The moment we’ve all been dreading has finally arrived. The FDA just today released a 499 page document detailing the new regulations that will cover the vaping industry. In other words, we lost. Big Tobacco and the greedy state governments have won. It might be time to start stocking up on mods and juice. The Vapepocalypse is here (well, it starts in 90 days and then gets really bad in 2 years).
These sweeping regulations are going to completely fuck over the entire vaping industry, put companies out of business, and worst of all, cost peoples lives by depriving them of the most effective tool to quit smoking ever devised.
What is regulated?
From the FDA:
FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS (Electronic Nicotine Delivery Systems)* but excludes accessories.
The following components will be regulated by the FDA:
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
Things that are considered accessories and aren’t regulated? Screwdrivers and lanyards, among other things. I’m dead serious. You can’t make this shit up:
Many comments also sought clarification and examples as to which objects used with ecigarettes would be considered components, parts, and accessories. The following is a nonexhaustive list of examples of components and parts of ENDS (including e-cigarettes): Atomizers, flavors used or intended to be used with ENDS (with or without nicotine), e-liquid solvents, tanks and tank systems, batteries (with or without variable voltage), coils, cartomizers, digital display/lights to adjust settings, clearomisers, and programmable software. The following is a nonexhaustive list of examples of objects used with e-cigarettes or other ENDS that would likely be considered accessories: Screwdrivers and lanyards.
Manufacturers
Hardest hit will be the manufacturers, who will have to submit each individual product to the FDA’s costly review process. This process will effectively eliminate any company other than Big Tobacco from making e-cigs.
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
Most disturbingly, this even applies to your local small-time vape shop that mixes their own e-liquid. Under these new rules they will be considered a manufacturer and will have to cough up insane amounts of money and go through the approval process for each flavor.
From the FDA Regulations:
If an establishment mixes or prepares e-liquids or creates or modifies aerosolizing apparatus for direct sale to consumers for use in ENDS, the establishment fits within the definition of “tobacco product manufacturer” in section 900(20) of the FD&C Act and the combinations it mixes and/or prepares are new tobacco products within the meaning of section 910(a)(1).
Are you someone who likes to buy individual parts separately? Too bad. You’re gonna have to buy the entire system as a single product:
However, as noted elsewhere in this document, for ENDS hardware or delivery system components or parts, such as batteries, FDA expects that it may be difficult for manufacturers to obtain premarket authorization for such products, given the great extent of possible variations in combinations of hardware components, if all considered and sold separately. Thus, with respect to such apparatus, FDA expects that manufacturers will be most successful where authorization is sought for entire delivery systems, rather than individual components.
Additionally, in 90 days there will be a market freeze in which no new vaping products can be manufactured:
In addition, we note that any new tobacco product that was not on the market on the effective date of the rule (i.e., 90 days after the publication date) is not covered by this compliance policy and will be subject to enforcement if marketed without authorization after the effective date.
So any products that come on to the market within the next 90 days will be safe for two years, supposedly giving manufacturers time to comply with the FDA approval process. At the two year point only products that have been approved by the FDA will be allowed to be sold (bye bye anything not manufactured by Big Tobacco).
Retailers
Here are the FDA’s new rules for retailers, some of which take effect in 90 days and some of which don’t take effect until 2018:
Some examples of ENDS include e-cigarettes, vape pens, e-hookahs, e-cigars, personal vaporizers and electronic pipes.
- Check photo ID of everyone under age 27 who attempts to purchase e-cigarettes or other ENDS.
- Only sell e-cigarettes and other ENDS to customers age 18 and older.1
- Do NOT give away free samples of e-cigarettes or other ENDS, including any of their components or parts.
- Do NOT sell e-cigarettes or other ENDS in a vending machine unless in an adult-only facility. 2
- Beginning in 2018, do NOT sell or distribute e-cigarettes or other ENDS without a health warning statement on the package.
- Beginning in 2018, do NOT display advertisements for e-cigarettes or other ENDS without a health warning statement.
- 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 tobacco product manufacturer and must comply with all of the legal requirements for tobacco product manufacturers.
Say goodbye to sampling stations, promotional giveaways, and most likely even free products given away with a purchase.
Importing
Importing e-cigs and vaping products are now considered to fall under the same laws as importing tobacco:
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.
Nicotine Warning Statement on Packaging and Advertising
All advertising and packaging must contain an absurd nicotine and tobacco warning. It’s unclear how this will affect online advertising and affiliate programs at this point:
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.
You read that right. Vaporizers and e-liquids, which may or may not contain nicotine and definitely do not include tobacco, must place a warning that they contain a product that they don’t actually contain. What the fuck.
These soulless bastards care more about making money and protecting the tobacco industry than they do about people’s lives. Hopefully there is some kind of miracle in congress that can stop this madness within the next two years. Come on Duncan, you can do it!
