The U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products. The foundational rules provide additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports – two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
The finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act.
“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,” said Acting FDA Commissioner Dr. Janet Woodcock. “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.”
Mitch Zeller, director of the FDA’s Center for Tobacco Products, added that conducting a review of new tobacco products before they can be legally marketed is a critical responsibility of the FDA. “These final rules will provide greater clarity and efficiency in review of new tobacco products by describing information that any company must provide if they seek to market a new tobacco product in this country,” said Zeller.
On Jan. 19, 2021, the PMTA and SE final rules were displayed in the Federal Register, but did not publish. On Jan. 20, 2021, a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules were withdrawn at that time. The newly-issued rules reflect clarifying changes made from the previous versions, but no significant substantive changes. Both final rules are effective Nov. 4, 2021. Beginning on the effective date, applications submitted through these pathways must meet the requirements described in the final rules.
SE Final Rule
The FDA expects the SE pathway to market to continue being the most commonly utilized pathway for applications for cigarettes, smokeless tobacco, cigars, hookah tobacco and roll-your-own tobacco.
In order for a new tobacco product to be found substantially equivalent, the FDA must determine either that it has the same characteristics as a predicate tobacco product, or that it has different characteristics than the predicate tobacco product but any differences in characteristics do not cause the new tobacco product to raise different questions of public health.
As explained in the SE final rule, the SE Reports that the FDA has received range widely in the level of detail they include. Some of these reports include very little information on the comparison of the new tobacco product with a predicate tobacco product while other reports include much more.
In addition to these foundational rules, the FDA is continuing to work toward issuing proposed product standards to ban menthol as a characterizing flavor in cigarettes and ban all non-tobacco characterizing flavors (including menthol) in cigars. The proposed product standards will be based on clear science and evidence establishing the addictiveness and increased appeal of these products. There is also strong evidence that a ban on menthol in cigarettes will help people quit, the agency said in a statement. These actions are an important opportunity to achieve significant, meaningful public health gains and advance health equity.
The FDA continues to conduct premarket review of thousands of applications, which represent more than 6.5 million products, including those submitted on or before the September 9, 2020 deadline. To date, the FDA said it has taken action on over 96% of the applications submitted by that deadline, including issuing marketing denial orders for more than one million flavored ENDS products