2016 FDA Regulation - Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS)

Vaporizers, vape pens, hookah pens, electronic cigarettes (E-Cigarettes), and e-pipes are some of the many types of Electronic Nicotine Delivery Systems (ENDS).

These products use liquid containing nicotine, as well as varying compositions of flavorings, propylene glycol, glycerin, and other ingredients. The liquid is heated into an aerosol that the user inhales.

What do ENDS look like?

Many ENDS are manufactured to look like conventional cigarettes, cigars, or pipes. Some resemble pens or other everyday items. Larger devices such as tank systems or mods bear little or no resemblance to cigarettes.

On this page, you can find:

Statistics about ENDS Use

FDA Regulation of ENDS

Manufacturing ENDS and E-Liquids

Nicotine Warning Statement

Retail Sales of ENDS, E-Liquids, or their Components or Parts Made or Derived from Tobacco

Vape Shops That Mix E-Liquids or Modify Products

Importing ENDS and E-Liquids

Report Adverse Experiences and Product Violations

Statistics about ENDS Use

More than 3 million middle and high school students were current users of e-cigarettes in 2015, up from an estimated 2.46 million in 2014.1, 2

 Sixteen percent of high school and 5.3 percent of middle school students were current users of e-cigarettes in 2015, making e-cigarettes the most commonly used tobacco product among youth for the second consecutive year.1

During 2011-2015, e-cigarette use rose from 1.5 percent to 16.0 percent among high school students and from 0.6 percent to 5.3 percent among middle school students.1

In 2013-2014, 81% of current youth e-cigarette users cited the availability of appealing flavors as the primary reason for use.3

 In 2014, 12.6% of U.S. adults had ever tried an e-cigarette, and about 3.7% of adults used e-cigarettes daily or some days.4

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FDA Regulation of ENDS

In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes (E-Cigarettes), e-pipes, and all other ENDS. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS* but excludes accessories.

However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the FDA through the Center for Drug Evaluation and Research (CDER). FDA recently proposed a rule clarifying the jurisdiction over tobacco products, drugs, and devices.

Components

Click for larger version

*“Components” or “parts” include, among other things, software or an assembly of materials intended or reasonably expected alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or to be used with or for the human consumption of a tobacco product. For a full definition of ENDS components, parts, and accessories, please read the Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. Examples of components and parts of ENDS include, but are not limited to:

E-liquids

A glass or plastic vial container of e-liquid

Cartridges

Atomizers

Certain batteries

Cartomizers and clearomizers

Digital display or lights to adjust settings

Tank systems

Drip tips

Flavorings for ENDS

Programmable software

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Manufacturing ENDS and E-Liquids

If you manufacture ENDS, these are some requirements that apply to you:

Submit an application and obtain FDA authorization to market a new tobacco product (for timelines and more details please see Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act)

Register establishment(s) and submit product listing to FDA by December 31, 2016 (this currently only applies to domestic manufacturers)

Submit listing of ingredients

Submit information on harmful and potentially harmful constituents (HPHCs)

Submit tobacco health documents

Do not introduce into interstate commerce modified risk tobacco products (e.g., products with label, labeling, or advertising representing that they reduce risk or are less harmful compared to other tobacco products on the market) without an FDA order

Manufacture your tobacco product with the required warning statement on packaging and advertisements

Market your tobacco product in compliance with other applicable statutory requirements, rules and regulations

CTP’s Office of Small Business Assistance can answer specific questions about requirements of 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.

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Nicotine Warning Statement

The product packages and advertisements of all newly-regulated covered tobacco products must bear the following warning statement:
 

“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

If the tobacco product manufacturer submits a self-certification statement to FDA that the newly-regulated tobacco product does not contain nicotine (and that the manufacturer has data to support this assertion), then an alternate statement must be used on product packages and advertisements:
 

“This product is made from tobacco.”

You can find more information about nicotine warning statements in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. 

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Retail Sales of ENDS, E-Liquids, or their Components or Parts Made or Derived from Tobacco

Federal Rules for ENDS Sales Flyer

If you sell ENDS, e-liquids, or their components or parts made or derived from tobacco, please read this summary of federal rules that retailers must follow.

You may also share the fact sheet below with your staff and post it in your store.

You can find a list of retailer responsibilities for ENDS in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. In addition, our website offers more information on regulations, guidance and webinars for retailers.

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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, you are considered a manufacturer and must comply with all of the legal requirements for tobacco product manufacturers. As a result, some vape shops may have legal responsibilities as both manufacturers and retailers of tobacco products.

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Importing ENDS and E-Liquids

Tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). You can find more information on theImporting and Exporting webpage.

You can also learn more about the importation process in the FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions.

If you have questions about importing a specific tobacco product, please contact the FDA district into which your product will be imported.

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Reporting Adverse Experiences and Product Violations

If you have experienced an unexpected health or safety issue with a specific tobacco product, you can report an adverse experience to FDA. Knowledge about adverse experiences can help FDA identify health or safety issues beyond those normally associated with product use.

If you believe these products are being sold to minors, or you see another potential violation of the FD&C Act or FDA’s tobacco regulations, report the potential violation.

You can read the adverse event reports for ENDS that were voluntarily reported to FDA at the FOIA Electronic Reading Room.

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What’s in Your E-Cigarette?

What’s in Your E-Cigarette?

By Matt McMillen 
WebMD Health News

Reviewed by Arefa Cassoobhoy, MD, MPH

Feb. 18, 2015 -- As the popularity of electronic cigarettes has grown over the past several years, so have concerns over the health risks tied to them.

