The FDA new regulations on E-cigarettes has virtually ended the market with the exception of the two brands of e-cigarettes owned by the Tobacco Companies. Special Interest has won again, not the American people.
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.
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.
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 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.