FDA Issues E-Cigarette Market Guidelines: A Guide to U.S. Vaping Regulation

On June 11, the FDA finalized the "Tobacco Product Marketing Application (PMTA) Guidelines for Electronic Nicotine Delivery Systems (ENDS)," which further clarifies the PMTA process for e-cigarette and related tobacco product manufacturers.

The guidelines aim to assist individuals submitting PMTAs for e-cigarettes (ENDS) under Section 910 of the FD&C Act (21 USC 387j). The guidelines explain what types of products require PMTAs, when they need to undergo the PMTA process, and the general procedures for PMTAs for ENDS; including what information must be submitted in PMTAs as required by the FD&C (Federal Food, Drug, and Cosmetic) Act; and information that the FDA suggests can be submitted that may benefit public health.

Although these guidelines are not binding, they reflect the FDA's current attitude and thoughts regarding innovative tobacco products like e-cigarettes. On April 18 of this year, U.S. Senate leader Mitch McConnell called for raising the legal smoking age to 21, as the popularity of e-cigarettes is extremely detrimental to preventing youth smoking, prompting the FDA to reflect on its policies.

In fact, the FDA's regulatory history over the tobacco industry is not long, especially regarding e-cigarettes, which have undergone a dramatic shift from leniency to strictness in just over three years. Regardless of how regulatory styles change, the starting point is to reduce the harm of tobacco to people.

1. Key Points of U.S. E-Cigarette Regulatory Policies

The U.S. government granted the FDA the authority to regulate tobacco products through the "Family Smoking Prevention and Tobacco Control Act" issued in 2009, but the regulatory scope was limited to cigarettes, roll-your-own tobacco, smokeless tobacco, and cigars.

The formal regulation of e-cigarettes in the U.S. began in May 2016. The FDA officially announced that a new rule would take effect on August 8, 2016, to regulate all tobacco products, including e-cigarettes, cigars, hookahs, and pipe tobacco. Before this rule was implemented, there was no federal law prohibiting retailers from selling e-cigarettes, hookahs, tobacco, or cigars to individuals under 18.

After the implementation of this law, the FDA can legally regulate the manufacturing, importation, packaging, labeling, advertising, promotion, sale, and distribution of ENDS (e-cigarettes, Electronic Nicotine Delivery Systems). For example:

(1) U.S. manufacturers are required to register every tobacco production facility with the FDA and report any harmful substances and potential harmful substances. (Companies outside the U.S. are temporarily not required to register but will have to in the near future.)

(2) U.S. manufacturers are required to submit a list of tobacco products they produce to the FDA.

(3) ENDS manufacturers are required to submit a list of ingredients for each product (Note: This applies to Chinese manufacturers as well).

(4) Hazardous descriptors, such as light, low, and mild, cannot be used to describe tobacco products.

(5) Free samples of tobacco products (such as e-cigarettes) are not allowed to be sold (except B2B) etc.

Notably, this rule also stipulates that unless tobacco products were on the market before February 15, 2007, all new tobacco products must undergo PMTA (Tobacco Product Marketing Application) review. Since almost all e-cigarette products were launched after this date, e-cigarettes are fully included in the PMTA.

According to the FDA, the PMTA application is relatively complex, requiring a lot of information to be submitted, including ingredients, product design, and potential health risks, and can cost hundreds of thousands of dollars.

However, to strike a proper balance between regulation and encouraging the development of potentially less harmful innovative tobacco products than cigarettes, in July 2017, the FDA announced a comprehensive plan for tobacco and nicotine regulation, extending the PMTA submission deadline for ENDS (e-cigarettes) to August 8, 2022. According to the previous 2016 rule, if no response is received from the FDA during the PMTA submission period, manufacturers can continue to sell products on the market. This effectively gives e-cigarette companies a breathing space.

2. Policy Buffer Period Meets Youth Smoking Issues

However, this measure has led to unexpected consequences.

Despite the 2016 new regulations prohibiting the sale of e-cigarettes to individuals under 18, instances of e-cigarettes being sold to minors still exist. Moreover, since e-cigarettes can still be sold on the market, the rate of e-cigarette use among American youth has significantly increased in recent years. According to a set of figures provided by the FDA, this dangerous trend can be observed:

In 2018, there were 3.62 million e-cigarette users among middle and high school students.

