http://www.electroniccigaretteban.org

California senator Jerry Hill is the main author for the Senate Bill No. 793 which adds onto the existing (STAKE) Stop Tobacco Access to Kids Enforcement Act. This law, "...prohibits a person from selling or otherwise furnishing tobacco products, as defined, to a person 21 years of age.

No one wants the youth to start vaping, it is a cure for the currently nicotine addicted populous to ditch traditional combustible cigarettes. So originally, the STAKE act was a good thing because it made bad people selling adult products to young people a crime.

Jerry Hill among about 20 co-authors decided the STAKE act wasn't good enough, and the only way to stop youth from getting access (illegally) to e-cigarettes was to ban them almost entirely. SB 793 would prohibit a tobacco retail store fronts, from selling or possessing with intent to sell, any flavored or flavor enhancing tobacco products.

Something interesting to note is when Jerry Hill published a news release on August 4th, the title of the article associated the ban as a win towards fixing the COVID-19 pandemic. The title is, "Landmark Legislation to Protect Public Health Amid COVID-19 Resurgence Passes Asm. Health Committee". The question of e-cigarettes being linked with elevated symptoms of COVID has been debunked numerous times, but still our congressmen and congresswomen feel inclined that studies are wrong.

Read More Here: SB 793 Passes CA Assembly Health Committee

My communications firm represents a new group, Vapers United  We have long worked on vapor policy issues and we’ve identified a really bad Rhode Island vape tax proposal that could have bad implications for vapers inside and outside of Rhode Island.

The short version: Rhode Island's state revenue bill contains a provision imposing an 80% wholesale tax on vaping equipment and liquid. See pages 33-34 here (http://webserver.rilin.state.ri.us/BillText18/HouseText18/Article-004.pdf), and the definitions preceding these sections.

This is a big deal, and not just for Rhode Islanders, for a couple reasons:

1) One of the country’s biggest vapor product companies is located in Rhode Island  If they stay there, this bill will adversely harm them, and probably by extension, many vapers outside of Rhode Island. If they leave, which we assume they will, it’ll be better for vapers but bad for Rhode Island because not only will they not get the money they’re seeking from this tax, they’ll also lose employees, consumers and taxpayers. This is a huge reason why the tax proposal is misguided and dumb.

2) Consumption taxes on tobacco and tobacco-like products (including e-cigs) rarely bring in the revenue projected, and that’s especially been the case in Rhode Island because it’s such a small state and people will just drive to Massachusetts, Connecticut or New Hampshire to buy products that are over-taxed in Rhode Island. Here are a few things worth reading relevant to this, and which underline how dumb this proposal is, not just for vapers, but for Rhode Island itself:

- Tax Foundation study on how high cig taxes have driven smuggling, specifically citing Rhode Island. https://taxfoundation.org/new-study-high-excise-taxes-drive-cigarette-smuggling-boston-new-york-providence/

- Mackinac Center study that emphasizes that where the divergence between consumption tax rates between neighboring states is lower, states collect more revenue than where there’s a big difference. Rhode Island’s cigarette tax collections increased when Massachusetts raised its cigarette taxes. http://www.mackinac.org/archives/2016/s2016-09.pdf

- Tax Foundation publication which underlines that a bunch of states nearby to Rhode Island do not have vape taxes, while Rhode Island is proposing a particularly large and punitive one. https://taxfoundation.org/vapor-taxes-2017/

3) My boss and her husband say vaping was the only pathway that worked for them to quit smoking. I’m guessing others here have had the same experience. Imposing a high excise tax on vapor arguably incentivizes more smoking and less switching to vaping, which is a questionable public policy outcome.

You can get further information via Vapers United (https://vapersutd.com/) — they are planning to send email updates as this bill proceeds to people on their list, and we may post some here, too.

Vendors licensed to sell tobacco products would be subject to fines of up to $1,000 for violating the law.

Christie, a Republican, has made anti-addiction initiatives a priority of his two terms in office.

“By raising the minimum age to purchase tobacco products to 21, we are giving young people more time to develop a maturity and better understanding of how dangerous smoking can be, and that it is better to not start smoking in the first place,” Christie said in a statement.

“My mother died from the effects of smoking, and no one should lose their life due to any addictive substance,” he said. “Additionally, the less people who develop costly tobacco habits that can cause heal

read full story

Vapor beast is one of my favorite online vendors. They are selling a RX 2/3 for $29 and change add a vapor Joe discount and it goes to $26. Wow great price. Will I go to check out and there is an $11 tax on $26.

I can't do it I refuse to pay the thieves in there state. So wrote them an e mail telling how much I like them but will not pay the ransom in tax to get a mod.

I am almost self sufficient when it comes to Vaping thank goodness. It's bad enough my state (PA) has a 40% wholesale tax.

We all need to know how to make our stuff.

That ends my Christmas rant. Have a safe new year.

FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death
Protecting American Families: Comprehensive Approach to Nicotine and Tobacco
FDA's New Plan for Tobacco and Nicotine Regulation

Scott Gottlieb’s special announcement on tobacco/nicotine/vapor policy is at
Center For Tobacco Announcement

Gottlieb also said FDA CTP intends to:
- maintain Deeming Rule’s sales ban on all new vapor products since August 8, 2016,
- maintain Deeming Rule’s ban on truthful health claims by vapor manufacturers,
- reevaluate Deeming Rule’s policies on vapor products, cigars and OTP,
- promulgate regulations and final guidances for PMTA, MRTP and SE applications,
- promulgate rules on "kid-appealing" flavors in tobacco/vapor products (after FDA and its funding recipients falsely claimed, since 2009, that flavorings are marketed to youth),
- promulgate more rules and standards for ENDS (vapor products), and
- mandate low nicotine cigarettes (which would increase harms for many/most smokers, and would create an enormous black market for cigarettes).

News articles on FDA Commissioner Scott Gottlieb’s announcement are at
FDA unveils plan for major changes to tobacco product regulations
FDA aims to lower nicotine in cigarettes in bid to get smokers to quit
Tobacco Shares Plunge After FDA Proposes Cut to Cigarette Nicotine
FDA aims to cut nicotine in cigarettes, shift toward e-cigarettes
British American Tobacco not surprised by FDA move to cut nicotine

Altria responds to Scott Gottlieb’s announcement
Press Release

Clive Bates: Huge FDA announcement on future tobacco and nicotine strategy
Huge FDA announcement on future tobacco and nicotine strategy

Reposted from Bill Godhsall's post over on ECF. 

