A new generation is getting addicted to nicotine based on a false promise that vaping is less poisonous than smoking. And regulators are out to lunch.

Two of the leading killers of Americans have one preventable cause in common. Many, many cases of lung cancer and cardiovascular diseases  are caused by tobacco abuse. Medical scientists long ago proved this beyond a doubt. There’s cigarette smoking, of course, but also inhaling harmful byproducts from burning tobacco in cigars, pipes, hookahs, and the like.

Big Tobacco and its allies, however, have worked for decades to maximize profits and work around anti-smoking initiatives that aim to prevent needless disease, death, and many billions of dollars in related costs. The industry has the advantage, not only in its huge spending but also in a fundamental component of tobacco: nicotine. Experts know this poisonous substance is wickedly effective in addicting users and keeping them hooked.

But federal regulators — due to their own blunders — now find themselves in another giant tobacco twist. The Food and Drug Administration recently was supposed to give its big answer to how it planned to deal with the public health crisis swirling around e-cigarettes, vaping, and more. But agency officials punted. And the issue likely will involve the courts soon —and for some time after.

A lot remains at stake in this sorry chapter of Big Tobacco oversight — for users of not only tobacco but also marijuana, as well as for those concerned with the health of the young and those eager to determine how to safeguard people from their own injurious behaviors.

Quitting tobacco can be an ordeal. Many of us know this firsthand. But years of research can add important insights into why tobacco abuse persists as a confounding health problem.

Just consider the extensive examinations conducted by the Cochrane group, internationally respected researchers and others who try to make rigorous studies as accessible as possible. Cochrane has issued dozens of reviews of medical-scientific studies on tobacco addiction and efforts to deal with it (the library is available by clicking here).

Stopping smoking isn’t a snap

Rigorous research shows there is an ever-increasing array of approaches to quitting tobacco, without any best, most convenient, or certain way to do so. Cochrane reviews show. Kicking this habit may require multiple strategies, and the combinations can be productive, another influential group — the blue-ribbon, independent U.S. Preventative Services Task Force — has found.

Those who stop “cold turkey” do about as well over the long run as those who taper down. Common aids can be helpful, including nicotine replacement with gums and patches. More serious pharmaceutical interventions — with anti-depressants like bupropion (sometimes called Zyban) and nortriptyline or blood-pressure drugs like clonidine or mecamylamine — can carry risks. Counseling and other behavioral modification techniques can work, as do financial rewards or competitions.

The federal government and health groups have extensive resources available online to help smokers who want to stop (click, for example, here, here, or here.)

A decade ago, though, manufacturers started promoting a different cessation device: “smokeless” or electronic cigarettes. These gizmos heat a liquid, often flavored to disguise the brews’ hefty nicotine content, and deliver a vapor (or vape) for inhaling. Makers argue this slashes a major problem of burned tobacco — the stew of toxins and cancer-causing chemicals created by traditional cigarettes, cigars, and pipes. Advocates assert the new devices let users taper off tobacco with big health benefits.

Officials in the Obama Administration were unconvinced, battling e-cigarette makers and vaping advocates to force them to produce clear and compelling evidence of the benefits of their products before they could be allowed on markets. The FDA was on the brink of a crackdown.

A promise of a new focus on nicotine

But before strict rules could take effect, a pro-business, anti-regulation Republican administration took office. Scott Gottlieb, who became the head of the FDA, put on the hook the plans to toughen oversight on e-cigarettes, vaping, and flavored cigarettes (notably menthol varieties).

Instead, he decided the FDA should undertake new and extensive studies of nicotine, arguing that breakthroughs were needed to deal with its addictive powers — if these could be lessened, wouldn’t that reduce tobacco abuse? This looked like a prime application of a public health strategy known as “harm mitigation” or “harm reduction” — accepting that a bad condition could not be eliminated and trying instead to reduce its damage.

