Dr. Lawrence Deyton, the Director of the FDA's Center for Tobacco Products, has released a letter announcing that the FDA plans to take steps to ensure that appropriate regulatory mechanisms govern all tobacco products and all other products made or derived from tobacco.
Dr. Deyton's letter can be found on the FDA's Web site by clicking here.
Response to Soterra Court Decision: The letter released by the FDA is in response to a recent decision by the U.S. Court of Appeals for the District of Columbia Circuit in the case titled Soterra, Inc. v. Food & Drug Administration.
In this decision, the Circuit Court of Appeals held that e-cigarettes and other products "made or derived from tobacco" can be regulated as "tobacco products" under the FDA's Tobacco Control Act, and are not drugs or devices unless they are marketed for therapeutic purposes. The FDA has decided not to appeal the Soterra decision to the U.S. Supreme Court.
In his letter, Dr. Deyton states that although the Tobacco Control Act "places certain 'tobacco products' immediately under the general controls and premarket review requirements (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of 'tobacco products.'"
Dr. Deyton goes on to state that the FDA plans to take four specific steps "to ensure that appropriate regulatory mechanisms govern all 'tobacco products' and all other products made or derived from tobacco after the Soterra decision."
Briefly, these four steps include the following:
Propose a regulation that would extend certain existing FDA tobacco regulations to other categories of tobacco products to make these products "subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for 'new tobacco products' and 'modified risk tobacco products.'"
Consider issuing a guidance document and/or a regulation on "therapeutic" claims.
Finalize a draft guidance that prohibits the marketing of "tobacco products" in combination with other FDA-regulated products.
Grandfather tobacco products marketed as of February 15, 2007, which have not been modified since then, and to not subject these products to premarket review as "new tobacco products." NATO will monitor FDA action on this matter and continue its dialogue with the agency regarding its plan to extend certain FDA regulations to other tobacco products.