The Pros and Cons of the FDA’s Ruling on E-cigs

The Pros and Cons of the FDA’s Ruling on E-cigs

The United States’ Food and Drugs Association (FDA), has this week passed a ruling that will bring e-cigarettes, cigars and hookah under the same federal rule that conventional cigarettes and smokeless tobacco are already subject to. According to Harold Wimmer, the president and CEO of the association, the new rules will allow the FDA to have the “basic authority to make science-based decisions that will protect our nation’s youth and the public health from all tobacco products, including e-cigarettes, cigars and hookah.”

This monumental move has been met with a mixed reception. So what does it mean for the industry? How will it effect smokers? And is this a step in the right direction?

One problem with e-cigarettes is that the market is currently completely unregulated. This means that manufacturers of e-liquids have no mandate to label the products as dangerous, use certain ‘safe’ ingredients, or even include their ingredients on the packaging. In fact the free-reign with which companies currently operate has lead to the market being dubbed the “Wild West” on more than a few occasions. This obviously leads many parents, health professionals and e-cig users to worry that the vapour being inhaled may contain harmful toxins that we are not being told about, and these worries are not unfounded. 

One of the benefits of the FDA’s latest ruling is that it looks set to try to iron out these issues. It states that every single product that made it to the market after 2007, and indeed any new products that are currently being created, must be tested and certified by them before being sold to the public. A tighter regulated market, with tested and certified products, cannot possibly be seen as a bad thing for the nation’s health and this move has been met with a relatively warm reception. The president of the American Cancer Society Cancer Action Network, Chris Hansen, showed his support, stating that the current danger lies in the fact that “There are thousands of [unregulated] products on the market” and he believes that “This important final regulation puts several strong provisions in place that will serve to protect the public health and rein in a unscrupulous industry”.

The FDA’s ruling will also see the introduction of an age limit for those looking to buy e-cig products, where currently there isn’t one. This aims to tackle another of the main issues with the current setup, as health professionals become increasingly worried about the rapid growth in ‘vaping’ amongst the youth of the country. The Centres for Disease Control and Prevention (CDC) recently found that e-cigarette use among teenagers has tripled in only one year. This is a troubling statistic and it was only a matter of time before age restrictions were implemented. 

So with several clear health benefits coming from the new ruling, how do those that make up the burgeoning industry feel about the new, tighter regulations? Well, not everyone is happy. One of the main reasons behind this lies in the sheer expense of of getting a product regulated and on to the market. The FDA has estimated that the cost of doing this, for each individual product, will range between $390,000 and $759,000, and each submission will take around 209 days to process. Bearing in mind that there are thousands of different types of e-liquids, each with their own strength and range of flavours, companies will be faced with a huge bill should they want to get even a small portion of their products on to the shelves. 

The Smoke Free Alternatives Trade Association (SFATA) believe that these costs will put as much as 99 percent of the industry out of business. Frank Blankenship, the founding member of the SFATA Texas chapter stated that “There’s not one [E-cig] shop in the US that will be able to afford to go through the process. Even if they could, there’s no guarantee that the FDA will approve it.” This statement has been backed up by many other business owners, and ‘vape activists’, across the country, with many arguing that the new regulatory system will end up depriving the country of a healthier, smoke-free alternative to smoking tobacco, and even lead many people back to cigarette smoking.
Ray Story, the founder and CEO of the Tobacco Vapor Electronic Cigarette Association, took this stance when labelled the ruling as a “complete disaster”. He seemed to acknowledge that some of the rules being put into place are necessary when he said “No children should have access to these products. Just like alcohol, these are adult products”, however his overall opinion that the ruling was simply brought in as a way for the American government and corporations to ensure that they are cashing in on the industry, was apparent when he stated: “When you see everyone switching back to conventional tobacco, the pharmaceutical industry will be happy, since they will now have an endless supply of new customers.”

The new rules and regulations that have been put into place clearly have their benefits, however if you take a look at the whole picture, they could also destroy an industry that, for the most part, is looking to help those suffering from an unhealthy and life threatening addiction. The move to improve the nation’s health through a tighter regulated market is one that is hard to argue against, however the overall impact that it could have on the industry seems counter intuitive. But what are the other options?

One would humbly suggest that tight regulations, such as age restrictions and the requirement to include ingredients and health warnings on the packaging of e-cigarettes, are essential for the industry to move forward and be trusted by those around the country, however a certified list of ingredients that can be used in the products would perhaps be a better way of ensuring safety without companies having to go through the actual process of certifying each product individually. This would allow small businesses to continue to sell e-cig products without the inordinate costs that the new system seems to impose. They would simply have to adhere to the ‘legal’ ingredients list, and if caught breaking rules they would of course face punishment. 

Many companies across the United States are likely to file lawsuits in the coming weeks in a bid to oppose the new laws and we must hope that a fuller and more involved discussion on the options available takes place during these cases. The nation’s health is clearly the most important factor here and we must be sure that we don’t further damage it by being too tough on those that are creating tobacco alternatives that seek to improve it. 

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