Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports rule (2021)
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The Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports rule is a significant rule issued by the Food and Drug Administration (FDA) effective November 4, 2021, that laid out content and format standards for Substantial Equivalence reports submitted by companies that sell and market tobacco products. This rule is pursuant to the Federal Food, Drug, and Cosmetic Act.[1]
Timeline
The following timeline details key rulemaking activity:
- November 4, 2021: The final rule took effect.[1]
- October 5, 2021: FDA issued the final rule.[1]
- June 17, 2019: The comment period closed.[1]
- April 2, 2019: FDA issued the proposed rule and opened the comment period.[1]
Background
Under the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act of 2011, any new tobacco products must gain premarket approval from the FDA before entering the interstate commerce market. There are three ways tobacco products can gain premarket approval, one of them being the submission of a Substantial Equivalence Report (SE Report), which proves that the product is substantially equivalent, or similar enough, to a tobacco product already on the market. Since 2011, the FDA has received thousands of SE Reports with inadequate information. The FDA issued the Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports rule to guide applicants through creating and submitting adequate SE Reports.[1]
Summary of the rule
The following is a summary of the rule from the rule's entry in the Federal Register:
| “ | This final rule provides further information on the content and format of SE Reports, including the information that SE Reports must contain. FDA is finalizing this rule after reviewing comments to the proposed rule (84 FR 12740, April 2, 2019), as well as the SE review experience the Agency has gained since enactment of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111–31). As explained in the proposed rule, the SE Reports that FDA has seen to date range widely in the level of detail included, with some reports including very little information on the comparison of the new tobacco product with a predicate tobacco product and some including much more. This final rule will provide applicants with a better understanding of the level of detail that an SE Report must contain. The final rule also addresses issues such as FDA communications with the applicant, the retention of records that support the SE Report, confidentiality of SE Reports, and electronic submission of the SE Report and amendments.[1][2] | ” |
Summary of provisions
The following is a summary of the provisions from the rule's entry in the Federal Register:[1]
| “ |
Under the final rule, an SE Report must provide information comparing the new tobacco product to a predicate tobacco product, including information that will enable FDA to uniquely identify the new tobacco product and the predicate tobacco product, as well as comparison information. The requirements will help ensure that an SE Report provides information necessary for FDA to determine whether the new tobacco product is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007 (as required by section 910(a)(2)(A) of the FD&C Act). In addition, the rule explains how an applicant can amend or withdraw an SE Report, and explains how an applicant may transfer ownership of an SE Report to a new applicant. The rule also addresses FDA communications with applicants on SE Reports and explains FDA review cycles and FDA actions, including the issuance of orders and the rescission of orders. The rule also establishes the length of time records related to the SE Report must be maintained, describes FDA's disclosure provisions, and requires electronic submission of SE Reports, unless the applicant requests and is granted a waiver.[2] |
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Significant impact
- See also: Significant regulatory action
Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.
Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]
The text of the Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports rule states that OMB deemed this rule significant, but not economically significant:
| “ | This final rule is a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because we have determined that the compliance costs are less than 0.2 percent of revenues, we certify that the rule will not have a significant economic impact on a substantial number of small entities.[2] |
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Text of the rule
The full text of the rule is available below:[1]
See also
External links
Footnotes
