Category Archives: News

The FDA Announces A New Tobacco Regulatory Plan That Benefits Vaping

Last week, Dr. Scott Gottlieb, the newly appointed Commissioner of Food and Drug Administration, did a live on-air announcement of the FDA’s new approach to nicotine and tobacco. You can read the transcript here. The FDA also published an accompanying press release to announce their new comprehensive tobacco product regulatory plan. The focus of this new plan is mainly on nicotine and addiction, but also harm reduction, which is new for the FDA. And what’s especially exciting about this news is that Dr. Gottlieb has finally addressed electronic cigarettes, and mostly in a positive way. Until now, we had no idea how Gottlieb felt about vaping. Most of us were hopeful, while some of the more pessimistic people believed Gottlieb wasn’t going to help at all. Well thankfully, the pessimistic were wrong.

The FDA’s announcement talks about weakening addiction by reducing nicotine levels in cigarettes, encouraging innovative technology to deliver nicotine in a less harmful ways, giving vape product manufacturers clear guidelines on submitting their products for approval, extending timelines for newly classified tobacco submissions, and better regulations on newly deemed products.

Let’s discuss all of those things.

Gottlieb’s First Remarks On Electronic Cigarettes

As I mentioned earlier, none of us really knew what to expect from Gottlieb as far as electronic cigarettes were concerned. We knew that he had a penchant for cigars though, and since cigars are also newly deemed products along with electronic cigarettes, it seemed to be a potential positive for our industry.

And in Gottlieb’s speech, he finally addressed his thoughts on vaping.

He was quoted as saying “as we move forward with this approach, we must also take a new and fresh look at the non-combustible side of the house. And that is why part of CTPs task is to reconsider aspects of implementation of the final deeming rule with an eye towards fostering innovation where innovation can make a public health difference”

He’s clearly talking about vapor products and harm reduction here.

He later talked about how there are still things that need to be researched in regards to the safety and efficacy of electronic cigarettes in reducing harm, these products may be a solution. He also talked about how the Center for Tobacco Products will explore the benefits of new non-combustible products with an open mind.

Reducing Nicotine Levels

Very early on in Gottlieb’s presentation, he talked positively about how new products are now on the market that can deliver nicotine without combusting tobacco, referring to non-combustible products like vapor products.

He spent a lot of his presentation focused on issues with nicotine addition. He noted that nicotine is by no means completely safe, but that the problem isn’t just the nicotine. It’s how it’s delivered. He pointed out that it’s the dangerous particles in combustible cigarettes and the thousands of dangerous chemicals in cigarette smoke that are the real problem.

One of the ways they want to reduce smoking rates is by exploring ways to reduce nicotine levels so that they are minimally or not addictive by reducing their nicotine levels. I’m not sure how they plan to do that with cigarettes or if it’s even possible, but something I want to point out is a key comment in this regard from Gottlieb’s live announcement – he specifically stated they do NOT plan to alter the nicotine content of non-combustible products such as e-cigarettes.

Harm Reduction

Gottlieb talked a lot about harm reduction. He mentioned several times about how he wants the CTP to look at how innovative products can help smokers reduce their risk.

Gottlieb said that they need to focus more squarely on the nicotine and that they want to take a renewed look at nicotine delivery to save lives. He said he wants a world “where adults who still want or need nicotine can get it from alternative and less harmful sources.”

A Four-Year Deadline Extension!

One of the first huge components of this new plan that benefits us is that the deadlines for having products approved have been extended by four years. Gottlieb said that this gives the FDA time to better inform their policies and efforts.

The deadline was originally August 2018, which is a year from now. Many of us were expecting that the vape industry would shut down if something big didn’t happen before the original deadline. A lot of businesses were planning on staying open as long as they would but also planning on closing up shop when the time came. And A lot of people have avoided starting new small vape businesses due to the impending deadline.

But that has all changed with this extension.

With the four-year extension, the vape industry now has five more years from today. That deadline will still come eventually, but this gives us much more time to continue developing positive scientific research, help smokers quit, advocate for the industry, and it also allows thousands of people to keep their jobs.

Current Policies, New Regulations, and Guidelines

Gottlieb confirmed that any current policies already in place will remain in place. That means that new products are still not allowed on the market after August 8th, 2016. Laws like age requirements, labeling requirements, child safety protections, and advertising restrictions are still in effect.

But the FDA wants to build on the current policies by further developing standards for the vape industry, some good and some not. Well, depending on how you look at it.

The FDA plans to develop new standards on battery safety and children’s exposure to liquid nicotine. We don’t know what that entails yet.

