What Do The New FDA Rules Mean For Vaping?

August 8th marks the beginning of a two-year countdown to FDA prohibition of 99.9%+ of vapor products on the market. Unless we are successful in getting Congress to force the FDA to change their arbitrary date of February 15, 2007, the vapor industry will shrink to almost nothing beginning August 8, 2018.

No longer are we vapers operating in a pseudo Wild West without regulation and rules. It is now August 8th and the end of vaping as we know it. From now on, there will be far less innovation going on in the world of vaping… at least from companies here in the US. And hopefully, this will just be a hurdle that some will be able to jump over and start moving us forward once again.

In the past decade, vaping has become a phenomenon throughout the global stage. We are getting order inquiries from all over the planet – South Africa, Turkey, China, Cairo to name a few. Vaping has saved countless lives, with some studies proclaiming that millions of lives have been helped through the use of vaping to help them quit smoking. And yet, the morality police have been hounding vaping since the beginning. They have turned the narrative from “Vaping helps smokers quit” to try and insinuate teens are getting hooked on nicotine because of us (which the research does NOT support).

Due to the machinations and smear campaign by those who are anti-nicotine regardless of what the research states (whether ideological or due to concerns of profit loss by Big Tobacco), The USA is rolling out regulations that are more heavy-handed and oppressive than even Europe’s treatment of vape products.

But there are reasons to be cheerful. These regulations could have come out two years ago when they were first proposed. Instead, the intervening years have seen vast improvements in products available to vapers, and many of these products will be available for the next two years at least.

If we, that is vapers and congressmen and women who support us, are unable to get the FDA to change its rules and intervene, these are the regulations that will come to pass:

First off, the Food & Drug Administration (FDA) will consider vapor products to be “tobacco products” under the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act). This is what allows the FDA to issue the following regulations legally.

August 8th – Effective Date of FDA Authority over Electronic Nicotine Delivery Systems

Newly deemed “tobacco products,” including Electronic Nicotine Delivery Systems
(ENDS), become subject to FDA authority.

This is what starts all of this into motion, the FDA giving the FDA the authority to rule on vaping products, ejuice, and supplies.

Sale to Minors Banned

Sale prohibited to anyone under 18 years of age (or older if state law requires).
Retailers must see photo ID of anyone who appears 26 or under.

Most states already have sales to minors banned, but the photo ID of anyone who is younger than 26 is new. It will make things harder for online companies to process sales as they will need to have a comprehensive age verification system due to a simple checkbox will not cut it.

Product Adulteration

All manufacturers must operate their facilities in a sanitary manner such that no
products are manufactured or shipped that are contaminated in a manner that
might injure the public health beyond the risks that may be inherent in the
product.

This means that shops will no longer be able to help with coil building or troubleshoot issues with mods. They can show you what to do on their products, but they cannot do it for you. Youtube is already full of videos showing how to build coils, how to fix mod problems, and more so that is where I would head now that in-person help is no longer legal.

This also means that the ability to head down to a local vape shop to test out different flavors before you make a decision is no longer legal. Shops have to charge for this, if they are going to continue to offer it, and that charge cannot be subtracted on any sales that day. From listening to the FDA Q&A panels, it seems that a $1 charge for sample testing would be allowed, while less than a $1 will more than likely get the store into hot water with the FDA.

Modified Risk Claims

Companies may not make any advertising claims or other public statements
directed to consumers that their product may have less risk, be less harmful, have
fewer or no additives as compared to other tobacco products prohibited.
Prohibition on use of “light,” “low”, “mild” or similar descriptors.

Meaning, vape stores and companies cannot even state facts from scientific studies on the harm reduction of vaping which will tax the ability to convert current smokers towards vaping in order to save their lives and the lives of those around them. Clearly, the FDA cares about our health. *eyeroll*

New Products

No new products can be introduced until FDA has issued a marketing order
authorizing sale based on an SE or PMTA.

No new mods. No new ejuice. No new flavors. No new coils. No new tanks. No new ANYTHING related to the vape industry. If it wasn’t for sale and a current product today, it cannot go on sale after today. This is not to say that we still won’t see innovation and new products from overseas, as we will, but nothing done here in the USA.

Misbranding

FDA will begin enforcement on false or misleading labeling and advertising.

This means that mods and ejuice and everything will have to contain warnings similar to analog cigarettes.

Vending Machines

Vending machines are prohibited except in facility where retailer ensures that no
one under 18 (or higher legal age) is present or permitted to enter at any time.

Speaks for itself: Can’t have vending machines that contain vape products anywhere that someone under 18 could every possibly go or be allowed to go.
By December 31, anyone who imports vaping products, who makes eliquid domestically, or who brings products to market in the United States needs to register as a tobacco manufacturer.

Feburary of 2017 is when domestic manufacturers will be forced to list their products and all constituents with the FDA. For liquid manufacturers, this will be a major issue as many in the ejuice business use “flavoring houses” for their products, and some of these businesses may very well refuse to disclose the ingredients of their clients for all to see. There is a system for maintaining the trade secrets flavor makers are trying to protect and many of the flavor houses have promised to go down this route.

Even so, it’s completely unknown how many, and therefore how many eliquid brands will be unable to comply. Non-compliance will mean no more sale.

After that, vape businesses have 18 months then to file a PMTA. If no PMTA is filed, then products will have to come off the market on 8/8/2018. I would imagine that a few handful of companies will attempt this, some may even consider combining their businesses in order to get the capital necessary. But I have a feeling that the vast majority will simply be unable to pay for the PMTA and close shop.

 

These rules and regulations are in the process of being challenged by vape companies, congressmen and women, even producers of nicotine that do not originate through tobacco. So don’t dispair vapers. We are still fighting the good fight over here! And please, realize that it is going to be hard on vape businesses, both those online and those with physical retail locations, as they have to explain the rules to customers and why they can no longer help them as they used to. Or why they cannot sell them certain products like they used to (especially in-house custom juice). This is beyond their control and everyone needs to be understanding of that nor just for themselves, but towards the customers who are new to vaping or are unaware of these FDA regulations. Remind them that there is already an amendment to the Agricultural Appropriations bill, sponsored by House Representatives Tom Cole and Sanford Bishop, could move the predicate date from February 15, 2007, meaning that everything sold up to today would still remain available for purchase and sale.

 

And the regulations put into place today is not the end. It is just the start of the regulations that the FDA will be pushing unless we can stop them. Contact your Congressional representatives. Spread the message through social media. Let people know that we will not go back to using analog cigarettes.