What Vape Retailers Need to Know – Part 3

I am putting out this information about the vape industry and the realities of life under the Deeming Regs in small articles so our readers have the time to read and digest the information. I only have 1, maybe 2, more articles of the easy stuff.  The rest gets much deeper and more difficult to ingest. If you don’t know already the “deeming” regulations are 499 pages long.

I read ALL 499 pages; most of the information is repetitive and had a lot of comments from those who responded to the FDA during the comment period.   I will have much more information after August 3rd, so stay tuned.  I will be participating in webinars and I am sure I will get more information for our readers.

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Vape Shops Do’s, Don’ts and What?

This next section is about those Vape Shops that are mixing their own e-juice, or buying e-cigarettes from China, or are building kits for customers.   Here are the rules.  (Take a deep breath)

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.

I will not go into specific details here because it’s very detailed and very expensive.  99% of vape shops will not be able to handle the cost or the rules.  If you are interested in applying here is the link.  Click Here for Information on Manufacturers Application.

Vape Shops that are importing ENDS and E-Liquids also are considered manufacturers and will need to abide by the Import/Export Rules.   You can find more information on the Importing and Exporting webpage.

Trust me, I have a Federal Import License and these rules are very difficult to understand and overly burdensome, so most would rather go out of business then attempt to import.  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).

I want to add a note.  There are other ways to continue to do business.  That’s another article in itself.  We will discuss loop holes in future articles.

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

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

With those facts in mind, here is a summary of the specific rules for those who will be manufacturing ENDS. (Remember, if you put a kit together:  battery, maybe a small tank, and a charger you are a manufacturer) I give you this information now so you can see what is in store for you if you choose this route.

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

Of course you can always call the CTP’s Office of Small Business Assistance, who 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.   (I think this is a joke)

The next step and this will happen down the road for all ENDS and e-liquids.  (By 2018)

The 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.”

This makes no sense to me, but there it is.  Even if it contain NO NICOTINE, it still requires warning statement. In what world does this make a lick of sense?
You can find more information about nicotine warning statements in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. 

Folks, really, it’s not the end of the world… yet.  I will try my hardest to get you information on loop holes and pending lawsuits.  Stay Tuned….  I’ll get all this summed up in the next article.

Wendy Bivona

Wendy Bivona is also a vape retailer. Wendy is the owner of Premium eCigs, in Melbourne Florida. Follow Wendy on Facebook. Wendy is the most informed advocate on the pro-vaping side, and she will be bringing Spinfuel Readers and Vape Shop Owners vital information for Life after August 8th.