This doesn't mean everyone should start popping bottles, PMTA is still greatly in effect. This just means that deeming regulation has been pushed forward. 

In short, this is something posted on the FDA website regarding battery safety.  Good information for newer vapers and a good refresher for seasoned veterans.

So as most of you have probably heard by now the FDA has release their deeming regulations for electronic cigarettes. It's extremly broad and a potential devastating blow to the industry. Especially for small to medium sized vape shops that produce their own hardware or e-liquids. I'll leave my own opinion out of the top post and reserve this for the most current information. There seems to be a lack of simplified summaries so I'll do my best, with what we know so far, to explain the situation.

UPDATED 7-1-2016

Hi folks SFATA provided a great breakdown that makes things very easy to understand. You can view that document - HERE

Here is a summary for everyone: 

The U.S. Food and Drug Administration (“FDA” or “the Agency”) issued a prepublication version of its final Deeming Rule on May 5, 2016. This Rule extends FDA’s authority to all tobacco products, products derived from tobacco, and devices used with tobacco products (except accessories). With this action, and as of the Rule’s effective date, the FDA will or could have authority over the following products:

● Liquids containing nicotine (products without nicotine are not under FDA’s authority)
● Batteries
● Tank systems
● Cartomizers
● Atomizers
● Digital Displays
● Device Software

The Rule was published in the May 10, 2016 edition of the Federal Register. The Rule’s effective date is 90 days from publication in the Federal Register ( i.e. , August 8, 2016). Once the Rule is published in the Federal Register, it starts the clock ticking on a number of dates. The Deeming Rule also creates a distinction among businesses in the industry: retailers and manufacturers. 

Retailers: Means any person who sells tobacco products to individuals for personal consumption, or who operates a facility where vending machines or selfservice displays are permitted.

Manufacturers: Means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product. As explained below, if an establishment mixes or prepares eliquids, or creates or modifies aerosolizing apparatuses for direct sale to consumers, such a firm would be a tobacco product manufacturer. A manufacturer could also be any business that rebuilds coils or devices beyond simple repairs. 

Depending on number of employees and annual revenues, it is possible that a manufacturer could qualify as a “small scale tobacco product manufacturer.” Qualifying for this designation will not reduce the compliance requirements, but will afford such firms with additional time to comply with certain requirements under the Rule. Under the Rule, a “smallscale tobacco product manufacturer” is a manufacturer of any regulated tobacco product that employs 150 or fewer fulltime equivalent
(“FTE”)employees and has annual total revenues of $5,000,000 or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with such manufacturer. In other words, if a firm employs 150 or less FTE employees and has $5,000,000 or less in annual total revenues, but is controlled by, controls, or under common control with another manufacturer that puts them over the 150 FTE/$5,000,000 revenue thresholds, they would no longer be
considered a smallscale tobacco product manufacturer.

IMPORTANT DATES:

• May 10, 2016 - The Deeming Rule is officially published and will be effective 90 days thereafter.
• August 8, 2016 - The Deeming Rule is effective, as it is 90 days after the Rule is published in the Federal Register. This starts the clock on the various premarket pathway options and it also implements some key changes in the near term.
• December 31, 2016 - As a result of The Deeming Rule manufacturers will now need to submit a list of all products twice a year December and June of each year. Because the Rule will go into effect August 8 th December of this year will be the first time that vapor product manufacturers have to submit this information.
• February, 2017 - Manufacturers will need to submit an ingredient list of all products that are manufactured in February of 2017. It is not clear at this time what items the FDA will be expecting although we do expect that the level of detail required will be significant. As we know more, we will provide updates.
• August 8, 2018 - Premarket tobacco product application (“PMTAs”) are due.
• August 8, 2019  -Three years after the Rule’s effective date. By this time, all products on the market must have been grandfathered or the subject of an FDA marketing authorization order.

How Suppliers must obtain FDA authorization 

Manufacturers of newlydeemed products that are "new tobacco products” will be required to obtain premarket authorization of their products through one of three pathways:

(1) substantial equivalence (SE): This will require a manufacturer to show that a new product is substantially equivalent to a product on the market as of February 15, 2007. As I'm sure most of you know, It is unlikely that many products will be able to demonstrate SE given both the lack of comparable products on the market in February 2007 and the differences between products then and now. These submissions are due 18 months after the effective date (Anyone remember the old pen style 801's? Yikes...) 

(2) exemption from SE; This pathway is intended primarily for cigars and is unlikely to be an avenue for vapor products. These applications are due 12 months after the effective date.

(3) premarket tobacco product application (PMTAs): This will be the path that almost all vapor products will need to follow. Manufacturers for both eliquids
and devices will have 24 months to submit a PMTA application. After an application has been submitted, manufacturers will have an additional 12 months to market products.

At the close of these compliance periods, products will be subject to FDA enforcement unless they are grandfathered or are the subject of a marketing authorization order. It should be noted that the administrative costs of compiling a PMTA will cost at least a few hundred thousand dollars PER product. This conservative estimate does not account for the testing that will be required to generate data sufficient to inform a PMTA submission. Such testing could cost at least $1 million per product.

Short Term:
Nothing will significantly change the way you operate your business until August 8 th . Beginning on August 8 th , the FDA can and likely will, to some degree, begin to enforce the following requirements:

∙ Products may not be sold to persons under the age of 18 (both in person and online);
∙ Age verification required by photo ID;

You've no doubt run across a few suppliers already requests age verification documents. These are suppliers getting ahead of the curve, expect this to become more normal. 

Vapor Talk

Quite a few members have PM'd me asking how this will affect Vapor Talk and what our stance is. (.... the PR firm kindly requested I refrain from using the exact words I'd like to express. But I'm sure you can take an educated guess if you know my history here!) First, the forum will always remain! No doubt forums are a gateway to the most current information. Secondly, I've taken back a large controlling share of Vapor Talk. We've just closed a joint, multi-million dollar venture and I can assure you, we're in this for the long haul (PR Release will be available at the end of the month). Vapor Talk started in 2008 and since then we've gone through early year bans, border seizures, California state ban (then reversed by good ol' Arnold) and much more. We've been doing this well before many of the new vapers arrived. 

