905(j) “Substantial Equivalence” Reports for Tobacco Products

January 10, 2011

By David B. Clissold

Last week, FDA released Agency's first guidance for tobacco product manufacturers concerning the introduction of “new” tobacco products.  The guidance was issued in final form since some manufacturers will need it to help them submit reports to FDA over the next few months.

A “new tobacco product” is a product that was not sold in the U.S. before February 15, 2007.  Any change made to a tobacco product after that date also makes it a “new tobacco product.”  In general, a tobacco product manufacturer must obtain an order after review of a premarket application under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (“the Act”) before the manufacturer may introduce a “new tobacco product.”  Such an order is not required, however, if a manufacturer submits a report under section 905(j) of the Act for the new tobacco product (a “905(j) report”) and FDA issues an order finding that the tobacco product is (1) “substantially equivalent” to a tobacco product commercially marketed in the United States prior to February 15, 2007 or to a product found to be “substantially equivalent” to such a product (the “predicate tobacco product”), and (2) in compliance with the requirements of the law.  The guidance describes the information manufacturers should submit in the 905(j) report in order for FDA to make a “substantial equivalence” determination.

According to this guidance, the 905(j) report should provide side-by-side quantitative and qualitative comparisons of the new tobacco product with the predicate tobacco product with respect to all product characteristics.  These include design features (components, subcomponents, specifications, etc.), a listing of ingredients (ingredient names, common names, the function of each ingredient, and the amount of each ingredient), a list of materials used, a description of the heating source used in the consumption of the finished tobacco product, an explanation of how the design, materials, ingredients, and heating source of the product are integrated to produce the final product, and a listing of “harmful and potentially harmful constituents.”  The Act requires that the manufacturer submit or make publicly available an “adequate summary of any health information related to the tobacco product” that must contain “detailed information regarding data concerning adverse health effects.”  FDA recommends that this summary be provided in the 905(j) report.

Although similar to the process used to introduce new medical devices under section 510(k) of the Act, there are some differences.  Medical devices may use more than one “predicate device” for purposes of showing substantial equivalence.  In contrast, only a single predicate tobacco product should be used for comparison purposes in a 905(j) report since “FDA believes that a meaningful scientific comparison intended to determine whether the characteristics of the products are the same or are different but present no different questions of public health cannot be made between a new tobacco product and multiple predicate products.”  In addition, FDA may request additional data needed to make a substantial equivalence determination for a tobacco product.  The additional data that may be requested for a tobacco product include consumer perception studies (data comparing consumer perceptions that could affect initiation, cessation, frequency of use, patterns of use, smoking behavior, and perceptions of harm or addictiveness), clinical data (data comparing the biomarkers of exposure and biomarkers of potential harm and human toxicity between the tobacco products), abuse liability data (animal and human studies), and toxicology data including studies to assess carcinogenic potential.

A 905(j) report must be submitted at least 90 days before marketing a tobacco product that was not marketed in the United States as of February 15, 2007.  For tobacco products first introduced after February 15, 2007, and before March 22, 2011, the manufacturer must submit the report no later than March 22, 2011, or the product will be deemed to be misbranded and adulterated.  If a 905(j) report is submitted before March 23, 2011, the tobacco product may continue to be marketed unless and until FDA issues an order that the tobacco product is not substantially equivalent to the predicate tobacco product.  If a manufacturer is not able to submit all the data and other information recommended in the guidance by the statutory deadline, FDA will permit manufacturers “who have acted diligently” in preparing their 905(j) reports “a reasonable amount of time to supplement their initial submissions.”

Categories: Tobacco