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How New FDA ENDS Regulations Will Be Affecting Vaping Business Owners

The new FDA regulations (dealing with “vaping products”), may close one door, but also may open up another for new business owners.

Before we get to all that, let’s take a look at exactly what the regulations are and what they mean.

What are these FDA ENDS regulations

The U.S. Food and Drug Administration, or FDA, has long been a source of contention for both the tobacco industry and the vaping industry. Until recently, the vaping industry operated at the fringes of FDA regulations, not really included in the sanctions or the safety checks required by the government department. Due to the fact that e-cigarettes and vapes sometimes use nicotine but do not necessarily have to, many vaping companies were able to bypass the FDA entirely. Tensions came to a head with the most recent set of FDA laws and rules, where the FDA passed a sweeping set of regulations on vaping products.
The FDA brought all vaping products under the umbrella term “ENDS”. ENDS stands for Electronic Nicotine Delivery System and includes vaporizers, vape pens, hookah pens, e-cigarettes, and e-pipes. In doing so, they either intentionally or unintentionally brought all vape shops under the same regulation status as tobacco shops. This means that the FDA now can regulate every aspect of the vaping industry, from the manufacture of devices and e-liquids to advertising and promotion of various good related to vaping. Everything from e-liquids and drip tips to flavoring compounds, and even software are all under the strict gaze of the FDA.

How this affects current businesses

So what does this mean for vaping businesses? The imposing of FDA sanctions on ENDS means much stricter laws will be in place for every single business in the industry. Vape shops that create, modify, mix, or prepare e-liquids that contain nicotine are considered tobacco product manufacturers and must comply with the FDA’s manufacturer laws under fear of getting shut down. For advertisers, the regulations mean that all ads must prominently display a health warning. It also means that all packaging, big or small, must also have a health warning statement in clear sight. Device and e-liquid sellers can no longer legally give away free samples of any component related to vaping. E-cigarettes and related ENDS devices cannot be sold to customers under the age of 18, and photo identification must be provided if buyers are under the age of 27.

Some of the regulations are understandable. High school students in the United States drastically increased their e-cigarette usage in the past four years, and the government fears that this increase will lead to and an increased rate of traditional cigarette smoking. However, many of the rules give little or no leeway to sellers and manufacturers. Since the cost of creating and selling e-liquids was so low, the vaping industry was able to boom. Now that the same regulations the tobacco industry has been able to evolve with for decades are being placed on the fledgling vaping industry, many shop owners will find it hard to cope. Fines will be doled out, and store shutdowns will become commonplace.

I talked to two small business owners in the industry; Nick and Daniel, and asked them their thoughts, and how they would be affected.

Nick (better known as Grimm Green) is not only big into vaping and the community surrounding it, but also has an e-juice company as well. Here is what he had to say:

“The FDA is attempting a full blown vapor prohibition through regulation.  The only companies in the market that could afford these  incredibly expensive PMTA applications ( which all companies will be forced to submit if they want to stay in business ) is big tobacco companies.   I’ve run pretty successful liquid company since 2012.  We have all sorts of QC procedures in place.  We manufacture our liquids in an ISO and AEMSA certified lab.  We practice GMP’s and all out bottles are certified child resistant.  

If we want to stay in business past 2018,  it will cost us millions upon millions of dollars to apply to be a “new tobacco product”  even though there is absolutely zero tobacco in our products.  With no guarantee that we would even get approved.  reasonable regulations are completely understandable.  Obviously we want to have the safest product possible, and abide by things like social and economic transparency.   What the FDA is requiring us to do is absurd in the most true sense of the word.  

The RCP in the UK recently said that vaping is at least 95% safer for you than cigarettes.  They are encouraging their use to smokers as a form of harm reduction.  Yet in the US were treating the very non-lethal drug Nicotine as if it were worse than heroin.  Vaping saves lives, and I’m hoping that the FDA will wake up and stop over-reaching their authority to vapor products.”  

Daniel is the owner of Vape Craft Inc, and these are his thoughts:

“With the way the current FDA regulations are worded, Vape Craft Inc., as it stands today will no longer be able to manufacture its own products. We have over 120 different skus of products here and we simply don’t have the 2-3 million dollars to submit an application per sku. And this is just an application! It doesn’t even guarantee your product will be approved on the market. This will literally destroy 95% of the companies on the market that produce their own e-juice or electronic cigarette products and only further empower big pharmaceutical companies and big tobacco.

I can only hope that the law is changed and it allows smaller manufactures like ourselves to be able to continue in this industry and continue to help people find an alternative to smoking.”

So what’s next?

While some may view the FDA laws as logical and sound, vaping stores and business probably do not. The laws may usher in a new era of DIY vaping, but only time will tell.

If you’d like to help and have your voice heard there is a petition you can sign here.

As of now, making your own e-juice has only been a hobby for a select few, but the community of DIY juice makers is growing every day. They even have their own subreddit, DIY_eJuice, with over 27,000 subscribers.

The FDA rules cannot be imposed on individuals unless they are selling their e-liquids in large quantities. Furthermore, vaping has traditionally instilled a sense of engineering ingenuity and do-it-yourself characteristic traits. Coil building, modifying devices, and more tweaking are integral parts of the vaping lifestyle. These will carry over into a craft beer-esque vaping world, where certain areas could become homes for custom vape building and e-liquid flavoring.

With a new wave of people looking to make their own juice, there will surely be a need for someone to supply them with the proper tools, information, and ingredients.

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