This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts.
In This Issue…
Learn about recent FDA actions under the agency’s nicotine-focused tobacco regulatory framework and Youth Tobacco Prevention Plan—all with the common goal of reducing tobacco’s disease and death toll in the United States.
On this page:
- FDA’s Early Steps Under New Tobacco Regulatory Framework: Seeking Input, Shaping Policy
- Agency’s Steps Under Youth Tobacco Prevention Plan
- Did You Know…?
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.”
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.
If such a product standard was implemented, many positive health effects could be achieved, such as addicted smokers switching completely to a potentially less harmful product or quitting tobacco altogether, and future generations being much less likely to get addicted to cigarettes in the first place. An FDA-funded study, “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” published in the March 2018 issue of the New England Journal of Medicine, considered the public health implications of one possible policy scenario for a nicotine product standard. The analysis found that about 5 million additional adult smokers could quit smoking within one year of implementation, compared to a baseline scenario. And an even greater impact could be felt over time. By the year 2100, more than 33 million people—mostly youth and young adults—could avoid becoming regular smokers. This could result in more than 8 million fewer tobacco-related deaths by the end of the century. A summary of the main findings is available on CTP’s website: “How Could Lowering Nicotine Levels in Cigarettes Change the Future of Public Health?”
“No statistical model can truly capture the full impact of this effort—including the joy from years of quality life gained with a loved one, or how much pain and suffering would be avoided for millions of families across the country,” said FDA Commissioner Scott Gottlieb, M.D., He added, “Our estimates underscore the tremendous opportunity to save so many lives if we come together and forge a new path forward to combat the overwhelming disease and death caused by cigarettes.”
The ANPRM provides examples of issues on which FDA requests input. They include:
- What potential maximum nicotine level would be appropriate for the protection of public health;
- Whether such a product standard should be implemented all at once or with a gradual, stepped approach;
- Whether a nicotine product standard should also cover additional combustible tobacco products; and
- What unintended consequences—such as the potential for illicit trade or for addicted smokers to compensate for lower nicotine by increasing the amount they smoke—might result from such a standard.
As part of its announcement of this ANPRM, FDA also issued a draft concept paper, “Illicit Trade in Tobacco Products After Implementation of an FDA Product Standard,” discussing potential illicit trade implications of product standards generally. Comments on this paper are invited through June 14 to a separate docket.
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 Gottlieb 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.”
FDA received a considerable number of public comments on previous rulemaking actions, including the July 2013 ANPRM on menthol in cigarettes and questions about flavors generally in the 2014 deeming proposed rule. The current ANPRM on flavors in tobacco products is a new opportunity to look more broadly at the issue and consider all flavors, including menthol, as we comprehensively explore their public health impact and hear from the public what regulatory action, if any, the FDA should take with respect to any tobacco products with flavors.
Topics on which FDA seeks information through this ANPRM include:
- The role flavors play in initiation and patterns of tobacco use, particularly among youth and young adults;
- The role flavors may play in helping some adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products;
- The role flavors in non-combusted tobacco products may play in quitting use of combusted tobacco products, quitting all tobacco use, or starting to use more than one type of tobacco product;
- Consumer perceptions of health risks and addictiveness of flavored tobacco products;
- Whether certain flavors used in tobacco products present potential adverse health effects on users or others; and
- The impact of local, state, and international efforts to restrict the sale or marketing of flavored tobacco products.
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.
These are among the topics on which FDA is requesting comments, data, research results, or other information not submitted in response to the proposed deeming rule:
- The definition of “premium” cigars;
- Use patterns of “premium” cigars, generally and among youth and young adults specifically;
- Public health considerations associated with “premium” cigars, including health effects;
- Studies or information regarding consumer perceptions of the health risks of “premium” cigars; and
- Studies or information on whether any applicable manufacturing, marketing, sale, distribution, advertising, labeling, and/or packaging requirements and restrictions should be applied differently to “premium” cigars compared to other tobacco products, including other cigars.
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.
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.
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.”
Among other related steps, FDA has:
- Issued warning letters to 40 retailers for violations related to youth sales of JUUL e-cigarettes;
- Sent an official request for information to JUUL Labs and additional companies requiring them to submit important documents to support a better understanding of the reportedly high rates of youth use and the particular youth appeal of these products; and
- Taken steps to preclude online sales of JUUL to minors.
The responsibility for preventing kids from getting hooked on nicotine “falls not only to FDA,” Commissioner Gottlieb remarked in his statement, “but also to the companies making these products, the retailers selling them, and the online venues that help fuel the teen popularity of, and access to, these products.”
Learn more about these actions:
- Statement from FDA Commissioner Scott Gottlieb, M.D.
- FDA requires additional e-cigarette makers to provide critical information…
As part of ongoing efforts under FDA’s Youth Tobacco Prevention Plan designed to limit youth access to all tobacco products, FDA and the Federal Trade Commission (FTC) issued 13 warning letters on May 1, and FDA issued four additional ones on May 10, to companies selling e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products, such as juice boxes, candy, or cookies. Several of the companies receiving warning letters were also cited for illegally selling the products to minors.
Examples of products outlined in the warning letters are “One Mad Hit Juice Box,” which resembles children’s apple juice boxes such as Tree Top-brand juice boxes, and “V’Nilla Cookies & Milk,” a product resembling Nilla Wafer and Golden Oreo cookies. The products, some of which use cartoon-like imagery in their labeling or advertising, are sold through multiple online retailers.
“No child should be using any tobacco product, and no tobacco products should be marketed in a way that endangers kids—especially by using imagery that misleads them into thinking the products are things they’d eat or drink,” said FDA Commissioner Gottlieb. “Looking at these side-by-side comparisons is alarming.” Acting FTC Chairman Maureen K. Ohlhausen said of the action, “Protecting young children from unwarranted health and safety risks is one of our highest priorities. Nicotine is highly toxic, and these letters make clear that marketing methods that put kids at risk of nicotine poisoning are unacceptable.”
Read more about the actions by FDA and FTC:
- FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies
- FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
May is National Asthma Awareness Month!
- Youth cigarette smoking may cause severe wheezing, shortness of breath, and possibly asthma.
- Secondhand smoke can trigger asthma attacks in children with asthma.
May is also National Stroke Awareness Month!
- Smoking cigarettes can cause plaque buildup in your arteries that can lead to stroke.
- About four years after quitting, a smoker’s risk of stroke can drop as low as a lifetime nonsmoker’s.
- Secondhand smoke exposure is known to increase the risk for strokes in nonsmokers.
For support, tips, and tools to help with quitting smoking, visit smokefree.gov.