Understanding FDA Vapor Regulations and Vaping Advocacy

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The vaping industry has endured its fair share of controversies over the last few years. From bad science and scare-mongering news headlines to strict laws placing vaping under the same category as smoking, it’s no wonder why vapers have felt the need to step up and begin educating smokers and non-vapers; hence, the creation of vaping advocacy groups.

The Fight Against FDA Vaping Regulations

From massive vaping advocacy groups such as the Consumers Advocates for Smoke-Free Alternatives Association (CASAA) and the Smoke Free Alternatives Trade Association (SFATA) to state level advocacy groups such as the Tennessee Smoke Free Association, there are several groups working to promote vaping awareness while battling unfair regulations.

During our DeMISTified Webinar Series, we spoke with a couple of head members from these groups who provided some important insights into what vapers can do to join the fight against the FDA’s Deeming Regulations. Below you will find questions surrounding vaping advocacy with answers from the industry experts.

What more can we do beyond writing and calling Congress?

There are multiple ways to join the fight against the FDA’s Deeming Regulations. It’s important to note that the regulations will never completely disappear. They can, however, be altered.

↓ Watch the video explanation here ↓

“So I think that what everyone can do, who is concerned about this, is to write, call, or email their Congress members, especially in the House of Representatives right now, and let them know that this is going to lead many people back to smoking and that, for the interest of public health, we’re asking them to prevent the FDA from taking this action.” – Dr. Michael Siegel

To show your support for vaping advocacy in the fight against overly strict regulations, consider the following:

As Cynthia Cabrera said in our webinar series, “We need to educate, not intimidate, not threat, not insult,” when it comes to non-vapers.

↓ Watch the video explanation here ↓

share on twitterClick to tweet: “We need to educate, not intimidate, not threat, not insult.” @cyncab http://bit.ly/FDARegs #FDADeeming #ECigs #Vaping #VapeNation

Besides supporting advocacy groups, what should business owners be doing to help with advocacy efforts?

Business owners have a vested financial interest in a thriving vapor industry—an interest politicians in their areas also share. Creating jobs and stimulating the economy are as important to politicians as to entrepreneurs; thus, it’s important to educate politicians of the negative economic impact of overly burdensome regulations. Senator Ron Johnson is a great example of one of the many political leaders in support of vaping who are stepping up to protect the industry.

↓ Watch the video explanation here ↓

“Book meetings, don’t just send emails, book meetings. Meet with them face to face. Sit down, express your concerns, express what these regulations would do to your business, to your employees, and have them understand tobacco harm reduction.” – Dimitris Agrafiotis

How difficult is it to start a state level advocacy group like Smoke Free Tennessee and what steps does it take?

State level politics are no less important than the Federal level, and they are an important layer of advocacy that should not be ignored. Starting a state level advocacy group is not without its challenges, but it may be easier than you imagine.

↓ Watch the video explanation here ↓

“It’s extremely difficult for a small shop to reach directly into a national organization, so my goal was to form an association that the shops can turn to for help locally. The organization can turn to a federal group such as the VTA (because the Tennessee Smoke Free Association is a member of the VTA) when we need federal guidance and we can help each other in the state.” – Dimitris Agrafiotis

How does the FDA plan on enforcing these new regulations?

If you do not take steps to comply with the FDA’s Deeming Regulations, you will first receive a warning letter from the FDA, (here’s an example), then the No-Tobacco Sale Orders or Civil Money Penalties, and finally judicial actions will occur, including injunctions or even criminal prosecution.

The FDA has released extended compliance dates for some rules, such as the packaging requirements, and is taking into account that some changes will take longer than others.

↓ Watch the video explanation here ↓

“Essentially, they have abandoned their mission, which is to regulate tobacco products and they’re turning it into a single-handed focused crusade on vaping products.” – Dr. Michael Siegel

share on twitterClick to tweet: Not going to comply with #FDADeeming? Find out what happens: http://bit.ly/FDARegs #ECigs #Vaping #VapeNation

Will any of the pending lawsuits put the regulations on hold?

Lawsuits challenging FDA Deeming Regulations have the potential to delay certain parts of the regulations; however, this process could take months, years, or even decades to obtain an end decision.

↓ Watch the video explanation here ↓

“Litigation only stops things if it’s an injunction. The cases, the two that have been filed so far, are not injunctions. So things are just gonna continue as planned.” – Cynthia Cabrera

What would it take to get an injunction?

We suggest you seek out an attorney for advice. Cynthia Cabrera goes into great detail in our webinar video below.

↓ Watch the video explanation here ↓

“Courts tend to side with the FDA, so already we’ve got that working against us.” – Cynthia Cabrera

Has the release of the federal regulations slowed the state level legislation?

No, in some cases it has increased the visibility to states. Let’s take a look at California, for example: they are leading the charge in not selling to minors by increasing tobacco purchasing age to 21, increasing delivery restrictions and photo identification rules, and are pushing towards banning vaping in public parks and beaches.

Then we have Utah, where online e-cig orders are banned; then New Jersey, where legislators are attempting to ban flavors. Other states have been looking into implementing or increasing taxation, such as Pennsylvania’s massive tax on vapor products

Vaping has been an issue that has long been put on the backburner, and the states are happy to jump on board.

↓ Watch the video explanation here ↓

“We’ve got challenges at the federal level, at the state level, sometimes at the local level and it’s just never ending. It’s absolutely exhausting. Yeah, we’ve got a lot of work to do.” – Cynthia Cabrera

What do you attribute to the different views of England and the U.S.?

Dr. Siegel does a great job explaining the differences between the two forms of public health in our webinar. Watch the video below for a snapshot overview.

↓ Watch the video explanation here ↓

“I think that one difference is that, what they have in England that we don’t have here is have public health groups that are embracing harm reduction.” – Dr. Michael Siegel

Related: Regulating Vapor Products: A Tale of Two Views

What will happen next?

Based on the direction of the FDA and news stories, we predict that we’ll start to see a push for flavor bans, requirements for ingredients to be listed on the products, and even more tax hikes on e-cigs. We have been waiting for this industry to become regulated for quite some time now. Unfortunately, the regulations failed to address some of the major concerns plaguing the vaping industry. For instance, the FDA deeming regulations did not address the risk of exploding e-cig batteries, nor did they specify a set temperature for e-liquids to prevent the release of carcinogens due to overheating.

As most pro-vaping tobacco control experts predicted, the FDA is already experiencing issues in keeping up with enforcing the regulations. As a result of their website crashing while vape companies were attempting to register their products by the December 31, 2016 deadline, the FDA has extended the registration deadline to June 30, 2017 for all vaping companies who were already manufacturing their products prior to August 8, 2016, when the regulations officially took effect.

Additionally, some other changes to the regulations have already been made, including the withdrawal of a direct final rule outlining when the FDA would be entitled to deny PMTAs. According to the FDA, a revision of the rule was made “due to some significant adverse comments received”; thus, it is quite possible we may see some other changes to the regulations within the next few years.

Back To Understanding FDA Regulations Guide

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