FDA & PMTA Updates 10.03.2020

FDA & PMTA Updates 10.03.2020 - BLV Delivery

Vape Industry Update

Retracted Study on eCigs that were associated with heart attacks

A study published in the Journal of the American Heart Association that claimed vaping led to higher risks of heart attacks was retracted after it was determined that the study didn’t specify whether or not the subjects had the conditions prior to using eCigs. It’s worth noting that the WHO still is using this inclusive study among others to run their “War on Vaping” propaganda using inconclusive or false claims with redacted studies. 

The Pathway to Transition the Illegal Market to Legal Market

It’s estimated that more than 99.9% of vapor products sold today are unauthorized. In a July 2019 Gallup poll, 8% of adult Americans said they have vaped within the past week. That’s over 15 million Americans (over the age of 21). With that many people vaping and that many products unauthorized, the FDA simply can’t remove everything unauthorized at this point. Realistically the 1% of authorized products (if that) need to become the majority of sales to transition away from unauthorized products completely. It’s likely that customers simply won’t stop buying products because they are unauthorized, but will instead need to be the result of stores and distributors deciding (or forced) to only carry the authorized products. Odds are unlikely that ALL stores will cut down their selection and customer base just because the products are unauthorized. Even if stores today trimmed back considerably due to fears of the FDA’s compliance checks, eventually those stores and distributors will start to bring those items back if they begin to lose market share if no significant enforcement action is present among unauthorized products. We have seen this sort of thing happen over the last few years when fears of the FDA, potential flavor bans, or local laws cause businesses to tighten down their inventory. If customers can’t find the products they want from their current stores, they will look elsewhere. Eventually stores begin to loosen back up if their business is hurting and competitors aren’t being asked to get rid of unauthorized products. The same could be said with respect to manufacturers that are currently trimming down their production of products today. While on one hand businesses don't want to risk getting penalized by the FDA, they also don't want to risk losing their customer base if following the rules ends up driving them out of business in the long run. Each business will determine which risks are more worth it to them based on current and predicted future outcomes.

How Corruption in the Vape Industry Begins

The most viable solution at this moment with regard to ensuring all vapor products sold have marketing orders, would be for the FDA to partner with these PMTA approved products to ensure they replace all the other products on the market to meet the demand and ensure a smooth transition to compliant products. This also means more products need to be approved overall to fill the gap. That brings up a bad case of potential corruption. It's likely larger companies (but not specifically) like USA Vape Labs (Naked), Turning Point Brands, and Juul won’t be too happy if all the other brands that didn’t submit PMTAs are still being sold in their place. Think in terms of Naked’s perspective who is no longer producing or selling their salts in the USA…. Would they be pleased that all the other salt brands are still being produced and sold on the market? Especially if those other companies didn’t put forth the time, effort and money to submit a PMTA application? It likely won’t be long till the companies who filed start to get unsettled if they pulled product or spent millions of dollars to be on the market the right way and gave up their market share expecting the FDA to protect them by rolling out more aggressive enforcement actions. With them having closer relationships with the government through the FDA, it’s likely they will start to ask if they can bring their other products back, (just do it anyways) or ask for the FDA to get more aggressive. This is just the beginning of how the larger companies use the government to stomp out competitors using regulations that favor the big guys. Something we have seen Juul move in the direction of since they have had to lay-off nearly 50% of their workforce. Originally we were all on the same side, but that could change as those companies who submitted will advocate for the FDA to do compliance checks to protect their market share if they are PMTA approved. Suddenly a regulation that hurt everyone, now favors a handful of companies that might encourage enforcement action take place. This could come in the form of supporting a flavor ban for example, if their products that are PMTA approved are exempt from it. PMTAs have driven up the cost of their operations and generally those companies would like to see at least those costs recouped as an investment. 