The New England Journal of Medicine, for example, recently published a letter from researchers that set off alarm bells. They reported that some e-cigarettes release formaldehyde, a probable cancer-causing substance (or carcinogen), when heated with batteries set at high voltages. 

On Jan. 28, the California State Department of Public Health released a report declaring e-cigarettes a public health threat and calling for regulation.

So, What’s in E-cigarettes?

That’s not an easy question to answer. No federal agency oversees the e-cigarette industry. That means no standards exist. Labels may inaccurately describe ingredients, and what you find in one brand may be vastly different from that found in another, for better or worse.

The results of one FDA review of 18 different e-cigarette cartridges found toxic and carcinogenic chemicals in some but not others. All but one of the cartridges labeled “no nicotine” did, in fact, contain nicotine. The authors suggest that “quality control processes used to manufacture these products are inconsistent or non-existent.”

Here’s some of what we do know.

The E-Liquid

E-liquid, or e-juice, is the name for the solution that’s heated up and converted to an aerosol, which e-cigarette users inhale. Here are its most common ingredients:

Nicotine: The addictive ingredient in e-cigarettes and regular cigarettes, nicotine stimulates the central nervous system and raises blood pressure, respiration, and heart rate. “People smoke because of the nicotine,” says researcher Maciej Goniewicz, PhD, PharmD. He's a tobacco and e-cigarette expert at the Roswell Park Cancer Institute in Buffalo, N.Y.

While it's addictive, nicotine doesn't cause cancer, says Goniewicz: “What causes concern are the other chemicals (in the e-liquid).”

Flavorings: Goniewicz says hundreds of flavors exist, including cherry, cheesecake, cinnamon, and tobacco. Many of those flavoring chemicals, he says, are also used to flavor food.

“These are the big unknowns,” he says. “When we eat them, they are safe, but we don’t know what’s going on when we inhale them.”

It would be impossible to list all the various flavoring chemicals here, but one such chemical, diacetyl, is commonly used to add buttery flavor to popcorn. It's been linked to obstructive lung disease when inhaled. Other chemicals that add buttery flavor might be harmful as well, says Neal Benowitz, MD. He's a former member of the FDA’s Tobacco Products Scientific Advisory Committee.

Propylene glycol (PG): PG is a lab-made liquid that the FDA generally views as safe in food, drugs, and cosmetics. It's also used to make artificial smoke or fog for rock concerts and other performances. It can irritate the lungs and eyes and may be more harmful for people with chronic lung diseases like asthma and emphysema.

Glycerin: Odorless and colorless, liquid glycerin has a slightly sweet taste. Like PG, the FDA generally views it as safe. It’s found in many products, including food and drugs, both prescription and over the counter.

While both PG and glycerin are safe in food and drugs, Goniewicz says, “we don’t know what happens if someone inhales large amounts of these chemicals over the long term. This is really unknown.”

Heating Up

Toxic chemicals are formed as the e-liquid heats up to make the aerosol that e-cig users inhale. Some of these chemicals can cause inflammation and blood vessel damage responses, says Benowitz, who's also a professor at the University of California, San Francisco's School of Medicine. “In most preparations, they are much lower than you find in cigarette smoking, but they are of concern, no question about it,” he says.

Those chemicals include:

Formaldehyde: A probable carcinogen.

Acetaldehyde: Another probable carcinogen.

Acrolein: Formed from heated glycerin, acrolein can damage the lungs and contribute to heart disease in smokers.

All three are released in increasing amounts as the temperature of the e-liquid rises. And, says Benowitz, users may be tempted to go for those higher temperatures.

“Unfortunately, the higher you heat the liquid, the more nicotine you get from it,” he says. “People who want to get a big dose of nicotine may use really high voltage batteries or an adjustable voltage battery.”

Goniewicz says flavors might mask the unpleasant taste that results when users heat their e-cigarettes to the point at which formaldehyde is made.

Particulates and Metals

The tiny particles in e-cigarette aerosol also may be harmful. This is certainly the case for cigarette smoke and other air pollution, which can cause blood vessel damage, inflammation, and nervous system effects, Benowitz says.

E-cigarette aerosol has similar levels of particulates as regular cigarettes. But not enough research has been done on e-cigarettes to draw any conclusions about the safety of breathing in the particles they produce.

Toxic metals such as tin, nickel, cadmium, lead, and mercury have been found in e-cigarette aerosol, too. A 2013 study notes that some metals, such as nickel, occur in concentrations 2 to 100 times that of cigarettes.

Are E-Cigarettes Safe?

“It’s all relative to cigarette smoking,” Benowitz says. “Based on what we know now, they are much less hazardous than regular cigarettes.”

And regular cigarettes, as everyone should know, are truly bad for you. According to the American Lung Association, cigarettes give off about 7,000 chemicals when burned, many of them poisonous -- at least 69 of those chemicals cause cancer.

E-cigarettes do appear to be less dangerous for those exposed to secondhand aerosol. E-cigarette users exhale very little of what they breathe in, says Benowitz, and their devices emit no aerosol. Cigarettes, by contrast, pollute the atmosphere and others’ lungs at a very high rate.

“Seventy-five percent of the smoke generated by cigarettes is sidestream smoke, and that goes into the environment,” Benowitz says.

Still, much more research needs to be done to fully figure out the health risks that e-cigarettes pose for both users and bystanders.

Both Benowitz and Goniewicz say e-cigarettes may prove helpful to smokers who are trying to quit. But that's another issue that needs much more study.

And for people who don’t already smoke?

“This is not a product for non-smokers,” Goniewicz says. “If you are not a smoker, don’t use it. There’s no reason to try electronic cigarettes.” The nicotine is addictive.

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