This week, the Food and Drug Administration (“FDA”) released a new guidance that creates three tracks for showing that a new tobacco product is “substantially equivalent” to one that has already been on the market. Substantial equivalence is a key concept in the regulation of tobacco because, under the Family Smoking Prevention and Tobacco Control Act and the Food, Drug and Cosmetics Act, new tobacco products must undergo a lengthy process to receive premarket approval from the FDA unless the products are “substantially equivalent” to products that were sold before February 15, 2007. The new guidance, available here, is not binding on the FDA, and only “represents the current thinking” of the agency.
Under the regime laid out in the guidance document, there are at least three means of creating “new” products by modifying previously marketed products: by altering the composition of the product, by changing the name or packaging of the product, or by increasing or decreasing the quantity in which the product is sold. The three types of newly modified products are subject to three different tracks to “substantial equivalence” approval under the FDA’s guidance letter.
When the company changes an ingredient or additive in the tobacco product, it must submit a full substantial equivalence application. The full application requires, among other things, a listing of all the ingredients and materials in the old and new products, laboratory analyses of any potentially harmful constituents, and data demonstrating the equivalence of the new ingredients or materials. The FDA may take three months or more to complete its review of a standard substantial equivalence application.
Under the new guidance letter, if the company has only changed the name or branding of the tobacco product, the company may also be required to submit an application for a substantial equivalence determination. However, the agency’s guidance does not draw a bright line on what changes to the packaging of the product are substantial enough to render the previously marketed product a “new” product; instead, it states that a product with new labeling is new “if consumers are likely to perceive it as ‘new’ by virtue of the different label.” For instance, the agency suggests that changing the background color of the package from green to red would be enough change render the product a “new” product, while changing the color from white to cream would not. The agency’s letter does not provide guidance on the ways in which petitioners might show how consumers will perceive packaging in situations where the packages are less dissimilar than a change between red and green. If the change to the packaging does require a substantial equivalence determination, the guidance letter provides for an abbreviated application process that requires less information than when a change to the ingredients is made.
Perhaps most surprising, the agency also opined that a product is “new” even if the company only changes the quantity in which it is sold, such as–in the agency’s example–selling 24 cigarettes in a pack instead of 20. The agency claims that changing the quantity in the package amounts to changing the “amounts of ingredients, materials, [or] other features” in the product. Under the guidance document, if the company changes only the quantity in which the product is packaged, it must submit “[s]cientific data demonstrating that the change in product quantity is not likely to alter consumer use behavior.” If the company had already changed the quantity in which the product is packaged before the guidance letter was released, it has only 30 days to submit this data to the agency.
The FDA plans to place the branding- and quantity-change applications in separate queues from the ingredient-change applications. The agency anticipates that it will take less time for it to review branding and quantity substantial equivalence applications than it does for ingredient-change applications, but it has not yet provided specific timelines for review.