Common Issues Found in Substantial Equivalence Reports
To help companies prepare a Substantial Equivalence (SE) Report for submission and to avoid common deficiencies that may result in an unfavorable decision on an application, the FDA has posted appendices (organized by product type) containing common issues the agency has identified in previous SE Reports. To provide additional clarity, these appendices are also included with the acknowledgment and notification letters related to these SE Reports.
The information included in these appendices reflects deficiencies frequently seen in previous SE Reports that FDA has reviewed, organized by tobacco product:
- Cigarettes
- Cigars*
- Pipe Tobacco Products*
- Roll-Your-Own Tobacco Products*
- Smokeless Tobacco Products*
- Waterpipes
*Documents include the outdated CTP terminology "grandfathered tobacco product." In August 2022, FDA updated the term "grandfathered tobacco product' to "pre-existing tobacco product."
Additional Resources
- Statement from FDA Commissioner Scott Gottlieb, M.D., on actions to advance our comprehensive plan to reduce tobacco-related disease and death, through new efforts to improve the tobacco product application review process, including a newly proposed rule
- Substantial Equivalence Marketing Orders
- Tobacco Product Review and Evaluation Process