FDA Vaping Regulations: A Cloud Chasing Duel

May. 31, 2017
by Vaping Guru

Given the fact how many burning issues our society is facing, it is rather interesting to see how lawmakers are efficient in voting out laws regarding e-cigarettes. Some might think, shouldn’t a thing like this, with all the ongoing crises and political turbulences, be at the end of government’s’ agenda? However, the growing popularity of e-cigs was followed by equally growing numbers of laws, bans, and regulations initiated by the U.S. Food and Drug Administration, the FDA.

FDA and Vaping Regulations

2009: between courtrooms and the White House

The FDA is coming down hard on e-cigarettes since their initial import to the territory of the USA in 2006/7. Just two years after that, the FDA directed the U.S. Customs and Border Protection to reject the entry of e-cigarettes into the US. The rejection was based on the fact that the FDA first characterized them as drug delivery devices.

This sparked a controversy and even a lawsuit against the FDA. Company “Smoking Everywhere”, whose delivery was rejected, aimed to, well, just point to the FDA that by their previous doings e-cigarettes rather fit under a tobacco product, and by no means under a drug delivery product. While e-cigs are not smoking cessation products, an interesting comparison with other products can be found here.

The fuss made it even into the Oval Office, with President Obama signing the law Family Smoking Prevention and Tobacco Control Act. With this Act, Obama gave power to the FDA over the tobacco industry. With such power in its hands, the FDA still sharply defended the opinion that e-cigs are drug delivery products. Even though carcinogens found in e-cigs were similar to those found in the FDA-approved nicotine cessation products, and that the amount of diethylene glycol found was not toxic, the FDA did not seem to change its mind.

First legislation banning indoor usage of e-cigs in areas where smoking is also prohibited soon followed. Suffolk County, NY, laid foundations as a pioneer in e-cig bans that are yet to come.

2012: E-cigs are not drugs, finally!

In 2010, the FDA found itself between two fires. American Medical Association desperately urged FDA to keep the e-cigs as drug delivery products, while the court had a different order. From now on, the FDA can regulate e-cigs as a tobacco product only. Relieved, vapers organized their first vape fest, both in the UK and the USA. In the next couple of years, many vapers around the world gathered to peacefully promote vaping as a healthier alternative to smoking. UK researchers dived deeper into researching possibilities of e-cigarettes as a tool of tobacco reduction and prevention. In 2012, World’s first Vaping Day took place!

2016 and beyond

Come 2016, the FDA finalized a rule extending its regulatory authority to cover all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes, e-pipes, and all other Electronic Nicotine Delivery Systems (ENDS). The FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS but excludes accessories.

This means that all manufacturers, importers, retailers and distributors have to oblige to specific laws concerning vaping.

Manufacture regulations

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, re-label, or import tobacco in any form, then you are considered a tobacco product manufacturer, according to the FDA. In addition to regular registering of the business, the FDA prepared a plethora of, as it seems discouraging compliances for e-cigs manufacturers.

As of 2016, and up to 2019, all manufacturers will have to submit ingredient listing, include required warning statements, and submit quantities of harmful and potentially harmful constituents.

Retail regulations

As of e-cigarettes selling, retailers of these devices have to oblige to the same rules as other retailers of tobacco and nicotine related products. No underage sales or distribution, no promotion, and even that – only with health warning statement. Once again, the question is, if the same warnings are put on all products, how people, especially youth, will know what choice to make? As of quitters, such statements might lead them to thinking that smoking regular cigarettes is the same as smoking e-cigs, so why quit anyway? From 2018, the product packages and advertisements of all newly-regulated tobacco products must bear the following warning statement:

“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

If the product does not contain nicotine, then an alternate statement must be used on product packages and advertisements:

“This product is made from tobacco.”

A concerning fact is that some e-cigarette based products and related merchandise do not contain any of these; so, the question is how these statements will be placed on them.

Import regulations

For those that mix e-juices and modify vaporizers with the purpose of selling them, fun does not stop here. Those will have to oblige to rules applying both to manufacturers and retailers! As of importing the e-cigarettes, you will have to read just hundred-something instructional pages before you even dive into this business. Imported merchandise will be subject to dozens of laws and acts, some of them even decades old.

Through all of these, the FDA of course aims to regulate the main action regarding e-cigs, which is their consumption. By defining laws concerning production, import, sales and distribution, the FDA actually maintains the usage of e-cigarettes.

Same law, different things

For the FDA, what seems important is to get rid of smoking in general, by all possible means. However, it seems that the FDA, especially after equalizing all tobacco products and subjecting them to the same laws, makes little, if at all, effort in differing these products.

While consuming both cigarettes and e-cigarettes is essentially the act of “smoking”, e-cigarettes still have potential in battle against tobacco. This potential should be approached with curiosity and belief, like in the case of the UK. In the USA, it seems that, despite everything that is going on there, e-cigarettes are seen as a freaky clown from horror movies chasing kids down the streets. That is one of the reasons why vaping culture is growing stronger, and its communities bigger. Thanks to vaping, many are now ex-smokers, and are urging public to realize benefits and potentials of vaping over smoking, like in this case. See the difference? Vaping. Not smoking.

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