05/24/2018 - FDA’s Early Steps Under New Tobacco Regulatory Framework: Seeking Input, Shaping Policy

FDA has taken major steps in carrying out its comprehensive plan for tobacco and nicotine regulation announced in July 2017. Among these strides, the agency has issued advance notices of proposed rulemaking (ANPRMs) seeking input on three issues:

  • A potential product standard to lower nicotine in cigarettes to a minimally or non-addictive level;
  • The role of flavors—including menthol—in youth and adult use of tobacco products; and
  • Patterns of use and the public health impacts of “premium” cigars.

FDA values public input and will consider all comments when determining its regulatory options in these areas. On each topic, if the agency decides to move forward, a notice of proposed rulemaking would be issued first in the Federal Register, providing the public with another opportunity to comment.
In another example of progress under the new framework for tobacco and nicotine regulation, FDA has updated its processes related to the agency’s review of a subset of tobacco products known as “provisional substantial equivalence (SE) tobacco products.”

Three Advance Notices of Proposed Rulemaking

Potential Product Standard Limiting Cigarette Nicotine Level

In one advance notice of proposed rulemaking (ANPRM), “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,” published in the Federal Register March 16, FDA is requesting public comment on a potential product standard that would limit nicotine in cigarettes to a minimally or non-addictive level.
Cigarettes are the category of tobacco product causing the greatest public health burden. As a cornerstone of FDA’s comprehensive new framework for tobacco regulation, the type of product standard being considered has the potential to save millions of lives, in the near and longer term.
FDA is seeking comments, research, and data through June 14 on topics related to this potential product standard.


Role of Flavors in Tobacco Products

Through another advance notice of proposed rulemaking, “Regulation of Flavors in Tobacco Products,” published in the Federal Register March 21, the agency is seeking comments, data, research results, or other information related to the role of flavors—including menthol—in tobacco product use, and regulatory approaches the agency could take to better protect kids and significantly reduce overall tobacco-related disease and death. Comments will be accepted through June 19.
“In the spirit of our commitment to preventing kids from using tobacco, we are taking a closer look at flavors in tobacco products to better understand their level of impact on youth initiation,” said FDA Commissioner Scott Gottlieb, M.D., in his statement upon issuance of the ANPRM. “And as a public health agency, it’s important that we also explore how flavors, under a properly regulated framework that protects youth, may also be helping some currently addicted adult cigarette smokers switch to certain non-combustible forms of tobacco products.”


Premium Cigars: Patterns of Use, Public Health Impact

To inform FDA’s regulatory policies related to products often referred to as “premium” cigars, the agency has issued an advance notice of proposed rulemaking, “Regulation of Premium Cigars,” to seek related comments and scientific data. Specifically, the agency requests comments and information not previously submitted in association with the proposed deeming rule. Comments are being accepted through June 25.
The now-final deeming rule extended FDA’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act to cigars, among other tobacco products. The rule made requirements such as mandatory age and photo-ID checks, warning statements, and submission of health documents applicable to these additional products.
As proposed, the deeming rule presented two alternative regulatory options, one of which would have excluded “premium” cigars from FDA regulation. After carefully considering public comments, FDA concluded all cigars pose serious negative health risks, and the evidence did not provide a public health basis for FDA to exclude any type of cigars from regulation.
Given the ongoing interest on this issue—as well as the potential for new data on the topic since publication of the deeming rule—stakeholders are being provided this opportunity to submit relevant new information that could inform the agency.

Update to FDA’s Approach for “Provisional Substantial Equivalence” Tobacco Product Review

Since the Family Smoking Prevention and Tobacco Control Act became law in 2009, CTP has used its tools of product regulation to help reduce disease and death from tobacco use in the United States. As part of that effort, the agency reviews substantial equivalence (SE) applications for new tobacco products to determine if they can be sold and distributed on the market in accordance with the law.
To accomplish these goals, FDA has developed processes and policies for how it would review and issue decisions on SE applications. Earlier this month, FDA announced it has updated its processes related to the agency’s review of a subset of tobacco products known as “provisional substantial equivalence (SE) tobacco products.” The change is based on years of experience reviewing thousands of regular and provisional SE applications, and allows the agency to better use its resources while continuing to protect the public health.
On CTP’s website, you can find additional information, including an agency In Brief and Web Statement, about the provisional SE review process and FDA’s recent steps to improve transparency and efficiency of these reviews.

Agency’s Steps Under Youth Tobacco Prevention Plan

FDA is committed to efforts to restrict youth access, limit youth appeal, and reduce youth toxic exposure from tobacco products, and has begun a series of these types of efforts under its new Youth Tobacco Prevention Plan. For example, the agency has taken action involving JUUL and other e-cigarettes, and also e-liquids that kids could confuse with food products because of how the e-liquids are labeled or advertised.

Steps to Help Prevent Youth Use of JUUL, Other E-Cigarettes

FDA has announced several enforcement actions under the Youth Tobacco Prevention Plan to stop youth access to JUUL and other e-cigarettes. FDA understands that many kids are using e-cigarettes with some characteristics that may make the products more attractive to children and teens: an appearance closely resembling a USB flash drive, high levels of nicotine, and emissions that are hard to see. These types of products are more difficult for parents and teachers to detect. Several of these products fall under the JUUL brand, but other brands may have similar characteristics.
To address concerns about these products, FDA has announced a series of new efforts as part of the Youth Tobacco Prevention Plan, including conducting a large-scale, undercover, nationwide blitz to crack down on the sale of e-cigarettes—and JUUL products, in particular—to minors by both brick-and-mortar and online retailers. “Let me be clear to retailers,” said FDA Commissioner Scott Gottlieb in a statement about the enforcement actions. “This blitz, and resulting actions, should serve as notice that we will not tolerate the sale of any tobacco products to youth.”

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