Exemption from Substantial Equivalence
When may a tobacco product be considered for an exemption from substantial equivalence?
A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence if:
- The product is a modification of another tobacco product and the modification is minor
- The modifications are to a tobacco product that may be legally marketed under the FD&C Act
- A Substantial Equivalence Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for the protection of public health
- The modified tobacco product is marketed by the same organization as the original product
- An exemption is otherwise appropriate
Before legally marketing your product, you must obtain written notification that FDA has granted the product an exemption from demonstrating substantial equivalence. In addition, at least 90 days before commercially marketing the product, you must submit a report notifying FDA of your intention to do so and establishing that your product is covered by a granted exemption. (See 21 CFR 1107.1 and Section 905(j) of the FD&C Act.)
FDA is proceeding with its review of substantial equivalence (SE) reports submitted by industry. As part of its SE review process, FDA has taken steps to communicate with manufactures about the status of their tobacco product submissions. More specifically, FDA has completed jurisdictional reviews for nearly all SE submissions with notifications provided to the submitters about whether or not their product is currently being regulated by the Center for Tobacco Products (CTP). Additionally, FDA has sent “Advice and Information Request” letters to some submitters whose reports were missing administrative and/or scientific information, requesting clarification or the submission of the missing information.
FDA has also notified some manufacturers that have requested a determination on the eligibility of their product to serve as a predicate, that their product is eligible because the Agency has determined that the product was commercially marketed in the United States as of February 15, 2007.
This web content highlights provisions of the Food, Drug and Cosmetic Act (FD&C Act). It is not intended to be comprehensive or reflect FDA's interpretation of the Act. For complete information, you must read the entire law. For your convenience, the section number of the FD&C Act is referenced and relevant sections are linked to throughout the web content.