E-Cigarette and E-Liquid Regulations in the United States: An Overview

Electronic cigarettes and vapes sold in the United States are subject to safety, labeling, documentation, and other requirements. These requirements apply not only to the e-cigarette device itself, but also to batteries, chargers, and e-liquids.

In this guide, we explain what importers and manufacturers must know about the Food, Drug, and Cosmetic Act, the Child Nicotine Poisoning Prevention Act, the Hazardous Materials Regulations, UL standards, and other compliance requirements relevant to e-cigarettes.

Food, Drug, and Cosmetic Act (FDCA)

The Food, Drug, and Cosmetic Act covers various product types, including e-cigarettes. Specifically, it regulates electric nicotine delivery systems (ENDS) such as:

• E-cigarettes
• E-cigars
• E-pipes
• Hookah pens
• Vape pens
• Vapes
• Vaporizers

Here are several examples of FDA-regulated ENDS components and parts:

• E-liquids
• Atomizers
• Cartomizers and clearomizers
• Mouthpieces or drip tips
• Tank systems
• Certain batteries

Here are some of the key requirements you should keep in mind:

• You should submit an ingredient list to the FDA
• You should report any harmful and potentially harmful constituents (HPHCs) to the FDA
• You should affix a health warning statement
• You should register your establishment with the FDA
• You should submit a Premarket Tobacco Product Application (PMTA) for new product types

Ingredient list submission

Importers and manufacturers of ENDS, including e-cigarettes, should submit an ingredient listing 90 days before selling their product. They should either submit the list electronically, or fill out FDA Form 3742 and mail it to the Center for Tobacco Products (CTP) Document Control Center.

Here are three steps you should take to complete the submission online:

1. Request an Industry Manager Account

2. Prepare your ingredient listing using the FDA’s e-Submitter tool

3. Submit your ingredient listing via the CTP Portal

If you cannot register your e-cigarette electronically, you should fill out and mail Form FDA 3741 to the Center for Tobacco Products (CTP)’s Document Control Center.

Harmful and potentially harmful constituents

The FDA has an established list of 93 “harmful and potentially harmful constituents (HPHCs)” that can be found in e-cigarettes and other ENDS. Here are a few examples of those constituents:

• Acetamide – carcinogenic
• Lead – carcinogenic, cardiovascular toxicant, reproductive or developmental toxicant
• Nicotine – reproductive or developmental toxicant, addictive

You should report several key pieces of information to the FDA if your product contains HPHCs. This includes:

a. Importer or manufacturer identification

• Phone number
• FDA Establishment Identifier (FEI), if known
• Your headquarters’ Data Universal Numbering System (D-U-N-S) number, if available
• Point of contact’s title, name, address, email address, and phone number

b. Product identification (e.g. by brand, and quantity in each brand and sub-brand)

c. HPHC quantities and testing information

Labeling and warning statements

ENDS, such as e-cigarettes, should carry relevant warning statements, as specified in 21 CFR Part 1143. Here is an example of warnings for e-cigarettes containing nicotine:

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

The statement should:

• Be placed on an obvious location on the package
• Take up at least 30% of the principal display panel
• Be printed in a minimum 12-point font
• Occupy as much of the required warning label area as possible
• Be printed in obvious and readable Helvetica bold or Arial bold type
• Be capitalized and punctuated
• Be centered on the principal warning area

If the product is too small to contain the warning statement, you can place the text on:

• The outer container
• The wrapper
• A tag that is permanently affixed to the package

Registration

If you own or operate a domestic establishment that manufactures regulated tobacco products, you should register it with the FDA. You should submit the following information:

• Your establishment’s name and full address
• Your name and place of business
• Your email address
• A D-U-N-S number, or a unique identifier number

You should register your establishment immediately after you start manufacturing tobacco products, and register again every year by December 31.

Premarket Tobacco Product Application (PMTA)

The FDA generally permits you to sell only authorized products, which are listed in the Tobacco Products Database.

When you filter the category for “e-cigarette”, the sub-category for all seven options (“Check all”), and the submission type for “PMTA”, the database returns 34 e-cigarette products you are authorized to sell.

If you plan to sell a new type of e-cigarette product, you should submit a Premarket Tobacco Product Application (PMTA). In this case, the product should undergo a PMTA review process, after which you can sell your product if the FDA provides you with a marketing granted order letter. You should also maintain records for the FDA to determine if they can withdraw the granted order.

Child Nicotine Poisoning Prevention Act

The Child Nicotine Poisoning Prevention Act covers the importation, manufacture, distribution, and sale in the United States of nicotine products provided in liquid nicotine containers. This includes e-cigarettes and e-liquid containers.

