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When it comes to e-liquids and nicotine, the requirements listed in the FDA's regulations for vaping products have created a bit of confusion – especially when it comes to nicotine-free e-liquids. The FDA has listed out regulations for both nicotine-containing and nicotine-free e-liquids and has categorized both as tobacco products, even though they do not actually contain tobacco. Yes, nicotine can be derived from tobacco; however, it can also be derived from vegetables, such as potatoes and eggplants, so science would say it's not actually tobacco, right? Well the FDA has a different idea of what nicotine is and how it should be regulated when it comes to vaping products.

How the FDA Regulates Vaping E-Liquids

Some of the confusing language found among the FDA's deeming rules for vapor products applies to how e-liquids are regulated. Questions have been raised about how the requirements apply to nicotine-free e-liquids and the use of synthetic nicotine for vaping products. As a result, we received quite a few of these types of questions during our DeMISTified Webinar series. Below you will find these questions with answers from the industry experts.

Will flavor extracts, PG, and VG be considered "tobacco products"?

Yes, if you are purchasing flavor extracts, PG (propylene glycol), or VG (vegetable glycerin) at a vape store or electronic cigarette manufacturer, then it is considered a tobacco product. E-liquids ingredients usually include nicotine (unless nicotine-free), flavoring, and a VG/ PG mixture. Flavor extracts, VG and PG are also used in other consumer products such as candy and soaps; therefore, users can purchase these separately. For example, users can purchase flavor extracts from Bulk Apothecary and they will not be considered tobacco products. However, it still all depends on the intended sale of the product: the intent of sale must be clear that it is not to be used with a tobacco product, including vaping devices,otherwise it will be categorized as a tobacco product. So all of our pre-filled e-cigarette cartridges and bottled e-liquids at White Cloud are now considered tobacco products.

↓ Watch the video explanation here ↓

“If it could be used with a tobacco product, then the definition likely extends to it.” – Cynthia Cabrera

Click to tweet: “If it could be used with a tobacco product, then the definition likely extends to it.” @cyncab http://bit.ly/FDARegs @WCcigs #ECigs

Are there any plans to ban flavored e-liquids?

The current regulations do not ban flavors; however, a flavor ban was included with the original set of regulations that were sent to the White House to be reviewed by the Office of Management and Budget (OMB). As originally submitted to the OMB, the FDA's rule gave a grace period for flavored products of only 90 days after the rule became effective. Luckily for vapers and vape companies, the OMB deleted both the FDA's planned policy and the rationale for the policy, which included pages of data and scientific studies in support of its plan. The FDA noted that the proposed ban was due to a rise in youth and young adult use of flavored tobacco products, including e-cigarettes, along with the theory that vape companies were creating flavors to appeal to children.

The FDA's proposed flavor ban falls in line with the Tobacco Control Act of 2009, when the organization banned flavored tobacco cigarettes, with the exception of tobacco and menthol. Public health organizations, such as the Campaign for Tobacco-Free Kids, continue with claims that flavored e-liquids target children in order to encourage policy makers to implement a future ban on flavored e-liquids, despite the results of vaping surveys and thousands of testimonials from former smokers stating flavored vaping products contributed to their success in quitting smoking.

Related: CASAA Survey Shows the Importance of Flavored E-Liquids

↓ Watch the video explanation here ↓

“They didn't get them here, but they have plans to get them. That is going to happen.” – Cynthia Cabrera

Click to tweet: “Q: Are there any plans to ban flavored e-liquids? Answer: http://bit.ly/FDARegs @WCcigs #FDADeeming #ECigs #ELiquid

What are the specific requirements for manufacturers for product labeling?

The packaging and labeling requirements for vapor products include restrictions on advertisements and specific warning statements for product packaging and labeling. The timeline for these restrictions and requirements are as follows:

Effective August 8, 2016: No false or misleading advertising for vapor products, as determined by the FDA, is allowed. This means vape companies are not allowed to make any health statements or compare their products to tobacco. For example, vape companies are prohibited from claiming their products are a safer or healthier alternative to tobacco or that their products can be used for tobacco cessation.

