It’s no secret that the FDA has been cracking down on vape shops, online retailers, manufacturers, and any other company that is involved in the e-cigarette industry. If you’re a vape shop owner or employee, you’ve experienced first hand how difficult it can be to comply with these constantly changing and opaque regulations.
We created this checklist to ensure that your vape shop is compliant with all of the latest FDA regulations. Protect your business and do right by your customers and make sure that you meet these standards immediately. Feel free to share this page with your employees so you can be sure that they aren’t inadvertently violating any of these regulations.
FDA checklist for vape shops (retailers)
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FDA checklist for vape manufacturers
Unfortunately, if you choose to make your own e-juice or modify vaporizers in any way in your vape shop, you’ll be considered both a retailer and a manufacturer. That means you get the privilege and joy of complying with both sets of FDA regs. Yay!
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More info on manufacturer requirements
While the rules for retailers are relatively straightforward, the requirements for manufacturers are a bit more vague and hard to understand. I mean, really, WTF does “submit quantities of harmful and potential harmful constituents” even mean?
We’ve decided to give a breakdown of some of the more confusing elements of the manufacturing checklist below. Hopefully this will help your business stay compliant and avoid any unnecessary fines or legal action.
Report user fee information
According to the FDA, all tobacco manufacturers (including e-cigarettes) must submit user fee information. According to the FDA, each domestic manufacturer and importer must submit the following information and documents:
- Its name and the mailing address of its principal place of business;
- The name and a telephone number, including area code, of an office or individual that FDA may contact for further information;
- The email address and postal address for receipt of FDA notifications;
- Its Alcohol and Tobacco Tax and Trade Bureau (TTB) Permit Number(s);
- Its Employer Identification Number(s) (EIN);
- For each TTB tobacco permit:
* The units of product (i.e., number of sticks for cigarettes and pounds for other tobacco products), by class, removed and not tax exempt for the prior month and
* The Federal excise tax paid, by class, for such removal;
If the domestic manufacturer or importer did not remove any amount of tobacco product, it must report that no tobacco product was removed into domestic commerce;
- Certified copies of the returns and forms that relate to:
* The removal of tobacco products into domestic commerce (as defined by section 5702 of the Internal Revenue Code of 1986); and
* The payment of the Federal excise taxes imposed under chapter 52 of the Internal Revenue Code of 1986. (§ 1150.5(b))
The FDA states that this information is currently submitted on TTB Forms 5210.5, 5000.24, and 5220.6 and Customs CBP Form 7501.
Register your establishment and submit a list of registered products, including labeling and advertisements
If you’re classified as a manufacturer, you must both register your shop and also submit a list of all registered products. To do this, you must submit using the FDA Unified Registration and Listing System (FURLS). This process is about as riveting and fun as you can imagine. For more information, read the FDA’s official guidance (PDF file).
Submit tobacco health documents
The FDA also has some really fun health forms that you have to fill out if you’re selling e-cigarettes or other tobacco products. Most of these forms are standardized. You can learn more by reading the FDA’s official Health Document Submission Requirements for Tobacco Products.
Submit ingredient listing
All e-cigarette and e-liquid manufacturers are also required to submit a listing of the ingredients used in their manufacturing process. Fortunately the FDA makes this really easy to do via an online form. If you’re unable to use the online method, you can also submit your ingredient listing through the mail.
Interestingly, the FDA is choosing not to enforce the ingredient listing requirements for certain products. According to the FDA, these are the products they are not enforcing the ingredient disclosure requirement on. This is subject to change.
