FDA Approves an E-Cigarette for the First Time but Still Seems Bent on Banning the Flavors Former Smokers Overwhelmingly Prefer –

The FDA finally approves a vaping product seven years after it declared that it would regulate electronic cigarettes. The FDA has refused to approve millions of applications for other vaping products and seems still inclined to ban e-liquids that ex-smokers prefer. Why is that? They are also liked by teenagers.

Yesterday, the FDA approved Vuse Solo’s marketing. It is a R.J. Reynolds Vapor Company vaping device. This decision implicitly acknowledges the lifesaving power of electronic nicotine delivery systems (ENDS), which provide a safer alternative to traditional cigarettes for smokers. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

The FDA also rejected 10 applications from Vuse Solo for other flavor cartridges. According to the FDA, the agency is still evaluating the application of the company for Vuse Solo-branded menthol-flavored products.

These decisions are not good news for either manufacturers who are still waiting for FDA approval or vapers using e-liquids that contain non-tobacco flavours, which is much more common among adult users. Data from the Population Assessment of Tobacco and Health Study shows that three quarters of adults prefer flavorings other than tobacco.

R.J. Reynolds Vuse products represent nearly a quarter of the ENDS marketplace. This is a huge company that has the funds to carry out the kind of costly research required by FDA. However, it was not able to convince the FDA that flavor ENDS were beneficial in helping smokers quit.

Vuse Solo has a proprietary closed-system design, so it cannot be used to refill with eliquids from other companies. FDA seems to be determined to regulate which flavors are allowed in vapes’ devices.

The FDA states that young people who use non-tobacco flavored end-of-life products are more likely than those who start with tobacco-flavored ENDS product and later switch to products of higher risk, like combusted cigarettes. Data also show that most young people who start using ENDS are able to choose flavors other than tobacco, such as mint, fruit or candy, rather than tobacco. Because these flavors are more appealing to youth, the FDA has authorized the use of tobacco-flavored products. Authorizing these products could be beneficial to adult smokers who switch completely to ENDS or drastically reduce their smoking habits.

Contrary what the FDA claims, it is not clear that vaping can be used as a gateway to nicotine use among teens who wouldn’t otherwise smoke. Recent trends indicate that ENDS have accelerated the decline in teenage smoking.

“With high-school students’ smoking declining at an increasing rate since youths began using e-cigarettes, some may vape to reduce or quit smoking,” David J.K. Balfour and 14 other leading tobacco researchers note in a recent American Journal of Public Health Article. It is unlikely that vaping will cause some youth to smoke. A recent study estimated that if vaping increases nonsmoking youths’ odds of trying cigarettes by 3.5…smoking initiation among young adults would increase less than 1 percentage point. US data show that the rate of smoking among youth has fallen at an unprecedented pace since vaping was introduced. Vaping may increase smoking initiation. But there are other factors that might compensate.

Research data shows that most teenagers who smoke regularly vape are former or current smokers. Therefore, FDA fears about an “epidemic of nicotine addiction in adolescents” is exaggerated. Balfour, Balfour, and others. Write. However, there is no evidence that it makes people addicted. That fear seems all the more misplaced in light of survey data showing that e-cigarette use by teenagers fell substantially in 2019 and 2020—a development that the FDA prefers to ignore.

The FDA must decide whether a product for vaping is appropriate to protect public health. This is done under the 2009 Family Smoking Prevention and Tobacco Control Act. It is also required to consider the risks and benefits of the products to all members of the general population. This collectivist standard, while morally ambiguous and extremely subjective, suggests that FDA should weigh the advantages of flavor e-liquids against any potential harms to the public health. However, it is clear that FDA does not intend to make any effort in this regard.

Instead of asking teens if they like certain flavors, the FDA appears to be asking them. If the flavors are popular, then that is crucial, no matter if they are equally loved by adults who vape or have recently switched to it. Vaping might be less attractive to minors, but it would also make vaping more appealing to those who smoke. Balfour and his associates note that while flavor bans might reduce interest among youths in electronic cigarettes, it could also make vaping more appealing to adults who are trying to quit smoking. As with youths, adult smokers also prefer flavors that are not tobacco-based. Both groups like sweet or fruity flavours.

There will be more early deaths if the FDA refuses to permit non-tobacco flavor. The FDA legally has to take into account this risk. However, there has been no evidence to support this.

Zeller last month stated that “Flavored electronic cigarettes are still very popular with children.” The FDA is continuing to pursue those selling or targeting e-cigarettes, eliquids, and other products to children. This was evident in the refusal of over one million applications for flavor electronic nicotine delivery systems. This is crucial that these products are taken off the market.

It was unclear at the time whether these products meant ENDS that were sold to underage customers or ENDS that are “flavored”. Vuse products have been approved by the FDA selectively. This strongly supports this interpretation. The FDA seems to be taking the position that any vaping product in a flavor other than tobacco (and possibly menthol) is ipso facto targeted at teenagers, even if the vast majority of its consumers are adults.

A ban by the FDA on flavor ENDS is not going to eliminate these products. If there’s strong demand, then there will also be supply. The FDA has limited resources and cannot pursue all suppliers. The FDA only approved Vuse products at this time. EachE-liquid and vaping products sold in the United States are illegally marketed and could be subject to FDA enforcement. The vaping devices can still be purchased, even though the FDA has denied all applications for flavor-specific ENDS.

This does not necessarily mean that FDA refusals to approve such products are ineffective. This will increase legal uncertainty and risk for vape shops and manufacturers, and drive consumers to black-market vendors who are more accountable but not subject to civil or regulatory liability. The FDA might have thought that they would be more aware of the potential dangers associated with prohibition after the tragic experience with black-market THC vapes causing lung injuries.

Good news! The FDA will approve ENDS, based on the evidence that some manufacturers actually can produce it. The FDA released a press release regarding the Vuse Solo approval. It stated that the agency found study participants exposed to less harmful and potentially dangerous constituents (HPHCs), from aerosols than those who used combusted cigarettes. Based on nonclinical research and data, the toxicological analysis also concluded that aerosols from authorized products are substantially less toxic than those found in combusted cigarettes.

But the FDA also rejected the flavor cartridges. The aerosols they make are much safer than cigarettes. These products also have an advantage: Former smokers clearly prefer these flavors. This makes them more likely to be used. StayEx-smokers. For current smokers looking to quit smoking, vaping offers a variety of flavor options. However, these considerations don’t seem to be relevant in FDA’s analysis.