Advocacy

It is easy to forget that the PMTA doesn’t only cover vaping products, but also flavored tobacco products. So far, the majority of PMTA submissions have been from tobacco companies and cigar companies in particular. Only last week have we started seeing vape companies submitting their forms for PMTA approval.

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Possible FDA Delay

In a letter to a District Judge Paul Grimm this week, the FDA has asked for a delay/deferment for many flavored premium tobacco companies, mainly cigar companies. This would provide an extension to the fast approaching PMTA deadline to the cigar companies, yet it completely excludes any vaping products. The document was approved August 5th, 2020.

This all stems from the FDA’s ability to defer submissions on a “case by case” basis.

“The FDA intends to exercise its retained discretion by deferring enforcement of the premarket authorization requirement for premium cigar manufacturers and importers on a case-by-case basis,” says the letter. “The deferrals are intended to help prioritize the use of the FDA’s limited enforcement resources while the agency undertakes a new research effort to evaluate the public health impact of premium cigars. The FDA intends to describe how manufacturers and importers can submit deferral requests in a guidance document that would take effect immediately upon issuance.”

Why would they do this? Well, the FDA has extremely limited resources when it come to enforcing the PMTA. If they defer more tobacco products, this opens up more resources to enforce the new laws on vaping products. On the other side of that, the FDA says that they will use this extra manpower to “fast track” any vaping applications.

“The FDA’s top priority for pre-market review of deemed products remains products that pose the greatest risk for initiation or use by underage persons, such as flavored, cartridge-based e-cigarette products targeted to or easily accessible to youth. Because the FDA’s current information indicates that youth smoke premium cigars comparatively less than most other deemed tobacco products, like e-cigarettes, premium cigars remain the FDA’s lowest priority for pre-market review.”

Youth vaping is at an all-time low since new regulations forcing people to be 21 years old to even step foot into a vape shop. Let’s also not forget that recent moves by the FDA has also halted importation of popular disposable vapes. Teen vaping is a trend that has pretty much ran it’s course at this point, yet it remains the main argument when it comes to the banning of vape products.

Reaching Out To The FDA

There have been many letters sent by small vape manufacturers over the past month asking to delay the PMTA deadline on September 9th. With Covid-19 looking like it’s here to stay for a while, vape companies have asked for more time to gather documents and research for their submissions. Many companies are working on a small skeleton crew because of the pandemic.

With this new development though, it looks like any delays that would be granted on the vape side of things probably won’t be considered.  It would seem that a delay would already be announced considering the deadline is only a month away.

The War on Nicotine

The FDA must have all changes to their timeline approved by Judge Grimm due to last years lawsuit from the many anti-vaping organizations, including the American Academy of Pediatrics. The plaintiffs won the lawsuit, which moved the PMTA deadline to September 9th 2020. The “Youth Vaping Epidemic” was at the forefront of the federal case.

These same associations, as well as many anti-tobacco groups, plan to try and over-turn the exemption/delay for premium tobacco and cigars. The plaintiffs have acknowledged the recent letter to Judge Grimm and will be opposing it on August 17th. However this just seems to be for show, as the plaintiffs include the Campaign for Tobacco-Free Kids. The same group that brought vaping to the forefront last year.

This move to rise against any PMTA delays will ensure that vaping doesn’t lose any attention when it comes to regulation. Because is certainly doesn’t seem fair to allow cigars and tobacco to delay their submissions, while vape companies have to stick to regulation. This becomes a double-edged sword for us. While tobacco may not get the delay the want, that also means any future vaping delays will be denied as well.

Whether we like it or not, the deadline continues to loom over the heads of vapers all over The United States. While there have been a few submissions, we have yet to see a “big push” from both large and small vape companies. Hopefully this changes over the next few weeks.

Flavor bans have been a sweeping issue in the United States. Whether it is the ominous FDA rules, or the individual state rules. Here is a current list of State rules for vaping as of July 2020.

This past year has been very tough for anyone in the vape industry. Before we saw any of the bogus “Vaping deaths” we saw legislation starting to hit the courts. The legislation began as a way to fight the “Youth Vaping Epidemic”, and combat access to flavored products.

On December 27th, the entire country enacted the T21 law. This makes any tobacco product or vape product illegal to purchase for anyone under the age of 21. As of July 2020, Youth Vaping is down by 40%.