I'll be working to expand the Vapor Talk online store, get the forum backup to spec (Many updates and bug fixed have been applied to the forum today.) as well as open new locations. VT is currently managed by the Whitney Group out of New Jersey but we'll be reopening offices in Los Angeles, a new office in Beijing (I'm flying out in two weeks so be sure to check the VT blog!) and finally England (Location TBA). Many of you have supported not just me personally but Vapor Talk as a company and community for a long time. As such we plan to stay for many, many years to come. 

http://vaping360.com/fda-rules-vape-shops/

In a nutshell, the FDA has issued a new interpretation that says refilling a tank, changing a coil and setting up a new mod does not constitute a manufacturer.  Here is the actual FDA interpretation.

Here is a complete breakdown of the Prop 56 Tax in California. (Something that affects Vapor Talk directly as we have an office and soon wharehouse in California). Credit goes to Blue Dot Vapers. 

You asked us to clarify apply how the new Proposition 56 tax will apply to your various business functions. As you well know, Proposition 56, also known as the Tobacco Tax Increase Initiative (or “Prop 56”), was adopted into law by California voters on November 8, 2016. Prop 56 amended the existing California cigarette and tobacco product laws to: (1) define e-cigarettes as tobacco products under the tax code (note that e-cigarettes are already defined as tobacco products in section 22950.5 of CA’s Business and Professional Code (Cal. Bus. & Prof § 22950.5), (2) increase the tax on distributors of cigarettes by $2.00 a pack, and (3) impose an “equivalent” increase of the tax on distributors of “tobacco products”, which include “e-cigarettes”. Importantly, many of the details related to how this law will be applied to e-cigarettes will be worked out in the coming months, as the CA State Board of Equalization has been tasked with developing regulations to determine how to implement an “equivalent tax” for products like e-cigarettes.

We note that we interpret the “e-cigarette” definition below to mean that for purposes of the Prop 56 tax, closed-system (cigalikes) and open-system e-liqiuds are “electronic cigarettes,” but open-system devices (and related accessories sold separately) that are sold without e-liquid are not electronic cigarettes under this definition.

The Prop 56 tax (the amount of which, as noted above, has not yet been determined for e-cigarettes or e-liquid) applies to the distribution and distributors of e-cigarettes in California. Cal Rev. & Tax. § 30130.51(b). Manufacturers (or original importers) who sell e-cigarettes directly to licensed distributors are exempt from the tax. Cal Rev. & Tax. §§ 30103 and 30105. Rather, the tax is triggered the first time the (previously untaxed) e-cigarette is sold by a distributor to another distributor, wholesaler, retailer, or consumer in the state. (Please note we define these key terms (e.g., distributor, importer, manufacturer, etc. below). For example, a California-based manufacturer of a nicotine-containing e-liquid is not required to pay the tax for selling the product to a CA distributor. However, when the distributor then sells the e-liquid to a retailer or a consumer in California, the distributor is obligated to collect the appropriate tax for the state.

Distributors who sell e-cigarettes directly to CA consumers via the internet (i.e., are participating in delivery sales) must also pay the tax, regardless of their physical location, provided the tax has not already been paid by some entity upstream in the supply chain. Cal Rev. & Tax. §§ 30101-30111. See also Cal. Code Regs. ***. 18 § 4011. If the tax already has been paid, the distributor is classified as a wholesaler, and no tax is due. Distributors who sell to CA wholesalers (i.e., CA retailers and retail stores) via the internet also are required to pay the tax, even if they are located outside of the state.

Sales made to out-of-state consumers or distributors (who are not reselling into California) are not taxed. Also, in-state sales of e-cigarettes which are shipped to a point outside the state are not subject to the tax. Cal. Code Regs. ***. 18 § 4080. Importantly, if an e-cigarette for which the tax has not been paid is sold to a consumer, the obligation to pay the tax then falls onto the consumer. Cal Rev. & Tax. § 30107. See also Cal. Code Regs. ***. 18 § 4091.

The tax becomes effective on the first day of the first calendar quarter commencing more than 90 days after the effective date of Prop 56 (i.e., April 1, 2017).

You are correct that the tax will be due on the wholesale cost of the purchase price for the tobacco product.Cal Rev. & Tax. § 30123. California recently promulgated new regulations which determine how to interpret the term “wholesale cost”. Cal. Code Regs. ***. 18 § 4076; see also https://www.boe.ca.gov/regs/pdf/Reg4076_OAL_Approval_2016.pdf. In “arms-length transactions,” the wholesale cost is the amount paid for the e-cigarette, including any relevant federal excise taxes, but excludes transportation charges for a shipment originating in the U.S.

The wholesale cost for transactions of tobacco products where the manufacturer or importer is also the distributor are computed as specified in Cal. Code Regs. ***. 18 § 4076(b)(2). Specifically, these regulatory provisions provide that:

“If a manufacturer or an importer is also the distributor, the wholesale cost of tobacco includes all manufacturing costs, the cost of raw materials (including waste materials not incorporated into the finished tobacco product) prior to any discounts or trade allowances, the cost of labor, any direct (including freight-in) and indirect overhead costs, and any federal excise and/or U.S. Customs taxes paid. Wholesale cost includes all freight or transportation charges for shipment of materials and/or unfinished product from the supplier to the manufacturer concurrently licensed as a distributor, but excludes domestic freight or transportation charges for shipment of finished tobacco products.”

Cal. Code Regs. ***. 18 § 4076(b)(2). Thus, you cannot act as a manufacturer and sell a product to yourself for a deep discount, as doing so would not comply with the spirit or requirements of Cal. Code Regs. ***. 18 § 4076(b)(2). There is a relatively complex scheme in place to determine the wholesale cost of these non-arms-length transactions, and we advise you to carefully review the provisions in Cal. Code Regs. ***. 18 § 4076. You may find it necessary to obtain the assistance of a tax attorney or CPA to properly compute the cost of the tax due in these scenarios (if so, let us know).

