FDA ENDS

The FDA deeming rule extended authority over Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS). There are several key requirements that will go into effect for the first time for FDA ENDS. The effective dates are staggered. It is important NOT to see the staggered dates as extra time to wait. The FDA provided the time because it will be needed to come into compliance.

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

The FDA defines vaporizers, vape pens, hookah pens, electronic cigarettes (E-Cigarettes), and e-pipes as 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.

In FDA deeming rule extended 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.

The FDA defines “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

As before the deeming rule, if a therapeutic claim is made about supporting in smoking cessation, then the product is outside the FDA deeming rule and regulated as a medical device.

Manufacturing ENDS and E-Liquids

As a manufacturer of ENDS, there are several requirements that now apply. Those include:

• Submit an application and obtain FDA authorization to market a new tobacco product (among the requirements: went on sale after Feb. 15, 2007, unless the manufacturers can prove to the FDA that they’re “substantially equivalent” to products that were already being sold or that there is some other reason they should be exempt).
• 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

Nicotine Warning Statement

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

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:

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

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.

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.

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 the Importing 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.

Reporting Adverse Events 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.