The FDA and other experts, though, already knew much about nicotine and its detrimental effects, as reported in one study posted online by the National Institute on Drug Abuse. Researchers wrote of nicotine’s buzz:

“A transient surge of endorphins in the reward circuits of the brain causes a slight, brief euphoria when nicotine is administered. This surge is much briefer than the ‘high’ associated with other drugs. However, like other drugs of abuse, nicotine increases levels of the neurotransmitter dopamine in these reward circuits, which reinforces the behavior of taking the drug. Repeated exposure alters these circuits’ sensitivity to dopamine and leads to changes in other brain circuits involved in learning, stress, and self-control. For many tobacco users, the long-term brain changes induced by continued nicotine exposure result in addiction, which involves withdrawal symptoms when not smoking …”

Smoking, the researchers found, offers a swift, potent way to get nicotine into the body, via the lungs. But this high is fleeting, causing users to dose (smoke) often, especially to avoid withdrawal:

“Being without nicotine for too long can cause a regular user to experience irritability, craving, depression, anxiety, cognitive and attention deficits, sleep disturbances, and increased appetite … When a person quits smoking, withdrawal symptoms peak within the first few days of the last cigarette smoked and usually subside within a few weeks. For some people, however, symptoms may persist for months …”

Nicotine may make smokers feel sharper and more focused, briefly, but with big downsides, too:

“[L]ong-term smoking is associated with cognitive decline and risk of Alzheimer’s disease, suggesting that short-term nicotine-related enhancement does not outweigh long-term consequences for cognitive functioning. In addition, people in withdrawal from nicotine experience neurocognitive deficits such as problems with attention or memory. … .”

With an estimated 23 million Americans already struggling with substance abuse and addiction, wouldn’t the FDA want to take urgent action against a known, addictive toxin like nicotine? No. Gottlieb — a physician, onetime resident of a conservative think tank, and former FDA staffer — didn’t blink. The media-savvy FDA commissioner, who was a board member of and investor in Big Pharma enterprises and an e-cigarette firm, knew the regulatory halt had White House backing. This was especially true because it played well with the southern, ex-urban, and rural voters who have made up the GOP base and were big party contributors.

What Gottlieb did not anticipate was the consequences of the FDA decisions.

In late 2015, the nation began to take notice of high-tech’s embrace of smokeless cigarettes and the switch to vapor-based nicotine delivery.

Juul, a San Francisco-based company, took this product to an exponentially higher level with slick design and cutting-edge marketing, advertising, and sales. The company refashioned dumpy looking e-cigarettes and morphed theirs into a small and sleek device that looked like a computer flash drive. The company, though it would deny this, also shifted the target audience for e-cigarettes and vaping — away from older adults looking for a way to quit smoking and more toward a young, hipper crowd looking for the latest hot lifestyle trend.

Juul boosted the nicotine content of its flavored liquids. The company reformulated its nicotine, too. That gave users less burn and a stronger kick, increasing the brain stimulation that is an addictive hallmark of nicotine. The company also maximized the hype machinery that Silicon Valley had mastered as it sold brands that dominated the globe. Regulators would be blind to much of the firm’s aggressive push for its products because many of the seasoned Ph.Ds. steeped in tobacco laws and policies were, like so many parents coast to coast, oblivious to the rising force of social media and its myriad channels obsessed over by the young.

To the dismay of Gottlieb and his FDA, as well as educators and parents, vaping became a rage among the young. Parents were baffled at not only how their youngsters thronged to get vaping products but also how they afforded them — a Juul and its supplies, which needed steady replenishment, initially ran around $50.

Trying to halt a hip trend

Regulators and politicians were inundated with complaints about e-cigarettes and vaping. The FDA would spend months chasing the wildfire fad it had helped launch. The agency imposed age limits on the devices and products and forced vendors to put them in special areas for sales to adults only. Regulators, far too late, tried to jaw and guilt-trip makers to stop targeting the young. The agency cracked down on sweet and fruity flavors with huge appeal for young users — and led to poisoning cases when children downed vaping liquids.

Then, of course, the agency found itself under greater fire as research began to build about younger vapers. The studies were not definitive. But they suggested that e-cigarettes showed no great benefit for getting users to stop tobacco use. To the contrary, studies showed that vaping led some younger users to cigarette smoking. It also began to fuel another troubling trend — the increasing abuse of marijuana by younger Americans. Vaping fast became a trendy way to deliver not only nicotine but also the extracted chemicals that produce the marijuana high.

The FDA also could not duck the findings of other government agencies about the damage that nicotine itself causes in younger people, as the Centers for Disease Control and Prevention reports on its web site, citing detailed findings by the U.S. Surgeon General:

“Nicotine can harm the developing adolescent brain. The brain keeps developing until about age 25. Using nicotine in adolescence can harm the parts of the brain that control attention, learning, mood, and impulse control … Using nicotine in adolescence may also increase risk for future addiction to other drugs.”