Below is a short summary of the other key provisions of Prop 56.

I. California Proposition 56

A. Key Definitions

• 1 Arm’s-length Transaction – An “arm’s-length” transaction means a sale entered into in good faith and for valuable consideration that reflects the fair market value in the open market between two informed and willing parties, neither under any compulsion to participate in the transaction.
• 2 Consumer – A person who purchases tobacco products.
• 3 Dealer – Includes every person, other than one holding a distributor's or wholesaler's license, who engages in the sale of cigarettes or tobacco products.
• 4 Delivery Sale – Means the sale of tobacco products into and in CA in either of the following cases: “(a) The consumer submits the order for the sale by means of a telephone or other method of voice transmission, the mail, or the Internet or other online service, or the seller is otherwise not in the physical presence of the consumer when the request for purchase or order is made; (b)the cigarettes or tobacco products are delivered to the consumer by common carrier, private delivery service, or other method of remote delivery, or the seller is not in the physical presence of the consumer when the consumer obtains possession of the cigarettes or tobacco products.”
• 5 Delivery seller – A person who makes a delivery sale.
• 6 Distribution – Includes the sale or use of untaxed tobacco products in CA. Distribution also includes the placing of an untaxed tobacco product in a vending machine or in retail stock for purposes of selling the product to consumers.
• 7 Distributor – A person who distributes, as the term is defined above, tobacco products. The distributor is the person or entity that makes the first tobacco product distribution (i.e., sale of a previously untaxed tobacco product) in CA. See https://www.boe.ca.gov/sptaxprog/spctdistributor.htm.
• 8 Electronic cigarette – Defined as “any device or delivery system sold in combination with nicotine which can be used to deliver to a person nicotine in aerosolized or vaporized form, including, but not limited to, an e-cigarette, e-cigar, e-pipe, vape pen, or e-hookah.” The term includes any component, part, or accessory of a device that is used during the operation of the device when sold in combination with any liquid or substance containing nicotine. The term also includes include any liquid or substance containing nicotine, whether sold separately or sold in combination with any device that could be used to deliver to a person nicotine in aerosolized or vaporized form. Electronic cigarettes do not include any device not sold in combination with any liquid or substance containing nicotine, or any battery, battery charger, carrying case, or other accessory not used in the operation of the device, if sold separately.

As noted above, we interpret this to mean that for purposes of the Prop 56 tax, closed-system (cigalikes) and open-system e-liqiuds are “electronic cigarettes,” but open-system devices (and related accessories sold separately) that are sold without e-liquid are not electronic cigarettes under this definition.

• 9 Importer – Any purchaser for resale in the U.S. of tobacco products manufactured outside of the United States for the purpose of making a first sale or distribution within the United States.
• 10 Tobacco Product (Revenue and Taxation Code Definition) – A tobacco product is defined in the Revenue and Taxation Code as a “product containing, made, or derived from tobacco or nicotine that is intended for human consumption, whether smoked, heated, chewed, absorbed, dissolved, inhaled, snorted, sniffed, or ingested by any other means, including, but not limited to, cigars, little cigars, chewing tobacco, pipe tobacco, or snuff, but does not include cigarettes.” Electronic cigarettes are captured within this definition of tobacco product. See Cal Rev. & Tax. § 30121(b).
• 11 Wholesaler – A wholesaler is a person who engages in making sales of tobacco products intended for resale for which the tobacco product tax has been paid.

And, on to my question...

Has anyone been to a B&M in california and does anyone have an idea how this affects ejuice prices locally? I haven't been yet so no clue...

And, I'm really curious how this affects on line purchases, whether purchasing out-of-state products are affected. What about DIY nicotine products or other products tobbacky related?  

Has anyone from California seen any changes yet?

...you know, aside from that really strange smell coming from the neighbor's house...

Questions on FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

What are the costs associated with submitting an application?

The costs associated with submitting an application to market a tobacco product can vary greatly and depend on a number of factors, such as the pathway to market being applied for, the type of tobacco product and the availability of data on the specific product or other similar products. Generally, high costs may come from needing to conduct original research and testing to inform the application, as well as staff time spent compiling it. For further information on the different premarket pathways, please refer to the Tobacco Product Review & Evaluation webpage.

On page 94 (Table 14) of the "deeming" Regulatory Impact Analysis (RIA), the FDA has estimated the average cost for each premarket review pathway for newly regulated tobacco products to be:

• an SE exemption report = around $1,500
• an SE report = anywhere from around $3,500 to around $22,700
• a premarket tobacco application (PMTA) = in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000), not in the millions of dollars described by some others

In general, and especially over time as manufacturers become more experienced and relevant research develops, the FDA expects many efficiencies to lower the average costs of premarket review. For example, we expect that manufacturers' costs will be dramatically lowered by the bundling of applications for similar products; by reliance on Tobacco Product Master Files; and by bridging of data from one product to another. Due to these and other efficiencies, the FDA expects submission costs to vary across products and to diminish broadly over time, thus resulting in lower average costs per product, as reflected in the cost estimates that accompanied the rule.

Recognizing that some of the costs associated with this process may be challenging to small businesses, the FDA is taking several steps to ease this process. Those steps include:

• issuing final guidance on Tobacco Product Master Files (which can help applicants use existing information, rather than developing their own, when submitting premarket applications),
• issuing draft guidance on submitting PMTAs for ENDS products (which, when final, will reflect the agency's current thinking on what information the FDA recommends an applicant submits and how the FDA intends to review PMTAs),
• issuing two Small Entity Compliance Guides for deeming and user fees,
• revising and updating several other previously issued guidances to include the newly-regulated products,
• posting training videos and live webinars to the website to assist industry, and
• providing a final "deeming" rule web hub to help industry navigate the new regulations.

I am a vape shop with hundreds of different e-liquids. Do I need to submit an application for each flavor/ingredient variant or nicotine strength? Can I bundle similar products into one, or just a few, applications?

Each tobacco product application is a unique situation. However, generally speaking, a manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA. Where the same information applies to multiple products, it should be noted.

FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product.

