How FDA is Regulating E-Cigarettes
By: Ned Sharpless, M.D., Acting Commissioner
When I was Director of the National Cancer Institute (NCI), I would be frequently asked “What topic in cancer research and cancer care keeps you up at night?” I always answered this question the same way: “tobacco control in the era of e-cigarettes.”
On the one hand, as someone trained in internal medicine and oncology, I am all too familiar with the devastating impact of combustible cigarettes on the public health: The 480,000 deaths per year in the U.S. from tobacco-associated cancers, emphysema, heart disease, stroke and the 34.3 million Americans who still smoke combustible cigarettes despite decades of efforts to help them quit. So, any product that can diminish the use of combustible cigarettes substantially has to be considered of enormous potential value. Are e-cigarettes that product? Well, given that most e-cigarette users continue to smoke cigarettes, the answer is not clear. Though there are some data, both epidemiological and from direct clinical trials, that some electronic nicotine delivery systems (ENDS, which includes products known as “e-cigarettes”) can reduce the use of combustible cigarettes and may be less harmful than traditional cigarettes.
What is clear is the explosion of use and nicotine addiction in children driven by the advent of ENDS, especially the pod-based products such as JUUL. After years of witnessing a steady decline in the use of tobacco products by children and young adults, we are now seeing a rapid resurgence of the use of tobacco products in these populations. There are many unanswered questions about ENDS: we do not yet know how dangerous these products are when used over the long-term; we do not know if they are truly effective at helping addicted adults quit smoking traditional cigarettes, or even if some types of ENDS are less harmful than traditional cigarettes; we do not know to what extent they can serve as a “gateway” to the use of combustible cigarettes. Clearly, some of the rapid rise in youth use of these products has resulted from irresponsible practices of the manufacturers, who have targeted kids in their marketing of these products. And while ENDS products appear to hold some promise in helping addicted adult smokers transition away from combustible tobacco to a potentially less harmful form of nicotine delivery, these products are not safe, and we cannot allow the next generation of young people to become addicted to nicotine.
So, it’s clear why this topic is a complicated one with many unknowns. There is great potential to significantly reduce the national burden of cancer and other diseases if we can help addicted smokers quit what is perhaps the most dangerous product that is mass marketed in America today, but there is also the terrible risk of having millions of new Americans become life-long addicts to a new class of products that are not safe and possibly transitioning to other tobacco products that are known to be deadly. I considered this topic as one of the leading issues facing American public health when I was leading the NCI, and that view has not changed since I came to the U.S. Food and Drug Administration (FDA) last April.
Despite the tremendous increase in the use of ENDS over the last few years, it is important to note that these products are still a relatively new class of products on the U.S. market. When FDA’s foundational “deeming rule” went into effect on Aug. 8, 2016, it gave the agency’s Center for Tobacco Products (CTP) regulatory authority over all ENDS, including e-cigarettes, vapes, e-liquids, e-cigars, e-pipes, and e-hookahs. Since late 2016, FDA has worked at maximal speed to regulate this rapidly evolving class of new tobacco products, but our policies and procedures in this area are still evolving.
FDA’s oversight of these products is a top priority for the agency. This ongoing work includes investing in more science to address the unanswered questions about ENDS, developing guidances and regulations, educating industry and the public, and aggressively enforcing the law — all of which have had a wide-ranging impact on the manufacturing, marketing, and selling of ENDS. CTP’s work is constant in its effort to keep these products out of the hands of kids.
Restricting Youth Access to ENDS
On the deeming effective date of Aug. 8, 2016, it became immediately illegal to sell e-cigarettes and other ENDS to people younger than 18. Retailers also became legally responsible for requiring age verification by photo ID for individuals under 27 to purchase a tobacco product. Several other provisions of the Tobacco Control Act also immediately went into effect with the finalization of the deeming rule, including a ban on the distribution of free tobacco product samples and the prohibition of sales in vending machines (except in strictly adult-only facilities).
Enforcement of the law is one of the most important ways FDA regulates e-cigarettes. Since 2016, FDA has issued more than 8,000 warning letters to retailers — both online and in brick-and-mortar retail stores — for sales of ENDS and their components to minors. In September 2018, in the largest coordinated enforcement effort in the agency’s history, the agency issued more than 1,100 warning letters and initiated 131 civil money penalty complaints to retailers who sold e-cigarettes to minors.
