicotine products—referred to as “deemed” products—and made effective Aug. 8, 2016.

    In the coming months, the FDA will be requiring manufacturers of deemed tobacco products (that is, all products other than cigarettes, smokeless tobacco and RYO) to file marketing authorization requests by Sept. 9, 2020, or be subject to FDA enforcement. Note that the original filing deadline was May 12, 2020, but the FDA obtained court permission to extend the deadline by 120 days due to the impact of the Coronavirus.

    The FDA is very limited in what information it can disclose regarding an application’s status. Some manufacturers have already sent out communications to their retail and wholesale customers indicating that they are complying with the market authorization filing requirements for their particular family of products. These communications may serve as confirmation that those products may remain on the market during the FDA review process. In the absence of communication from manufacturers, retailers and wholesalers should consider contacting manufacturers directly to inquire about whether market applications have been or will be filed for the company’s products.

    The FDA’s requirements for market authorization applications depends on various factors, including the date of product availability in the marketplace. This article is an in-depth review of the FDA’s marketing authorization process that will affect a significant number of tobacco products currently on the market.

    Marketing Authorization Submissions
    All tobacco products that were first introduced into the market or modified after Feb. 15, 2007, must receive FDA authorization. Manufacturers satisfy the marketing authorization requirement primarily through one of the following two product authorization pathways.
    The first type of marketing authorization submission is known as a substantial equivalence (SE) report. In this pathway, a manufacturer must demonstrate that a new product either has the same characteristics as a “predicate” product (either a grandfathered product that was already on the market as of Feb. 15, 2007, or a product that has previously received an SE marketing authorization), or that the new product does not raise different questions regarding public health.

    This approach is most common with changes to existing combustible or moist smokeless tobacco products.

    The second kind of marketing authorization submission is called a premarket tobacco product application (PMTA). The FDA’s PMTA review, among other things, evaluates a product’s risk to the individual user as well as its possible impact on the population, taking into consideration both tobacco users and non-users. A product will be granted a PMTA marketing authorization order by the FDA if the regulatory agency finds that marketing of the new product would be “appropriate for the protection of the public health.”
    A PMTA will be most common among new product categories such as e-cigarettes, e-vapor, hookah products, nicotine gels and novel oral alternative nicotine tobacco products.