How does a manufacturer know if they need to conduct clinical trials?

For assistance, manufacturers of newly regulated products can reference the FDA's Applications for Premarket Review of New Tobacco Products draft guidance from 2011 and the recently-issued Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery Systems (ENDS) draft guidance. The PMTA ENDS draft guidance discusses circumstances when a new clinical trial might be helpful and when it might be less necessary. As these are both draft guidances, FDA will review the comments and feedback submitted before issuing final guidances. Once final, they will represent the agency's current thinking on this topic.

What is the grandfather date?

Congress wrote and passed the Tobacco Control Act, which states that any tobacco product on the market as of February 15, 2007 is eligible for grandfather status (this includes products that were in test markets).

Otherwise, any products introduced or modified after that date are considered "new" tobacco products and must submit a premarket application to the FDA through one of the three available pathways.

Are there any e-cigarettes that are grandfathered and could be used as a predicate for a Substantial Equivalence application?

It's possible that an ENDS product exists that may have been on the market in the United States as of February 15, 2007 and could be used as a valid predicate. However, the burden of identifying a predicate falls to the applicant, so a manufacturer would have to prove such a product is grandfathered.

The FDA expects that most ENDS products that companies submit for market authorization will utilize the PMTA pathway, which does not require a comparison to a predicate product.

Why can't the FDA just change grandfather date as it relates to newly regulated products?

Only an Act of Congress can change the grandfather date.

In the proposed rule, the FDA stated it lacks the legal authority to change the grandfather date and specifically asked for the public to comment on this legal interpretation. The agency received a large number of comments in response to this statement, but none provided a legal theory that would support changing the date.

How can a vape shop be considered a manufacturer?

Vape shops that mix, prepare, or combine liquid nicotine and other components of tobacco products meet the definition of a "tobacco product manufacturer" under the law, and are therefore subject to the same legal requirements as all other tobacco product manufacturers.

If a vape store is not mixing, preparing or combining any products then that store may be considered a retailer, not a manufacturer. Certain requirements apply only to manufacturers, such as requirements relating to establishment registration, product listings, and premarket applications.  You can visit the new Manufacturer hub and new Retailer hub for additional information.

Can I mix or make my own e-liquids at home or do I need to register as a tobacco product manufacturer?

If you are mixing these components of a tobacco product and then selling them to other individuals or companies, you would be considered both a retailer and a manufacturer, and subject to all applicable requirements under the law.

Who has to pay user fees and what are the deadlines?

A final rule on user fees that accompanied publication of the final "deeming" rule explains that FDA can only assess user fees on tobacco products that fall within the six classes specified in the law. Cigars and pipe tobacco are the only newly-regulated products that fall within these six classes.

Beginning August 8, 2016, the total amount of user fees will be allocated across cigars, pipe tobacco, cigarettes, snuff, chewing tobacco, and roll-your-own tobacco. Accordingly, assessments on individual manufacturers or importers that currently pay user fees will likely either decrease or remain the same depending on the classes and volume of tobacco products they produce. As outlined in the FD&C Act, the total assessments for user fees are as follows:

• For fiscal year 2016, $599 million
• For fiscal year 2017, $635 million
• For fiscal year 2018, $672 million
• For fiscal year 2019 and each subsequent fiscal year, $712 million

Domestic manufacturers and importers of cigars and pipe tobacco will be subject to quarterly assessments beginning in Q1 of FY17 (from October-December.) Additionally, they have to report certain information monthly beginning August 20, 2016 (including, for this first submission, a retroactive monthly report from October 2015 – July 2016.)

See the small entity compliance guidance on these user fee requirements for more details on what information to submit in the monthly reports, how to submit it, and more.

Will adding warning labels to my product already on the market make it a "new" product, requiring me to submit an application for pre-market review?

If the only change to a product's label is the addition of a required warning statement in compliance with the deeming rule, including any modifications to the label necessary to accommodate the warning, it is unlikely to render the product distinct, and premarket review would not be required.  If, however, the label is modified in any other way, and if those changes rendered the product distinct, premarket review would be required.

Is the FDA banning e-cigarettes?

No, the FDA has not banned any class of tobacco products, including e-cigarettes. We expect that many products will remain on the market while manufacturers apply for authorization to market their products.

I am an importer of tobacco products – what requirements apply to me?

Importers who import finished tobacco products for sale or distribution in the U.S. are considered tobacco product manufacturers.  Examples of requirements applicable to importers of newly deemed, finished tobacco products include:

• Reporting ingredients, and harmful and potentially harmful constituents;
• Submitting an application for premarket review and receiving authorization from FDA before marketing new tobacco products;
• Complying with health warning requirements on product packages and advertisements; and
• Not selling modified risk tobacco products (including those described as "light," "low," or "mild") unless authorized by FDA.

Additionally, importers who own or operate a domestic establishment engaged in the manufacture, preparation, compounding or processing of a newly regulated tobacco product need to register the establishment and submit product listing to FDA by December 31, 2016.

Adulterated and misbranded tobacco products offered for import into the United States are subject to detention and refusal of admission.  Visit out new Manufacturer hub for more information.

What is the "registration and product listing" process and timeframe to comply?

Owners and operators of domestic manufacturing establishments engaged in the manufacturing of tobacco products are required to register with FDA and submit product listings.

Every person who owns or operates any establishment in the U.S. engaged in the manufacture, preparation, compounding, or processing of a newly regulated tobacco product must register with the FDA certain information. This information includes:

• Name;
• Place(s) of business; and
• All establishments engaged in these activities owned or operated by that person.

At this time, FDA intends to enforce the tobacco product registration and listing requirements with respect to finished tobacco products. Such registration information must be submitted annually on or before December 31st of each year.  Additionally, every owner or operator upon first engaging in the manufacturing of a tobacco product in any domestic establishment must immediately register, and registered owners and operators must immediately register any new establishment that begins manufacturing tobacco products.

All registrants must also submit a list of all tobacco products manufactured for commercial distribution, along with certain accompanying information (including all labeling). Complete product list information must be submitted at the time of first registration; certain changes in the product list must then be submitted biannually.