Since then, FDA has issued several guidances to inform stakeholders in these areas, including how certain requirements may apply to vape shops and how to comply with the prohibition on free samples of tobacco products.
Conducting Retailer and Manufacturer Checks
FDA also conducts regular inspections of ENDS manufacturing facilities, including vape shops that make or modify ENDS products. Since 2016, CTP has conducted more than 1,200 vape shop inspections to confirm that manufacturers and retailers in these facilities are complying with the Federal Food, Drug, and Cosmetic Act and FDA regulations, as well as to make sure these entities are not commercially marketing tobacco products without required premarket authorization or selling tobacco products to minors. In 2018, as a result of regular inspections that now include e-cigarette manufacturers and retailers, FDA issued the first warning letter to a company for selling e-liquids without the required marketing authorization. The same company was also found to be illegally marketing e-liquids with labeling and/or advertising that caused them to resemble child-friendly food products.
Increasing Requirements for ENDS Manufacturers
When CTP began regulating ENDS, many of the regulatory and legal requirements that had been in place for manufacturers of cigarettes, smokeless tobacco, and roll-your-own tobacco since 2009 — as well as several new requirements specific to ENDS — became applicable to makers of e-cigarettes and other ENDS products. As of June 2019, the compliance dates to meet many of these requirements have passed, and makers of all ENDS currently on the market should have met certain requirements, including, but not limited to:
- Registering an establishment and submitting lists of products, including labeling and advertisements
- Submitting tobacco health documents
- Submitting ingredient listings
- Including a required warning statement on packages and advertisements for ENDS (including certain ENDS components, such as e-liquids) stating, “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”
These submissions are a key step in FDA’s efforts to learn more about these products and to develop future regulations regarding ENDS manufacturing and marketing. Likewise, the warning statement on nicotine is an important requirement to let the public know that these products contain nicotine, an addictive chemical. FDA has also issued new or revised guidances on these topics.
Utilizing Premarket Review Requirements
All deemed products, including ENDS products, became subject to the premarket authorization requirements in the Tobacco Control Act, effective Aug. 8, 2016. This means that any ENDS product, as well as any other tobacco product, that was not on the market as of Feb. 15, 2007, is a “new” tobacco product that must be authorized by FDA to be on the market.
ENDS that were on the market as of Aug. 8, 2016, have been subject to compliance policies that deferred enforcement for lack of premarket authorization. In July 2019, a U.S. District Court in Maryland ordered that applications for deemed tobacco products such as e-cigarettes, cigars, pipe tobacco, and hookah tobacco, that were on the market as of Aug. 8, 2016, must be submitted to FDA no later than May 12, 2020. The court order also provided for a one-year period in which products with timely filed applications might remain on the market pending FDA review, but also clarified that FDA may enforce the premarket review provisions against deemed products prior to May 12, 2020, or during the one-year review period.
Ultimately, all e-cigarettes that are “new” tobacco products that seek to continue to be sold in the U.S. will have to be the subject of applications to FDA, and those that are authorized to be introduced, or stay, on the market will only receive authorization after undergoing a thorough scientific review by FDA.
In response to the sharp increase in youth e-cigarette use, the agency issued a draft guidance in March 2019, that among other things, will outline enforcement priorities FDA will consider with regards to ENDS products that lack the required authorization.
Any e-cigarettes or other ENDS products that were not marketed as of Aug. 8, 2016 need to receive marketing authorization from FDA before the product may enter the market or they will be subject to enforcement. FDA actively monitors the market to investigate products that may be on the market illegally. As part of these investigations, FDA has sent letters to about 90 companies seeking information on over 110 brands, including ENDS products, to determine if those products are being illegally marketed. To date, FDA has issued warning letters to six companies notifying them of the need to remove a combined 71 products from the market.
Providing Data to Inform Premarket Applications
To receive marketing authorization of any new tobacco product, manufacturers must follow one of three pathways. FDA anticipates most manufacturers of ENDS are likely to submit their applications through the Premarket Tobacco Product Application (PMTA) pathway.
Under the PMTA pathway, FDA evaluates a new tobacco product based on whether it is appropriate for the protection of the public health, among other things. Scientific evaluation considers the risks and benefits of the product for the whole population, including users and non-users. These data should show the increased or decreased likelihood that current tobacco users will stop using certain products, as well as the increased or decreased likelihood that non-users will start using the products.
