Regulations are Changing Constantly with Updated Guidance
FDA regulations are changing things within the vape community. The burden of compliance for vapor products can be daunting and easily misinterpreted. As we’ve spoken with customers and our legal advisers, we’ve learned about some misconceptions. So, we want to clear the air while reminding partners of the upcoming flavor listing deadline.
There’s Still Time to Include Flavorah in Your Ingredient Listings
The FDA has extended the deadlines for ingredient submission. As a result, the large-scale manufacturer deadline is now 05/08/2018 and small-scale manufacturer deadline is 11/08/2018.
Include Flavorah and Any Other Alternative Formulations in Your FDA Ingredient Listings
The FDA considers flavorings for ejuice to be “complex ingredients”, and regulations include listing potential interchangeable complex ingredients. Therefore, if you have used flavors from several manufacturers as substitutes in a recipe you still have time to list any and all flavorings that you consider suitable for making the vape juice.
For instance, if your peach cobbler vape juice can be manufactured with 4% peach flavoring from one vendor, or alternatively with 2% from a different vendor, then you should include the alternative formula in your ingredient list submissions. Another example: you made your juice with a flavor that contained D/A/AP and switched to multiple ingredients not containing those same compounds before 08/08/2016. You need to make sure that you put the new formulation into your ingredient listing.
Read the October 2017 Revised FDA Ingredient Listing Guidance. Pay special attention to Page 10 – where it talks about ingredients starting with “Complex Purchased Ingredients.” Line 343 – 387 are the key.
Listing various flavoring formulations enables continued success in the event of un-available flavorings down the road. Also, many multipurpose flavorings used in old vape recipes contain unsuitable beverage/baking ingredients. These ingredients may not pass future toxicology testing with your PMTA submission. Keeping your options open past those looming deadlines could be a life and death detail for many vape juice lines.
Bonus!
Many manufacturers have told us they love our flavorings and have already integrated them into their recipes. They just don’t feel like they have time to get it all submitted by the deadline. We have also seen many juice makers give up because of the burdensome requirements they will face in the future. Don’t quit now!
Oftentimes Flavorah flavors are so concentrated, you end up using way less than other brands, making your price point equal-to or cheaper-than less concentrated flavorings. You could end up saving enough costs to keep your brand profitable despite the high costs of compliance.
Required starting May 2018 for large-scale manufacturers and November 2018 for small-scale manufacturers, the FDA Form 3742:
FDA form 3742 Listing of Ingredients
Spreadsheet of Flavorah Names and Numbers
