By David B. Clissold –
On November 10, 2015, FDA announced that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. The FDA press release describes marketing orders for eight Swedish Match North America, Inc. snus smokeless tobacco products marketed under the “General” brand name. The PMTAs were apparently all submitted on March 11, 2015, as reflected in multipage “Decision Summaries” for each posted by FDA.
As we previously discussed, under the Family Smoking Prevention and Tobacco Control Act of 2009, if a tobacco product is not found to be “substantially equivalent” (SE) to a tobacco product on the market as of February 15, 2007, and is not exempt from an SE determination, then it is a “new tobacco product” subject to premarket review by FDA. Among other things, a PMTA must include:
- full reports of investigations of health risks posed by the tobacco product, which FDA interprets to mean both favorable and unfavorable studies regardless of whether the studies were conducted in the U.S. or abroad, and regardless of whether they complied with human subject protection guidelines;
- a “full statement of all components, ingredients, additives, and properties, and of the principle or principles of operation” of the product; and
- a “full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, where relevant, packing and installation a full description” of the product.
A PMTA must also include “information sufficient to enable FDA to make a finding that the marketing of a new tobacco product is ‘appropriate for the protection of the public health’” within the meaning of FDC Act § 910(c)(4).
According to the FDA press release, “[t]he PMTA decisions for these products reflect evidence showing that these products, marketed as described in the manufacturer’s application, would result in a low likelihood of new initiation, delayed cessation or relapse . . . [and] that these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively.” However, the press release emphasizes that the company may not claim that the products are “FDA approved,” and that the company must receive a separate modified risk tobacco product (MRTP) authorization in order to make any claims of reduced exposure or reduced risk. Swedish Match North America, Inc. has submitted MRTP applications to make such claims for at least some products bearing the “General” brand name, and these MRTP applications were reviewed by the Tobacco Product Scientific Advisory Committee in April of 2015. According to FDA’s website, those MRTP applications are still under FDA review.
Each PMTA “Marketing Order” identifies certain regulatory obligations that accompany the marketing of the new tobacco product. These obligations include recordkeeping, adverse event reporting, and annual reporting requirements. The annual reports must include, among other things, sales and distribution information including total dollar amounts broken down by census region and retail outlet, as well as “data on current product users” broken down by age, gender, and race/ethnicity. This information will “help FDA determine whether continued marketing of [the] tobacco product is appropriate for the protection of the public health or whether there are or may be grounds for withdrawing or temporarily suspending” the PMTA order.