Effective August 8, 2017: All tobacco products must also cease using descriptors such as “light”, “mild” or “low”, along with any other similar phrases.

Effective May 10, 2018: All packaging for tobacco products must include the following:

Name and place of business Quantity of the contents Percentage of domestic and foreign grown tobacco The statement: “Sale only allowed in the United States”

All tobacco product packaging must include the label warning: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” If the product does not contain nicotine, the manufacturer must submit a self-certification statement to the FDA for review. According to the FDA:

“If the tobacco product manufacturer submits a self-certification statement to FDA that the newly-regulated tobacco product does not contain nicotine (and that the manufacturer has data to support this assertion), then an alternate statement must be used on product packages and advertisements.”

If the FDA approves the self-certification statement, then packaging for the product must carry the warning statement: “This product is made from tobacco.” This rule is confusing to many vapers, including us here at White Cloud, because most e-liquids that do not contain nicotine are not extracted from tobacco; therefore, the product is not really made from tobacco. However, as the FDA stands, any product that can be used for human consumption with a deemed tobacco product, such as a vaping device, must meet the requirements set forth by the regulations regardless of whether or not that product contains nicotine.

The warning labels above must follow these rules set forth by the FDA:

Be displayed in a conspicuous and prominent place on the two principal display panels of the package. Comprise at least 30 percent of each of the principal display panels (warning label area). Be printed in at least 12-point font size and must occupy the greatest possible proportion of the warning label area set aside for the required text. Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other printed material on the package. Be capitalized and punctuated as indicated in § 1143.3(a)(1). Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other information on the principal display panels have the same orientation.

↓ Watch the video explanation here ↓

“The name and place of business, quantity of the contents, percentage of domestic and foreign grown tobacco, and the statement “Sale only allowed in the United States.” – Cynthia Cabrera

As White Cloud continues through the regulation process, our customers will begin to see such changes to our product packaging and labeling, in addition to the packaging changes we have already implemented in renaming our nicotine strengths.

Click to tweet: “Full details for product labeling for #FDADeeming by @WCcigs http://bit.ly/FDARegs #ECigs #Vape

When do retailers have to make sure all products have proper labels?

Effective May 10, 2018, retailers cannot sell, distribute, or import e-cigarettes or other vaping products without the health warning label and packaging requirements listed above.

↓ Watch the video explanation here ↓

“It's 12 months from the effective date of the regulations to get these warning labels in place.” – Michael Siegel

Click to tweet: Nicotine warning labels must be on #vapor product packaging by 8/8/17: http://bit.ly/FDARegs @WCcigs #FDADeeming #ECigs #Vaping #Vape

Will e-liquids without nicotine have to follow the deeming regulations?

Products that do not contain nicotine are not forced to follow the deeming regulations; however, manufacturers are required to submit a self-certification form to be approved by the FDA. The FDA is still finalizing the self-certification process, but has stated it will look something like this:

“The manufacturer has submitted to FDA a confirmation statement certifying to be true and accurate that the product does not contain nicotine (e.g., no nicotine at detectable levels) and that the tobacco product manufacturer has data to support that assertion.”

Products that receive self-certification approval from the FDA will then be required to carry the warning label: “This product is made from tobacco.”

↓ Watch the video explanation here ↓

“If you sell any liquid that doesn't contain nicotine and is not intended to be used with a nicotine containing liquid, then you are, essentially, exempt from the regulations.” – Michael Siegel

Click to tweet: Why are nicotine-free #vapor products forced to follow #FDADeeming? @WCcigs http://bit.ly/FDARegs #ECigs #Nicotine

Does this include synthetic nicotine?

Synthetic nicotine is not derived from a tobacco source; therefore, the FDA cannot regulate it at this time. However, it could very easily be pulled into a similar category as other regulated products depending on how it is marketed. For example, it if is marketed to be used for tobacco cessation or for therapeutic purposes, it could be regulated as a prescription drug; but if it is marketed to be used with a tobacco product, such as a vaping device, then it could be regulated as a tobacco product.

While synthetic nicotine may be an option for vaping products, it is not cost-effective, nor have there been studies to prove it does not have harmful effects. However, there are larger manufacturers already looking into targeting the vaping industry with synthetic nicotine, so this may be an available option in the near future.

