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FDA E-Cig Regulation

FDA E-Cig Regulation: First Steps for Manufacturers Explained

Although there’s still hope for changing the situation for vaping, the FDA e-cig regulations will start to impact the industry very soon. Vaping product manufacturers have until June 30th to register with the FDA, and you’ll also have to submit a list of products, including their labeling and a sampling of marketing materials. It may be nothing compared to submitting the premarket application (estimated to cost between $300,000 and $2 million per product), but it still means a lot of work.

So what do you have to do?

There are some differences depending on what your company does, but every manufacturer will have to use the FDA Unified Registration and Listing System (FURLS) and the Tobacco Registration and Product Listing Module (TRLM), as well as a Data Universal Numbering System (D-U-N-S) number.

You can read the full requirements in the guidance document, but we’ll go through the basics of what the systems are and what you have to do here.

FDA Vape Regulation: What Happens on June 30th

The timeline for the FDA vaping regulations means that while full applications won’t need to be submitted until August 8th, 2018, companies will have to register their establishment and give the FDA Tobacco Products office a list of products by the 30th of June this year.

This all takes place through the Tobacco Products Registration and Product Listing Module (TRLM), which is part of the FDA Unified Registration and Listing System (FURLS). Understanding how to operate these systems is the main thing you have to do for FDA compliance in the coming month.

Getting a D-U-N-S Number

The FDA tobacco office uses the Universal Numbering System (D-U-N-S), and so you’ll need a D-U-N-S Number for your business before you proceed. This is a 9-character code provided by Dun & Bradstreet, which you can get for free from this page.

To get one, you’ll need:

  • The legal name of your company
  • The name and address of your headquarters.
  • The year the business was established.
  • It’s legal structure and main area of business.
  • The name of the CEO or owner and his/her telephone number.
  • The number of employees working at your physical location.
  • Your SIC code (which you can find here).

With this information, you can request your D-U-N-S number for FDA compliance, and you should receive it within a day.

What is FURLS?

FURLS is the FDA’s main system for registering your manufacturing facility and your products. You’ll need to create a FURLS account at FDA to comply with the FDA vaping rules, and this should be done as soon as you can. You can either register as an owner/operator or as an “official correspondent,” which basically just means somebody appointed by the owner/operator to handle regulatory tasks. If you already have a FURLS account at FDA, then you should use your existing account rather than create a new one.

You need to make a payment to register your establishment, which you can do using this website. When you’ve made your payment, you will receive both a Payment Identification Number (PIN) and a Payment Confirmation Number (PCN). You’ll need both of these later on in the process.

Using the TRLM: Registering Your Products

The most important and demanding part of the initial stages of FDA compliance is fully registering your products with the FDA. When you’ve set up your FURLS account at FDA, you can click on the DRLM button to register your facility. Choose the “Register a Medical Device Facility” option from the menu, and then confirm that you don’t have any existing registrations and that your establishment isn’t already registered. If everything is fine, you can select “Register a New Facility” and proceed to the next stage.

As long as the information displayed is correct, you can choose “Continue Registration” and enter the required details about your facility. When you’re done with this, you press to continue again and then you’ll be taken to the next section: listing information about your products.

Although it leads you through the specifics, for each product you’ll need to identify the product’s category, its unique name and identification number (e.g. SKU or UPC). You also need to submit all of the labeling for the product in question, and provide a representative sampling of marketing materials. This isn’t 100% unambiguous, but broadly, if two ads are basically the same with only minor differences, you don’t need to submit both of them. If you give any information direct to consumers (that isn’t part of an ad), you’ll also have to include this as part of the submission.

For now, this is the most demanding part of compliance for the FDA vaping rules, and will require quite a lot of work if you have numerous products on sale.

If you need more information and a more detailed guide as to how you use the TRLM, this manual is thorough and easy-to-follow.

What Comes Next for FDA Vape Regulation?

This post has covered everything you need to have done by June 30th, but there are more requirements just around the corner. If you’re a small-scale manufacturer (defined as having 150 or fewer employees and annual revenues of under $5 million), the deadline to submit your “tobacco health documents” is August 8th. The requirements for this are described in this document

If you’re a large manufacturer, you also have to submit an ingredient listing to the FDA tobacco office by August 8th this year. However, most vaping companies will undoubtedly class as “small scale” manufacturers, and if your business does, then you have until February 8th next year to complete this step.

The FDA E-Cig Regulations Are Starting to Hit the Industry

The initial requirements might not be too severe, but the regulations are becoming increasingly real now, with vaping companies across the US having to take their first steps towards submitting a burdensome pre-market application for a new product. The first experience with FDA compliance isn’t going to hit many companies that hard, but it’s really just the start for the FDA vaping regs.   

https://www.nrcs.usda.gov/wps/portal/nrcs/detailfull/wa/programs/?cid=nrcs144p2_036140

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm#9

https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm189539.htm

https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm386651.htm

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM208916.pdf

https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM456130.pdf

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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