The Cigar Association of America reported that the Food and Drug Administration (FDA) has clarified its proposed rule on tobacco product jurisdiction.
Parker Kasmer, an associate in the FDA Group, provided the following summary regarding the proposed rule on Friday:
“FDA issued a proposed rule today, clarifying when a tobacco product is a drug, device, combination or tobacco product subject to the Center for Tobacco Products (CTP).
In short, products derived from tobacco intended for human consumption will be treated as medical products (i.e., drug, device or combination) if their claims fall into one of two categories: (1) disease prong (cure, mitigate, treat, or prevent a disease); or (2) structure/function prong (affect structure or function of the body). For the structure/function prong, such claims are limited to those that (i) are unrelated to the effects of nicotine and (ii) different from what was claimed for cigarettes or smokeless tobacco before FDA v. Brown & Williamson (March 21, 2000).
Examples of disease claims include: “treatment of tobacco dependence”; “wean yourself off of nicotine”; “for people who wish to quit smoking”; “stop smoking aid”; “prevent relapse”; “stay quit”; “reduce withdrawal symptoms”; “helps reduce symptoms including things like [list of withdrawal symptoms]”; and “relieve withdrawal symptoms while you are on the plane.” i.e., claims common to smoking cessation or withdrawal treatments.
Examples of structure/function claims unrelated to nicotine and not made about cigarettes or smokeless tobacco before March 21, 2000 include: “promotes weight loss.”
The comment period ends Nov, 24, 2015.
Read the proposed rule.