Earlier this month, FDA offered draft guidance for requests for approval of modified risk tobacco products under the Tobacco Control Act. Comments on FDA’s draft guidance may be submitted by June 4, 2012.
The 2009 Tobacco Control Act prohibits tobacco companies from using descriptors like “light” or “mild,” and from marketing their products as safer than other tobacco products, unless FDA has issued an order allowing the company to market its products as having modified risk. Since the Tobacco Control Act took effect, however, the process for the required approvals has been unclear.
The draft guidance indicates that FDA has 360 days to act on a modified risk application. The guidance describes two pathways for companies to show reduced risk. The first requires robust scientific evidence to demonstrate that that a product actually reduces harm. A more lenient standard applies where the evidence showing reduced harm is incomplete, but the evidence does show reduced exposure of a particular harmful constituent.
Although there is a fairly broad scientific consensus that certain types of non-combustible tobacco products, such as smokeless tobacco and electronic cigarettes, likely offer a lower cancer risk than cigarettes, FDA’s guidance does not categorize tobacco products for varying levels of evidence required for modified risk approval. Nor does FDA’s guidance allow smokeless or electronic cigarette manufacturers to tout modified risk without the required scientific evidence.