FDA Checklist for Vape Manufacturers



it's no secret that the FDA has been cracking down on fake shops online retailers manufacturers and any other company that's involved in the e-cigarette industry if you're a vape shop owner or employee you've experienced firsthand how difficult it can be to comply with these constantly changing and opaque regulations we created this checklist to make sure that your company 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 video with your employees so you can be sure that they aren't inadvertently violating any of these regulations if you choose to make your own ejuice 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 regulations yay buckle up because this is gonna be a long ride in case you missed it we also did an FDA checklist video solely for vape shops and retailers in this video we're gonna focus on the FDA checklist for vape manufacturers according to the FDA auto backhoe manufacturers including e-cigarettes must submit user feet information this includes things like the name and mailing address of its principal place of business the name and a telephone number including the area code of an office or individual that the FDA may contact for further information and stuff like the email address and postal address for the receipt of FDA notifications on top of that you have to pay user fees which will be determined by the FDA also you must 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 this process is about as riveting and fun as you can imagine the FDA also has some really fun health forms that you have to fill out if you're selling cigarettes or other tobacco products most of these forms are standardized and you can learn more by reading the FDA's official health documents submission requirements for tobacco products all each cigarette and eliquid 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 the FDA is choosing not to enforce the ingredient listing requirements for certain products like bowls cartomizers char coil coils connection adapters and other things like digital displays lights and buttons that are just settings this is subject to change new electronic cigarette products that released on or after as well as old ones that were modified on or after February 15th 2007 must be approved by the FDA however there is a category of products that are grandfathered in yes I used the picture of an old person for this don't judge me anyways according to the FDA the new tobacco product was commercially marketed after February 15 2007 but before March 22nd 2011 and a substantial equivalence report was submitted by March 22nd 2011 that new tobacco product may continue to be marketed 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 the FDA website contains a table of potentially harmful constituents that must be reported it seems like at this time the FDA hasn't finalized a way to submit these requirements we'll update you when we have more info 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 this 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 nine eleven of the Federal Food Drug and Cosmetic Act if you are lucky enough to be granted in order permitting the sale of a modified risk product that order will only apply to one specific product that means you can't be granted approval for one product and then transfer that over to an entire product line or a category of products additionally the order is not permanent and applies only during the time period specified in the order 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 could no longer make determinations regarding the risk level of a 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 so let's do a quick rundown of all the FDA requirements for vape manufacturers one report user fee information to pay user fees 3 register your establishment and submit a list of products including labeling and advertisements for submit tobacco health documents and 5 submit ingredient listing additionally you'll need to 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 and submit a modified risk tobacco product application if you would like to market your product that way I'm Adrienne with vapor vanity and we're the number one place for vape news and product reviews visit us at vapor vanity com

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