Please refer to the guidance for further details about the process. Additionally, the FDA has posted a Step-by-Step Instruction guide for users accessing the FDA Unified Registration and Listing Systems (FURLS).

The product I manufacture contains no substance made or derived from tobacco, e.g. is zero-nicotine, or has synthetic nicotine or nicotine made from tomatoes. Is my product subject to FDA regulation?

The definition of "tobacco product" includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities. FDA will review these products on a case-by-case basis.

I'm a supplier who sells to a manufacturer. I don't sell directly to consumers. Do I need to register with the FDA and submit premarket applications?

If you are solely a supplier and your product is sold only to another company for further manufacture into a finished tobacco product, at this time, FDA does not intend to enforce certain provisions of the law with respect to your product. For example, FDA does not intend to enforce the requirements that you register your manufacturing establishment and list your products, submit premarket applications or submit ingredient listing or health documents with respect to newly deemed products that are sold or distributed solely for further manufacturing into finished tobacco products.

I have an e-liquid line coming out next week. Will I be able to sell it next week?

New e-liquids entering the market after August 8, 2016 are in violation of the law and may be subject to enforcement if marketed without authorization.
To legally sell a new e-liquid, a manufacturer must submit an application through one of the three available premarket pathways for each tobacco product and receive marketing authorization from FDA.

Smoking premium cigars and pipes are a niche hobby. Shouldn't they be regulated differently from mainstream tobacco products like cigarettes and chewing tobacco?

After thorough review of the comments to the proposed rule and the scientific evidence, FDA believes it is appropriate to subject all tobacco products to its tobacco control authorities to best protect the public health.

General Questions

What is the Center for Tobacco Products (CTP)? How did it come about?

The Family Smoking Prevention and Tobacco Control Act, signed into law in June 2009, granted the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products. FDA then established CTP to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use.

What are the mission and goals of the Center for Tobacco Products (CTP)?

Tobacco use continues to be the leading cause of preventable death and disease in the United States. To help make tobacco-related death and disease a part of America's past, not its future, CTP is committed to educating the public about the harms of tobacco products, keeping tobacco products out of the hands of America's youth, and dramatically reducing the appeal of these deadly products. Everything we do is designed to reduce the impact of tobacco on public health, including the FDA's three key goals:

• Prevent Americans—especially youth—from starting to use tobacco
• Encourage current users to quit
• Decrease the harms of tobacco product use

What is the Center for Tobacco Products (CTP) authorized to do?

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) allowed FDA to establish CTP and granted CTP the authority to:

• Require tobacco product manufacturers register with FDA
• Establish standards for tobacco products, such as tar and nicotine levels, in an effort to reduce their toxicity and addictiveness
• Establish limits on sale and distribution of tobacco products
• Require premarket review for new and modified risk tobacco products to protect the public health

FDA regulates safe and effective products—but how does tobacco fit in?

FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco. FDA evaluates tobacco products based on a public health standard that considers the risks and benefits of the tobacco product on the population as a whole, including users and nonusers.
The law requires FDA to apply a public health approach when developing regulation that considers the net effect on tobacco-related behavior changes within the entire population, not just an individual user, for initiation, cessation, and re-initiation of tobacco use.

There is no known safe tobacco product. FDA does not have the authority to ban any class of tobacco products, such as cigarettes. We do, however, have the authority to dramatically reduce the harm of all tobacco products, and we will use that authority to continue improving public health.

Is there a way to find out the harmful ingredients in different tobacco products?

FDA is required by law to publicly display information about harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke that cause harm, or could cause harm, to users and non-users, in a way that is understandable and not misleading. The regulation includes listing the amount of each chemical present in specific brands and sub-brands of tobacco products.
FDA will make HPHC information available once the Agency is confident that the list is accurate, understandable, and not misleading to the public. FDA is still evaluating the data it has received from manufacturers, including verifying its accuracy. In addition, FDA is conducting scientific studies to assess consumer understanding of how the Agency presents information about HPHCs. Upon completion of these important activities, FDA intends to publish the HPHC information, so that consumers can make more informed decisions about tobacco products.

Can you provide me with a list of ingredients in a certain tobacco product?

Section 915 of the Federal Food, Drug, and Cosmetic Act requires FDA to issue regulations requiring the testing and reporting of tobacco product constituents, ingredients, and additives that FDA determines should be tested to protect the public health. Once FDA issues a proposed rule related to Section 915, it will be available for public comment. You can track the status of the proposed rule through the Unified Agenda, which semi-annually lists all of the Agency's projected publication dates. Additionally, for more information about the FDA rulemaking process, visit  the FDA's Rules and Regulations page.

Which tobacco product/brand is the healthiest option?

No matter what they taste, smell, or look like, all tobacco products can be harmful to your health. The Family Smoking Prevention and Tobacco Control Act grants FDA the authority, and responsibility, to reduce the harm of tobacco products. The most effective way to achieve the greatest reduction in tobacco-related death and disease is to stop using all tobacco products. However, FDA understands there is a potential market for tobacco products that could present less health risks to consumers. These items are called modified risk tobacco products (MRTPs), and they are tobacco products that are sold or distributed for use to reduce harm or risk of tobacco-related disease associated with commercially marketed tobacco products. FDA can issue an order authorizing the marketing of a product claiming reduced harm or risk, only if the evidence submitted in the application includes, among other things, data showing that the product will or is expected to benefit the health of the population as a whole. Furthermore, if a proposed MRTP is a new tobacco product (not yet on the market), a person or entity seeking to bring that MRTP to market is subject to premarket requirements (e.g., substantial equivalence, exemption from substantial equivalence, or a premarket tobacco application) in addition to MRTP requirements.  To learn more, see FDA's Modified Risk Tobacco Products webpage.

How do I report a violation of the Family Smoking Prevention and Tobacco Control Act, such as selling tobacco products to a minor?

To report a potential violation of the Family Smoking Prevention and Tobacco Control Act, you can call Center for Tobacco Products' Call Center at (877) CTP-1373 or send an email to AskCTP@fda.hhs.gov.

In addition, you may also use the downloadable Potential Tobacco Product Violations Reporting form.

Why was an FDA inspector just in my store?