But something that has given many manufacturers a sigh of relief is that not only do they get a 4-year extension on submitting their products, but the FDA also plans to create clear guidelines and guidance on how to submit complete applications, either for Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications or Substantial Equivalence (SE) reports.

And manufacturers will be allowed to market their products while their applications are being reviewed.

Regulating Kid-Friendly Flavors

This is one of the more worrisome aspects of the new regulatory guidelines. Gottlieb stated, “I have real concerns about kids’ use of e-cigarettes, and I know many others share those concerns, especially those products marketed with obviously kid-appealing flavors.”

He stated that CTP will re-double efforts in protecting kids from ALL nicotine-containing products, which will include looking at kid-appealing flavors.

The FDA plans to seek input from the public on how flavors might attract kids to tobacco products, but also how flavors might play a role in helping smokers switch to less harmful products.

Vapor Products as Medicinal Products

Many of Gottlieb’s statements were broad and some were hard to apply directly to electronic cigarettes. For example, he talked about the safety and effectiveness of nicotine when used in medicinal products when they aren’t attached to smoke particles in cigarettes.

But he didn’t specifically say by using electronic cigarettes. He even followed up his first statement by referring to gum, lozenges, and patches.

But he talked a lot about electronic cigarettes in his speech. He might have been referring to them in this line of thought. Does that mean that the FDA might consider classifying vapor products as medicinal products? Who knows.

What Does This All Mean For Us Moving Forward?

With the lack of support that the Cole-Bishop bill received with policy-makers and the recent loss against the FDA that Nicopure suffered in court recently, it’s still hard to believe that this new approach will change anything. But I think it’s also important to understand that a lot of the failures we’ve seen have been while the old administration was still in place or on their way out. Dr. Gottlieb has only just recently been appointed and it takes time for big changes to happen.

But I also want to point out that Gottlieb’s approach doesn’t change how states and cities might pursue their own regulations. Local governments can still propose public space bans, increased taxes, and even flavor bans like the one that just passed in San Francisco.

And vapor products are still potentially facing a nearly complete ban in 2022 when the new deadline hits.

We also still have a market freeze. No new products are allowed to come out and be sold in the U.S., even though a lot of companies are ignoring that part of the law and still doing it. I have mixed feelings on that. I think it’s good to continue innovating and bringing out products that help people quit smoking, but I also think it really sucks for the companies here who are obeying the law and suffering in sales while their competition breaks the law and reaps the rewards. Word has it though that in a recent FDA Stakeholder call the FDA plans to ramp up enforcement of the market freeze and that vape industry members have been helpful in pointing the FDA in the right direction. So that sounds like some seriously scary news for anyone ignoring the law on that front.

Anyway, with the FDA’s new stance regarding electronic cigarettes, a lot of advocacy groups are expecting anti-tobacco groups to come out in full force against vaping in the next few years. That means we’ll have to be extra vigilant about what anti-tobacco folks are doing and it also means we’ll have to fight back even harder.

And fighting back is extremely important. Do you think Gottlieb would be advising the FDA to look at electronic cigarettes and harm reduction if it wasn’t for the noise we’ve been making? Hell no! A decision like that doesn’t just flip like a switch. Nicopure lost their lawsuit against the FDA, but that doesn’t mean that it was for nothing. Everything we’ve been doing to advocate for vaping has made an impact and we need to continue those efforts

The war isn’t over, but each battle adds up and this is certainly a big win for us.

A New Specialty Mouth To Lung Online Store For Beginner Vapers

There’s a new specialty “Mouth-To-Lung” online vape store from veterans in the vape community, Phil Busardo, Dimitris Agrafiotis, and Schell Hammel.

You’ll find the site at MTLVapors.com

This is an online vape store that specializes in helping to introduce smokers to vaping, since most smokers prefer mouth-to-lung vaping because it mostly mimics the feel of smoking cigarettes.

All of the hardware and liquids on the site are designed specifically for restricted airflow vaping and are most likely to appeal to smokers transitioning to vaping.

For example, they sell e-juices from Mountain Oak Vapors, The Vapor Bar, and B. E-Liquids. Most of the flavors consist of various tobacco blends, coffee flavors, and menthols.

Phil’s line, B. E-liquids has a little more variety in flavors, such as his coconut vanilla yogurt or peach watermelon flavors, but something to note about his line is that they are made with 60pg/40vg, while most e-juices today are made with 70vg/30pg. It’s a small difference, but Phil’s ratio gives the e-juice a little more throat hit and also better wicking ability for mouth-to-lung tanks.

