What Actions Has the FDA Taken Over Vaping/E-Cigarettes?

So far, most of the FDA's regulation and enforcement efforts have been focused on vaping/e-cigarette products marketed to young people.

Tobacco use is the largest preventable cause of disease and death in the United States. Since 2009, the U.S. Food and Drug Administration (FDA) has had the authority to regulate tobacco products, thanks to the passage of the Family Smoking Prevention and Tobacco Control Act. However, it was not until 2016 that the FDA determined that its authority to regulate tobacco extended to e-cigarettes and vaping products like JUUL as well.

Unlike traditional cigarettes, e-cigarettes (or vape pens) produce an aerosol, which usually contains nicotine along with other products, that is inhaled into the user's lungs. Because they do not produce smoke that is inhaled into the lungs, e-cigarettes are generally thought to be safer than traditional cigarettes. However, while use of e-cigarettes may lower the risk of cancer and other diseases compared with traditional cigarette use, nicotine is still an addictive substance. And a rash of vaping-caused severe respiratory illnesses has made clear that vaping does not come without serious risks. By the end of last year, there had been over 2,500 hospitalizations and 55 deaths due to vaping-related lung injuries.

What E-Cigarette Regulations Are In Place?

The FDA policies in effect are largely aimed at protecting children. A 2019 National Youth Tobacco Survey found that approximately 1.6 million young people had recently used e-cigarettes, with nearly 1 million using e-cigarettes daily.

Beginning August 8, 2016, it became illegal to sell e-cigarettes to children under the age of 18. (With a December 2019 amendment to the Federal Food, Drug, and Cosmetic Act, the legal age for tobacco use is now 21.) The FDA further mandated that retailers check IDs on any tobacco or e-cigarette purchasers under the age of 27.The FDA is also enforcing a ban against the distribution of free tobacco-product samples and prohibiting its sale in vending machines (except in adult-only facilities). Learn more about liability for teen use of JUUL and other vaping products.

All e-cigarettes on the market must have authorization from the FDA in order to be legally marketed, although the FDA has deferred enforcement of this requirement for now. By September 2020, companies must demonstrate that their products meet applicable standards, after which there will be a one-year review period by the FDA. Currently, no e-cigarettes have been authorized by the FDA, meaning that all e-cigarettes are considered illegally marketed and may be subject to enforcement at any time, at the FDA's discretion.

In January 2020, the FDA prioritized enforcement of a ban on certain flavored e-cigarettes, including fruit and mint flavors, that appeal most strongly to children. Under this policy, which went into effect in March 2020, companies who continue to manufacture, distribute or sell unauthorized flavored e-cigarettes risk FDA enforcement actions.

What E-Cigarette Regulations Are Top Priority for the FDA?

The FDA is prioritizing enforcement against illegally-marketed e-cigarettes by focusing on flavored e-cigarettes and other e-cigarette products that are targeted to minors. Examples include labeling or advertising that resemble kid-friendly foods and drinks; characters designed to appeal to young people; or products marketed as being easy to conceal or disguised as another product.

The agency is also focusing its enforcement efforts on blocking products for which the manufacturer has not taken adequate measures to prevent minors' access. For instance, the FDA will consider whether the manufacturer is adequately ensuring compliance with age verification and sale restrictions, or enforcing penalties against retailers who fail to comply.

How Are FDA E-Cigarette/Vaping Rules Being Enforced?

The FDA conducts regular inspections of manufacturing facilities, brick-and-mortal retail stores, online retailers, and social media presences. As a result of these inspections, since 2016, the FDA has issued more than 8,000 warning letters to retailers regarding unauthorized sale of e-cigarettes or other vaping products—either online or in-store—to minors. In September 2018 alone, the FDA issued over 1,000 warning letters to retailers, and initiated 131 civil money penalty complaints (fines).

As a further example of the FDA's enforcement priorities, in April 2020, the FDA issued ten warning letters to companies that illegally marketed e-cigarettes and related products to young people. For instance, the warning letters were sent to an establishment marketing a backpack and sweatshirt designed with stealth pockets to hide e-cigarettes, e-cigarette products that resembled smartwatches and other seemingly innocuous items (like fidget spinners), and to companies marketing e-liquids that featured cartoon characters like SpongeBob SquarePants.

If these letters are ignored, the companies risk additional FDA action, including an injunction, seizure, and/or civil money penalty actions.

The FDA has also begun enforcing illegal marketing of products. As of September 2019, it had sent letters to around 90 companies seeking information on over 110 brands that may be on the market illegally. The FDA has issued warning letters to a handful of companies notifying them of the need to remove a total of 71 products from the market.

It also has taken enforcement actions related to the access and marketing of e-cigarettes to children, including working with eBay to remove listings for e-cigarettes and issuing several dozen warning letters as a result of deceptive marketing targeting children.

The FDA is also attempting to curb teens' use of e-cigarettes by engaging in an advertising campaign explaining the risks, and investing in more science and research to better understand e-cigarette's health impacts.

If you have developed an addiction to e-cigarettes because of deceptive or youth-centered marketing, or you've been diagnosed with a health problem linked to e-cigarettes, your best first step might be to discuss your situation with a lawyer. Get tips on finding the right lawyer for your JUUL/e-cigarette case.

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