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The InstantGMP Vape team recently presented a webinar on how e-liquid creators can prepare for FDA regulations titled E-liquid Manufacturers: Prepare to be Regulated. Attendees were encouraged to ask questions during and after the event. We had a great group of e-liquid creators eager to learn about GMP! Here are some of the best questions along with the answers:

Any ideas how to address the “public health” aspect required in Premarket Tobacco Applications?  Meaning, impact on overall population level of initiation and cessation rates?  This is the biggest hurdle for PMTAs.
The initial applications will have to draw on public literature. There will likely be a 2 year grace period to compile the information needed. Once the official regulations are published, there will be better guidance. The proposed regulations were adopted from regular tobacco products where their is already an abundance of literature on their impact on public health.


Are all ingredients subject to review by a DABT toxicologist and verified by testing at an accredited analytical lab?
Not all ingredients. Ingredients that are generally recognized as safe by the FDA, such as vegetable glycerine, aren’t likely to need testing. New ingredients or flavors will need to be tested in a lab, but doesn’t neccessarily need to be accredited. Raw materials and nocitine should be tested upon receipt.

Will nicotine levels be regulated?
Nicotine levels will likely be capped. Current accepted practices limit levels to 36 mg/ml.

Do you expect the paperwork for each variation to be hundreds of sheets of required paperwork?
Yes – the initial paperwork will be quite lengthy, but you will be able to use copies for subsequent filings.

 Do you have questions about the proposed FDA regulations for e-cigarettes? Tweet us at @InstantGMP_Vape with the hashtag #EcigRegs!



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