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FDA Extends PMTA to 2022

PMTA Delay Buys Vapers Some Breathing Space

Since the FDA first revealed its Deeming Regulations for e-cigarettes in April 2014, the looming threat of the new law has been the biggest worry for everyone involved with the US vaping scene – and, as Deeming is likely to wipe out hundreds of favorite juice flavors, it’s not that popular in the rest of the world either. So it’s no surprise that, when FDA Commissioner Scott Gottlieb announced a four-year delay this morning, there was widespread celebration.

The background to the delay is a 25-minute presentation Gottlieb delivered earlier today, outlining a new approach to nicotine addiction from the FDA. The aim is to radically cut the number of Americans who smoke, which of course isn’t a new goal. What is apparently new is a a willingness to look beyond the quit or die approach that American public health has been wedded to up to now.

 

Harm Reduction is in…

In his talk, Gottlieb highlighted the fact that nicotine is the reason people smoke, but it isn’t the reason they get sick and die. The FDA still seems to be taking a hardline position on how addictive nicotine actually is, but now Gottlieb has acknowledged, much more clearly than anyone at the agency has before, that there’s a spectrum of risk for nicotine-containing products.

One of the most alarming things that’s been happening over the last couple of years is the rising number of people who think vaping is as harmful as smoking. This has mostly been driven by tobacco controllers who’ve attacked anyone who says some nicotine products are safer than others. Now the FDA Commissioner has openly said exactly that, officially confirming what vapers have been saying all along.

While Gottlieb stopped short of actually saying that e-cigs are safer than smoking, that was a clear subtext of his speech. He referred several times to the unique risks of burning tobacco, and mentioned the potential for innovation to create safer products that have a satisfying amount of nicotine without the risks of cigarettes.

The bit that excited vapers was when Gottlieb, in what looked very like an admission that Deeming was rushed and not properly thought through, said that the agency needed time to implement its new nicotine strategy properly. To get that time, he said, he was telling the FDA’s Center for Tobacco Products to “reconsider” some aspects of Deeming. That was the cue for the announcement that the key deadline for manufacturers had been pushed back.

Few things about the Deeming Regulations are good news for vapers, but the worst was the November 8, 2018 deadline for Pre Market Tobacco Authorizations to be submitted. Any product that hadn’t had an expensive, time-consuming PMTA submitted by that date had to be immediately taken off the market. Gottlieb has now extended that deadline to August 8, 2022, gaining the industry almost another four years.

 

…but Deeming isn’t out

Of course it isn’t all good news. The extended deadline only applies to products that are already on the market; anything new still needs to be granted a PMTA before it can go on sale, so the entire US vape industry will be frozen in time for at least the next five years. There’s also no change to other deadlines – manufacturers will still have to submit health risk documentation next year, and add warning labels and ingredient lists to their products.

However, submitting the documentation should get a lot easier than it has been so far. A common complaint from manufacturers is that while the FDA want thousands of pages of PMTA paperwork for each product, they haven’t been very clear about what should be in it. Gottlieb says the agency will be releasing guidance to make the process less stressful and easier to navigate.

Another piece of good news is a revision of the “sunset policy”. Up to now the FDA has insisted that existing products which were under review would have to come off the market until the review was completed. That was annoying, because the review process isn’t quick and the agency is dealing with thousands of applications. Now, products can stay on the shelves until the review is finished.

The really bad news is that there’s still no change to the ridiculous 2007 grandfather date. The only products exempt from the PMTA process are ones that are “substantially equivalent” to products that were on the market on February 15, 2007. That basically means a handful of cigalikes loaded with low-grade synthetic tobacco flavor juice. Gottlieb has hinted that he thinks Mitch Zeller’s plan to review these to make sure they really are substantially equivalent is a waste of time, but he hasn’t changed the date. Bringing it forward to April 2014, when the Deeming Regs were published, would exempt a lot more products.

 

Other bad news also exists

A real worry in Gottlieb’s speech was how often he mentioned flavors, especially “kid-appealing” ones. Flavors are an easy target for anti-vapers, because a lot of people don’t seem to understand that all e-liquids are flavored – even tobacco ones. His focus on them is likely to encourage state and city efforts to push through flavor bans, and that’s already a worrying trend.

In fact vapers can expect to see a lot more attacks on their rights from states and cities. What Gottlieb said this morning is going to have annoyed a lot of people in public health and tobacco control, because he trashed a lot of what they’ve been saying about vaping. With their support at federal level suddenly looking a lot weaker they’re going to turn to state and local government as easier battlefields to attack us on.

Finally, there’s a real risk that Gottlieb’s whole nicotine plan could collapse. That’s because a key plank of it is rotten. While he’s identified the fact that the real problem is burning tobacco, not nicotine, his idea for getting people onto safer products has a real flaw in it. That flaw is the dumb idea of reduced-nicotine cigarettes.