The hardware they sell are all great setups for beginners too. You’ll find a lot of all-in-one setups, pod-based setups, high-quality vape pens like the Innokin Endura T18, and a few more powerful devices (but still beginner-friendly) like the Coolfire IV Plus.

They’ve created a few bundles too so that it’s easy to jump right in and get everything you need at once.

They’ve made the site very easy to understand and have removed a lot of the more advanced and confusing aspects of vaping, however, there are a couple of informational pages to get new users familiar with some of the terminology, how vape technology works, the ingredients that are used, and safety concerns.

I wish a site like this existed when I first started. This is a great idea and I’ll definitely mention it to any smoker I meet.

Naked 100 E-Juice Counterfeits Hit The Market

Update (08-10-17): Here’s the official page on their website with the latest information about identifying counterfeits

USAVapeLab, the creators of the Naked 100 e-juice line, sent out a notice to customers about counterfeit versions of their e-juice on the market and they posted pictures showing how to identify a counterfeit bottle from an authentic.

Here’s the gist:

  1. Both authentic and fake bottles have a clear anti-tamper seal, but the new seals on the authentic have the words USAVapeLab printed on it. You still might have an older authentic bottle if the seal doesn’t have any print on it.
  2. The label has minor quality issues, for example, the details are not as precise and some of the design on the fakes are a lot darker, probably because they are using a lower quality printer.
  3. The label on the fake has a wide space in the back
  4. The label on the fake is missing the “Caution” paragraph
  5. The color of the e-liquid of the authentic is clear, while the fake is amber colored.

And they have added two new features to identify authentic bottles:

  1. The words “USA Vape Lab” is embossed on the bottom
  2. The neck of the bottle will now be stamped with “USA Vape Lab”

Those are two new features, so if you don’t see them on your bottle, that doesn’t mean you have a fake, but just something to keep an eye on.

Complete Counterfeits of E-Juice Is Rare

Counterfeiting in the vape industry has been around for a long time, but it’s usually on hardware, not with e-juice. Companies stealing e-juice recipes from sites like E-liquid-Recipes.com and selling it isn’t unheard of, but stealing a recipe, along with the label and everything else is something I’ve never seen. It’s also illegal.

This is crazy and it’s also a little scary because who knows what’s in this e-juice, who’s making, and where it’s coming from.

This is also bad for the Naked 100 brand. Not only is USAVapeLab losing money, but if someone buys the fake and doesn’t like it, they might think that it’s terrible e-juice and never buy it again. They might even give it a bad review, not realizing that it’s not the real thing.

There are several Naked 100 clone recipes on the internet, which personally I think is fine because these are people’s best guesses, not exact recipes. But to take one of those recipes and counterfeit the e-juice down to the label, that’s too far.

The Latest Vaping News – The VapePassion Show Episode 73

Some of the topics discussed include:

  • E-Juice Review: Marilyn From High Class Vape Co.
  • E-Juice Review: DIY E-Juice From One Of My Listeners
  • Old-School Vape Review: Smok DC Tank V1
  • VapeNW Is Back….Sort of
  • A Case of an Exploding Wismec Exo Skeleton Mod
  • Should The Vape Community Hide Negative Stories From the FDA?
  • Two Vape Shop Studies Show That Secondhand Vapor is Not a Concern

Continue reading The Latest Vaping News – The VapePassion Show Episode 73

9-Year Old Gets Nicotine Poisoning After Drinking E-Juice Found on Playground

A young girl in Fredericton, New Brunswick found herself in the hospital after she found a bottle of e-juice on the playground and drank it. The bottle of e-juice was called Unicorn Milk from a company called New Beginnings Vape Studio, also out of Fredericton.

The girl and her friends saw that the bottle had a cartoon unicorn on the label and smelled it, so they thought it might be something good. Shortly afterward, the 9-year old girl started suffering from nausea, dizziness, and chest cramps.

The girl’s mother, Lea L’Hoir learned that her daughter had drunken e-liquid, looked up the effects of nicotine poisoning online, and decided to take her daughter to the hospital where medical staff confirmed that she had nicotine poisoning.

She was released later that night.

No other news about the other girls has been released, or whether or not they also got sick.

In light of the situation, the owner of New Beginnings has said that he is considering changing the label. If you go to their website now, all pictures of Unicorn Milk have been taken down.

There’s no word of how the bottle of e-juice ended up on the playground. It could be that someone accidentally dropped as they were walking through.

Re-Igniting The Labeling and Flavoring Controversy

But this brings up the controversy of e-liquid labels, candy flavors, and their appeal to children. Obviously, this is a freak accident and not at all common, but it definitely brings up the question whether or not it’s okay to have cartoony labels.