Politics of the Flavors

This is not to advocate for either political side because both parties have their place in regards to how government functions. This is acknowledging the historical advocates for or against the vapor industry based on party. There are plenty of democratic readers who are in support of our industry and we need your help the most to help protect the industry.  With limited exceptions, the vast majority of flavor bans and other regulatory hindrances put upon the vapor industry have come from the Democratic Party by way of example with the current 5 states with Flavor Bans being New York, California, New Jersey, Massachusetts and Rhode Island. All 5 states have been historically Democratic ran states. Most Republicans including the current president and most recently Republican Governor DeSantis who once called for the ban on flavors have changed positions based on new information provided by advocates, while most Democrats have not changed their stance. Additionally, the proposed National Flavor Ban Bill that passed the House back in Feb had 208 (Yeas) vs 17 (Nays) from Democrats with only 5 (Yeas) and 177 (Nays) from Republicans results here. There is a good reason why generally Democrats are against flavors or the vapor industry as a whole. In simplistic terms democrats tend to favor social causes while republicans tend to favor business. Democrats also see the vapor industry as big tobacco and big business, even though it was started and still largely run by independent and smaller companies not associated with big tobacco at all and wanted to help people quit smoking specifically. As a general social matter, vaping and nicotine usage is seen as bad for the public (though that is beginning to change with education - You Don't Know Nicotine Film is close to making it's premier). What you care about most tends to put people in one of two camps (since no one seems to care for independents or independent thinking anymore). Depending on which state you operate in along with your political representation, should give you a sense of how at risk a flavor ban is relative to your state and city (cities being more likely to ban flavors as well). If you are planning to relocate or open a new store, these are risk factors you should take into consideration. Also depending on who gets elected as president this year could also increase the risk of a nationwide flavor ban since The Trump Administration has already stated they would recommend a veto which is why the proposed flavor ban that passed the house in February this year hasn’t gone anywhere since March 5th. You can almost certainly predict based on the past support of a flavor ban, if the democratic party gets the Senate or the Presidency with the current support, that flavor ban waiting on the Senate floor will begin to move again. So if things turn blue, flavors are likely to run brown. This section is not an attempt to swing votes. For those of you planning to vote for Biden in the election or generally vote democratic, we need you to speak to your representatives to help address this issue. Since everything is so heated, Republicans and Democrats aren’t listening to each other. Instead, I would hope there are democratic or liberal supporters within the industry who are willing to speak to their constituents and help educate the elected officials to understand the research and data in favor of vaping to replace cigarette usage as public health matter and also that flavors aren’t the primary driver for underage usage as reported by the CDC in 2019 - the most common reasons for e-cigarette use were “I was curious about them” (55.3%), “friend or family member used them” (30.8%), “they are available in flavors, such as mint, candy, fruit or chocolate” (22.4%)

Brand Changes

Twist Liquids, Lost Art, OTR name changes for PMTA:


Previous Product Names NEW Product Names Previous Product Names NEW Product Names
Pink Punch Lemonade Pink No. 1 Chilled Melon Remix Chilled Remix
Watermelon Madness Red No. 1 Fruit Cocktail Blend Cocktail Blend
Honeydew Melon Chew Green No. 1 Frosted Sugar Cookie Frosted Amber
Tropical Pucker Punch Blend No. 1 Banana Oatmeal Cookie Banana Amber
Berry Medley Lemonade Purple No. 1 Strawberry Honey Graham Cookie Berry Amber
Iced Pink Punch Pink 0° Grape Berry Mix Purple Grape
Strawberry Crush Crimson No. 1 Peach Blossom Lemonade Yellow Peach
NA Tobacco Platinum No. 1 Pom Berry Mix Purple Berry
NA Tobacco Gold No. 1 Sweet & Sour Sour Red
NA Tobacco Silver No. 1 Wild Watermelon Lemonade Wild Red
NA Menthol No. 1 Lost Art The Grape White White Grape
Lost Art Space Rocks Space No. 1
OTR Bearhemian White Gummy White No. 1
OTR Sour Rainbow Rainbow No. 1
Previous Product Names NEW Product Names
Pink Punch Lemonade Salt Pink No. 1
Watermelon Madness Salt Red No. 1
Honeydew Melon Chew Salt Green No. 1
Berry Medley Lemonade Salt Purple No. 1
Iced Pink Punch Salt Pink 0°
Strawberry Crush Salt Crimson No. 1
Arctic Cool Mint Salt Mint 0°
Tropical Pucker Punch Blend No. 1
NA Menthol No. 1
NA Tobacco Gold No. 1


