The US Food and Drug Administration (FDA) has finalised two key rules for companies seeking to market new tobacco products, according to an FDA press release.

Both finalised rules provide further information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTA) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways manufacturers can choose when seeking marketing authorization from the FDA for a new tobacco product.
Under the PMTA pathway, usually chosen for electronic nicotine delivery systems (ENDS), manufacturers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health. According to the press release, the final rule ensures that the applications contain all sufficient information for the FDA’s evaluation and states the manufacturers must keep records of their tobacco products to show they are being legally marketed.
The SE pathway, which is commonly utilized for applications for cigarettes, smokeless tobacco, cigars, hookah tobacco and roll-your-own tobacco, means the FDA must determine either that a new product has the same characteristics as a predicate tobacco product, or that it has different characteristics than the predicate tobacco product but does not raise different questions of public health.
“The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn, M.D.
“These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”