You should properly package your products, and provide a general certificate of conformity for the product.

Packaging requirements

You should comply with the packaging requirements of the Poison Prevention Packaging Act (PPPA).

16 CFR Part 1700.15 requires you to ensure that the package:

• Functions for its lifetime
• Does not compromise child resistance or adult-friendliness
• Is child-resistant and adult-friendly (and is tested to ensure this)
• Should not be reusable
• Restricts the content’s flow to 2ml when squeezed or activated

This means you should have your product tested to determine if it meets the above requirements.

General Certificate of Conformity

If you are an importer, manufacturer, packager, or repackager of covered products, you should issue a General Certificate of Conformity.

Note that, according to the CPSC’s Liquid Nicotine Packaging guidance page, you can use one general certificate of conformity for all lines of nicotine strengths and flavors if the packaging for those products is the same.

You should also provide the following information on the certificate:

• Bottle type
• The package or closure manufacturer’s item codes
• Nicotine strengths

Hazardous Materials Regulations

The Hazardous Materials Regulations sets requirements for the transportation of dangerous substances and products, such as lithium batteries. The regulations are relevant to e-cigarettes because such products usually contain lithium batteries.

Documentation requirements

Manufacturers and distributors of lithium batteries should provide a UN 38.3 test summary that contains the following information:

• Manufacturer’s name, address, phone number, email address, and website
• Test lab’s name, address, phone number, email address, and website
• Distinctive test report identification number
• Date of test report
• Battery description
• List of tests conducted, and results (e.g. pass or fail)
• Reference to assembled battery testing requirements (if relevant)
• Reference to the UN Manual of Tests and Criteria used (e.g. UN 38.3)
• Name and title of the responsible person to indicate the information’s validity

Labeling requirements

According to the Hazardous Materials Table in 49 CFR Part 172.101, lithium batteries are categorized as having label code 9, which means that they should carry the CLASS 9 label as specified in 49 CFR Part 172.446.

Additionally, 49 CFR Part 173.185 requires packages of lithium batteries to carry information such as the following:

• The lithium battery mark
• The UN number (e.g. UN 3090, UN 3480, UN3091, or UN3481)
• The word “OVERPACK”, if the overpack contains lithium batteries
• Statements such as “PRIMARY LITHIUM BATTERIES—FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT”

Packaging requirements

49 CFR Part 173.185 requires lithium batteries to:

• Be packed in closed inner packaging
• Be subsequently packed in a strong and rigid outer packaging
• Withstand a 1.2-meter drop test
• Be labeled with the information in the previous subsection above

UL Standards

UL standards are generally voluntary unless incorporated by reference in a specific regulation. That said, you should still ensure your products are safe by having them tested against UL standards requirements – even if when this is not mandatory per se.

Note that, in addition, online marketplaces such as Amazon mandate the provision of valid test reports proving compliance with UL standards and may delist your products if you do not comply with their requirements.

Below we list and briefly explain two examples of standards relevant to e-cigarettes and lithium batteries. Note that other standards may exist.

UL 8139 – Electrical Systems of Electronic Cigarettes and Vaping Devices

UL 8139 contains requirements for the electrical systems (including their accessories, charging systems, components, and parts) of products, such as:

• E-cigarettes
• E-hookahs
• ENDS
• E-pipes
• E-shishas
• Hookah pens
• Vape pens
• Vaporizers

The standard’s requirements do not apply to:

• E-liquids
• Other inhaled aerosol substances
• Substances in the resulting emissions

UL 1642 – Lithium Batteries

UL 1642 covers requirements for the following types of lithium batteries:

• Primary (non-rechargeable) batteries
• Secondary (rechargeable) batteries
• Batteries meant for use in technician- or user-replaceable products

The requirements in this standard aim to help reduce the risk of injury when disposing of the removed batteries, and cover user-replaceable lithium batteries containing a maximum of 0.13 oz of metallic lithium.

This standard does not cover toxicity risks arising from battery ingestion, or injury risks due to cutting open the battery to expose the metallic lithium inside it.

47 CFR Part 15 – Radio Frequency Devices – Unintentional Radiators

47 CFR Part 15 regulates radiofrequency devices, both intentional and unintentional. Unintentional radiators are devices that generate radiofrequency energy within the device itself or send electrical signals via wiring but are not designed to emit radiofrequency energy via induction or radiation.

Most e-cigarettes should be classified as unintentional radiators because they contain electronic components that emit radiofrequency energy, but they do not include Wi-Fi, Bluetooth, and similar devices.

