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.

    PMTA Content and Review Process
    A PMTA is an extensive submission that the FDA subjects to a thorough review process. To be complete, a PMTA needs to include, among other elements, the following information and documentation:

    • A full statement of the ingredients, additives and properties of the tobacco product.
    • Published reports from studies and investigations that show the health risks of the tobacco product and whether the tobacco product presents less risk than other tobacco products.
    • Clinical human study outcomes based on the use of the tobacco product.
    • A full description of the methods used in­—and the facilities and controls used for­—the manufacturing, processing and packing of the tobacco product.

    In general, the FDA follows a three-step PMTA review process. At each juncture, the agency can reject a PMTA.

    • First, upon receipt of a PMTA, the FDA conducts an administrative review to verify that the tobacco product falls under the FDA’s jurisdiction and confirms that the required information accompanies the application. At this point, the FDA may issue either a letter to accept a PMTA or a letter to refuse to accept an application.
    • Second, the agency conducts a preliminary scientific review to ensure the application contains the required documentation, research and reports to qualify for a substantive review. If the required documentation is submitted, the FDA issues a letter of filing to the manufacturer. At this point, the FDA may also refuse to file an application.
    • Third, the FDA conducts a substantive review of the application and scientific research. Following this, the FDA issues a PMTA marketing order authorizing the sale of the tobacco product or a “no marketing order” denying the sale of the product. If the FDA issues a no marketing order for a tobacco product, the product is deemed unlawful and therefore must be removed from the market.

    Market Authorization Enforcement
    FDA enforcement of the marketing authorization requirement varies based on product type and date of availability in the market. In general:

    • All tobacco products that were on the market on or before Feb. 15, 2007, are “grandfathered” and therefore exempt from the premarket authorization requirement. This means that manufacturers are not required to submit SE or PMTA applications for grandfathered products to remain on the market, but the products must comply with all other FDA tobacco regulations.
    • New cigarettes, smokeless and RYO products introduced between Feb. 15, 2007, and March 22, 2011, were required to file marketing authorization submissions by March 22, 2011. Products for which manufacturers did so are referred to as “provisional” and may continue to be marketed unless the FDA issues an order declaring otherwise.
    • New cigarette, smokeless and RYO products introduced after March 22, 2011, must receive a marketing order from the FDA prior to being offered for sale.
    • The FDA previously extended timelines to submit tobacco product review applications for “deemed” products, including cigars, pipe tobaccos, electronic cigarettes, vapor products, hookah products, alternative nicotine products and heated-tobacco products introduced between Feb. 15, 2007, and Aug. 8, 2016.
    • Based on a recent court order, manufacturers of these products must now file SE or PMTA marketing authorization requests by Sept. 9, 2020. The FDA may allow these products to remain on the market for up to one year, or potentially even longer, during the application review period.
    • To be clear: The Sept. 9, 2020, deadline applies to all new (non-grandfathered) deemed tobacco products that were introduced after Feb. 15, 2007, including cigars, pipe tobacco, electronic cigarettes, vapor products, hookah products, nicotine gels and alternative nicotine products.
    • This can be achieved through either the SE or PMTA pathway. In fact, many brands of cigars, pipe tobaccos and some of the other deemed tobacco products are likely to be substantially similar to a tobacco product that was already on the market as of Feb. 15, 2007. In those cases, manufacturers can file SEs with the FDA by Sept. 9, 2020. At the same time, there were no electronic cigarette, vapor or alternative nicotine products on the market as of Feb. 15, 2007, which means that there is no substantially equivalent product to rely on to file an SE. For all of those products, manufacturers are required to file PMTAs with the FDA by the Sept. 9, 2020, deadline.
    • It is important to know that one SE or PMTA application is required per product SKU or per brand family, which is the reason why such a high number of PMTAs will likely be filed.
    • “Deemed” products, including cigars, pipe tobaccos, electronic cigarettes, vapor products, hookah products, alternative nicotine products and heated-tobacco products introduced to the market after Aug. 8, 2016, must receive a marketing order from the FDA prior to being offered for sale.

    Understanding the Status of Product Applications
    As you can see, some products currently on the market may not be authorized to be sold after Sept. 9, 2020, if the manufacturers of those new deemed products do not submit a market authorization application.

    The process will also continue to unfold. As outlined above, some products for which an application is submitted may receive “refuse to accept,” “refuse to file” or “no marketing order” determinations. If at any point the applicant receives one of these negative determinations, the product becomes unlawful, and it therefore cannot be legally sold.

    Under federal law, the FDA is, in general, prohibited from disclosing information about pending market authorization applications or even disclosing which product applications have been submitted. Indeed, the FDA has already indicated that it will not publish a list of those SE or PMTA applications that have been accepted for review by the agency or any status updates on a product’s review progress.

    This means that retailers and wholesalers will need to rely on manufacturers to inform them of whether they have submitted timely applications or have received a negative decision at any point in the process.

    This story first appeared in the May/June 2020 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

    Contributed by Thomas Briant, Executive Director, National Association of Tobacco Outlets (NATO)