And, of course, the FDA saw its bungled oversight of vaping take a worse turn. Hospitals nationwide began to report admissions of young vapers with serious respiratory illness and injury. Agency investigators scoured the country for the outbreak’s cause, deciding that too many users — lured by cheaper prices or promises of even greater “highs” — had turned to tainted street vaping products.

With law enforcement and FDA inspectors cracking down on vendors and sales of e-cigarettes and vaping — and, of course, with the coronavirus pandemic crushing normal life — the controversies over these products seemed to ease up. But not before device makers were hit with an onslaught of lawsuits and damage claims. And anti-smoking advocates had marched into court, persuading a judge to set a Sept. 9 deadline by which the FDA was supposed to have decided whether e-cigarettes and vaping products had made a convincing scientific argument as to the safety and benefits for their products.

By the way, Gottlieb, who presided over this mess when it blew up, served two years as FDA commissioner before returning to the private sector. He since has joined the board of the drug maker Pfizer and has been quoted extensively as a public health expert. He has written a book critical of the federal response to the coronavirus pandemic.

The hydra was a ferocious monster for the ancients, feared because they believed that when foes managed to lop off one of the beast’s many heads, several new ones arose from the wounds. These days the hydra is Big Tobacco.

In fact, as federal investigators and others would discover in documents given up by Juul during raids on the company’s headquarters, its product that took the country by storm was anticipated by Big Tobacco strategists. Juul’s founders had studied their playbook, adapted it, and followed key aspects of it as they confounded regulators.

Further, in a move that reportedly infuriated Gottlieb and his FDA colleagues, the San Francisco whiz kids formalized anti-smoking forces’ worst fears: They cut a deal with Altria and made the maker of the infamous Marlboro brand one of Juul’s major shareholders. Overnight the San Francisco startup alone suddenly was valued at $38 billion.

The Federal Trade Commission eventually sued Altria, asserting that its investment in Juul violated anti-trust laws. Altria lost big sums in its vaping investments when regulations and negative media coverage dented the companies’ bonanza youth markets.

But the firms that have survived the industry crackdowns (as well as the pandemic’s economic shocks) are Big Tobacco allies or subsidiaries, including: Juul and Altria, Vuse and British American Tobacco (which now included RJ Reynolds and Lorillard, maker of blu e-cigarettes), logic and Japan Tobacco International.

Along with the independent NJOY company, these major makers won a reprieve of uncertain length when the FDA on Sept. 9 punted on its big decisions on whether to keep allowing e-cigarettes and vaping products on U.S. markets.

Smacking little guys and ignoring the bigs

The agency argued with a defensive and defiant tone that it had acted on 6.5 million filings and 93% of the requests for approval to market e-cigarette and vaping-related products, rejecting most (including millions of flawed  applications from a single applicant). But the FDA said it needed more time — how much it didn’t say — to weigh evidence from big e-cigarette makers 

Leading health organizations have called on the FDA to ensure the evidence is clear and compelling as to the benefits of these products before allowing them to continue to be sold. The groups include: the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative.

Legally speaking, the FDA has set itself for a mess. It now may be hit with judicial orders, won by e-cigarette foes, forcing officials to rule on applications by market-leading firms. The agency also may end up wrangling in courts with parties on all sides of the issue after it acts on the requests to keep e-cigarette and vaping products on the market. 

The FDA has taken a reputational beating with its leaders allowing botched, dithering, and politicized actions during the pandemic on coronavirus testing, vaccines, and emergency approvals for unproven prescription medications promoted by the Trump White House. The FDA flabbergasted medical specialists and lawmakers when it overruled its own elite and independent advisors, approving on sketchy evidence a prescription drug for Alzheimer’s treatment. By the way, the Biden Administration, months into its term, has not nominated a full-time chief for this agency.

So, how much political clout can the FDA manage when it is confronted, as it is likely to be, with other challenges on inhaled products?