While as many as 16 states enacted some sort of ban initially at the end of 2019, many have released their bans.

Many of the bans last year were temporary. Usually lasting 30-90 days. For some small business owners, that was long enough to close their doors forever. And some states have placed even harsher laws than their predecessors.

You may find that a few vendors still ship to these places. But they are few and far between considering the fines imposed on the shipper.

These are the current states with outstanding bans. We will continue to update this list as situations change.

New York State

New York currently has a ban enacted to ship or receive vaping products as of July 1st 2020. All liquid, and hardware is included. Beyond shipping, not point of sale contact is allowed either.

This includes the entire state. New York has been the most extreme when it comes to vaping practices, and their new law is no exception.

New Jersey

All flavored E-liquids are currently banned in New Jersey. Only sales of Tobacco flavored liquids is allowed. Currently, it IS legal to ship products there. Whether this loophole was intentional or just an oversight, it has been a blessing for many vapers that were caught off guard during the cutoff date, in the midst of a pandemic.

Many New Jersey businesses have shut their doors due to the inability to sell flavored e-liquid.

Massachusetts

While there was initially a total vape ban in the state, the newer laws allow shipping to the customer. The items must be signed for, and must be Tobacco flavor only. This includes hardware of any kind as well.

Orders must be placed by phone, and received by the same person who placed the order.

Rhode island

The state has lifted it’s original ban of all nicotine/ENDS products. Only Tobacco flavors are permitted currently. Hardware can still be shipped and purchased in state.

This is a big win compared to the original ban. However, their original ban knocked out a ton of storefront businesses.

Connecticut

The original ban on all vape related items has been lifted. Currently there is legislation on the table to re-instate the ban. Confusingly though, there is also a bill regarding a flavor ban also.

Nothing has been voted into law yet. We will keep you updated on any changes.

California

California is in a tough spot right now. San Francisco paved the way with a total ban and many counties and cities are following suit. San Francisco currently has a ban on all products. Hardware included.

The list of all places affected is simply too long to mention. There are over 200 bills being looked at across the state.

90% of E-juice manufacturers are located in California. So far, these bills and regulations have not had an impact on their ability to ship out-of-state. Many brands like Naked and Vapetasia got their start in Southern California, and still have production facilities there.

Depending on your location, you are either looking at a total ban of all vaping related devices, or a flavor ban. Please check CASAA for a full list.

Flavors Are A Big Deal

Flavored e-juices are usually much more appealing to a long-term tobacco user. When I made the switch, tobacco was the last flavor I wanted. Most vapers have a preferred flavor they enjoy that does not remind them of tobacco.

On the business side of things, flavored liquids are what turns profit for your local vape shop. Liquid is not only the best selling item in any establishment, but it is also what keeps the lights on, and employees paid.

Profits can be made on hardware and accessories, of course. The margin is much lower, though. Like we have now seen in New Jersey, vape shops cannot stay in business without e-juice sales.

This is not only an attack on the vape industry. This is an attack on small businesses as well. If you cannot sell your one product that makes profit, then why stay open?

Join CASAA

Right now, we need all of the info we can possibly get regarding our right to vape. CASAA has a fantastic mailing list, and keeps you up to date with not only your state, but the country as a whole. Legislation can happen fast (sometimes overnight). Be the first to know about any issues within your state.

Their “Calls to Action” often presents you with access to petitions and contact info for law makers.

Know your state, and know your rights.

Colorado’s Tax Bill is attempting to raise taxes on all tobacco products this Fall. Vaping could see the highest tax hike of any state if this becomes law.

Fastest Taxing In The West

Colorado voters will have a new proposition on the table this fall for voting. The bill sets aside up to 300 million dollars a year in extra revenue for the state based on their tobacco sales. The proposed 300 million would be used exclusively for Colorado’s Pre-K program in public school.

Colorado currently has the 40th lowest taxes on excise items like tobacco. This is a pretty low rate, but they make plenty of money from the surplus of Marijuana taxes.

Their reasoning behind the new taxes presents the idea that it would be harder for teens to be introduced to vaping products. Colorado is said to have one of the highest youth vaping rates.

