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  1. Substantial Equivalence

Questions and Answers on SE

Q&A: Substantial Equivalence Tobacco Products 

What is the substantial equivalence pathway?

Substantial equivalence is a pathway to seek permission to market a new tobacco product that involves comparing the new tobacco product to a legally marketed predicate product.

How does the FD&C Act define substantial equivalence?

Substantially equivalent or substantial equivalence, as defined by Section 910(a)(3)(A) of the FD&C Act, refers to comparisons between a tobacco product and a predicate product when the tobacco product has:

  • The same characteristics as the predicate tobacco product; or
  • Different characteristics and the information submitted (in a Substantial Equivalence Report) contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under the new tobacco product application provisions of Section 910 because the product does not raise different questions of public health.

What is a predicate tobacco product?

FDA interprets a predicate product to mean a single tobacco product that the manufacturer will compare to its new tobacco product. For the purposes of Substantial Equivalence Reports, the new tobacco product is compared to a predicate tobacco product in determining substantial equivalence ( Section 910(a)(3)(A)). 

For more information, see Guidance for Industry and Food and Drug Administration Staff; Reports: Demonstrating Substantial Equivalence for Tobacco Products.

See the next question for what you can use as a predicate product for your Substantial Equivalence Report.

What can I use as a predicate product for my Substantial Equivalence Report?

A predicate product may be either:

  • A tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; or
  • A tobacco product that FDA has previously determined to be substantially equivalent and in compliance with the requirements of the FD&C Act.

FDA's standalone grandfathered submissions database contains grandfathered determination information from voluntarily-submitted requests for a grandfathered status review of a tobacco product.

Please note that this database does not list all grandfathered tobacco products. Substantial Equivalence Marketing Orders also contain information on predicate products.

The standalone grandfathered submission database will be updated periodically and contains original submission information that is typically released in response to a FOIA request.

Who may submit a Substantial Equivalence Report?

A manufacturer of a new tobacco product may submit a Substantial Equivalence Report if that manufacturer believes that its tobacco product is substantially equivalent to a predicate tobacco product.

How does FDA define a new tobacco product?

A new tobacco product is defined under Section 910(a)(1) of the FD&C Act as “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.”

What happens once a Substantial Equivalence Report is submitted to FDA?

Once a Substantial Equivalence Report is submitted FDA will review the report and determine whether or not the tobacco product is substantially equivalent and in compliance with the requirements of the FD&C Act. Before a new tobacco product may be commercially marketed under this pathway, the company must submit a report and FDA must issue a written order permitting the product to be marketed (Section 910(a)(2)).

What happens if I receive an order stating that my product is not substantially equivalent?

In that case, you may not legally market your product under this pathway. You may submit an application seeking permission to market your new tobacco product under the Premarket Tobacco Application provisions under Section 910 of the FD&C Act.

What happens if FDA does not receive a Substantial Equivalence Report for a new tobacco product that the manufacturer is commercially marketing?

The product is deemed adulterated under Section 902(6) of the FD&C Act and misbranded under Section 903(a)(6) of the FD&C. Continued marketing of adulterated and/or misbranded tobacco products may result in FDA taking regulatory action, including but not limited to, civil money penalty, no-tobacco-sale order, seizure, and/or injunction.

If FDA issues an order finding that a product is substantially equivalent and in compliance with the requirements of the FD&C Act, does that mean the product is safe, or safer than its predicate product?

No. There is no known safe tobacco product. The order means only that FDA has found that the new tobacco product is substantially equivalent to a predicate 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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