A flurry of new tobacco rules reveals an aggressive new chapter for the FDA

The last few months have seen a whirlwind of attacks on tobacco users. From an April proposal to ban the popular menthol cigarette flavor and prohibit all cigar flavors other than traditional tobacco to a plan to eliminate nearly all nicotine in conventional cigarettes sold in the U.S., the Food and Drug Administration’s (FDA) has been busy making a flurry of announcements. 

However, it was the FDA’s recent rejection of Juul Lab products that has revealed increasingly aggressive behavior on the part of the agency. FDA pronouncements like this one carry significant – and potentially harmful – consequences for American smokers and consumers.

For instance, the agency’s announcement that it intends to establish a maximum level of nicotine in cigarettes is notable because some plans currently call for a 95% reduction in nicotine levels. Nicotine is the primary ingredient in tobacco products that makes them addictive to users. However, the chemical is itself is fairly harmless. A plan to eliminate nearly all nicotine in cigarettes would upend a $95 billion industry by essentially banning all products currently on the market. It would also be devastating to consumers. 

An estimated 30 million American smokers would experience nicotine withdrawals as they search for alternative products to provide them with relief. Many of these people would likely seek out e-cigarettes and other non-combustible tobacco products that are currently exempt from the FDA’s proposal. But this plan could also result in unintended consequences, such as pushing consumers to make purchases on the black market where product safety is far from certain.

The FDA’s proposal is even more perplexing considering that the agency also wants to ban popular e-cigarette manufacturer Juul from selling products on the market. Juul, while no longer possessing the largest market share, none-the-less provides consumers a popular product associated with far fewer health effects than traditional tobacco products. 

While traditional tobacco products utilize combustion to function, and therefore carry greater amounts of dangerous chemicals and carcinogens, e-cigarettes and vape products do not. Instead, they use e-liquid heating, which tends to reduce the types of negative respiratory issues, such as shortness of breath, that are common for users of traditional tobacco products.

For this reason, e-cigarettes have the potential to play a powerful role in harm reduction and are increasingly incorporated in smoking cessation treatments. In fact, researchers at Public Health England have found that e-cigarettes are 95% less harmful than traditional cigarettes. While not completely risk free, e-cigarettes are a significantly better option for consumers attempting to quit tobacco. The way they mimic the motion of smoking is widely popular with users. Not surprisingly, they have been found to be more effective than nicotine patches, gums and other products.

It seems tremendously counterproductive for the FDA to ban a product that has been found to be safer than traditional tobacco, and that consumers are likely to demand should the agency follow through with its threat to establish a maximum threshold for nicotine in cigarettes. 

While the rejection of Juul’s product applications represents just one manufacturer, the action against them is symbolic of a much larger trend of hostility towards not just traditional tobacco, but also e-cigarettes and vape products.

Juul, in addition to offering a variety of similar products to competitors like Vuse, has also made a concerted effort in recent years to rebuild its public image as a company that is committed to playing by rules. Since first jumping onto the scene in 2015 with a variety of sweet and fruity flavors, the company has since willingly discontinued nearly all product lines that critics said helped fuel underage vaping. Only two flavors remain: Virginia Tobacco and Menthol. Even so, the company continues to draw the ire of the FDA. 

Despite submitting more than 6,000 pages of information requested by the agency, the FDA has stated that they still have concerns about Juul’s product toxicology data and stand by their decision to issue marketing denial orders to the company. Should those denial orders stand, it will mean the end for a manufacturer whose current $450 million market value is now less than 5% of its original value, and whose market share of disposable e-cigarettes has declined to 30%.

With such an insignificant footprint in the vape market, it seems simple to conclude that the FDA’s decision to ban Juul product applications is at least partially driven by the desire to make an example out of the company. Plenty of other sweet e-cigarette products remain on the market and continue to be sold in convenience stores across the country, despite many being cheap Chinese-made devices that offer sweet, fruity flavors not approved by the FDA. 

While Juul represents the first major e-cigarette manufacturer to potentially be shuttered by the agency, it will not be the last. Regardless of what happens to Juul, it is abundantly clear that the FDA has opened a new chapter in its pursuit of “protecting public health.” This next chapter will be much more aggressive and hostile to tobacco users than previous chapters. 

Therefore, it is important that the agency prioritize which major industry players truly need additional scrutiny and which, despite carrying limited risks, offer consumers a viable alternative to far more harmful tobacco products. The FDA should think twice before wasting federal resources on shutting down e-cigarette companies like Juul.

FacebooktwitterredditlinkedinFacebooktwitterredditlinkedin