On October 5, 2021, the Food and Drug Administration (“FDA”) published in the Federal Register its Final Rule on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (“SE Reports”). The rule originally was displayed in January in the Federal Register, but was quickly retracted by the Biden Administration and did not publish.

According to FDA, the Final Rule reflects clarifying changes made from the previous version, but makes no significant substantive changes (although, as described below with respect to application certifications, this is not quite true). The Final Rule is important as it establishes the general procedures the agency intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. Below are some quick takes on the new rule:

Effective Date: The Final Rule applies to SE Reports filed after the rule’s effective date, which is November 4, 2021. Beginning on the effective date, SE Reports must meet the requirements described in the Final Rule.

Non-applicability to Premium Cigars: The Final Rule is “not finalized” as to premium cigars. The Final Rule adopts the definition of “premium cigars” articulated by Judge Mehta of the US District Court for the District of Columbia. FDA intends to “undertake a research effort specific to ‘premium’ cigars…and their health effects, patterns of use…and other factors.” This is a matter that we have previously blogged about.

Certifications: The Final Rule permits filers to certify when the data between the new and predicate products are identical. Notably, the Final Rule includes a modification from the January 2021 version that now requires that the certification language that each applicant must sign upon submission now include a justification for any assertion that the applicant makes that the contents of the new product are identical to those of the predicate. The Final Rule now states:

Such a justification could include, for example, the type of test data that was compared between the new and predicate tobacco products and/or a description of the quality control checks that were conducted, which demonstrate the characteristics being certified are identical. The certification also is intended to provide FDA with assurance that the applicant has fully considered the SE Report and its contents, believes there is a basis for making the findings required by section 910(a)(2) of the FD&C Act, and understands the potential consequences of submitting false information to the U.S. Government.

Container closure system: In addition to a definition of packaging, the Final Rule contains a confusing definition of “container closure system” and requires that such subsets of packaging be disclosed in the SE report. FDA’s commentary indicates its intent is that “a container closure system is a component or part of a tobacco product because of its potential to alter or affect the performance, composition, constituents, or other physical characteristics of the product.” Notably, FDA has specifically called out that “packaging material that affects the characteristics of a tobacco product, including cigars, by impacting the moisture level or shelf life of a tobacco product is a container closure system (e.g., a plastic versus a metal container of smokeless tobacco)”.

“Same characteristics”: The agency did not propose definitions of “same characteristics” and “different characteristics” under section 910(a)(3)(A) of the Food Drug and Cosmetic Act. Instead, FDA set forth a list of examples of changes that are “likely to be appropriate to proceed as same characteristics at this time.” Industry will want to scrutinize this list.

“Different questions of public health”: FDA provided further information on its thinking as to its thinking as to this phrase, although it declined to provide a definition of the term. Notable considerations were whether:

  • The new tobacco product has higher HPHC yields compared to the predicate tobacco product, and the difference in HPHC yields is greater than the analytical variability of the method used to detect it.
  • The new tobacco product has potentially higher toxicity due to an appreciable increase in an ingredient associated with adverse health effects, compared to the predicate tobacco product. For example, the evaluation of the available toxicology information may show that an increase in an ingredient between the new and predicate tobacco products demonstrates an increase in cancer risk or non-cancer hazard for users of the new tobacco product compared to those of the predicate tobacco product, and thus causes the new tobacco product to raise different questions of public health.
  • The new tobacco product compared to the predicate has the potential to affect use behavior such as an increase in initiation of the product, especially among youth or other vulnerable populations; a decrease in cessation; or use by different tobacco-use status groups.
  • The new tobacco product compared to the predicate has potentially higher abuse liability.
  • The new tobacco product has the potential to increase dependence.

Co-packaging: In the Final Rule, FDA removed a sub-category for co-packages. Instead, FDA wants the unique identification of the co-package to include the specific items needed to identify each product within the co-package. For example, if the co-package is a pouch of roll-your-own (RYO) tobacco filler that contains rolling papers inside the pouch, the applicant would identify the tobacco product as a co-packaged product and provide the unique identification for both the enclosed RYO tobacco filler and the enclosed rolling papers. Whether FDA would require an SE Report for co-packaged products where separate SE Reports are filed on the individual products that are packaged together appears to depend, at least in part, on whether the products are co-packaged within a single container closure system.