Humble changes for PMTA - To produce 60mls (3mg, 6mg) and 30ml (36mg) salts only (120mls have been discontinued along with most of their flavors)

Available flavors in production:

  1. Banana Bread

  2. Blue Raspberry - Berry Blow Doe

  3. Blue Raspberry Menthol

  4. Creamy Crunch - Hopscotch

  5. Kiwi Berry Citrus - Pee Wee Kiwi

  6. Mango Passionfruit - Sweater Puppets

  7. Strawberry Banana - Donkey Khan

  8. Toffee Vanilla Custard

  9. Vanilla Almond Tobacco

  10. Watermelon

Charlie's Chalk has discontinued the following to focus on their Pachamama line exclusively:

Discontinued items:

  • Sweet Dream, Jam Rock, Slam Berry, Mustache Milk, Big Berry

  • Aunt Meringue

  • Miss Meringue

  • All the Black, White and Gold series flavors

  • All the Sub Ohm Salt Pachamama flavors

Coastal Clouds Name Changes - all 0,3,6mg options in 60ml and 30mls Salts in 35 & 50mg remain available with new branding and some name changes listed below:

Old Names New Names
Blood Orange Mango Snow Cone Blood Orange Mango
Iced Blood Orange Mango Snow cone Iced Blood Orange Mango
Blueberry Banana Muffin Blueberry Banana
Guava Punch Pineapple Guava
Sugared Nectarine Citrus Peach
Papaya Punch Tropical Lemonade
Lemon Meringue Pie Lemon Meringue
Cuban Tobacco
The Abyss Watermelon Cream
The Voyage Strawberry Cream
The Traveler Lemon Raspberry
Strawberry Daiquiri Strawberry Pineapple Coconut
Mint Menthol

Kilo Moo Series and Kilo Sour Series rebranded and TFN

The original Bazooka flavors (which later became the Kilo Sour Series) and the Kilo Moo Series have been rebranded with Synthetic TFN nicotine under a new vendor and line up here


Be Prepared for Complaints
With all the brand changes and discontinued flavors you can expect customers to throw a fit. It's important to prep customers early by identifying which flavors might be going away completely or are being changed in some way so you can find a solution for them such as finding a new flavor or pointing out it's just under a new name. Some of you may also opt to order as much as you can of those flavors now before they dry up completely. I'm planning to put together a master sheet for more of these major brands going through changes so stores can educate their employees and purchasing managers what is available, discontinued, or name swapped with a simple sheet to reference that can even be printed. If you would like an excel sheet for your store, please email me on "what brands" you would like a sheet for. This information could also change at any time so be flexible if not flavors come out or discontinued items show back up again. It's important to note, just because these brands submitted, are accepted, or changed branding in some way for their PMTA applications does NOT mean they are 100% risk free. Though generally their PMTA submissions will limit risk, The FDA can still reject any of these products so there is no full legal protection offered by these brands based on what you choose to purchase. These changes have been made based on the assumptions each manufacturer has with regard to what FDA is likely to approve or not based on incomplete or missing information.

New Products

Propaganda has changed their salt packaging to be available in 2x15ml options


Chain Vapez has added a new flavor Revenge (blueberry lemonade) in salt and freebase


Juice Roll Upz has added a new set of twin pack disposables with a unique design.