I’ve argued in the past that cartoons on labels should be allowed because e-juices can only be purchased by adults, but I’ve changed my mind on this since then. Not just because of this story, but because I’ve come to realize that these labels are not necessary and only harm the reputation of the industry.

I know people will argue that it’s up to the parents to lock up e-juice so that kids can’t get into it, but kids are resourceful. They will find a way. And if kids see a cartoon label and smell something that smells like candy, they’re going to want to taste it. It’s why manufacturers of toxic cleaning products don’t put labels on their bottles that look appealing to kids.

I don’t know what the answer is, but I think an e-juice company can make an appealing label that doesn’t have cartoons and other child-friendly characters on it. But that still might not stop a kid from drinking it. Child safety caps work for little kids, but not for 9-year olds. So is the answer to put a large toxic warning on the label? I don’t know. What do you think?

The Latest Vaping News – The VapePassion Show Episode 72

Some of the topics discussed include:

  • How to Get Free Concentrates from RealFlavors.com
  • Quick Update: Fix for Eleaf iCare Mini Not Firing
  • Old-Fashioned Vape Review: Aspire CF Maxx
  • Naked 100 Counterfeits Hit The Market
  • A New Online Vape Store Designed For Beginners
  • A 9-Year Old In Canada Drank E-Juice and Suffered Nicotine Poisoning
  • How to Heat Steep E-Juice Using Water in a Small Saucepan
  • Vaping Makes an Appearance In a New Foo Fighter’s Music Video

Continue reading The Latest Vaping News – The VapePassion Show Episode 72

528 Custom Gives Bad Advice to Vapers

According to a post on VapingUnderground.com, someone sent an email to customer support at 528 Customs asking them for some advice on the Goon 1.5 RDA they just bought the day before. This person mentioned to 528 that they had just purchased the Goon and even after installing several builds, the ohms constantly jump around.

He confirmed to 528 that the posts screws are tight and the coils don’t wiggle around at all. The RDA was also tightened all the way down on the device and it was tested on multiple devices. So basically, so there should be no reason for the ohms to move around once they’ve been fired.

Brittani Starkey of 528 Customs responded with this…

She said “Have you tried it on a mech mod?”

She then followed up an hour later saying that her husband is the owner of 528 and the designer of the Goon. She said that the advice she gave was his suggestion and she said that it’s impossible for ohms to jump around on a mech mod. She said using it on a mech first will usually fix the issue.

I don’t even know what to say about this. I guess it goes to show that even vape product manufacturers have no clue about vaping sometimes.

First, to say that firing an atomizer on a mech mod will produce different results than a regulated mod makes no sense at all. Either device will fire the coils. The only difference is that on a mech you’re limited by the batteries. There’s nothing physically different from how the atomizer receives power from the battery.

Then to say that it’s impossible for ohms to jump around on a mech mod is totally clueless. It’s impossible to know that ohms are jumping around because mech mods don’t have screens that show you the resistance changing, but that doesn’t mean it’s not happening. That’s equivalent to putting black tape over your check engine light in your car.

And to top it all off, someone posted the same issue on 528’s Instagram page. They were having issues with ohms jumping around. The owner responded condescendingly to this person saying that he already gave this person advice over email.

The owner thought it was the person from earlier but it wasn’t. He goes on to say that he’s been vaping for more than 4 years and that using an atomizer on a mech mod tends to fix voltage issues. He also states that the Goon 1.5 is the one of the safest RDAs on the market due to the materials and insulators they use.

I honestly can’t believe this is the advice the owner of an RDA manufacturing company gave to a customer. And he throws out the fact that he’s been vaping for more than 4 years, implying that he knows what he’s talking about.

I’m not trying to crap on the Goon, because it’s an amazing RDA, although I’ve seen lots of bad reviews of the new 1.5 version. But I wanted to cover this story just because this advice is not only terrible, but also dangerous.

I’ve experienced this issue with an atomizer in the past. If after making sure that everything is built correctly, tested with various builds and on various devices, and the issue still persists, it’s because there’s something wrong with the atomizer. It’s most likely that that there’s something wrong with the positive post or the 510 pin.

If the Goon 1.5 has some sort of shorting issue that’s causing the ohms to jump around, that could be extremely dangerous, especially on a mech mod. If the ohms jumped to below safe levels of the battery in a mech, that could hard short the battery and cause an explosion.

Seriously terrible advice. This might be an isolated issue, and not typical with the Goon 1.5 in general, but the advice they gave is so dangerous that I just had to talk about it.