Retailers play an important role in protecting the health of America's youth by not selling, marketing, or advertising tobacco products to underage children and adolescents. FDA conducts compliance check inspections of tobacco product retailers to determine a retailer's compliance with federal laws and regulations.

FDA generally issues Warning Letters for first-time violations and civil money penalties for violations found on subsequent inspections. Results from compliance check inspections are available on the FDA's website.

What should I do if I receive a Warning Letter?

FDA generally sends Warning Letters to retailers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws and regulations that FDA enforces. First, review the letter carefully to see what charges are listed. You should respond in writing to the letter within 15 working days. Include the following in your response to the Warning Letter:

• An explanation of the steps you will take to correct the violation(s) and prevent future violations (e.g., retrain your employees, remove the problematic items)
• Your current contact information, including telephone number and email address

Promptly and adequately correct the violations listed and be sure that you comply with all applicable laws and regulations. The Warning Letter includes contact information, so if you have any questions, reach out to us for more information. You may also visit the FDA's Warning Letters Overview page for further resources.

What documents do I need to submit to the Center for Tobacco Products?

Tobacco product manufacturers or importers are required to submit certain information to FDA, including:

• Tobacco health documents
• Establishment registration and product listing
• Listing of ingredients in tobacco products
• Reporting of harmful and potentially harmful constituents in tobacco products and tobacco smoke

For more details about the requirements and submission process, visit the FDA's Manufacturing webpage.

How can I get my new or innovative product approved by FDA?

FDA does not "approve" tobacco products, but the Family Smoking Prevention and Tobacco Control Act provides legal ways for new tobacco products to be marketed. If FDA determines a new tobacco product meets the relevant legal requirements, the FDA will issue a written notification permitting the marketing of the new tobacco product. Tobacco manufacturers may use one of the three Pathways to Market to seek to legally market new tobacco products. These include:

• Premarket tobacco products—This pathway requires the applicant to demonstrate that FDA permitting the marketing of the new tobacco product would be appropriate for the protection of the public health.
• Substantial equivalence—This pathway may be appropriate for a new tobacco product that demonstrates it has the same characteristics as a predicate tobacco product, or has different characteristics, but does not raise different questions of public health from a predicate product.
• Exemption from substantial equivalence—This pathway may be appropriate for new tobacco products with certain minor modifications to additives of a legally marketed tobacco product.

If you haven't already done so, please read my blog post here: http://www.vaportalk.com/understanding-the-fda-august-8th-2016-regulations-vaping-industry/ 

Surprised to see CA gets the lion share (monetarily speaking) by a lot compared to all other states. 

What does this have to do with the FDA regulations?  Subliminal messages.  I was chatting with a fellow vaper here at work today about the regs and where we see things going.  We are both in agreement that vendors not being able to promote vaping as a safer, healthier, less dangerous alternative to smoking is ridiculous.  So we came up with the following text that a shop owner could potentially post in the window of their shop (or even inside the shop).  It probably wouldn't fly very far, but it still might be fun to test the waters a bit.

Won't be able to use more than 2ml tank? Seriously?

Sent from my VF-895N using Tapatalk

http://blog.rollingpapersexpress.com/rolling-paper-blog/tobacco-products-directive-and-what-it-means-for-you/

Dear Mr. Songer,

Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act” (Deeming rule).  Thank you for sharing your article with us.  We cannot provide any comment on your opinion of the new law.  However, I have provided some information that may assist with any dissemination of information that you choose as a part of your advocacy.

You may be interested to know that the FDA Center for Tobacco Products is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009.  This law—commonly called the Tobacco Control Act—gives us broad authority to regulate the manufacturing, distribution, and marketing of tobacco products.  The FDA’s mandate is to protect Americans from tobacco-related disease and death.  Ultimately, we hope that regulating all tobacco products will have a positive impact on public health.  That is the motivation for finalizing the rule.

We understand that consumers, manufacturers, retailers and related businesses will be impacted by this rule in some way. Given your interest in the rule, I want to share some additional information about it in case you would like to read more.

Final Rule Addresses Public Health Concerns Focusing on Youth

The Family Smoking Prevention and Tobacco Control Act (TCA), passed by Congress on a bipartisan basis and signed by the President in 2009, gave the FDA tools to protect the public from the harms of tobacco use. Since June 2009, the FDA has regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products under its tobacco control authority. The law also gave the FDA the ability, through rulemaking, to regulate additional products that meet the legal definition of a tobacco product.

This new rule brings all tobacco products under FDA oversight, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic step will help improve public health and protect future generations from the risks of tobacco use by putting additional restrictions in place that make it illegal to sell tobacco products to minors. 

Before this rule, there was no federal law prohibiting stores and websites from selling e-cigarettes, hookah tobacco, and cigars to minors. The new rule aims to deter youth initiation through restricting youth access to these products by:

•             Not allowing products to be sold to persons under the age of 18 years;

•             Requiring age verification by photo ID;

•             Not allowing the selling of tobacco products in vending machines (unless in an adult-only facility); and

•             Not allowing the distribution of free samples.

The rule also serves as the foundation for future FDA actions related to tobacco, including where scientific data supports regulatory action, addressing flavors in combustible products.

Extending the FDA’s Authority is a Milestone in Public Health and Consumer Protection

Going forward, the FDA will be able to review all new tobacco products not yet on the market. The actions being taken also will help the FDA prevent misleading claims and provide consumers with better information about the risks of tobacco use. The rule also will allow the FDA to evaluate the ingredients of tobacco products, how those products are made, and their potential dangers.

The rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.  

These requirements include:

•             Registering manufacturing establishments and providing product listings to the FDA;

•             Reporting ingredients, and harmful and potentially harmful constituents;

•             Requiring premarket review and authorization of new tobacco products by the FDA;

•             Placing health warnings on product packages and advertisements; and

•             Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to three years while manufacturers submit – and the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise the product will be subject to enforcement.

For More Information

To assist the newly-regulated tobacco industry in complying with the requirements, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

For more information:

•             Final Rule:  https://federalregister.gov/a/2016-10685

•             Deeming – Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah:http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htm    

•             FDA takes significant steps to protect Americans from dangers of tobacco through new regulation:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM499234.htm  

We respect your opinion and value all of the comments that we receive.  We appreciate you taking the time to share your thoughts with us.