The FDA has decided not to enforce the requirements on the following items:
- Bowls
- Cartomizers
- Charcoal
- Coils
- Connection adapters
- Digital display, lights, and buttons to adjust settings
- Electrical components including, but not limited to, batteries, charging systems, circuit boards, wiring, and connectors
- Hoses
- Mouthpieces
- Pipes
- System software
- Tanks
- Waterpipes
- Wicks
Apply to market your new tobacco product
New electronic cigarette products release on or after, as well as old one that were modified on or after, February 15, 2007 must be approved by the FDA. However, there is a category of products that are “grandfathered” in. According the FDA, if a new tobacco product was:
- Commercially marketed after Feb. 15, 2007 but before March 22, 2011; and
- A Substantial Equivalence Report was submitted by March 22, 2011;
Then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.
Include required warning statements on packaging or advertisements
“WARNING: This product contains nicotine. Nicotine is an addictive chemical.“
That warning statement has to be placed on all product packaging and advertisements. Yes, even if your product doesn’t actually contain any nicotine.
The FDA states that this required warning statement must also meet certain requirements, with respect to font, text, size, placement and formatting of the warning statement on the package labels. That is, the required warning statement on package labels must also appear directly on the package, and be clearly visible underneath any cellophane or other clear wrapping, per 21 CFR § 1143.3(a)(2), as follows:
- Be located in a conspicuous and prominent place on the two “principal display panels” of the package;
- Comprise at least 30 percent of each of the principal display panels;
- Be printed in at least 12-point font size and must occupy the greatest possible proportion of the warning label area set aside for the required text;
- Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package;
- Be capitalized and punctuated as indicated in 21 CFR § 1143.3(a)(1); and
- Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panels have the same orientation.
The FDA goes on to state that a retailer of any cigarette tobacco, roll-your-own tobacco, or covered tobacco products (other than cigars) will not be in violation of this section for packaging that: (i) Contains a health warning; (ii) Is supplied to the retailer by the tobacco product manufacturer, importer, or distributor, who has the required state, local, or Alcohol and Tobacco Tax and Trade Bureau (TTB)-issued license or permit, if applicable; and (iii) Is not altered by the retailer in a way that is material to the requirements of this section.
Submit quantities of harmful and potentially harmful constituents
Submit a Modified Risk Tobacco Product application
If you want to modify your product as having a reduced or modified risk, you’ll need to undergo the Modified Risk Tobacco Product application process. Good luck.
The stringent process requires that you submit evidence that your product will or is expected to benefit the population as a whole. The evidence must meet the requirements of Section 911 of the Federal Food, Drug, and Cosmetic Act. If you are lucky enough to be granted an order permitting the sale of a modified risk product, that order will only apply to one specific product. That means that you can’t be granted approval for one product and then transfer that over to an entire product line or category of products.
Additionally, the order is not permanent and applies only during the time period specified in the order. The FDA will withdraw the order if they feel that they can no longer make determinations regarding the risk level of the product. Once your order expires, you’ll have to resubmit and gain approval all over again for the new time period.
As of right now, zero products have been approved by the FDA to be marketed as a Modified Risk Tobacco Product.
FDA requirements for vape retailers
- 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.
- Do NOT sell e-cigarettes or other ENDS in a vending machine unless in an adult-only facility.
- Do NOT give away free samples of e-cigarettes or other ENDS to consumers, including any of their components or parts.
- Do NOT sell or distribute e-cigarettes or other ENDS without a health warning statement on the package.
- Do NOT display advertisements for e-cigarettes or other ENDS without a health warning statement.
FDA requirements for vape manufacturers
- Report user fee information.
- Pay user fees.
- Register your establishment and submit list of products, including labeling and advertisements.
- Submit tobacco health documents.
- Submit ingredient listing.
- Apply to market your “new” tobacco product via one of three pathways.
- Include required warning statements on packages and advertisements.
- Submit warning plans for smokeless tobacco and warning plans for cigars.
- Submit quantities of Harmful and Potentially Harmful Constituents.
- Submit a Modified Risk Tobacco Product application if you would like to market your product as having reduced risk or harm.
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Sources
- Manufacturing, Food and Drug Administration
- Summary of Federal Rules for Tobacco Retailers, Food and Drug Administration
