Substantial Equivalence for New Tobacco Products

Substantial Equivalence for New Tobacco Products

In general, a tobacco product manufacturer must submit a premarket application and obtain a marketing authorization order before the manufacturer may introduce a new tobacco product into interstate commerce. A pre-market submission is not required if the manufacturer can demonstrate substantial equivalence for new tobacco products. The FDA Guidance states the following on substantial equivalence for new tobacco products:

A premarket application and a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act are not required, however, if a manufacturer submits a substantial equivalence report (SE Report) under section 905(j) (21 U.S.C. 387e(j)) and obtains an order under section 910(a)(2) finding that the new tobacco product is (1) substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007 and (2) in compliance with the requirements of the FD&C Act.

A key element to assessing the substantial equivalence for new tobacco products is defining “new” and “tobacco” products. The FDA defines those terms as:

The term “new tobacco product” means:

A. any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or

B. 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. (Section 910(a)(1) of the FD&C Act (21 U.S.C. 387j(a)(1)).)

The term “tobacco product” is defined as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” (section 201(rr)(1) of the FD&C Act (21 U.S.C. 321(rr)(1))). This term does not include an article that is a drug, a device, or a combination product as defined in the FD&C Act (see section 201(rr) of the FD&C Act).

If the criteria above is met then it is important to determine if a pre-market application is requires or if substantial equivalence for new tobacco products provides an exemption. There will still be reporting and a submission, but the burden is slightly reduced when compared to a pre-market application.

A second key element lies in establishing substantial equivalence for new tobacco products. Establishing substantial equivalence, as in the medical device context, must be done by identifying and comparing to a predicate product. The FDA Guidance sets the limits on what tobacco products can be used as predicates:

Under section 905(j)(1)(A)(i) of the FD&C Act, SE [Substantial Equivalence] reports may compare the new product to only products that were commercially marketed as of February 15, 2007, or products that FDA has previously determined to be substantially equivalent to a predicate tobacco product. Products that are the subject of “provisional” SE Reports, while legally sold or distributed, may not serve as predicate tobacco products under the FD&C Act unless they have been previously found to be SE.

Contact our Washington D.C. or Charlotte offices for more information on substantial equivalence for new tobacco products.