US E-Cigarette Ban Officially Issued: Enforcement Starts in 30 Days

On January 2, local time, the FDA promulgated a new policy on e-cigarettes in the United States on its official website. This is a regulatory policy on e-cigarettes made after three months of balancing the interests of all parties.

The FDA's new policy on e-cigarettes prohibits most flavored e-cigarettes, except tobacco and menthol, and the open e-cigarette systems of professional e-cigarette stores will not be affected. The new policy will take effect in 30 days.

The following is the full text of the FDA official announcement:

Against the backdrop of the prevalence of e-cigarette use among teenagers and the popularity of certain products among children, the U.S. Food and Drug Administration (FDA) today issued a policy to prioritize enforcement of certain unauthorized flavored e-cigarette products that are attractive to children, including fruit and mint flavors.

Under the policy, companies that do not stop manufacturing, distributing and selling unauthorized flavored e-cigarettes (other than tobacco or menthol flavors) within 30 days may be at risk of FDA enforcement action.

HHS official Alex Azar said: The United States has never seen a substance use epidemic emerge as quickly as the current epidemic of e-cigarette use among young people. The U.S. Department of Health and Human Services (HHS) is taking a comprehensive and aggressive approach to enforcing a law passed by Congress under which there are no legal e-cigarettes currently on the market.

By prioritizing enforcement actions against the products most widely used by children, our actions today aim to achieve the right public health balance by maintaining e-cigarettes as a potential alternative to adults using combustible tobacco, while ensuring that these products do not provide increased opportunities for nicotine addiction to young people. As the U.S. youth crisis develops and evolves, we will not stand by and we will continue to monitor the situation and take further action if necessary.

FDA's new director, Stephen M. Hahn said: As we work to respond to the worrying epidemic of e-cigarette use among young people, the enforcement policy we released today confirms our commitment to significantly restrict children's use of certain flavors of e-cigarette products that we know are attractive to them, so-called cigarette bomb-based products that are easy to use and easy to conceal.

We will continue to deliberate and fully utilize our full regulatory authority to address this alarming crisis affecting children, families, schools and communities, in conjunction with recently signed laws raising the minimum age for sale. We believe this policy balances the urgency of addressing the public health threat of youth use of e-cigarette products with the potential role e-cigarettes may play in helping adult smokers transition completely from combustible tobacco to less risky forms of nicotine delivery.

While we expect responsible industry members to comply with premarket requirements, we are prepared to take action against any unauthorized e-cigarette products outlined in the priorities. We will also closely monitor the use of all e-cigarette products and take other measures based on demand to address the use of young people.

The final guidance outlines the agency's implementation priorities for electronic nicotine delivery systems (ENDS) such as e-cigarettes and e-liquids, which are the results of the 2019 National Youth Tobacco Survey (NYTS) on e-cigarette use, showing that more than 5 million U.S. middle school students are current e-cigarette users (who have used them in the past 30 days)-with most reports showing that brands based on cigarette bomb products are the most popular among teenagers.

The annual NYTS survey jointly conducted by the FDA and the Centers for Disease Control and Prevention (CDC) also showed that approximately 1.6 million of current young e-cigarette users in 2019 used the product regularly (for 20 days or more; in 30 days), with nearly a million people using e-cigarettes every day.

Other data from another federal survey further highlighted that young people particularly prefer the fruit and mint flavors of e-cigarettes, preferring to tobacco or menthol-flavored e-cigarettes. The overall level of e-cigarette use among young people is particularly worrying, as e-cigarette use exposes them to nicotine addiction and other health risks.

In particular, there is evidence that exposure to nicotine among young people may have adverse effects on the brains of developing adolescents, and that young people who use e-cigarettes are more likely to try traditional cigarettes in the future than non-users.

On August 8, 2016, all e-cigarettes and other ENDS products will be subject to FDA regulation, including the Premarket Authorization Requirements (PMTA) under the Federal Food, Drug and Cosmetic Act (FD&C Act). All e-cigarettes and other ENDS products on the market later required FDA approval to be legally sold.

However, in order to exercise enforcement discretion, the agency has postponed the implementation of premarket authorization requirements. To date, no ENDS product has been authorized by the FDA, which means that all ENDS products currently on the market are considered illegally sold and enforced at any time at FDA discretion.