“Placing taxes on these products is the best way of keeping these products out of the hands of kids,” said Jake Williams, executive director of Healthier Colorado. 

With a national T21 law in effect, this seems excessive. You must be 21 to even set foot into a vape shop or tobacco store, and you must have a valid ID. The T21 law was enacted solely to dissuade teen vapers, and makes them much more difficult to acquire.

New taxes on a pack of cigarettes or vaping products would range from $1.20 to $2.60, depending on which version of the ballot proposal is selected. At 84 cents a pack, With a $1.01 federal tobacco tax, the measure would bring total taxes to between $3.05 and $4.45 a pack.

This could mean a huge increase in something like Juul pods, or any type of bottled e-juice. The increase could result in up to a 30%-64% increase in price for all nicotine products.

What You Can Do

You can visit CASAA for updates to the bill, and sign a “call to Action” form. This lets you legislators know that you will not be taxed for choosing a healthier lifestyle! Let your voice be heard!

UPDATE: The bill passed unanimously. The USPS will no longer be able to ship vaping products after July, 2020.

Back in November 2019, The Senate proposed a bill under the name of S-1253. This would bill ensures a total United States Postal Service Vape Mail ban. Here is everything you need to know, including how to fight back.

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The Senate’s Vape Mail Ban

The proposed bill S-1253, first came about at the end of last year. The bill states that the USPS would be completely prohibited from accepting any form of vape mail being delivered to individual consumers. This includes liquid, hardware, and even batteries from hundreds of domestic retailers.

This will force you, as a consumer to use only private carriers. The reason for this would be age verification upon delivery. This becomes a two-fold problem. Not only do you need to be home when your products are being delivered, but this drastically bumps up the cost of shipping to you, the consumer. This could result in a few extra dollars, up to 20% of your total purchase. Prices all depend on the distance traveled, and the weight of the package.

A Cruel Blow At A Tough Time

Due to Covid-19, online vape sales are at an all time high. Many online retailers have seen a huge spike in sales since many states see vaping as a “Non-essential” business. Vape mail is at an all-time high across the country.

The bill not only has an effect on the consumer. Many websites and companies have contracts with the Postal Service, which allow them to offer special rates. This why you see so many offers for free shipping if you spend X amount of dollars with a retailer. S-1253 would cut ties with the Postal Service all together for these big websites.

This again hurts the consumer. But it also takes a toll on the United States Postal Service, whom amid the current business climate has been struggling for years. This comes as one more nail in the coffin of a struggling institution that employs over a hundred thousand American workers.

The biggest consumer blow will come to people who live in rural areas. Many vapers use online retailers almost exclusively, due to where they live. Some people have reported to CASAA that the nearest vape shop may be a 100 mile round trip, making a quick stop to the local vape shop nearly impossible. This also effects areas where public transit doesn’t exist.

Even though face-to-face transactions at a vape shop is the preferred way to end any allegations of teen vaping, for some people it is just not feasible.

Playing Devil’s Advocate

Age verification and teen vaping have been hot topics when it comes to legislation. While it’s easy to point out the flaws of this bill, it’s also easy to see a bit of sensibility. If the issue of teen vaping is such a problem, this is yet another safeguard in place as prevention.

I cannot have a prescription of a controlled substance delivered to my doorstep without requiring a signature and photo ID. While nicotine and tobacco products are not necessarily in the same realm, they still carry similar restrictions.

So while this bill may be incredibly inconvenient for many people, it also presents a more controlled environment. And perhaps a step in the right direction for legislation, and a clearer path to legality when it comes to vaping in The United States.

All of this comes at the same time as the quickly approaching PMTA guideline enforcement. Which could impose even harsher regulations on vapers throughout the United States.

What Can You Do?

CASAA.org has created a “Call to Action” regarding Bill S-1253 where you can have your voice heard by clicking here and following the directions.

The Consumer Advocates for Smoke-free Alternatives Association (CASAA) is a non-profit 501(c)(4) organization with an all-volunteer board and a grassroots membership of more than two hundred thousand individuals from all walks of life, and we are growing daily.  We are a consumer organization, not a trade association.  We are dedicated to ensuring the availability of reduced harm alternatives to smoking and to providing smokers and non-smokers alike with honest information about those alternatives so that they can make informed choices.

