Earlier today, U.S. Food and Drug Administration (FDA or the Agency) Commissioner Scott Gottlieb, M.D., announced FDA’s issuance of an advance notice of proposed rulemaking (ANPRM) to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels (Nicotine ANPRM).  Gottlieb’s announcement comes nearly eight months after the Agency unveiled its planned tobacco regulatory policy shift to place nicotine, and the issue of addiction, at the center of FDA’s tobacco regulatory efforts, which we discussed here.

In addition to offering some of the details of the Nicotine ANPRM, Gottlieb also indicated today that FDA will soon issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – play in initiation, use, and cessation of tobacco products (Flavor ANPRM), and a second to solicit additional comments and data related to the regulation of premium cigars (Premium Cigar ANPRM).  As reported by Inside Health Policy on March 7, 2018, the White House Office of Management and Budget (OMB) has already cleared the Menthol ANPRM and the Premium Cigar ANPRM.

The Nicotine ANPRM, which will be published in the March 16, 2018 edition of the Federal Register, provides a wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and seeks comment from the public as well as additional research and data for public review for FDA to consider as it evaluates a nicotine product standard.  More specifically, FDA is asking for feedback on a number of questions, including:

• What potential maximum nicotine level would be appropriate for the protection of public health?
• Should a product standard be implemented all at once or gradually?
• What unintended consequences - such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by smoking more - might occur as a result?
• How should potential consumer surplus or utility loss from the removal of nicotine in cigarettes be considered, given the availability of other sources of nicotine such as electronic nicotine delivery systems (ENDS) (e.g., c-cigarettes and vapor products) and the continued availability of combustible tobacco products?

On the topic of ENDS, the Agency refers to such products in the Nicotine ANPRM as “potentially less hazardous” than other tobacco products (i.e., combustible tobacco products).  This is a continuation of a theme introduced for the first time in FDA’s announcement in July 2017 that within the continuum of risk of tobacco products, nicotine is most harmful when delivered through smoke particles in combustible cigarettes.

With regard to the soon-to-be released Flavor ANPRM, as some may know, there is already a flavored combustible cigarette ban in place, as established by in the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).  However, Congress specifically carved menthol out of that ban, and mentholated cigarettes continue to be available.  In addition, the flavor ban does not apply to non-combustible products (i.e., ENDS products), and flavored vapor products are wildly popular.  This begs the question: what exactly will the Flavor ANPRM contain?  Recall the language used by Commissioner Gottlieb in today’s announcement: FDA plans to seek comment on “the role that flavors – including menthol – play in initiation, use and cessation of tobacco products.”  If FDA moves to restrict menthol, it would not be the first time the Agency has tried to regulate the flavor.  By way of background, in July 2013, FDA issued an ANPRM to obtain public input on menthol in cigarettes but the Agency never moved forward with regulatory action on the same, due in large part to a successful industry challenge to the menthol report issued by FDA’s Tobacco Products Scientific Advisory Committee (TPSAC).  While the U.S. Court of Appeals for the D.C. Circuit eventually upheld the Agency’s right to rely on TPSAC’s menthol report, FDA did not pursue further regulatory action.  In addition to or in lieu of menthol, the ANPRM will likely address ENDS product flavors.  Per the pre-rule abstract on OMB, Office of Information and Regulatory Affairs’ (OIRA) website, the “Kid-Appealing Flavors in Tobacco Products…ANPRM will seek information on how [FDA] might regulate flavors in tobacco products to limit appeal to youth while taking into account the potential role that some flavors may play in helping some users transition away from combusted products.”  This excerpt sums up nicely the current debate about flavored ENDS products: how does the Agency limit appeal to youth while preserving adult choice and helping adults transition away from combustible products, which FDA suggests could be more harmful than ENDS products?

On the topic of premium cigars, Commissioner Gottlieb indicated in a speech last July that FDA is considering whether and how the Agency would exempt such cigars from the Deeming Rule, and that FDA plans to ask for “new information related to the patterns of use and resulting public health impacts from so-called premium cigars.”  While the Agency’s Deeming Rule covers all cigars, Gottlieb has said that FDA will “explore any new and different questions raised, and seriously consider any additional data submitted relevant to the appropriate regulatory status of premium cigars.”  It is expected that the Agency will ask for this and other feedback in its Premium Cigar ANPRM.

To be sure, FDA is still a long way off from promulgating nicotine, flavor, and/or premium cigar regulations.  Between now and issuing final rules, the Agency would have to, among other things: (1) consider public comments received on the ANPRMs; (2) issue proposed regulations; (3) consider public comments received on the proposed rules; and (4) issue final regulations.  Moreover, the dates by which industry would need to comply with final regulations, if any, would probably not be immediate, as effective and compliance dates would likely be staggered.  And of course the Agency could give small-scale tobacco product manufacturers even more time to comply with final rules, as is FDA’s custom.  With that said, it is possible that the Agency will merely publish the above-referenced ANPRMs and then take no further action.  As discussed above, there is some precedent for this in the tobacco regulatory space.  On the other hand, Commissioner Gottlieb has addressed repeatedly the importance of these dockets, including in his December 2017 blog post on FDA’s major policy goals for 2018 and in a January 2018 speech to Agency staff regarding the same.

Beyond announcing the issuance of the Nicotine ANPRM and indicating that release of the Flavor and Premium Cigar ANPRMs is imminent, Commissioner Gottlieb also discussed that the Agency is continuing to re-evaluate and modernize its approach to the development and regulation of safe and effective medicinal nicotine replacement products such as nicotine gums, patches, and lozenges that help smokers quit.  Gottlieb, together with Janet Woodcock, M.D., Director of FDA’s Center for Drug Evaluation and Research (CDER), and Mitch Zeller, J.D., Director of FDA’s Center for Tobacco Products (CTP), issued a blog post on this topic in November 2017.  

Finally, Gottlieb also addressed in the announcement that the Agency plans to take new steps to ensure that its policies and processes for the regulation of tobacco products are efficient and predictable, and consistent with the mandate Congress gave FDA under the Tobacco Control Act.  More specifically, he indicated that the Agency plans to issue a series of foundational rules and guidance documents on regulatory process, including on the demonstration of substantial equivalence (SE) and the submission of applications for new tobacco products, and release soon a framework for how FDA will address provisional SEs.