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  5. Exemption from Substantial Equivalence
  6. Questions & Answers on Exemption from SE
  1. Exemption from Substantial Equivalence

Questions & Answers on Exemption from SE

On this page:

Under what circumstances may FDA grant an exemption to substantial equivalence?

Under Section 905(j)(3) of the FD&C Act, an exemption may be granted when an additive is added or deleted or when the quantity of an existing additive is changed if FDA determines that:

  1. The modification is a minor modification to the additive of a tobacco product that can be sold under the FD&C Act (i.e., a legally marketed tobacco product);
  2. A Substantial Equivalence Report under Section 905(j)(1)(A)(i) is not necessary to ensure that allowing the product to be marketed would be appropriate for protection of the public health; and
  3. An exemption is otherwise appropriate.

Who may request an exemption from substantial equivalence requirements?

Exemption from substantial equivalence requests may be submitted by the manufacturer of a legally marketed tobacco product for a minor modification to that manufacturer’s product. The request must be for minor modification to additives (adding or deleting a tobacco additive or increasing or decreasing a quantity of an existing additive). 

What is an additive?

Additive is defined in the FD&C Act as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any tobacco product. This includes any substance intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding. The term additive does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical (Section 900(1)). 

What is the definition of a tobacco product manufacturer?

A tobacco manufacturer is anyone who manufactures, fabricates, assembles, processes, or labels a tobacco product. This includes repackers, relabelers, and those who import a finished tobacco product for sale or distribution in the United States. (Section 900(20)).

Why didn’t FDA establish categories of exempt modifications?

FDA considered whether to include categories of exemptions in the rulemaking, meaning that manufacturers could make certain types of modifications to additives in tobacco products without having to request and obtain an exemption from the substantial equivalence requirements. However, FDA determined that it does not have sufficient information at this time to establish categorical exemptions.

Although FDA is not establishing categorical exemptions at this time, manufacturers may submit a single exemption from substantial equivalence request for multiple tobacco products if the request identifies the specific products and the information submitted under 21 CFR 1107.1(b) applies to all the specified products.

A manufacturer may also submit an exemption from substantial equivalence request for a tobacco product(s) for a minor modification of an additive if the manufacturer specifies a range with a minimum and maximum quantity of additive as has been typically used for that individual tobacco product; again, the request must include the information required in 21 CFR 1107.1(b) in order for FDA to make the necessary findings.

FDA does not have sufficient information to enable us to make the findings required by the statute to support categories of exemptions, but we believe this information will develop as we review exemption requests. We intend to establish categories of exemptions when we have such information.

What information must be included in a request for exemption from the substantial equivalence requirements?

The request for an exemption from substantial equivalence must include the information described in 21 CFR 1107.1(b), including all the following:

  • The manufacturer’s address and contact information
  • Identification of the tobacco product
  • A detailed explanation of the purpose of the modification
  • A detailed explanation of why a Substantial Equivalence Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health
  • A certification signed by a responsible official of the manufacturer summarizing the supporting evidence and providing the rationale for the official’s determination that the modification does not increase the tobacco product’s appeal to or use by minors, toxicity, addictiveness, or abuse liability
  • Other information justifying an exemption, and
  • An environmental assessment under part 25 of this chapter prepared in accordance with the requirements of 21 CFR 25.40.

What is an environmental assessment?

An environmental assessment is described in 21 CFR 25.40 and, in general, is a document that provides information on the basis of which FDA can determine the environmental impact of an agency action (e.g., the action of granting an exemption from substantial equivalence).

Why must an exemption from substantial equivalence request include an environmental assessment?

FDA’s regulations implementing the National Environmental Policy Act (NEPA) of 1969 require that “[a]ll applications or petitions requesting agency action require the submission of an [environmental assessment] ….” (21 CFR 25.15(a)).

How do I submit my exemption from substantial equivalence request?

Submit online through the CTP Portal, an alternative to the existing FDA Electronic Submissions Gateway (ESG) WebTrader tool. The CTP Portal provides a convenient, secure online system for electronically submitting documents.

If you are unable to submit online, you can mail your submission to CTP's Document Control Center.

Can I submit a single exemption from substantial equivalence request for multiple tobacco products?

Manufacturers may submit one exemption from substantial equivalence request for multiple tobacco products if the request identifies the specific products and if the information submitted under 21 CFR 1107.1(b) applies to all the specified products.

A manufacturer may also submit an exemption request for a tobacco product(s) for a minor modification of an additive if the manufacturer specifies a range with a maximum and minimum as has been typically used for that individual tobacco product. Again, the request must include the information required in 21 CFR 1107.1(b) in order for FDA to make the necessary findings.

If I receive written notification that FDA has granted my request for an exemption from substantial equivalence, can I immediately introduce the product into interstate commerce?

No. Under the FD&C Act, if you obtain an exemption from substantial equivalence, you are also required to submit a report to FDA under Section 905(j)(1)(A)(ii) of the FD&C Act. In addition, you must submit an updated ingredient listing under Section 904(c) of the FD&C Act.

More specifically, under Section 905(j)(1)(A)(i) of the FD&C Act, you must report to FDA at least 90 days before introducing or delivering for introduction into interstate commerce the tobacco product for which you have obtained an exemption from substantial equivalence. While an FDA order is not required in response to a report submitted under this Section, you may not market your product until at least 90 days after the date that you submit this report. This report required under this ection must address:

  • The basis for the manufacturer’s determination that:
    • the tobacco product is modified within the meaning of the exemption provision,
    • the modifications are to a product that is commercially marketed,
    • the modifications are to a product that is in compliance with the requirements of the FD&C Act, and
    • all of the modifications are covered by exemptions granted by FDA, and
    • actions taken to comply with the requirements under Section 907 of the FD&C Act which are applicable to the tobacco product.

FDA requests that the cover letter for a Substantial Equivalence Report be prominently identified as a 905(j)(1)(A)(ii) report. FDA also requests that these reports be submitted to FDA in an electronic format that FDA can process, review and archive (see response to a previous question).

Why does the final rule include procedures for rescinding an exemption from substantial equivalence?

It is important that FDA be able to rescind an exemption from substantial equivalence to protect the public health.

How long will it take FDA to review an exemption from substantial equivalence request?

FDA intends to review exemption from substantial equivalence requests in a timely manner, and does not expect the review process to be lengthy if the request includes the information stated in 21 CFR 1107.1(b). Please note that under the rule, FDA may request additional information if necessary to make a determination. FDA will consider the exemption from substantial equivalence request withdrawn if the additional information is not provided within the requested timeframe. 

If FDA does not grant my request for an exemption, do I need to submit a different premarket submission?

If FDA does not grant your request for an exemption from the substantial equivalence requirements, you have two options for marketing your tobacco product:

  1. Submit a Premarket Tobacco Application under Section 910 of the FD&C Act, and obtain an FDA order permitting marketing, or
  2. Submit a Substantial Equivalence Report under section Section 905(j)(1)(A)(i) and obtain an FDA order finding your product substantially equivalent when compared to a predicate tobacco product and in compliance with the requirements of the FD&C Act.

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.

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