Gottlieb seems to have fallen for the line, being pushed by some in public health, that reducing the amount of nicotine in cigarettes will make them less addictive and so smokers will stop smoking them. This sounds good, but it isn’t.

Unfortunately, we already know what happens when you reduce the amount of nicotine in cigarettes – people just smoke more. Ironically, tobacco controllers are still furious at the tobacco companies for doing this with light cigarettes, but now they want to try exactly the same thing.

 

So what now?

Today’s announcement is good news. While not perfect, it buys vapers and industry four years of desperately-needed breathing space. It’s not final victory, though; what we can’t afford to do is sit back and relax. There will still be state and local laws to resist, and the Deeming Regulations themselves still need to be amended or scrapped. What Gottlieb’s new plans do is take away some of the momentum that, yesterday, looked set to steamroller the regulations right over the top of us. Vaping advocates need to seize on this loss of momentum to push for more changes.

This might be a good time to remember that great Anglo-American statesman, Winston Churchill, as he announced that the British Army had routed the Germans at el Alamein in 1942. El Alamein didn’t change anything very important. It didn’t defeat the U-Boats in the Atlantic, or slow down the panzers advancing through Russia. But it did, for the first time, stop a German army in its tracks and throw it back to where it started from. It broke their momentum, just like the Deeming Regulations’ momentum was broken today, and Churchill knew what that meant:

“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”

  • Jerry Wayne

    I love the last line….Vapor is well on its way to curing the burning of tobacco for millions. It will probably never go away in total, but we humans may take our time, but we do learn eventually.

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What is E-Juice?

E-juice, also known as e-liquid or vaping liquid, is the liquid that’s placed in the vaping device and subsequently atomized into vapor. When you go to buy e-juice, you’ll notice it contains a mix of several ingredients. These typically include vegetable glycerin (VG), propylene glycol (PG), some type of flavoring, and nicotine.

VG and PG form the base of the e-liquid. VG is a component used in food and personal care products; its role in e-liquid is to create a thick, dense vapor. PG is another popular solvent used in a variety of everyday items. It carries the e-liquid flavor, provides the “throat hit,” and enhances the vaping liquid’s ability to soak into wicks or cartomizer materials.

Nicotine is an optional ingredient, often available in different levels. E-juice also contains some type of flavoring.

Black Note leads the pack of tobacco vaping liquid by using only natural flavoring – extract from real tobacco leaves to produce real tobacco taste. When you go to buy e-juice from other companies, you may find any number of chemicals used to create synthetic flavors that include fake strawberry, manufactured vanilla, and even man-made tobacco flavors.

If your aim when you buy e-liquid is to experience the subtle nuances, genuine flair and authentic taste of real tobacco, then you’ll be on the mark if you buy e-juice from the Black Note lineup.

Best E-Juice

When you’re going to buy e-liquid, it’s only natural you’ll want the best e-liquid. But what, exactly, does it “best e-juice” mean? We’ll tell you.

For starters, you’ll want an e-juice that doesn’t contain all kinds of strange chemicals and concoctions that you can’t even pronounce. True, even the best e-liquid will contain vegetable glycerin (VG) and proplene glycol (PG), which serve as the base of e-juice, but you don’t necessarily need a host of other chemical compounds.

The best e-juice will stick to natural ingredients, like real tobacco extract, rather than rely on synthetic flavorings, colorings and other additives. Diacetyl is one of those synthetic ingredients that has gotten a pretty bad rap, although its use is not all that uncommon for producing sweet e juice flavors.

Definitely read the ingredient list before you buy e-juice to ensure you recognize what’s on it. Better yet, see if the e-juice company offers a lab report to confirm what’s actually inside the e-liquid.

In addition to having as few chemical ingredients as possible, the best e-juice will have an amazing taste. For those who enjoy authenticity over imitation, the most amazing taste is the most natural taste, especially when it comes to tobacco. Since Black Note uses real extract from tobacco leaves, we not only avoid all those weird chemical flavorings, but we also produce the most authentic experience: tobacco vaping liquid that actually tastes like tobacco.

Best E-Liquid on the Market

Anyone looking for the best e-liquid on the market need look no further than Black Note. Black Note tobacco vaping liquid ranks as the best e-juice across the board in every category, starting with the taste.

Black Note’s main claim to fame is producing a tobacco vaping liquid that actually tastes like real tobacco. That because we use real tobacco extract, not chemicals, to create the best e-juice tobacco flavor. Using extract from real tobacco leaves retains tobacco’s nuances and flavor notes, giving you the most authentic and multi-faceted tobacco experience.

In addition to being the best e-juice for tobacco taste, Black Note also has the best e-liquid manufacturing process. We spent years researching and testing various production methods, and finally landed on one that we believe is absolutely perfect.