↓ Watch the video explanation here ↓

“If a company were able to synthesize or obtain synthetic nicotine or obtain nicotine from another source, then it would not be subject to the regulations.” – Michael Siegel

Click to tweet: Will synthetic #nicotine be regulated by #FDADeeming? Find out http://bit.ly/FDARegs #ECigs #Vape #WCCigs #Vaping

How do the new e-liquid container laws, not related to the FDA regulations, affect vape shops?

On July 26, 2016, the Children's Nicotine Poisoning Prevention Act (CNPPA) went into effect. This act requires e-liquid manufacturers to enforce child-resistant packaging for all products and follow the packaging testing guidelines set forth by the Poison Packaging Prevention Act of 1970. Child-resistant packaging is only required for bottled e-liquid. Other vapor products, such as disposable electronic cigarettes, pre-filled cartridges and other sealed vaping products are exempt from the requirements.

FDA Seeks Volunteers for Vaping Manufacturing Facility Visits

The FDA is hoping to send staff to manufacturing facilities involved in the vapor industry, including facilities for e-liquids, components and parts. These site visits are not going to be inspections, but instead will serve to educate the FDA staff about the vapor industry. If you are interested in being a part of these visits, you can apply in the comments section of the Tobacco Product Manufacturing Facilities information page on the Federal Register website.

Back To Understanding FDA Regulations Guide

The post FDA Vaping Regulations: E-Liquids & Nicotine appeared first on Electronic Cigarette Blog | White Cloud.

Tue, Nov 01, 2016
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Although the FDA's Deeming Regulations are contained within an extensive 499-page document, some areas of regulation were left a bit hazy. Among the haze is how the regulations affect the DIY vaping market, or more specifically how the rules will affect the individual components that make up electronic cigarettes and e-liquids.

FDA Deeming vs. The DIY Vaping Market

When it comes to the FDA's regulation of vapor products, there have been tons of questions about how the rules affect the DIY vaping market. Vapers who create vaping products for their own use have questioned if and how the regulations will affect them, which is why we received quite a few questions about the DIY market during our DeMISTified Webinar Series. Those questions are listed below with answers from the experts.

How will the regulations affect the DIY market?

The regulations do not affect consumers creating e-cigarette products for their own consumption; however, if consumers create vapor products or components to be used outside of personal consumption, then they would be considered tobacco manufacturers and would be subject to the deeming rule. According to the FDA, a tobacco retailer is:

Any person, government, or entity who:

Sells tobacco products to individuals for personal consumption, or Operates a facility where vending machines or self-service displays of tobacco products are permitted. Retailers include brick and mortar stores and online tobacco retailers.

In an article titled “F.D.A Imposes Rules for E-Cigarettes in a Landmark Move”, Mitch Zeller, the Director of the Center for Tobacco Products for the FDA, stated, “There are retailers selling these products, but in the back room, they are also mixing. That means under the law, they are manufacturers.”

There is speculation among experts, including Dr. Michael Siegel, that a vaping black market will arise as a result of strict regulations, as consumers will now have to seek out their favorite DIY juices and vaping devices and components under the table. As the American Vaping Association says, “This is not regulation — it's prohibition.” And, we will most likely see history repeat itself in terms of the failed prohibition on alcohol back in the 1920s.

Click to tweet: “This is not regulation — it's prohibition.” More via @WCcigs at http://bit.ly/FDARegs #ECigs #FDADeeming#Vaping

↓ Watch the video explanation here ↓

“It's the maker of the finished product, the manufacturer of the finished product, that would be responsible for submitting these applications.” – Dr. Michael Siegel

Can a shop sell each ingredient separately and have the consumer blend it at home?

Technically, yes: A shop could sell each ingredient separately for the consumer to blend at home; however, each ingredient would then be subject to a separate PMTA process if the sale's intent is for the ingredient to be used to create an e-liquid and/or be used with a tobacco product. It all depends on the purpose of the end use.

