The Legacy of FDA Commissioner Scott Gottlieb

FDA Commissioner Scott Gottlieb Resigning

FDA commissioner Scott Gottlieb is resigning at the end of the month. A vocal critic of the vaping industry,  FDA has clashed with the Juul-Altria alliance over the increased rates of underage vaping on his watch. His year-long crusade against the teen vaping epidemic defines his tenure. Gottlieb’s family has continued to reside in Westport, Conn since he took office in May of 2017. It has been reported that the commute took a toll on his family life and prompted his decision to step down. Gottlieb, 46, also served on President Trump’s transition team and has extensive experience in the private sector. He attended medical school at the Icahn School of Medicine at Mount Sinai and his internal medicine residency was completed at Mount Sinai Hospital. Under George W. Bush, Gottlieb was a senior adviser to the FDA Commissioner and served as the FDA’s Director of Medical Policy Development.

A Figure Out of Central Casting

The New York Times described Gottlieb as being, “a figure right out of central casting for the Trump administration. As a venture capitalist who served as both a consultant and board member for drug companies, he had made a fortune from the industry he would regulate, written impassioned anti-regulatory columns in conservative journals.” His track record as FDA commissioner demonstrated the weakness of this analysis, as he proposed increasingly onerous regulations on e-cigarettes. His willingness to drown the vaping industry in sea of rules and regulations led to pressure from Republican congressional leaders in recent weeks.
It is easy to paint Gottlieb as a classic authoritarian, who conveniently used the philosophical fig leaf of libertarianism and free markets to oppose any effort to restrict the freedom of his varied business interests when out of power. Now with the coercive power of the federal government at his disposal, he has proven quite comfortable imposing his will and disregarding the anti-regulatory arguments that he once championed for such diverse interests as GlaxoSmithKline, Tolero Pharmaceuticals, and New Enterprise Associates, the world’s largest venture capitalist firm.  

New Restrictions on E-Cig Sales

In November 2018, Gottlieb announced a series of new FDA regulations on e-cigarettes that would ban the sales of non-tobacco and menthol flavored products at gas stations and convenience stores. His heavy handed approach to vaping assigns little value to the lives of adult smokers, especially rural residents and marginalized groups. The disproportionate impact and lives that will be lost as a result were the subject of an open letter to the FDA by Iowa Attorney General Thomas Miller. Despite his strong efforts to limit access to e-cigarettes, Gottlieb has acknowledged the potential benefit of vaping. This is something that many vaping critics fail to understand and he deserves credit for at least acknowledging harm reduction strategies. Gottlieb made these remarks at a Tobacco Regulatory Science Program Meeting in June 2018:
Millions of lives could be saved by moving people away from these most harmful products, while encouraging innovation in potentially less harmful tobacco products for those adults who still seek to use nicotine.
His concerns about teen vaping were certainly not without merit. Unfortunately, adult vaping was caught in the crossfire of his anti-nicotine campaign. Under Gottlieb, the FDA is preparing to institute widespread flavor and retail sales bans on e-cigarettes. This flies in the face of earlier stance:
“We want to preserve e-cigs as one among a number of possible options for adult smokers and believe that fully transitioning smokers to ENDS can reduce the morbidity and mortality associated with tobacco use.”  

E-Cigs Easily Outperform Nicotine Replacement In Study

Among the most shameful displays during Gottlieb’s tenure was his summary dismissal of a high impact New England Journal of Medicine study that compared e-cigarettes to nicotine replacement therapy. This study demonstrated what vapers have long known: e-cigarettes are a much more satisfying and effective cessation tool than nicotine replacement products like the patch and gum. Critics of this study pointed out that e-cig users who ceased smoking continued to vape one year later. A higher percentage of the nicotine replacement therapy users who quit smoking were totally nicotine free. This criticism fails to take into account the sheer amount of money, research and resources that have been dedicated to nicotine replacement therapy. There are established guidelines for weening smokers off of the less effective nicotine replacement therapy products. Rather than backing the wrong horse, perhaps it is time to create titration schedules and tapering methods that will allow vapers to successfully reduce the nicotine levels in their e-juice. Many vapers accomplish this on their own, but unlike products like the patch, vaping simply does not have the vast ecosystem of guidelines, trained behaviorists, counselors and support resources that facilitate the use of nicotine replacement therapies.

Fruit Flavor Fallacy

For a man of considerable education and expertise, Gottlieb was frighteningly quick to fall prey to a number of zombie vaping myths and the fruit flavor fallacy. The fruit flavor fallacy is the dangerous and influential belief that sweet flavored ejuices exist to hook minors. Dr. Konstantino Farsalinos dismantled this myth with his comprehensive analysis of 69,000 adult vapers. Farsalino conclusively demonstrated that fruit and dessert flavors are favored by a solid majority of adult vapers.