47 CFR Part 15’s requirements for unintentional radiators include:

a. Undergoing the Supplier’s Declaration of Conformity (SDoC) procedure

b. Providing documentation (e.g. user manual, test reports, SDoC Compliance Information Statement)

c. Carrying proper labels (e.g. compliance statement, product identification label, FCC logo)

10 CFR Part 430 – Energy Conservation Program for Consumer Products

10 CFR Part 430 establishes performance requirements and standards for electrical consumer products and components, such as external power supplies, which you can be sold together with e-cigarettes. For example, it incorporates by reference, and therefore mandates compliance with, the following standard regarding external power supplies:

IEC 62301 – Household electrical appliances—Measurement of standby power

Also, Appendix Z to Subpart B of 10 CFR Part 430 sets a uniform test method for measuring the energy consumption of external power supplies

10 CFR Part 429 – Certification, Compliance, and Enforcement for Consumer Products and Commercial and Industrial Equipment

10 CFR Part 429 establishes compliance requirements and certification procedures for consumer products, such as external power supplies, covered by 10 CFR Part 430.

Further, you must submit a certification report that includes at least the following information:

• Product type
• Product class
• Manufacturer’s name and address
• Brand name
• The basic model number and manufacturer’s model numbers
• Product specific characteristics (e.g. average active mode efficiency for power supplies)
• Compliance statement

E-Cigarettes State Regulations

On top of federal regulations, many states have different specific e-cigarette requirements on packaging, sales licenses, taxes, and underage sales restrictions. Here we list some examples:

a. California – Cal. Bus. & Prof. Code §§ 22958(a) – Stop Tobacco Access To Kids Enforcement Act

b. New York – N.Y. Tax Law § 1183 (2024) – Vapor Products Dealer Registration and Renewal.

c. Florida – Fla. Stat. § 569.45(5) (2024) – Mail order, Internet, and remote sales of nicotine products; age verification

d. Texas – Tex. Health & Safety Code Ann. § 161.252 – Possession, Purchase, Consumption, Or Receipt Of Cigarettes, E-Cigarettes, Or Tobacco Products By Minors Prohibited.

Lab Testing

In general, you need to have your products lab-tested to prove compliance with various regulations and requirements. Regulations such as the Hazardous Materials Regulations mandate testing. Even if some regulations may not explicitly mention testing, it may still be a practical necessity to test your e-cigarette, for example, to determine if your product contains harmful substances.

Regulation	Lab testing
Food, Drug, and Cosmetic Act	You may need to have your e-cigarettes undergo lab testing to ensure they do not contain harmful constituents or, if they do, report the information to the FDA.
Child Nicotine Poisoning Prevention Act	The package of your products should undergo testing according to the requirements under the Poison Prevention Packaging Act. Product tests should prove that your product is, for instance: Easy for adults to open Child-proof
UL standards	You should ensure that your product is safe by having your e-cigarettes and lithium batteries tested against UL standards, such as UL 8139 and UL 1642.
Hazardous Materials Regulations	Under the Hazardous Materials Regulations, lithium batteries should undergo testing according to UN 38.3 requirements.
FCC 47 CFR Part 15	You should ensure that your e-cigarettes meet relevant FCC requirements. This means, for example, to test the products using a measurement procedure as specified in 47 CFR Part 15.31(a): “ANSI C63.4 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz”
10 CFR Part 430	You should use the uniform test method in Appendix Z to Subpart B to measure the energy consumption of external power supplies and have them tested against the IEC 62301 standard or other relevant standards.

E-cigarette testing companies

Here we list some examples of companies that offer to test e-cigarettes and their components:

• UL Solutions
• Intertek
• SGS
• LabStat

Additional Requirements

Here we briefly explain how other regulations, such as California Proposition 65 and RoHS, apply to e-cigarettes.

Regulation	Description
Country of Origin Marking	You should label your product and packaging with a country of origin marking, such as: Made in China Made in Vietnam Made in Mexico
RoHS	Some states in the US set substance restrictions for electronics under RoHS laws. You should have your electronic products (e.g. e-cigarettes) lab-tested to ensure they do not contain any restricted substances above acceptable maximum concentration levels. Here we list some examples of restricted substances: Lead < 0.1% Mercury < 0.1% Cadmium < 0.01% Chromium VI < 0.1%
California Proposition 65	California Proposition 65 sets substance restrictions for consumer products, such as e-cigarettes. For example, the Proposition 65 list includes the following substances, which may be contained in, or may be emitted as a result of using, e-cigarettes: Nicotine Lead Cadmium

Recommended articles

• Country of Origin Requirements in the United States: An Overview
• RoHS Requirements in the United States: An Overview
• California Proposition 65 Guide for US Importers & Amazon Sellers