↓ Watch the video explanation here ↓

“It all depends on the intended use of a product, the intended use of sale—what it is for.” – Dr. Michael Siegel

How difficult will it be to purchase DIY e-liquid, PG, VG, flavorings, and parts for mods?

It will be very difficult to purchase DIY e-liquid, PG, VG, and flavorings if you're looking to purchase from vape shops. Prior to the August 8, 2016 deadline, there was talk amongst the Reddit community about users buying e-liquid ingredients in bulk in an attempt to stock up so they could continue creating their own e-liquids.

Are there restrictions on individuals purchasing liquid nicotine with the regulations in effect?

Although nicotine can be derived from vegetables, such as potatoes and eggplant, and can be synthetically created, it is most well-known for being derived from tobacco plants, which is why the FDA places it in the same category as tobacco products for deeming regulations. So, since nicotine is considered a tobacco product, the same restrictions that apply to tobacco products also apply to liquid nicotine, particularly purchase age. It's best to become familiar with the age restrictions for tobacco products in your region.

When the FDA discusses "tobacco accessories" to what items are they referring?

If an accessory, component, or part can be used for human consumption with an electronic nicotine delivery system, then it must follow the rules listed in the regulations.

According to page 3 of the deeming regulations, this includes:

“E-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software.”

So, what does this mean? Let's take a look at a few examples:

1. Lithium Polymer (LiPo) Battery

Lithium polymer batteries were originally designed to use in radio-controlled cars and model trains. Now, we use them in our mobile devices such as tablets, smartphones, and even our rechargeable e-cigs. This is the same battery White Cloud uses for both our Cirrus rechargeable and Fling disposable e-cig lines.

Another type of battery used in vaping devices and subject to regulations is the lithium-ion battery. These batteries are commonly used with more Advanced Personal Vaporizers (APVs), Mods, and other highly customizable vaping devices.

Related: E-Cig Batteries: Lithium Polymer vs. Lithium-Ion

2. Cotton Wadding

With electronic cigarettes, cotton wadding soaks up the e-liquid to be vaporized and is most often used with pre-filled e-cig cartridges for cig-a-like products.

Cotton wadding is now labeled as a tobacco product if you want to buy it at a vape shop. However, if you purchase cotton wadding from a retail store like Walgreens, it is not considered a tobacco product.

These examples are labeled as tobacco accessories because they can be used for tobacco consumption. If you are knowingly selling for tobacco consumption, you must follow the rules set forth by the regulations.

How Does the FDA Define an Accessory for Tobacco Products?

In the FDA's Small Entity Guidance Guide, they explain their definition of an accessory for a tobacco product:

Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following:

(1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or

(2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) Solely controls moisture and/or temperature of a stored tobacco product; or (ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product (parts 1100, 1140, 1143 (21 CFR parts 1100, 1140, 1143)).

Accessories of regulated tobacco products that are not required to follow the FDA's ruling include carrying cases, lanyards, and holsters.

↓ Watch the video explanation here ↓

“Any aspect, any component of the product that actually affects the function of the product in terms of the delivery of the aerosol is considered to be a component of the product.” – Dr. Michael Siegel

Click to tweet: “If an accessory can be used for human consumption with #ECigs, then it must follow #FDADeeming.” http://bit.ly/FDARegs Via @WCcigs

Do flavoring components have to meet regulations?

Again, this is another part of the FDA's Deeming Regulations that is based on the intent of sale.

Ask yourself: Is the intent to sell a flavor to be used for e-liquid? If the answer is yes, then you are subject to the regulations. It all comes down to intent to sell.

If you are an e-liquid manufacturer, meaning you are purchasing flavorings to be used in the creation of e-liquids, then you are responsible for meeting the regulations.

The good news for vapers is that, while the White House's Office of Management and Budget (OMB) was reviewing the finalized version of the FDA's Deeming Regulations, they apparently deleted part of the FDA's planned policy that would have removed all flavored e-liquids from the market within 90 days after August 8, 2016. This is the version we see today in the US Federal Register.

The bad news for e-cigarettes is that anti-smoking activists are continuing to argue that flavored e-cigarette products appeal to youth, and are working on new regulations that they hope will extend to flavor bans in the future.

