FDA Vaping Final Deeming Regulation: Nicotine Base.

May 14, 2016

How the FDA will regulate nicotine base/liquid nicotine is an area of great confusion in the vaping community, which includes some vendors. I’ve seen responses that include assertions that a given vendor is already licensed to sell NIC base by a given states “Tobacco Manufacterer” laws. Since Federal law usurps state law, I decided to dive down into the Draft Guidance on PMTA and see what I could learn. Here are some extracts and bolded by me:

E. E-liquids 187
For the purposes of this guidance document, liquid nicotine and nicotine-containing e-liquids 189 (i.e., liquid nicotine combined with colorings, flavorings, and/or other ingredients) are generally 190 referred to as e-liquids. Liquids that do not contain nicotine or other material made or derived 191 from tobacco, but that are intended or reasonably expected to be used with or for the human 192 consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s 193 tobacco control authorities.

See what they did? They created their own deplorable definition of “e-liquids” so they can obliterate the industry. That spells PMTA per skew and you can forget the flawed argument about a given states authority for you to sell. Note the deplorable little gem about zero NIC ejuice. Using the weasel words “intended or reasonable expected” they just slammed the door on vaping sites and B&Ms who thought they could skirt the PMTA requirements. You will need a PMTA per skew. Since NIC Base has no other uses outside of the Vaping world, that door is closed. Although not as crystal clear, the same is true of finished ejuice which has no other uses outside of the Vaping world. This is the “context” argument I made with wire, batteries and KGD, all of which are used in other industries and will continue to be sold by the likes of Amazon etc but NOT by Joes Vapor Shop unless a PMTA is obtained.

F. Finished Tobacco Product 196
The term finished tobacco product refers to a tobacco product, including all components and 198 parts, sealed in final packaging intended for consumer use. For example, an e-liquid sealed in 199 final packaging that is to be sold or distributed to a consumer for use is a finished tobacco 200 product, but in contrast, an e-liquid that is sold or distributed for further manufacturing into a 201 finished ENDS product is not itself a finished tobacco product. At this time, FDA does not intend 202 to enforce the premarket authorization requirements against e-liquids or other components and 203 parts of newly deemed products that are not finished tobacco products. Finished tobacco 204 products that are not covered tobacco products are not subject to the health warning statement 205 requirements (21 CFR part 1143), age and identification restrictions (21 CFR 1140.14), and 206 vending machine restrictions (21 CFR 1140.14) (see definition of covered tobacco product).

Think your going to be clever. I wish! Their are about a dozen companies which sell NIC base which the FDA considers a finished product. Although it’s not crystal clear, refined NIC which is generally imported from China, Brazil, India, etc is not a finished product so would not be regulated by the FDA, however you and I can’t purchase 55 gallon drums of this NIC. Only wholesale distributors and merchants who sell NIC base have access to this pipeline. In another words, if you sell NIC base you will need a PMTA for each skew. Some examples of the “skew” which might give you a headache. NIC base from many vendors is sold in various strengths like 3MG, 6MG, 12MG, 24MG, 36MG, 48MG, and 100MG which is what most of the DIY world and eJuice manufacteres purchase. Then each one of these NIC strengths is available is various solvents like 100%PG, 100%VG, 50/50, 70% PG, and 70% VG. Add all the possibilities up and it’s a staggering number of PMTAs for a given strength. Six different combinations for 100MG. Around 40 PMTAs for a given vendor. Even if you took the low ball of 330K per PMTA that’s over 13 millon dollars for all the PMTAs. Think one millon per PMTA then it’s 40 millon. We use the same logic with eJuice. Let’s take “Funky Duck Custard” as an example: 4 NIC strengths with 4 PG/VG options for each strength. That’s a total of 16 PMTAs for a single flavor. Not likely! Slim to none of a chance that any NIC base seller or ejuice manufacterer will get a PMTA.

Bridging 1908
Ideally, a PMTA will include studies conducted using the new tobacco product; however, 1910 bridging of data from one product to another may be feasible for a subset of products or for 1911 certain types of studies. For example, “X-flavor” e-liquids with nicotine concentrations ranging 1912 from 1 milligram per milliliter (mg/mL) to 24 mg/mL may not require unique studies for each 1913 nicotine concentration of the “X-flavor” product if data from a subset of nicotine concentrations 1914 (e.g., low, middle, high) of “X-flavor” products may be bridged to other concentrations of “X-1915 flavor” products. If you choose to bridge data from a studied tobacco product to your new 1916 tobacco product, you should provide the rationale and justification to support bridging (e.g., why 1917 the data used are applicable to your new tobacco product).

When I first read this I had a glimmer of hope since this could reduce the number of PMTAs for NIC base. Then it got real! Although we can read it, I’m quite skeptical that the FDA would use “bridging” to reduce the number of PMTAs per merchant/manufacters. I could be wrong and you can call me skeptical but I think it’s a CYA and PR move which has no basis in the real world.

FDA Deeming Regulation Compliance Calendar

I’ve struggled trying to create a regulatory timeline for the Final Deeming Regulations. I finally found a good one courtesy of VTA (Vapor Technology Association). Easy to read and complete. I took the images and created a .pdf so it’s easier to read and pass along.

If the above data does not display you can also use Complete FDA Deeming Regulation Compliance Calendar prepared by VTA (Vapor Technology Association).