____________________

Center for Tobacco Products

Food and Drug Administration

CTP Call Center: 1-877-CTP-1373

www.fda.gov/tobaccoproducts

------------------------------------------------------

-----Original Message-----
From: John T Songer Jr [mailto:jtsongerjr@hotmail.com] 
Sent: Tuesday, May 10, 2016 8:17 PM
To: AskCTP
Subject: Questions

After me and a few other reviewers and advocates came together we wrote this article, wanted to know if we left anything out?

The FDA has declared war on vaping. This so called deeming regulations aren’t rules any vaping business can work with. They’re an attack on what we do and who we are, and vapers are right to feel mad and betrayed. The regs are as bad as the most pessimistic advocates expected — or maybe even worse.

Don’t let anyone kid you. If you’re a manufacturer or seller of vapor products in the US, this is a death sentence for your business. And if you’re a consumer of anything other than cigalikes, it’s going to reduce your choices of legal products to almost zero.  As it stands, on August 8 the vaping market will be frozen. You will not be able to make or sell any new products without approval from the FDA. And common consensus is, no one besides makers or cigalikes (Tobacco companies) will ever receive any sort of approval. No doubt after quite large financial fee (officially or under the table) Beyond that, vendors will have two years to file their pre-market tobacco applications. Each application for approval to sell “tobacco products” will probably cost over a million dollars, and there is no guarantee it will be accepted by the FDA.

The requirements are stupidly extreme. Aside from exacting scientific studies, you will have to prove that your product has a net benefit to the overall public health. Really? It’s an impossible standard to meet. If you don’t have several million dollars to gamble with, you can’t and won't survive if these regulations go into effect. That’s intentional on the FDA’s part. They know we can’t live in the world of extreme and exacting tobacco regulations and compliance. Our only hope is to stop the regulations from choking the thing that we love and depend on.

The Vapor Technology Association has a pretty good summary of what we know so far. And Mark Dickinson of Clarityse sums it up neatly: “The sheer scale of the regulatory burden is very likely to be the death knell for the huge majority of independent manufacturers and vape stores in the US, with almost all products currently available being taken off the market in 2-3 years time. It will also bring to an immediate halt all the US based innovation that has been so prevalent in the last few years.”

While claiming to protect children from nicotine addiction, Mitch Zeller and his agency have delivered a carefully crafted ban of all vapor products, except perhaps cigalikes made by Big Tobacco. They justify this by quoting the National Youth Tobacco Survey(NYTS) that shows vaping among teenagers growing. But they ignore the National Institute on Drug Abuse survey that showed only 20 percent of teens use nicotine in their e-cigs. The NYTS surveys don’t even ask whether kids use nicotine — or if they’re regular users or have just taken a single puff in the last 30 days. How convenient! They also ignore that all surveys show teen smoking at its lowest level ever. It’s not about smoking anymore; the objection is now to nicotine itself.

The FDA specifically says that nicotine in pharma products like patches and gum, lollipops, and flavored lozenges is not addictive or dangerous. But they ignore all evidence that the same may be true of nicotine in vapor products and couch their regulation in the lie that they’re protecting kids from “a lifetime of addiction.” Hello, nicotine candy and lollipops. If your company’s name is Pfizer or Johnson & Johnson, your tobacco-derived nicotine is a safe, non-addictive medicine. If your name is Joe’s Vape Juice, you’re a producer of deadly addictive poison that is a menace to society.

The age limit on buying vapor products that goes into effect on August 8 is window dressing. 48 states already ban sales to minors (and the others don’t because “health groups” fought against the minor bans because they wanted other restrictions included). But the FDA is playing this as an example of “protecting children.” And most of the mainstream media is swallowing it whole.

Meanwhile, the most dangerous consumer product in the history of the world will remain available and protected from competition. Adult smokers desperate for a way out will have the option of buying ineffective junk from the same companies that make the cigarettes that are killing them — or, if they want to jump through hoops and skirt the law, they can seek out black market vapeproducts. Many will just keep smoking.

The FDA wants to hand the vapor market to the supposed enemies of tobacco control on a silver platter. Call it a gift, a token offering to the tobacco industry that has learned to play so well within the restrictive regulatory framework they built together. The FDA loves Big Tobacco, but not because of bribes or collusion. It’s because they speak the same language and inhabit the same world — the world of legalistic government business regulations. The tobacco industry knows how to play this game, and has the resources available to play it.

In the UK, voices of logic have won the day. Public Health Englandand the Royal College of Physicians have advocated a harm reduction approach that includes encouraging smokers switching to vaping to avoid cigarettes. The FDA, afraid of criticism from their friends in the pharma-funded anti-nicotine “health” groups, went in the polar opposite direction: prohibition.

So, Is It All Over? Should We Pack up Our Mods and Buy a Pack of Camels?

No! We still have avenues open to fight this thing. But everyone needs to stop pretending that this pathway of pre-market applications and substantial equivalence is one we can walk. The deemings regs are a ban, plain and simple. But we need to get busy and act now. We have to get embrace the fact that we are the only ones who have a chance to stop the deeming ban from killing vaping as we know it. No white knight is riding in to protect us. What should we do now?

http://blog.casaa.org/2016/05/fda-deeming-regulations-release-and.html

https://vaping.com/deeming-live-blog/

"California Vapers Alliance, founded 2016.     Our mission is simple; to unite every vaper, and reach all corners of the industry. Advocacy is our primary focal point. A few voices are not enough to be heard by our opposition though. If every vaper stands beside one another, our voice will thunder and move mountains." 

    "By holding events, we can join all the corners of this industry to promote advocacy, and donate to our cause. We must rise up together, and proclaim to our opposition; We are the people of vape, we are the movement of vape. Allies over enemies. Support the cause. World Vapers Unite 🌎😤👊"

We have made connections with many major players, as well as influences, advocates, etc, in the industry. We have an extremely strong backing, and our ultimate goal is too make a gigantic impact, and unite all vapers. We can all rise to the occasion, and protect our right to vape.

Like us on FB. Follow on IG. Most importantly, stand beside us. #worldvapersunite 🌎😤👊