It starts with growing carefully selected tobacco seeds, followed by an equally precise of steps that include an extensive natural extraction process. Even our bottling and packaging is done with the utmost care, using recycled and recyclable packaging materials to ensure our products are as earth-friendly as they are vapor-friendly.

One more category where Black Note ranks as the best e-liquid is with the value. Every order comes with free domestic shipping, one-to-three day domestic shipping guarantee, and a 90-day, money-back satisfaction guarantee. If you’re not happy for any reason, or don’t agree we’re the best e-juice on the market, send it back on us and we’ll refund your money.

Vape Juice Ingredients

Vape juice ingredients can be pretty straightforward – or not. At the very least, most vape juice contains propylene glycol (PG), vegetable glycerin (VG), and some type of flavoring. Nicotine has largely become an optional ingredient that can be included at varying levels or left out altogether.

Vegetable glycerin (VG) and propylene glycol (PG) are usually the two main ingredients that make up the base of most vape juice.

VG is a plant-based substance with the ability to produce a dense, thick vapor. PG is an additive found in many food items and certain medicines. It carries the flavoring, provides the “throat hit” and enhances the vape juice’s ability to soak into the wicking materials.

Nicotine levels can vary, as can ingredients that make up the flavorings. The components that make up vape juice flavoring are where ingredients can get rather complicated.

Vape juice that relies on artificial flavorings can contain any number of extraneous chemicals and other additives, whatever it takes to recreate the flavor the ecig juice is going for.

Black Note uses only natural flavorings: extract from real tobacco leaves. That keeps our ingredient list incredibly simple, backed by a lab report to prove it. You won’t find any strange chemical concoctions used to produce our tobacco flavor, just real tobacco extract that delivers a real tobacco experience.

What is the Best Flavor for Ecig Juice?

From strawberry shortcake to banana rum, ecig juice comes in tons of flavors. While folks can debate and discuss all the fruity, sweet or food-like flavors all day long, the best flavor for e-cig liquid is straight-up tobacco.

Why? Vaping was originally created as an alternative for traditional cigarettes, mainly for those who enjoy the taste of tobacco. And when you can find an e-cig liquid that is able to recreate tobacco’s full-bodied yet delicate flavor notes and nuances, but without the harmful chemicals found in cigarettes, then you’ve found the best ecig juice.

Recreating tobacco’s complex flavor isn’t easy, especially when it’s attempted with artificial ingredients. That’s why Black Note sticks to the real thing, extracting the essence of real tobacco leaves to flavor our vaping liquid. Not only does this avoid the harmful chemicals in cigarettes, but it also eliminates the flavoring chemicals found in many ecig juices. The end result is real tobacco taste, an authentic tobacco experience and the best flavor for ecig juice you can find.

Notice also we said the best e-cig flavor was straight-up tobacco, not plain old tobacco. Black Note’s real tobacco vaping liquid happens to come in a variety of different blends, from the light and airy to the peppery and robust. Not all tobacco is created equal, and different blends capture the specialized subtleties that make each tobacco unique.

Best Sweet Tobacco E-Juice

When it comes to sweet tobacco e-juice, your options can be broken down into two categories.

The first category contains tobacco e-juice that overlays the tobacco flavor with artificial chocolate, caramel, vanilla, fruity or other dessert-like flavorings. We wouldn’t classify any such flavors as the best tobacco e liquid, simply because they typically use chemicals and other artificial ingredients to create the tobacco taste, the sweet taste, or both.

The second category of sweet tobacco e-juice is where you’ll find the best tobacco e-liquid, sweet or otherwise. This category contains vaping liquid created using only natural flavorings, which is exactly where Black Note fits in. Instead of concocting flavors using synthetic ingredients, Black Note uses an extensive extraction process that slowly and deliberately extracts the tobacco essence from real tobacco leaves.

The result is the best tobacco e-juice: tobacco vaping liquid that actually tastes like real tobacco. And if you’re going for the best sweet tobacco e liquid, we have a few tobacco blends that offer varying levels of sweetness.

Prelude is our sweetest tobacco e-liquid, containing golden Virginia tobacco. Made from fire-cured dark Virginia tobacco, Sonata is our Cavendish blend with a mildly sweet and nutty flavor. Solo is our menthol blend, giving you a semi-sweet minty taste created from natural menthol crystals extract from dried mint leaves.

For the best tobacco e-liquid that’s naturally sweet and remarkably delicious, Black Note is at your service.

WARNING: Black Note products are not smoking cessation products and have not been tested as such. Black Note products are intended for use by adults of legal smoking age (21 or older in California), and not by children or women who are pregnant or breastfeeding. Black Note products contain nicotine, a chemical known to the State of California to cause birth defects or other reproductive harm. Ingestion of the non-vaporized concentrated ingredients can be poisonous. Keep out of reach of children and pets. For immediate advice, contact poison control center: (800) 222-1222