To provide additional information to manufacturers submitting these applications, FDA has advanced important regulatory documents such as guidance on tobacco product master files, a final rule outlining the minimum threshold for acceptability of an application for review, and a final guidance for companies with recommendations to consider as they prepare to submit PMTAs for ENDS products. In addition, a proposed rule on PMTAs is undergoing OMB review. These types of documents will ultimately help us conduct the product application reviews in a more efficient and transparent manner.
The premarket review of tobacco products is the bedrock of FDA’s consumer protection efforts. FDA encourages companies to use these regulatory documents, as well as the many webinars and resources available on CTP’s website, as a guide for submitting applications and to reach out to FDA’s Office of Small Business Assistance as needed.
Preventing Youth Tobacco Use Through Enforcement Actions, Policy and Education
The U.S. has seen a sharp increase in e-cigarette use among youth, and particularly teens. In response to the concerning prevalence of youth use of these products, FDA created its Youth Tobacco Prevention Plan, which focuses on three crucial areas to prevent youth use of tobacco products — especially e-cigarettes:
- Preventing youth access to tobacco products
- Curbing the marketing of tobacco products aimed at youth
- Educating teens and their families about the dangers of tobacco products
Key efforts of the Youth Tobacco Prevention Plan involve regular retailer inspections, as well as surveillance—both in brick-and-mortar stores as well as on websites, social media, and in publications — of manufacturers and retailers who sell and/or advertise regulated tobacco products in the U.S.
The agency has taken many actions related to the access and marketing of ENDS to youth, including:
- Working with eBay to remove JUUL listings and implement measures to prevent new listings
- Sending letters to JUUL and other ENDS manufacturers requiring them to submit important documents on marketing and research on the effects of certain ENDS products
- Issuing more than 40 letters to companies marketing e-liquids with misleading labeling that mimicked food products specifically appealing to children, including juice boxes, candy, cookies, and kid-friendly cereals
- Issuing warning letters to two companies for manufacturing, selling, and/or distributing nicotine-containing e-liquids with misleading labeling and/or advertising that imitate prescription cough syrup
- Issuing joint warning letters (with the Federal Trade Commission) to four e-liquid manufacturers for violations related to online posts by social media influencers on each company’s behalf, including failure to include the required nicotine warning statement
An integral part of the Youth Tobacco Prevention Plan is direct education to teens themselves. In 2018, FDA expanded the youth tobacco prevention campaign, “The Real Cost,” to include an e-cigarette prevention campaign. “The Real Cost” Youth E-Cigarette Prevention Campaign focuses on educating the nearly 10.7 million youth aged 12-17 who have ever used or are at risk of using e-cigarettes on their potential dangers, such as nicotine addiction and exposure to other chemicals. Campaign ads can be found in schools and on age-verified digital and social media sites where teens spend most of their time and will expand to television beginning in summer 2019.
Continuing to Invest in More Science and Research
Because ENDS products are still relatively new, FDA supports and funds research to evaluate ENDS’ public health impact both at the individual and population levels. For example, in 2018, the agency commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM) to evaluate the available scientific evidence of the short- and long-term health effects related to the use of ENDS.
FDA also collaborates with CDC on the annual National Youth Tobacco Survey (NYTS), funds nine Tobacco Centers of Regulatory Science (TCORS), and collaborates with NIH and NIDA on the Population Assessment of Tobacco and Health (PATH) study. Data and information on e-cigarettes are major components of these important research efforts and inform regulatory actions.
FDA has made great strides in regulating ENDS as tobacco products over the last three years and remains committed to keeping e-cigarettes out of the hands of minors through enforcement actions, while exploring the potential for harm reduction for adult addicted smokers through scientific research.
As a physician and scientist, the issue of ENDS use continues to interest me. With further research, we will come to understand the toxicities of ENDS, as well as their possible value to reduce combustible cigarette use, and these features will ultimately dictate their long-term impact on the public health. But we do know today that our nation’s youth are initiating use of these products in alarming numbers, and as Acting FDA Commissioner, I will do everything in my power to prevent a new generation from beginning a lifetime of nicotine addiction like those of the past. Together with FDA Center for Tobacco Products’ Director Zeller, and with the support of HHS Secretary Azar and the White House, I am personally dedicated to leading FDA on this issue. I assure you that we are working as hard and expeditiously as possible to protect the public's health from the harms associated with e-cigarette use.