FDA In Brief: FDA takes steps to improve transparency, efficiency of provisional substantial equivalence tobacco product review as part of comprehensive nicotine and tobacco regulatory framework

For Immediate Release: April. 5, 2018

Media Inquiries

"As part of our comprehensive plan on tobacco and nicotine regulation, we continue to take important steps to ensure our policies and processes are efficient, predictable and transparent, while upholding the FDA’s important science-based public health mission,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s actions allow us to focus resources on provisional product reviews that are likely to raise more significant public health questions ‒ rather than those that don’t. This is the latest step we’re taking as part of our comprehensive, risk-based framework focused on protecting kids and significantly reducing tobacco-related disease and death. This framework allows us to focus our resources on products that have the greatest potential to raise pertinent public health issues, so we can make sure our regulatory efforts are appropriately targeted on protecting Americans. We’re committed to making sure the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act."

Today, the U.S. Food and Drug Administration updated its processes related to its review of a subset of tobacco products – known as “provisional substantial equivalence (SE) tobacco products” – as part of the agency’s comprehensive plan on tobacco and nicotine regulation announced last July.

Under the Family Smoking Prevention and Tobacco Control Act, tobacco products introduced into commercial distribution after Feb. 15, 2007 – but before Mar. 22, 2011 – could remain on the market if an SE application was submitted no later than Mar. 22, 2011, unless the FDA issued a not substantially equivalent (NSE) order. As part of these applications, the manufacturer must demonstrate that the new product has the same characteristics as a valid predicate, or if it has different characteristics, that those changes do not cause the new product to raise different questions of public health.

These nearly 3,600 provisional applications received represent a range of product changes, some potentially more significant than others. For example, some provisional products use new blends or cuts of differently sized tobacco that vary from their selected predicate in ways that might cause the release of greater amounts of harmful chemicals. As a result, these provisional products have the greatest potential to raise different questions of public health. At the other end of the spectrum are cigarettes making changes to adopt fire standard compliant cigarette paper that is less likely to cause fires if left unattended.

As part of our review process, the FDA has categorized the applications to determine the likelihood that any new product raises different questions of public health. As a result of this assessment and the resulting categorization, the FDA is removing about 1,500 provisional SE applications from review because the agency concluded that these products are less likely to raise different questions of public health. Therefore, the agency has notified the impacted companies that these products will not undergo any further review and can continue to be legally marketed so long as they don’t undergo subsequent changes or are used as a predicate for a subsequent tobacco product. In addition to changes to fire standard compliant cigarette paper, about one third of these applications are for roll-your-own tobacco products, including rolling papers.

The agency has resolved over 1,000 SE provisional applications and will importantly continue its full multi-disciplinary scientific review for about 1,000 additional applications that have been determined to have a greater potential to raise different questions of public health, of which more than 675 are already under review. The products subject to these applications will maintain their provisional status to be legally marketed unless the FDA issues an NSE order following the FDA’s review. The agency is also establishing new performance measures for the review of provisional SE applications to help make sure that its review process is efficient, and standards are applied consistently across the review of similar products.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.