You can become a member of CASAA for free, buy joining their email list.

Update 6/26/2020 – Aussie PM Cancels Nicotine Import Ban!

Just a few hours ago, the news came through that the Nicotine Import Ban has been put on hold for at least 6 months.

Greg Hunt’s (Minister of Health) original campaign would have banned all importation per the Governor-General for the next year. It would have been effective as of July 1st.

Due to overwhelming amounts of phone calls, petitions, and emails, the ban has been called off for now. Over 70,000 people have voiced their opinion over just the past two days. This pressure was created not only locally in Australia, but globally! Vapers from all over the world made calls and signed petitions.

This shows just how much can be done when we band together in solidarity. But while the battle has been won, the war will continue. It’s easy to see this is an important political issue and it only buys people 6 months of time. This is a win, but more importantly, this is a wake-up call for all Aussie vapers.

Now is not the time to back off. Continue to write petitions. Keep fighting for your right to vape!

Below is our original report which was published prior to the change in law…

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Buy Now

Nicotine Importation will be illegal as of July 1st. This is a huge blow to the vape industry in Australia, but it has been in the works for quite a while. It has been a threat for at least the last 2 years but is finally coming to fruition.

Before we move on, it would behoove you to order NOW. Due to the nature of the law, you may face import fees (up to $150) if your nicotine is delivered after the 1st. There are many companies in New Zealand, currently working overtime to get orders out as soon as possible. It’s important to only order what you need, and not panic buy.

The RACGP president, Dr. Harry Nespolon has put his support behind the move, which will come into effect on 1 July and apply to all e-cigarettes containing vaporizer nicotine (nicotine liquids and salts) and nicotine-containing refills, unless on prescription from a doctor. And even by prescription, nicotine will be temporary, as it is only a means to wean you off.

Their argument is there are no long term studies on the effects of e-cigarettes and vaping in general.

When asked about the import ban, and usage of prescriptions, Dr. Nespolon is quoted saying:

‘This is not a smoking cessation aid that should be embraced by all smokers in the community, it is the last resort prescription for people who have already tried evidence-based smoking cessation options and not succeeded. I urge all people who smoke to see their GP and explore the pharmacotherapy treatments available. This includes nicotine replacement therapy in the form of a patch, spray, gum, or lozenge. There are also effective drugs available such as varenicline, which blocks the pleasure and reward response to smoking, as well as bupropion hydrochloride which reduces the urge to smoke and helps with nicotine withdrawal.”

This comes as a huge blow to vape shops, and employees. Australia already has a huge amount of legislation and this could be the final blow to the industry as a whole. America is facing a similar situation with the PMTA deadline in September.

The PMTA takes things to a whole different level, however, removing all flavored liquids and most hardware.

Most major sites in New Zealand have already cut off their shipping, the time to act is now. The current ban will be for the next 12 months and will be reviewed this time next year.

The deadline for the PMTA is quickly approaching in the United States. The date originally set for May 11th, 2020 has been pushed back to September due to the COVID pandemic. While this is good news, it doesn’t change the fact that the date continues to loom over all of our heads.

You can easily check how many people have already submitted a PMTA  through the FDA’s website. So far, the tobacco companies have sent their forms in for products like JUUL, VUSE, LOG, and MyBLU.

But what about open tank systems? What about your standard mod and tank combo? What about your favorite juice companies?

Everyone seems to have an opinion and a different outlook. Many of the rules and regulations have been rumor controlled on the internet, especially on reddit…here are the facts.

In The Beginning

Things changed forever for the vape industry in May of 2016. The FDA had spent years trying to gain control of all tobacco products, including vapes and e-cigarettes. The pressure was put on the FDA by the Democratic members of Congress. Panic ensued all over internet forums. People were scared that the government wanted to get involved in what many considered “off the map” when it came to regulations.

At the time, the vape industry was doing a pretty good job of regulating itself. Of course, the number of people who vaped regularly was half of what it is today.

The Deeming Regulations were decided upon on April 24th, 2014. The FDA proposed many rules, that seemed by design to completely wipe out the independent/small vape companies. This is where the PMTAs first get mentioned. Manufacturers would have two years to submit their applications once the regulations were passed.