Within 30 days of the publication of the guidance's usability notice in the Federal Register, the FDA intends to prioritize enforcement of these illegally marketed ENDS products by focusing on the following product groups that do not have premarket authorization:

1. Any flavored cigarette project-based ENDS product (except tobacco or menthol-flavored ENDS products);

2. All ENDS products where the manufacturer fails to take (or use) adequate measures to prevent use by minors;

3. and any ENDS product that targets or may promote use by minors.

A carry-based ENDS product is a product consisting of the ENDS architecture, including or involving a cartridge and an atomizer, which can hold the liquid required for atomization. For the purposes of this policy, a cartridge or atomizer is any small enclosed device (sealed or unsealed) that is intended to be installed in or operated as part of an ENDS product.

By not prioritizing enforcement of other flavored ENDS products as with the use of flavored box ENDS products, the FDA is trying to balance public health issues related to the use of ENDS products by young people with considerations of potentially addicted adult smokers. End the transition from combustible tobacco products.

In addition to data showing that cigarette bomb-based ENDS products are the most commonly used data among young people, the important findings of the 2019 Monitoring Future Survey, focusing on the use of JUUL by young people, indicate that young people's preference for menthol and tobacco-flavored e-cigarettes is far lower than peppermint and fruit-flavored e-cigarettes. Because the number of young people using both menthol and tobacco-flavored, smoke-based ENDS products is relatively small, these products are not a current law enforcement focus.

But if the FDA realizes that the number of young people using any other flavored products, whether they are based on cigarettes or otherwise, has increased, the agency will take other measures to address the issue of young people's use of these products if necessary. nbsp;

For all other products (carry-based or otherwise), whether menthol, tobacco, or non-flavored ENDS products, the FDA will prioritize restrictions if the manufacturer fails to take appropriate measures to prevent use by adolescents. For example, the FDA will consider whether manufacturers have implemented adequate procedures to monitor retailers 'compliance with age verification and sales restrictions, or whether penalties have been established and implemented for retailers who do not comply with these procedures.

The agency will also consider whether manufacturers use appropriate age-verification technology (or require retailers selling their products to use it) to prevent minors from accessing their websites, while also preventing minors from purchasing via the Internet.

In addition, the FDA intends to prioritize any ENDS product that targets or may promote nicotine use among young people. Examples: products with labels/advertisements similar to children's foods and drinks, such as juice boxes or children's cereals; products sold directly to minors by concealing the product or disguising it as something else; and products with characters that appeal to young people.

Importantly, the FDA's enforcement focus is not on banning flavored or bomb-based e-cigarettes. The FDA has accepted and begun reviewing the premarket use of several flavors of ENDS products through the path established by Congress in the Tobacco Control Act. Manufacturers wishing to sell any ENDS product (including flavored e-cigarettes or e-liquids) are required by law to submit an application to the FDA to certify that the product meets applicable standards in the law, such as whether the product is suitable to protect public health. If a company can demonstrate to the FDA that a particular product meets applicable standards set by Congress, including considering how the product's marketing affects use and use by adolescents, the FDA can authorize the product to be sold.

The guidance also states that after May 12, 2020, the FDA also intends to give priority to any ENDS product that continues to be marketed and the manufacturer has not yet submitted a premarket application. For ENDS products other than the three categories above, if a premarket application is submitted before that date, the FDA intends to continue to exercise enforcement discretion for up to a year until the FDA reviews the application, unless the company takes negative action. FDA authorizations for such applications or products are sold by the FDA.

The FDA has demonstrated a strong commitment to taking measures to prevent adolescents from using and addicted to any tobacco products, including e-cigarettes.

This enforcement policy is an important step in the agency's ongoing work to ensure that agencies do not sell, sell or use these products to children in compliance with the Youth Tobacco Prevention Plan, including investing in public education activities to educate young people about tobacco, the risks of using e-cigarettes, etc., and provide resources for educators, parents and community leaders to prevent use among young people, And further explore how to help children who are already addicted to e-cigarettes quit smoking.

The FDA is an agency of the U.S. Department of Health and Human Services that protects public health by ensuring the safety and effectiveness of human and veterinary drugs, vaccines, and other human biologics and medical devices. The agency is also responsible for the regulation and safety of national food, cosmetics, dietary supplements, products that release electronic radiation, and tobacco products.