The Food and Drug Administration (FDA) has released an Advanced Notice of Proposed Rule Making (ANPRM) to lower nicotine levels in tobacco.
While this is just the first step in a long-term regulatory process, the notice suggests the FDA is taking a serious look at developing a tobacco product standard and reducing nicotine levels in tobacco products.
In a statement, FDA Commissioner Scott Gottlieb said the FDA “believe[s] this unprecedented approach to nicotine and tobacco regulation [in the ANPRM] not only makes sense, but also offers us the best opportunity for achieving significant, meaningful public health gain.”
The proposal is part of a comprehensive, multi-year plan by the FDA to reduce tobacco-related disease and death.
It is the first of three ANPRMs that the FDA intends to issue. ANPRMs on flavored tobacco, including menthol, and premium cigars will follow.
The FDA also indicated it will take a fresh look at provisional Substantial Equivalence applications for products currently on the market; will issue specific guidance for Modified Risk Tobacco Products (MRTP); and will closely examine the issue of innovation and the role that alternative nicotine delivery products that do not involve combustion or inhalation can play.
With respect to the notice, the FDA is requesting public input on the following questions:
- What potential maximum nicotine level would be appropriate (per the ANPRM, the FDA is particularly interested in comments about the merits of nicotine levels at 0.3, 0.4, and 0.5 milligrams of nicotine per gram of tobacco filler).
- How a maximum nicotine level should be measured.
- If a product standard should be implemented gradually or all at once.
- Whether the product standard should cover additional combustible tobacco products or other products.
- What unintended consequences (e.g., illicit trade, or compensatory smoking) could result from this rule.
Comments are due to the FDA by June 14.
