FDA Regulations
The U.S. Food and Drug Administration (FDA)’s Center for Tobacco Products regulates the manufacturing, marketing, and distribution of tobacco products.
The FDA’s authority originally was limited to cigarettes, smokeless tobacco, and roll-your-own tobacco. However, in August 2016, it issued a regulation deeming other Smokeless Products, such as Vapour Products and Oral Nicotine Pouches, to be tobacco products under the agency’s authority.[3]
The FDA has recognised the principles of harm reduction, and it weighs the health impact on the public as part of its Premarket Tobacco Product Application (PMTA) process. Additionally, the Modified Risk Tobacco Product (MRTP) process is specifically designed to recognise reduced-risk and reduced-exposure products, by authorising the use of product claims to alert adult smokers to products considered to be of reduced exposure and/or risk, so that they might consider the claims in making purchasing decisions.
FDA’s Regulatory Process
Smokeless Products, including Heated Products, Vapour Products, Oral Tobacco Products, and Oral Nicotine Pouches, are subject to various statutory and regulatory requirements, including the following:
- Premarket authorisation, including existing products (that have been modified or that were not previously authorised), and net new entrants to the market;
- Ban on sales to those under 21 years of age;
- Requirements to place text health warning statements on packaging and advertising; and
- Requirements that manufacturers submit ingredient information and product listings to regulatory authorities.
Premarket Review Requirements
All tobacco and non-medicinal nicotine-containing products not on the market prior to 15 February 2007 require FDA authorisation (‘pre-market review’) in order to stay on (or enter) the market.
For new-to-market products, manufacturers generally must submit a PMTA[4], which must contain sufficient scientific evidence to demonstrate that marketing the product is “appropriate for the protection of the public health.” The FDA evaluates the evidence provided to determine whether the potential risks and benefits of the marketing of a product would have a net benefit to public health, including tobacco product consumers as well as non-consumers.
Many improvements to devices, such as for ease of use, toxicity, and consistency of delivery, cannot be introduced without an appropriate filing and related marketing order.
Tobacco-flavoured Vuse Solo, Vuse Ciro, Vuse Vibe, and Vuse Alto have all received Marketing Granted Orders (MGOs) through the PMTA process
Figure 1. Premarket Tobacco Product Application (PMTA) Status [5]
PMTAs received by FDA
26,644,627*
Number of Marketing Granted Orders (MGOs)
1,488,684*
Combined number of PMTAs refused acceptance and refused filing
24,919,028*
Number of Marketing Granted Orders (MGOs)
67**
Percent of MGOs for devices
24%
Percent of MGOs for Consumables**
Heated Products
7%
Vapour Products
31%
Percent of Heated Product Consumable MGOs, Tobacco Flavoured
72%
Percent of Heated Products Consumable MGOs, Menthol or Non-Tobacco Flavoured
28%
Percent of Vapour Product Consumable MGOs, Tobacco-Flavoured
85%
Percent of Vapour Products Consumable MGOs, Menthol or Non-Tobacco Flavoured
15%
* Note: Totals reflect the FDA’s latest metrics covering Oct. 2019 – Sep. 2025 for Heated Products, Oral Nicotine Pouches and Vapour Products PMTAs
** Total from 1 October 2019 to 30 November 2025. FDA, Searchable Tobacco Products Database, accessed 11 December 2025.
Modified Risk Tobacco Product Requirements
The 2009 Family Smoking Prevention and Tobacco Control Act introduced the term ‘Modified Risk Tobacco Product’ (MRTP), defined as: “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”[6].
Manufacturers may apply to the FDA for a modified risk order, or a modified exposure order, which necessitates the submission of a vast amount of supporting material – including epidemiological data, biomarker data, preclinical toxicology, and information on projected behaviour and marketing impact – to support the application.
Successful applications allow for specific reduced risk or reduced exposure claims to be made on specific brand variants of tobacco or nicotine-containing products for a time-limited period, subject to ongoing post-market review and reporting requirements. Approved claims then can be placed on advertising materials as well as on product packaging, as specified in the MRTP order issued by the FDA.
PMTA & MRTPA Process
Footnotes
* Totals reflect the FDA’s latest metrics covering Oct. 2019 – Sep. 2025 for Heated Products, Oral Nicotine Pouches and Vapour Products PMTAs
** Total from 1 October 2019 to 30 November 2025. FDA, Searchable Tobacco Products Database, accessed 11 December 2025.
References
A full list of references for this page can be found in the section 11. References.
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