528 Customs has since removed the Instagram thread and supposedly blocked everyone who commented on it, but the screenshots are on the Internet forever. And people are still commenting on other recent Instagram posts.

VapeNW.com Loses Their Shop and Warehouse in a Fire

Federal Way, WA vape vendor, VapeNW.com, is now temporarily out of business due to a fire in their building. They are a popular online vendor due to their low prices and fast shipping.

VapeNW was one of 9 businesses located in a strip mall that went up in flames at around 4am on Sunday, May 21st.

A call to report the fire came in around 4:20am with the person saying that smoke was coming out of the coffee shop. Firefighters responded and finally put the fire out around 11am.

The fire department stated that this building did not have a sprinkler system or fire detectors, which is not a requirement because this building was built in the 70’s.

The fire department released a press release stating that they have not been able to determine the case of the fire yet, but that fire patterns indicate that it originated in the northern part of the complex, which looks to me is not where VapeNW was located, but rather where several restaurants were.

VapeNW has stated that it was a total loss. The entire shop and their warehouse burned down, which means all orders that have not yet been shipped will not go out and they are also not able to process any returns or answer Help Desk tickets.

They are refunding all orders and are no longer taking orders online.

Nobody was hurt, but it’s sad news for VapeNW and for their customers. I’ve actually ordered from them several times because they always have really good prices and because they ship so fast. Hopefully they can get this all sorted out and get back in business in a new location soon.

High Schoolers Vaping Oxycontin in Ontario

According to Almaguin Highlands High School principal, Donna Breault, students in the Near North District in Ontario are using vaporizers to vape THC e-liquid with crushed oxycontin mixed in.

They are also sharing their devices with groups of people which are causing worries of spreading hepatitis.

According to the school district board chairman, David Thompson, there’s no way for administrators to know what is being vaped, because there’s no smell. So they’ve made the decision to outright ban vaping on school grounds entirely, including vaping in their anti-tobacco free policies.

This is pretty scary. Oxycontin is such a dangerous and highly addictive drug. I’ve known Oxycontin addicts and their lives are not pretty. I would hate to see a young high school destroy their lives so early.

What also scary about inhaling oxycontin is that oxycontin is coated in a plastic polymer substance. That means these kids are inhaling heated particles of plastics.

So with all of that being said, I can see why schools would want to ban vaping if a lot of kids are actually vaping oxycontin in school.

But it sucks to punish the kids who are legitimately using vaping as an alternative to smoking.

So if they don’t ban it, what’s the answer? I really don’t know. If you have thoughts on this, please feel free to share.

NJOY Submits a Citizen Petition To The FDA

The United States Foods and Drug Administration has a process that allows individuals and organizations to request that the FDA change their health policies through what’s called a citizen petition.

At any time, someone can file a citizen petition that asks the FDA to “issue, amend, or revoke a regulation or order.” The law also states that the FDA must respond to petitions within 150 days.

On May 17th, NJOY, the Vapor Technology Association, The Smoke-Free Alternatives Trade Association, Turning Point Brands, Nicopure Labs, Five Pans, Johnson Creek, and other businesses submitted a citizens petition asking for the FDA to provide clear guidance for vape manufacturers about how to submit premarket applications and also to extend compliance deadlines by 24 months.

If you read the petition on Regulations.gov, you’ll see the reasoning behind these requests. For example the petition points out that it’s now nearly a year after the FDA released the Draft PMTA Guidance on electronic cigarettes and in that time, we still have not received recommendations from the FDA on completing Pre-Market Tobacco Applications or substantial equivalence reports.

That’s a pretty solid reason if you ask me.

This isn’t your typical everyday online petition that the government brushes off and ignores. The citizen petition process is a formal process that the FDA must follow as defined in the Code of Federal Regulations.

With that said though, the FDA still has final say in whether or not the requests in the petition are granted. There was an empirical study that reviewed every citizen petition filed with the FDA between 2001 and 2010, so nine years of data. What they found is that the FDA granted 19% of petitions and denied 81%.

Also worth noting though is that most petitions are from pharmaceutical companies trying to delay generic brands from coming onto the market. So the success rate or denial rate might not reflect the chances that this new petition from NJOY might have.

So what can you do to help? Go to CASAA.org to find the call to action. You can submit comments on the petition on Regulations.gov until November 8th, 2017. In your comment, you can share your experience with vaping, talk about how long you’ve smoked and how vaping has helped you quit or reduce smoking, what your favorite flavors of e-liquid are and why flavors are important to you, and how the FDA deeming rule has changed your ability to buy vapor products.