↓ Watch the video explanation here ↓

“It all depends on the intended use of the product.” – Dr. Michael Siegel

Click to tweet: @mbsiegel says #FDADeeming all comes down to the intent of sale.” More here http://bit.ly/FDARegs Via @WCcigs #ECigs #Vaping

Back To Understanding FDA Regulations Guide

The post FDA Vaping Regulations: The DIY Market appeared first on Electronic Cigarette Blog | White Cloud.

Wed, Oct 26, 2016
Cynthia Cabrera

Among the 499 pages of the FDA's Deeming Regulations is an option to avoid the PMTA process if a manufacturer can prove that any of their products introduced to the market after the set grandfather date of February 15, 2007, are “substantially equivalent” to a product that was on the market prior to the set date. This is known as the “Substantial Equivalence” process.

Vaping vs. The FDA's Substantial Equivalence Process

One of the biggest concerns with the FDA's Substantial Equivalence process is the fact that about 99% of the vaping industry didn't exist prior to the grandfather date. Electronic cigarettes were first introduced to the US market in 2007, and at that time simple cig-a-likes were the only vapor products available. Other types of vaping devices, such as Mods and Ego pens, did not exist; therefore, those who manufacture vapor products other than cig-a-likes really don't have the option to apply for the Substantial Equivalence process. But for those who might have a chance, the set requirements are still a bit murky and have raised some questions.

Below you will find those questions, along with answers from industry experts.

What are the specifications for claiming substantial equivalence to another product that was on the market before 2007?

When going through the substantial equivalence pathway to FDA approval, an e-cig manufacturer must provide proof that a product has the same characteristics as a predicate tobacco product – a product that was on the market prior to the grandfather date. According to the FDA's website, “If the new product raises different questions of public health, the product is not substantially equivalent.”

Click to tweet: “If the new product raises different questions of public health, the product is not substantially equivalent.” @fda http://bit.ly/FDARegs

The FDA has also stated that at least one vaping product was introduced to the market prior to the grandfather date; however, the FDA has not provided any information on the product.

↓ Watch the video explanation here ↓

“There was nothing on the market in 2007 that is going to help us with the products on the market today.” – Cynthia Cabrera

How is it possible for the FDA to say any e-liquid on the market today is not "substantially equivalent" to the e-liquids of 2006 considering the ingredients have not changed?

Although the majority of e-liquids are made up of three major ingredients – Propylene Glycol (PG), Vegetable Glycerin (VG) and nicotine – not all e-liquids are the same. The different flavorings added to e-liquids are what make all e-liquids unique, and each flavoring has more than one component. Therefore, flavored e-liquids, along with their varying nicotine levels, will be required to enter a separate PMTA process per flavor and per nicotine level.

↓ Watch the video explanation here ↓

“Any combination of flavoring and nicotine strength is considered a separate product. So if you sell 10 e-liquids and each of them come in 3 different nicotine strengths, that's 30 different products.” – Dr. Michael Siegel

If a company is using vegetable glycerin that has been tested and approved by another company, would other companies that use the same product be subject to their own testing and PMTAs?

When it comes to individual e-liquid ingredients, it all depends on the intent of how the ingredient will be used. If the vegetable glycerin in question is intended to be used as an ingredient mixed into an e-liquid to then be sold to a consumer, then the PMTA process would be required in order for the e-liquid to remain on the market. The same also applies to flavorings: if a flavoring manufacturer sells a flavoring with the intent for that flavoring to be used in e-liquids, then that flavoring will be subject to the PMTA process.

Click to tweet: Individual #eliquid ingredients must enter the PMTA process if intended to be used for #vaping. #FDADeeming @WCcigs http://bit.ly/FDARegs

↓ Watch the video explanation here ↓

“It all depends on the intended use of the product – the intended sale. If the intended sale is to the consumer, then you are subject to the requirement; but, if the intended sale is to a manufacturer who is going to process that material, then you're off the hook.” – Dr. Michael Siegel

Back To Understanding FDA Regulations Guide

The post FDA Vaping Regulations: Substantial Equivalence appeared first on Electronic Cigarette Blog | White Cloud.

Wed, Oct 19, 2016