How The FDA Vape Regulations Affect You

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If you’ve been confused by the headlines lately regarding recent FDA vape regulations, you’re not alone.

They are confusing and complicated.

 

Currently, the legal jargon is unclear. So we broke apart the FDA’s language to let you know how the FDA vape regulations will affect consumers, in plain english.

 

Here’s the overview of the FDA Vape Regulations situation:

In May, the FDA passed sweeping regulations that may eventually have an impact on the e-cigarette and vaping world. If you use vaporizers,  e-cigars or e-liquid, these regulations will have a significant impact on the products you love and the way you vape.

This article will give you an outline of the “what’s what” with proposed regulations and let you know what you can do.

ENDS – The new term in Vaping

The FDA is clarifying the products that fall under the act as ENDS: Electronic Nicotine Delivery Systems.

For a full report and classification of the proposed FDA regulations, please visit:

 The FDA ENDS overview.

It is surprisingly easy to read and geared toward manufacturers rather than the public. 

 

How FDA Vape rules affect you

 

Big Increases in Price

While it is not exactly certain how much prices will go up, it is guaranteed that an increase will occur. The FDA vape regulations will require that vaping companies submit an application to the FDA in order to sell existing products. This is called “retroactive approval.”

  • Expensive FDA approvals

This process is incredibly expensive for companies and requires that put in enormous amounts of research in order to obtain the retroactive approval. You, the consumer, will be forced to pay more to account for these additional costs and pay more for both e-liquids and vaporizers.

  • New Packaging

The FDA also states that the packaging of products must be changed: “The product packages and advertisements of all newly-regulated covered tobacco products must bear the following statement: ‘WARNING: This product contains nicotine. Nicotine is an addictive chemical.’”

With these new regulations, companies will be forced to design new product packaging and change their existing packaging.

This additional cost on top of the costs associated with new research will result in you paying more for products.

 

Less Device and Flavor Options

Testing is expensive and the new FDA regulations will require extensive testing for each product. Product testing will be required for each flavor, nicotine level, PG/VG mix varieties and vaporizer products.

Your available options will decrease. You will see less interesting and experimental flavors and some of your favorites may disappear.

Instead of having thousands of options to choose from, the most popular, highest selling flavors will  prevail.

Imagine spending a year in Italy tasting the most exquisite gelato flavors and then going to the ice-cream aisle in your hometown and only having the choice of Vanilla or Chocolate!

Less choice of companies

Smaller, niche companies will not be able to afford FDA testing. This means many companies will be forced out of the market, leaving only the giants (read: Big Tobacco brands) to remain.

 

A Black Market May Arise

 As with anything that the government begins to regulate, a black market may form. If some of the most beloved small companies are forced to close shop, people may begin selling e-liquid under the table and through illegal means.

While the United States will be enforcing these regulations, other countries still have the option of creating e-liquids and vaporizers.

The new act does state, “tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act.” It will be illegal to import products that do not comply with the current act.

As with anything that gets banned by the federal government, people will find ways around the law. These regulations could result in more crime and less safe products.

 

The Vape Industry and the FDA Vape Regulations

     

While the FDA has claimed that they put these regulations in place to reduce the number of deaths attributed to tobacco, they have failed to mention the fact that the regulations will decimate many companies in the e-cigarette industry.

Dr. Michael Siegel, a professor in the Department of Community Health Sciences at the Boston University School of Public Health, created a detailed analysis that covers many of the aspects of the new FDA vape regulations. He believes these new changes “will decimate the e-cigarette industry.”

“The regulations will make it all but impossible for anything but the largest companies to survive,” said Siegel in his analysis.

The regulations will require that all products currently on the market be retroactively approved by the FDA as tobacco products. Companies that manufacture these products will be forced to conduct millions of dollars worth of research to keep their products on the market. He stated,

 

These regulations are absolutely insane. The FDA has no idea what it is doing. And what the FDA is doing is losing perspective.

-Dr. Micheal Siegel

The Fight Back.

       

The FDA has drawn an enormous amount of criticism from consumers and businesses alike. A few companies have filed lawsuits against the FDA with the hopes of crushing these new regulations. Lost Art Liquids, a company that creates and sells e-liquids for vaporizers, was one of the first to file such a lawsuit.

“The FDA has introduced one of the most burdensome, misguided, and harmful regulations in its history without adequately sound science, or adhering to required, legal procedures. These regulations will harm the business… and customers by eliminating vapor products from the market, forcing consumers to resort to more harmful products like cigarettes and cigars,” said Ryan Thomas, the co-founder, and COO of Lost Art Liquids. 

 Thomas believes that the FDA is violating essential first amendment rights. He argues that these products should not be viewed as tobacco products, but rather as technology products that have the potential to reduce the harm caused by smoking.

Vaping companies are not the only ones that have complained and risen against the FDA.

Global Premium Cigars LLC, makers of the 1502 cigar brand, have also filed a lawsuit against the FDA. They believe that the new regulations violate essential Fifth Amendment due process rights. While it may seem strange to consider,  tobacco companies could help the vaping world if they can help to scale back some of the new regulations.  

 

What You Can Do To Help.

     

 If you’re concerned about the FDA’s new regulations and see the potential harm that they could cause, there are ways for you to contribute to the cause. One of the simplest and easiest things you can do is to join a consumer advocacy group.

CASAA, the Consumer Advocates for Smokefree Alternatives Association, is one of the largest groups advocating for vaporizers. You can join their organization here for free and get updates about the FDA vape regulations and find out ways to help.

Another way to take action is to support HR2058. This is a bill that will allow for modern vaping products to not be forced to undergo retroactive approval. CASAA has created a call to action that gives users a pre-written letter to send to their state representatives. Find it here. 

If you’re feeling passionate, call your state representative. Tell them how vaping has helped you quit smoking or benefited your life. Your voice matters. Use it and you can make a difference.

As the fight for these FDA vape regulations wages forth, the future of the vaping world will be determined.

We will keep you updated as more changes take place.

 

FDA infographics

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5 Comments

  • Reply August 2, 2016

    Jeremy

    BRING ON THE BLACK MARKET!!!

  • Reply August 5, 2016

    James Yeo

    THANKS NINJAS FOR “HOW THE FDA REGULATIONS AFFECT YOU”, A USEFUL CLARIFICATION OF A VEXED AND COMPLEX MATTER.

    THE ITEM COULD BE IMPROVED BY A SMALL ADJUSTMENT. THE ILLUSTRATED SUMMARY AT THE END OF “HOW THE FDA REGULATIONS AFFECT YOU” CONTAINS EITHER A TYPO OR A NON SEQUITUR IN THE TEXT ACCOMPANYING THE PIC FOR “You’ll have less options in both devices and flavors”.

    WILL FOLLOW THE PROGRESS OF THIS REGRESSIVE LEGISLATION WITH INTEREST AND ANXIETY.

  • Reply September 20, 2016

    Claire Cox

    E-cigarettes are not risk-free, but research by Public Health England has estimated they are at least 95 percent safer than traditional tobacco cigarettes. They’ve already proven an effective tool for many smokers seeking to quit, and their broader use has tremendous potential to improve public health. This new FDA vaping regulations will harm public health.

  • Reply December 4, 2016

    Alex Bratton

    Thank you for such a well written post. It’s full of insightful information and entertaining descriptions. Your point of view is the best among many.

    • Reply April 28, 2017

      Marylouise

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