The e-cigarette usage rate among high school students increased by 78% from 2017 to 2018 (from 11.7% to 20.8%), and among middle school students, it increased by 48% (from 3.3% to 4.9%).

According to a survey from 2013 to 2014, 81% of youth e-cigarette users cited appealing flavors as the primary reason for use.

The youth smoking issue in the U.S. has long attracted the attention of academia and policymakers.

A 2015 study by the National Academy of Medicine found that about 90% of adult smokers started smoking before the age of 19. The study found that raising the minimum legal age to 21 would prevent 223,000 premature deaths.

In April of this year, U.S. Senate Majority Leader Mitch McConnell stated that he plans to legislate to raise the minimum age for purchasing tobacco products, including e-cigarettes, from 18 to 21 to curb the rampant youth smoking behavior. So far, 12 states, including New Jersey and California, have enacted laws raising the minimum age to 21. Legislators in New York and Maryland have also approved this bill.

Originally, the FDA considered regulating the nicotine content in cigarettes to prevent addiction, so products like e-cigarettes could potentially provide a lower-risk alternative for adult smokers. However, if these products attract young people to start using tobacco and nicotine, the feasibility of using these products to reduce the harm of tobacco to people would be severely undermined, contradicting the FDA's original intention of a "tolerant" policy towards e-cigarettes in 2017.

Previously, former FDA Commissioner Scott Gottlieb (who resigned in April 2019) also repeatedly stated that the 2017 policy would be re-evaluated. He indicated that the FDA underestimated the dangers of e-cigarettes, as they also contain nicotine that can cause addiction, and using e-cigarettes significantly increases the likelihood of smoking traditional cigarettes, which is extremely detrimental to preventing youth smoking. This has also prompted the FDA to take new strong measures to firmly combat and reverse this youth "epidemic."

3. From Leniency to Strictness, the FDA's Policy Shift

To address this adverse change and implement the youth tobacco prevention plan, on April 24, 2018, then-FDA Commissioner Scott Gottlieb announced enforcement actions to curb youth use of JUUL and other e-cigarettes.

The FDA conducted a nationwide large-scale undercover inspection. From the inspections that began in early March 2018, the FDA discovered 40 instances of JUUL products being illegally sold to minors.

Due to the increasingly severe situation of youth e-cigarette use, on September 12, 2018, the FDA further announced a series of enforcement actions against the sale and marketing of e-cigarettes to children. The FDA required e-cigarette manufacturers to provide plans to reduce sales to minors within 60 days.

Since flavored e-cigarettes are more appealing to youth, the FDA also restricted flavored e-cigarettes. On November 15, 2018, former FDA Commissioner Scott Gottlieb stated that flavored ENDS (e-cigarettes) would be restricted from being sold to children, with the exception of menthol, but menthol-flavored e-cigarette products would be closely regulated regarding their appeal to youth, and policies could be adjusted at any time.

Despite two large-scale enforcement actions, the trend of selling e-cigarettes to minors has not been curbed.

On March 4, 2019, the FDA announced new enforcement actions targeting retailers and manufacturers to combat illegal sales of e-cigarettes to minors in physical stores and online.

The FDA has expressed regret over its previous "tolerant" stance. Former Commissioner Scott Gottlieb first mentioned in September 2018 that the FDA would re-evaluate the policy of extending the PMTA deadline for ENDS (e-cigarettes) to August 8, 2022, as outlined in the comprehensive plan for tobacco and nicotine regulation from July 2017.

On March 14, 2019, the FDA issued a statement announcing that it would recommend revising the current compliance policy for ENDS (e-cigarettes) (the July 2017 policy). The draft revisions particularly target flavored e-cigarettes, including:

Some flavored e-cigarette products will no longer be sold.

The PMTA deadline for flavored e-cigarettes will be moved up by one year to August 8, 2021.

Flavored cigars will no longer be sold.

The FDA recommends that e-cigarettes not be marketed through social media like traditional cigarettes.