The Pre-Market Tobacco Application (PMTA) is an application where new tobacco products need to be registered with the Food and Drug Administration (FDA) after February 15th, 2007.
The largest issue I saw, was the definition of a tobacco product. According to https://www.regulations.gov/document?D=FDA-2019-N-2854-0001 a tobacco product is defined as: As defined in section 201(rr)(1) of the FD&C Act (21 U.S.C. 321 (rr)(1)), the term "tobacco product" means any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product (except for raw materials other than the tobacco used in manufacturing a component, part, or accessory of a tobacco product). The term "tobacco product" does not mean an article that under the FD&C Act is a drug (section 201 (g)(1)), a device (section 201 (h)) or a combination product (section 503(g) (21 U.S.C 353g))).
E-liquid isn't derived from a tobacco product. Nicotine can be, but usually is synthetically made in a lab. There are some companies that do source their nicotine directly from tobacco, but the switch to that would be quite easy.
What the PMTA wants
The PMTA has various requirements that make it unattainable to complete by May 2020. For each product, the following requirements are required, and to gain a higher chance of acceptance, have some "recommended" portions of the application.
1. Airflow rate
2. Coil resistance
3. Coil resistance and battery output voltage determine PDU wattage
4. Increase in battery capacity (mAh rating)
5. Draw resistance
6. Puff count
7. Atomizer tank/cartridge volume
8. Number of coils
9. Coil diameter
10. Coil failure testing
11. Mass of wicking material
12. Wicking rate
13. Battery voltage operating range
14. Battery current operating range
15. PDU wattage deviation
16. Coil, solder and coil coating
17. Number of coils present
18. Position of coil
19. E-liquid absorbency of wick
20. Wicking material
21. Atomizer and cartridge components
22. Battery type and failure safety features
23. E-liquid boiling point
24. E-liquid viscosity
25. E-liquid volume
26. Particle number concentration
27. Count median diameter
28. Storage and expiration: pH, moisture content, water activity, TSNAs, NNN, NNK, nitrate and nitrite levels, preservatives, method of heat treatment
29. Location and name of testing laboratories and documentation that it is an accredited lab
30. Length of time between manufacturing and testing
31. Storage conditions prior to testing
32. Number of samples and measurements
33. Description of method procedure, method validity, and rationale
34. Testing protocols, quantitative acceptance criteria, line data, summary of results
37. Cardiovascular toxicity
38. Respiratory toxicity
39. Reproductive toxicity
40. Developmental toxicity
All of these need to be completed in order to have an acceptable application. All of this information is unattainable for several reasons. The first and foremost being man power to physically fill out each of these forms. Then, having labs perform all of the analysis on each of these products is time consuming and requires man power. Then ensuring that everything meets FDA requirements.
We've been a self-regulating industry for 10+ years now, and the FDA wants to change that. We are requesting for reasonable regulations, not an application that will costs thousands upon thousands of dollars to complete and have potentially accepted, or most likely denied.
The regulations that are wanted by the vaping industry have been discussed by the Vapor Technology Association (VTA). Here is a list of those regulations:
1. "Tobacco 21." Raise the age from 18 to 21 to purchase tobacco and nicotine vapor products, instead of restricting flavors.
2. Implement strict marketing standards to prevent nicotine vapor products from being market to or attractive to youth.
-Ban print advertising except in adult-only publications or media
-Ban advertising and/or sponsorship at stadiums, concerts, sporting or other public events that are not primarily targeted to adults
-Ban advertising, marketing and sale of tobacco products that use terms such as candy/candies/bubble gum/cotton candy/milkshake/etc.,
-Ban advertising and marketing of tobacco products, including vapor products that make any reference to the product as a smoking cessation device or as a product which may be used to help quit smoking.
-Ban advertising on outdoor billboards near schools and playgrounds
-Require labels to include warning protecting youth such as "Sales to minors prohibited."
-Require all advertising to be accurate and not misleading
3. Close loopholes by banning sales on third-party marketplaces like Alibaba, Amazon, eBay, et al.
4. "Three Strikes and You're Out" for any retailer accumulating three violations in three years for selling nicotine vapor products to minors lose the right to sell nicotine vapor products.
5. Restrict sale of "super high nicotine" products to adult-only stores.
6. Tax, Enforce & Educate. Impose taxes and/or user fees to pay for education and enforcement by implementing a 3% ad valorem tax and/or user fees on vapor products instead of restricting flavors.
7. Ban self service displays. Require all tobacco products, including vapor products, to be behind a counter or in a locked display and accessible only by an employee.
8. Point of sale age verification. Require use of third-party age verification software or technology for all online sales and all brick and mortar sales.
9. Brick and Mortar warning signs. Tobacco product retailers must display signage indicating that (a) "Unaccompanied Minors Are Not Allowed on Premises" or (b) "Product are Not for Sale to Minors" or (c) "Underage Sales Prohibited."
10. End "Straw man" sellers. Make it illegal for any person who is not a licensed tobacco product dealer to sell, barter for, or exchange any tobacco product.
11. End bulk sales. Prohibit the retail sale of more than 2 devices or 5 packages/bottles of e-liquids in one transaction.
These regulations will allow for flavored nicotine e-liquids to stay on the market while ensuring the youth have a more difficult time attempting to receive or purchase these products.
Take a moment to oppose the PMTA here: https://www.regulations.gov/document?D=FDA-2019-N-2854-0001 Click comment now in the right hand corner, and tell them you are against the PMTA and want to see reasonable regulations go into effect.
We've been fighting so hard and continuing to fight. Keep pushing forward, our voices are being heard.