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E-Cigarettes, Vapes, and other Electronic Nicotine Delivery Systems (ENDS)

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What are E-Cigarettes, Vapes, and Other Electronic Nicotine Delivery System (ENDS) Products?

Vapes, vaporizers, vape pens, hookah pens, electronic cigarettes (e-cigarettes or e-cigs), e-cigars, and e-pipes are some of the many tobacco product terms used to describe electronic nicotine delivery systems (ENDS). 

These products use an “e-liquid” that usually contains nicotine derived from tobacco, as well as flavorings, propylene glycol, vegetable glycerin, and other ingredients. The liquid is heated to create an aerosol that the user inhales.

ENDS may be manufactured to look like conventional combusted cigarettes, cigars, or pipes. Some resemble pens or USB flash drives. Larger devices, such as tank systems or mods, bear little or no resemblance to cigarettes. These products may have reusable parts, or they may be disposable and only used once before they are thrown away.


Are You Looking for General Health and Safety Information Related to E-Cigarettes, Vapes, or Other ENDS?

The longer ENDS and other e-cigarettes are on the market, the more information we know about their impacts on health. This includes data on youth use of these products, which has led to development of several educational programs designed to prevent adolescents and teens from using these products. Through tobacco product problem reports and tobacco product violation reports, the FDA also knows much more about many safety and health hazards they may pose.

FDA is committed to protecting the public health of all Americans while regulating an addictive product that carries health risks. We’re conducting ongoing research on potentially less harmful forms of nicotine delivery for adults, including studies of e-cigarettes and ENDS.  Many studies suggest e-cigarettes and noncombustible tobacco products may be less harmful than combustible cigarettes. However, there is not yet enough evidence to support claims that e-cigarettes and other ENDS are effective tools for quitting smoking.

To date, no e-cigarette has been approved as a cessation device or authorized to make a modified risk claim, and more research is needed to understand the potential risks and benefits these products may offer adults who use tobacco products.

Youth Use and Prevention 

The FDA monitors the national usage rates for all tobacco products, including an annual youth survey, and has seen a drastic increase in youth use of e-cigarette products in recent years. Due to what has been called an ‘epidemic’ of youth use of these products, FDA has prioritized prevention efforts. The agency has taken a multitude of actions to keep ENDS out of the hands of youth, from policy making to enforcement to education. 

Learn about public education efforts and resources that have been created to reach youth who are at higher risk of or more vulnerable to cigarette use and nicotine addiction. FDA created a toolkit, Resources for Professionals About Vaping & E-Cigarettes, for adults and professionals who work with youth. This FREE resource provides fast facts about youth vaping and e-cigarettes.

The Real Cost

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“The Real Cost” E-Cigarette Prevention Campaign 

FDA’s award-winning public education campaign, “The Real Cost,” continues to prevent youth from tobacco initiation and use. In 2017, the campaign began prioritizing e-cigarette prevention messaging to combat increasing youth vaping rates. “The Real Cost” campaign also educates teens on the health consequences of smoking cigarettes.

Resources in the FDA Tobacco Education Resource Library

The FDA Tobacco Education Resource Library, from FDA's Center for Tobacco Products, provides tobacco education resources. This site offers digital and print content for state and local health officials, nonprofit organizations, and schools to support public outreach efforts.

See E-Cigarettes and Vaping Resources

Scholastic Materials for Educators

FDA has joined forces with Scholastic to provide e-cigarette prevention information in English and Spanish to middle and high school educators.

Content includes:

E-cigarette Problems and Potential Violations

There are no safe tobacco products, including ENDS. In addition to exposing people to risks of tobacco-related disease and death, FDA has received reports from the public about safety problems associated with vaping products including:

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These problems can seriously hurt the person using the ENDS product and others around them. There may be added dangers, for example if a vape battery catches fire near an oxygen tank, a propane tank (such as used in backyard grills), or a gas pump, or if a person has a vape-related seizure while driving. FDA has a webpage with tips to help users avoid vape fires or explosions.

If you have experienced undesired health or quality problems with any tobacco product, including ENDS, you can report it to FDA. Knowing more about adverse experiences can help FDA identify concerning trends and causes or contributors for particular incidents or health or quality problems beyond those normally associated with tobacco product use. You can read some tobacco-related adverse experience reports on the Tobacco Product Problem Reports page.

If you think ENDS or other tobacco products are being sold to underage users, or you see another potential violation of the FD&C Act or FDA’s tobacco regulations, please report the potential tobacco product violation.


Are You a Manufacturer of E-Cigarettes, Vapes, or other ENDS?

FDA regulates the manufacture, import, packaging, labeling, advertising,   promotion, sale, and distribution of ENDS, including components and parts of ENDS but excluding accessories.

Examples of regulated components and parts of ENDS include:

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  • E-liquids
  • A glass or plastic vial container of e-liquid
  • Cartridges
  • Atomizers, the part of the ENDS that turns e-liquid into vapor for inhalation
  • Cartomizers and clearomizers, which, similar to atomizers also deliver e-liquid in vapor form
  • Certain batteries
  • Digital display or lights to adjust settings
  • Tank systems
  • Drip tips or mouthpieces
  • Flavorings for ENDS
  • Programmable software

Products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by FDA’s Center for Drug Evaluation and Research (CDER). FDA published a rule clarifying when products made or derived from tobacco are regulated as tobacco products, drugs, and/ or devices.

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import ENDS, you must comply with the requirements for manufacturers.

CTP's Office of Small Business Assistance can answer specific questions about requirements for small businesses and how to comply with the law. This office also provides online educational resources to help regulated industry understand FDA regulations and policies.


Are You a Retailer of ENDS Products?

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Tools for Retailers

This is Our Watch” is a complete toolkit of resources to help tobacco retailers better understand and comply with FDA tobacco regulations. Tobacco retailers play a direct role in protecting kids from nicotine addiction and the deadly effects of tobacco use. Learn what tobacco retailers need to do to comply with the rules designed to prevent our nation's youth from becoming the next generation of Americans to die prematurely from tobacco-related disease.

Retail Sales of Tobacco Products offers more information about federal rules that retailers must follow as well as information on regulations, guidance, and webinars for retailers.

Did you know? 
Beginning December 2019, it is illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21.
 

Vape Shops That Mix E-Liquids or Modify Products

If you operate a vape shop that mixes or prepares liquid nicotine or nicotine-containing e-liquids, or creates or modifies any type of ENDS, in addition to product sales, you may be considered a manufacturer and have to comply with the requirements for manufacturers linked above. 

Some vape shops may have legal responsibilities as both manufacturers and retailers of tobacco products.

For information about ENDS products that are authorized  for marketing in the U.S., see: 


Audience: Public Health Professionals, Retailers, Manufacturers

Topics: E-Cigarettes & Vaping, Prevention, Science & Research, Tobacco Product Laws

Source: https://www.fda.gov/tobacco-products/products-ingredients-components/e-cigarettes-vapes-and-other-electronic-nicotine-delivery-systems-ends