LAKEVILLE, Minn. — With the upcoming May 12, 2020, deadline for tobacco manufacturers to file premarket authorization applications with the U.S. Food and Drug Administration (FDA) to keep products introduced in the market after Feb. 15, 2007, on the market, NATO has produced an in-depth article reviewing the FDA’s Substantial Equivalency and Premarket Tobacco Application (PMTA) processes.
Here are highlights from "The ABCs of the FDA Premarket Applications."
In 2009, Congress authorized the FDA to regulate most traditional tobacco products (cigarettes, smokeless tobacco and roll-your-own tobacco); those products on the market as of Feb. 15, 2007, were grandfathered in and require no FDA approval to remain on the market.
Tobacco products first introduced after Feb. 15, 2007, or modified after Feb. 15, 2007, need FDA approval before being sold. This requirement was later extended to other tobacco products, including cigars, pipe tobacco and new product categories that simply did not exist in 2007, such as electronic cigarettes, vapor products and alternative nicotine products.
Two different application pathways are available to seek FDA marketing approval:
- Substantial equivalence (SE): A manufacturer must demonstrate the product has the same characteristics as a grandfathered product or a product with SE approval, or that the new product does not raise different public health questions. This is most common for changes to traditional products.
- Premarket tobacco application (PMTA): This is a more involved application and must include information and studies on the product’s risk to the user and impacts on both users and nonusers. Authorization to market the product will be granted if the FDA finds selling the new product is “appropriate for the protection of the public health.” PMTAs will be most common among the new product categories.
A PMTA application covers one SKU or brand family. The manufacturer must provide information on ingredients, additives and properties; health risks and whether the product presents less risk than other products; clinical human studies based on product use; and methods, facilities and controls in manufacturing, processing and packing.
The FDA applies a three-step PMTA review process. First, an administrative review verifies FDA has jurisdiction over the tobacco product and the application contains the required information. Second, a preliminary scientific review is conducted to ensure that the application contains the required documentation, research and reports. Third, a substantive review of the application and scientific research is undertaken to determine whether the FDA will issue a Marketing Approval Order, authorizing sale, or a No Marketing Order, requiring removal from the market.
Cigarettes, smokeless and RYO products marketed on or before Feb. 15, 2007, need no FDA authorization. Those introduced between Feb. 15, 2007, and March 22, 2011, were required to file for approval by March 22, 2011, allowing them to be marketed unless the FDA orders otherwise. Cigarette, smokeless and RYO products introduced after March 22, 2011, must receive FDA approval prior to being offered for sale.
Manufacturers of cigars, pipe tobacco, electronic cigarettes, vapor products, hookah, alternative nicotine products and heated tobacco products introduced after Feb. 15, 2007, must file SE or PMTA marketing authorization requests by May 12, 2020. FDA may allow these products to remain on the market during the application review. Many cigars, pipe tobacco and some other traditional products are likely to use the SE procedure; however, because there were no electronic cigarette, vapor, alternative nicotine products or heated products marketed as of Feb. 15, 2007, manufacturers of these new categories of products are required to file PMTAs with the FDA by May 12, 2020, or the products can no longer be sold on the market.
If an application is filed after May 12, 2020, the product may not be sold until the FDA approves the application. If the application is filed by the May 12 deadline but rejected by the FDA, the product may no longer be sold. The issuance by the FDA of a Marketing Authorization Order in response to a filed PMTA means the product may be sold.
The FDA will not publish a list of pending applications, so retailers and wholesalers should consider contacting manufacturers directly and inquiring whether they have filed for FDA approval by the deadline.
Thomas Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at firstname.lastname@example.org.