The FDA then gave the public 75 days to submit comments before they settled on the final rules. This 75-day window was extended. Of all the comments, one stuck out the most.

R.J. Reynolds Sends A Message

During the comment period, R.J. Reynolds (maker of Camel Cigarettes and many other brands) in their statement, suggested that:

The FDA should ban outright so-called “open-system” vaping products (the separate components that fit together in different combinations, like bottled e-liquid, mods, atomizers, and coils).

“Unlike closed-system products,” said Reynolds, “open-system products are highly customizable. As a result, there is no way to adequately evaluate how such a product will work or to establish whether the consistency of product composition and quality can be maintained.”

August 8th, 2016

August 8th is known as “The Deeming Reg Day” in the vape industry. This is the day that the FDA released their final statement on PMTAs. The document they released was almost 60 pages long and extremely confusing for a small vape company to decipher. It seemed that our comments were mostly ignored, in favor of the tobacco industry and their testimonies.

The rules contained guidelines that forced companies to shown compatibility with other products. For instance, if you design a 510 threaded atomizer, it must be shown which devices it is compatible with. That means any product it can be attached to. As well as attachments, you must show every type of e-juice that can be vaporized in such a device. This seems to be an impossible task, by design.

Manufacturers were told to comply immediately. But even with documents explaining the process, there was not a clear path to legality. The document was confusing and left many people in the industry in disdain.

Initially, there was also a ban written into a Bill on all flavors except tobacco. While this did not pass or take effect, it was left on the table for future use. Luckily, we dodged our first bullet. But panic had already set in.

Vaping Goes To Court

Luckily, before the deeming regulations were even submitted, there was a House Bill that would grandfather in any products made before August 8th. Republican Tom Cole drafted the Bill deemed HR 2058. The Bill would save any products and devices already on the market. This Bill continued to change and remained relevant for the coming years.

Along with the Bill, many (too many to list) companies and businesses took to the courtroom. Lawsuit after lawsuit was filed in an attempt to save vaping. By January of 2018, there were hundreds of companies wrapped up in litigation. So much so, it has been hard for the FDA to even enforce their rules.

But make no mistake, by this point everything on the market was officially illegal to sell. Vape shops and companies continued business and the FDA did not yet enforce the regulations. To this day, everything on the market is “technically” illegal in The United States. Nothing is FDA approved. Like the past though, the industry seems to continually regulate itself.

Hope From The FDA

Immediately after his election win, President Trump appointed many people to form his core team. One of those people was Scott Gotlieb. A medical doctor, who took over as the head of the FDA. Gotlieb had been involved with the FDA for years. Being a doctor he had a strict policy to rid the United States of smoking, and other tobacco use.

“We need to redouble efforts to help more smokers become tobacco-free,” said the new commissioner. “And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether. At all times, we must protect kids from the dangers of tobacco use.”

Gotlieb’s first order of business was to reduce nicotine in cigarettes. With that in mind, he mentioned during several speeches that his plan would include e-cigarettes for people that cannot quit using any other method. His next order of business was to postpone The Deeming Regulations until August 2022. He wanted to allow time for technology to improve in the e-cigarette realm, to eventually phase out traditional tobacco products.

By this point, vaping had seen a 45% increase since 2016.

Youth Vaping Sweeps The Media

Flavors had always been a point of contention when dealing with the FDA. Their argument is that flavors attract children to vaping, and create new addicts in the process. During late 2018 until December 2019 many advocacy groups started bombarding the FDA in regards to youth vaping. The Truth Movement almost immediately began campaigning for the total banning of vaping. Where their original focus was on teen smoking, vaping suddenly took the forefront.

These groups needed a scapegoat, and Juul Labs was immediately targeted. Juul was known for having a high content of nicotine.

What Is A PMTA?

PMTA is the abbreviation for “Pre-Market Tobacco Application”. Every product must be independently tested, and then reach the application stage. Once the product has been applied for, the FDA gives the manufacturer a grace period of one year.

Regulations require a PMTA for each of the following:

• Each Flavor
• Each nicotine strength
• PG/VG mixtures
• E-Hookahs
• Dry Herb personal vaporizers
• Any Pre-filled pods
• Batteries and power sources
• Packaging compliant with FDA guidelines
• Components and parts
• Mods, coils, and tanks