Use of standardized form: Applicants will have to use the forms that FDA provides when submitting an SE Report. We look forward to seeing these.

Characterizing flavors: The Final Rule does not define a characterizing flavor. Rather, the agency’s position is that it is up to the applicant to determine if the product has one. We anticipate this may be an area for litigation down the line as we are seeing examples where the lack of clarity on this point is creating the potential for arbitrary results.

Cross-segment comparisons: FDA is no longer requiring that the new and predicate products be in the same category and subcategory, but it noted its belief that “it would likely be difficult for an applicant to demonstrate substantial equivalence where the new product is in a different category or subcategory as its selected predicate, but it may, in rare cases, be possible for an applicant to make a showing of substantial equivalence. For example, an applicant may be able to compare a new snus tobacco product to a pouched moist snuff predicate tobacco product.” It also stated that “manufacturers of ENDS may find it difficult to show that their product is substantially equivalent to a combusted cigarette or a smokeless tobacco product because of the differences in product properties.” FDA also goes on to say:

  • If an applicant chooses to compare a new and predicate tobacco product that are not in the same category or subcategory, for FDA to be able to conduct a review of the SE Report, the applicant should provide a strong scientific justification for why a product that may differ from the new tobacco product in even the most basic of characteristics and parameters is an appropriate predicate and how any differences in characteristics do not cause the new tobacco product to raise different questions of public health.
  • For example, where the new and predicate tobacco products are not in the same category or subcategory, an applicant could provide information to demonstrate that users or likely users of the new product display very similar tobacco product use behaviors (e.g., likelihood of initiation, experimentation, switching, dual-use/polyuse, or cessation, as well as actual use patterns, frequency and amount of use) in addition to information on comparison of HPHCs exposure.

Product design and test data: The Rule revised § 1107.19(a) so that it does not require test data, target specifications and range limits be submitted in all instances, as the proposed rule would have required. Instead, § 1107.19(a) requires that SE Reports include test data (including test protocols, quantitative acceptance criteria, data sets (i.e., measured values), and a summary of the results) only when the target specification or range limits of the new tobacco product differ from the predicate tobacco product. Test data will need to be submitted for both the new and predicate tobacco products.

Fully characterizing information, like puff count: For both unfiltered, sheet-wrapped cigars, and unfiltered, leaf-wrapped cigars, Section 1107.19(a) includes the design parameters that the agency will require in an SE Report to fully characterize unfiltered, sheet-wrapped cigars and how changes to these parameters may impact public health, and contains a list of items, including puff count. FDA states that “[c]igar puff count can directly affect smoke constituent yields.” It later states that there are several test protocols recommended by CORESTA that may be appropriate for characterizing this feature, as mentioned in the next bullet.

HPHCs:   FDA defends its requirement of HPHC testing for cigars in Comment 65. Footnote 19 contains the CORESTA standards that FDA believes are appropriate cigar smoking methods.

Switching predicate products: FDA makes clear that it will not permit the applicant to change the predicate product identified in an SE Report that FDA has accepted for review. If an applicant determines that a predicate change is necessary, they should withdraw the initial SE Report and resubmit it as a new SE Report with the information related to the new predicate tobacco product.

Records retention: The Final Rule requires records supporting an SE marketing order be retained for four years from the date of the order. Because the agency has the right to insist on reviewing records relating to an original predicate where the current predicate is the result of an SE order, this is likely to counsel in favor of records for original predicates being maintained indefinitely.

Previously issued guidance: Whether the Final Rule will replace previously issued guidance is up in the air. The agency has indicated that it intends to review related guidance documents to determine whether to revise or withdraw them. In deciding whether to update or withdraw those guidance documents, FDA will consider whether the recommendations or information included in those guidance documents are outdated due to the Final Rule and will consider whether new guidance documents should be developed or whether updates should be made to existing guidance documents.