Retro Juice Packaging Appeals to Adults and Not Minors

Under Gottlieb, the FDA also cracked down on retro e-juice packaging that resembled 1980s and 90s breakfast cereal and candy packaging. Failing to note the passage of several decades since these products peaked in popularity, he falsely concluded that colorful packaging was being used to lure minors. Bold packaging is an easy way to attract the attention of nostalgic, adult vapers and stand out in a crowded field of sweet ejuices. Anti-vapers often fixate on e-juice labels that resemble Sour Patch Kids and Gummi Bears. The reality is that retro e-juice packaging appeals to adults and not minors. The questioning the wisdom of making a nicotine liquid resemble a food product is valid. Failing to realize sweet flavors are preferred by adults and neon 1980s style fonts are meant to appeal to older millennials and Gen Xers is where the critics go astray. Complex, sweet ejuices are what the majority of adult vapers, who make up the overwhelming bulk of e-juice buyers, prefer. It only makes sense that an e-juice blended to taste like Skittles or Captain Crunch will sell better than vaguely named fruit or cream flavor blend. Creating colorful packaging that advertises flavor features is pretty much Marketing 101.
If savory and sharp flavors were what the market demanded, would the same critics seethe and rage about e-juice labels that mimic the look of Manischewitz Gefilte Fish or French’s Mustard?
Juul changed the name of their Crème Brulèe flavored pod to Crème in response to these pressures. It is unclear why a decadent, French-inspired dessert that peaked in popularity twenty years ago would lure children to vape. The “Crème Brulèe” name is shared with Laura Mercier’s upscale skincare line, which is carried at a couple of stores not noted for their teenage clientele: Neiman Marcus and Bloomingdales. A little common sense is sometimes not that common. Unfounded fears about fruit flavors are no joke. They are driving flavor bans in New York and a virtual e-cig prohibition in California. Gottlieb is confident that the FDA’s guidelines on e-cigarette flavors will be implemented before his departure, but his moves against menthol cigarettes will probably remain unrealized for the time being.

Strict E-Cig Laws Punish Marginalized Groups

The lasting legacy of Gottlieb’s tenure will be setting in motion a flurry of regulations and creating an environment where local laws that limit adult access to e-cigarettes flourish. Strict e-cig laws punish marginalized groups, but Gottlieb has only paid lip service to this reality. Gottlieb acknowledged concerns about limiting adult access, but these concerns were thoroughly outweighed by his obsession with protecting the children from nicotine. Lawmakers in New York and California completely ignored the vulnerable populations that are harmed by flavor bans and restrictions on brick and mortar sales.

African Americans and Vaping

A study conducted by the CDC found African American smokers smoke fewer cigarettes on average, attempt to quit smoking more frequently and have less success at quitting than their White and Hispanic counterparts. International Journal of Environmental Research and Public Health conducted a study into racial and ethnic differences among e-cigarette users. They found that African Americans were more likely to embrace e-cigarettes as a cessation aid than Whites and Hispanics. They were also statistically more inclined to avoid dual use of cigarettes and e-cigarettes. The CDC study operated under the flawed premise that “evidence based” methods such as nicotine replacement therapy were more effective than e-cigarettes, and that transitioning to e-cigarettes was not a worthwhile end goal. Instead, e-cig users were still classified as smokers. In pursuit of their puritanical vision of total nicotine abstinence, the authors of both studies derided the African American community’s general skepticism about nicotine replacement and their widespread embrace of e-cigarettes. In light of the New England Journal of Medicine study that found e-cigarettes were nearly twice as effective as nicotine replacement, it is time to revisit how these results were interpreted. It is time for a full accounting of how e-cig bans could negatively impact the African American community.

Rural Areas Denied Cigarette Alternatives

Grim trends are also prevalent in rural and poor areas. Lung cancer rates are far higher and a lack of access to health care is blamed. Banning e-cigarettes from gas stations will heavily impact availability in rural areas. There is no reason to compound smoking health disparities by denying ash and smoke free alternatives. Iowa Attorney Thomas Miller, a long time foe of big tobacco, voiced these concerns but the health of smokers in fly over country is apparently not a national priority.

LGBT Community and Vaping

Vaping is most prevalent in the LGBT community. The CDC found that 20.3 percent of adults that identify as lesbian, gay or bisexual smoke cigarettes, versus an overall rate of 14 percent. Bisexual women are over twice as likely to smoke as heterosexual women. As a whole, the LGBT population in the US is three times more likely to use electronic cigarettes: 7.5 percent versus 2.6 percent. This is the highest rate for any group surveyed. Smoking rates among the transgendered have been estimated at over 80 percent and studies have tied this to structural discrimination. As a whole, the smoking rate in the LGBT community kills over 30,000 annually and leads significant health disparities.

The Wealthy Have Already Given Up Smoking

Ignoring the inevitable cost in human lives lost to smoking is easy when you don't deal with smokers. The fact is that the wealthy have largely given up smoking. Vaping is low-hanging fruit for regulators and politicians looking to score easy points. Smokers are not heavily represented in middle and upper income brackets, whereas drinking rates are highest among educated, high-income adults.
This explains why there is no call to ban alcohol (again), despite the fact that 13.5 percent of high school students binge drink versus the 2.4 percent who use electronic vapor products daily.

Teen Vaping Epidemic

The teen vaping epidemic poses an existential threat to the e-cigarette industry. At Vapor4Life, we have no interest in selling our products to minors. Our goal is to provide the best possible cigarette alternatives to adult smokers. There are hobbyists who use zero nicotine e-juice but the vast majority of our customers are former smokers. We use industry leading age verification technology on our e-commerce website and card everyone who enters our Northbrook vape shop. Gottlieb’s fixation on fruit flavors and underage sales at gas stations overlooked the potential catalyst of the teen vaping epidemic. Advances in nicotine salt technology have greatly increased the potency of ejuices and promoted the proliferation of smaller pod systems. Requiring less vapor to get a nicotine fix, e-juices which exceed 50 percent potency make discrete vaping easy. Most teens obtain these devices through social contacts and they are easy to conceal. You don't need to chain vape to get your nicotine fix. According to the Department of Health and Human Services, the smoking rate among teenagers was slashed from 24.6 percent in 1997 to 5.5 percent in 2015. This was accomplished through education, awareness and stricter age verification policies. This is clearly a more effective approach than flavor bans, sales restrictions and localized prohibitions.