Stopping the consumer tide

The vaping market, as mentioned, has exploded. It not only has industry behemoths trying to lure consumers in but also has become a big mom-and-pop business. Some of these enterprises, with owners’ personal money at stake, may take the risk that federal inspectors or cooperating local authorities won’t come after them. Let’s face it, vaping isn’t just a kid thing anymore. Wander around malls and shopping districts in tony suburbs and see how many parents, businessmen, and older adults are vaping. Take note at social affairs of how many grownups pull out devices to enjoy smokeless nicotine, or, yes, marijuana.

Consumers may be more than happy to wander into specialty stores that sell curios — not items identified as vaping materials or e-cigarettes. Vendors will never say what the items are for, merely that they might be legal without a defined regulated or illicit use. Vaping goods may become like bongs in “head” shops or as fine glassware was during Prohibition. 

For folks in the industry other strategies already are advancing, too. The FDA has mostly targeted e-cigarettes and their use of packaged “pods” or other closed but replaceable holders of vaping liquids and substances. The agency has not yet attacked variants, including vaping devices with large, refillable tanks.

These bigger units aren’t popular with younger people but have gained a foothold with older users willing to fuss with stocking up on, storing, and loading vaping liquids — which are yet more costly and may have flavors, not sweet or fruity, that appeal to grownups. On the other hand, kids have jumped aggressively to disposable, one-use vaping devices.  Regulators have not lit after their makers and vendors with the zeal shown against pod-based products like Juul.

Entrepreneurs also are pushing the regulatory bounds — and infuriating public health advocates — with technological turns. The FDA confounded Big Tobacco opponents when the agency, albeit with heavy restrictions on advertising and marketing claims, allowed Philip Morris International to peddle a jazzy-looking “heated” tobacco device named the IQOS (pronounced ick-woes). PMI managed to sway regulators to allow  IQOS because it and other products like it are less toxic for adult-limited users than burning tobacco cigarettes. Makers cannot claim that heated tobacco offers a way to quit traditional cigarette use.

Another way that makers and vendors may try to circumvent FDA oversight involves nicotine delivery orally and without heating or combustion. In Scandinavia, notably in Sweden, cigarette smoking is relatively lower, and experts long have attributed this to the popularity of a product called “snus” (pronounced like the word snooze). These are small tobacco pouches or packets that are tucked between the lip and gum, and, as occurs with more commonly used chewing tobacco in this country, users get a concentrated hit of nicotine in the saliva and in the blood-rich tissues of the mouth. European regulators have deemed this approach unacceptable, tying these products to pancreatic cancer, type 2 diabetes, fatal heart attacks, heightened blood pressure, preterm births, and stillbirths.

For others in the vaping trade, the workaround may rely on their claims that their products use “synthetic nicotine,” a substance not derived from tobacco. Makers and vendors have argued their products are permissible and beyond the FDA authority. Health advocates have assailed this legal legerdemain. The FDA has cautioned firms in writing already that it is not buying the synthetic nicotine dodge.

The agency, in its most recent crackdown on vaping and e-cigarettes, also has warned that it has significant powers and will not hesitate to use them, especially as it says it took out a cloud of vaping products and their makers with its most recent ruling on their submissions for market approvals of their liquids and devices.

Pot’s a rising and related problem, too

While the world waits to see exactly how the FDA pulls the country out of the mess that the agency helped to create, regulators — and not just from the FDA — have a collateral concern, too, to deal with, pronto: the spiking abuse of marijuana, especially by the young. As USA Today reported:

“Marijuana use among U.S. college students hit a historic high in 2020 … College students’ marijuana consumption rose in 2020, continuing a ‘significant increase’ over the past five years, according to the National Institute on Drug Abuse’s annual Monitoring the Future study. The recent surge has boosted college student marijuana use to its highest mark since 1983 … Marijuana use among college-aged respondents who aren’t in school has jumped from 32% in 2007 to 43% in 2020, relatively in line with their college student counterparts. For all young adults aged 19-30, the study revealed all-time highs in marijuana use on an annual, 30-day and daily basis. The gradual rise in marijuana use comes as more states elect to legalize or decriminalize the substance. More than a dozen states permit recreational weed.”

Vaping played an earlier, significant role in young people’s increasing abuse of marijuana, the researchers found and the Washington Post reported. 

There’s no need to be blue-nosed about pot abuse. It’s not good, just as excessive liquor consumption is damaging. Substance abuse is a huge negative for the young, with the research increasing that pot — like nicotine and alcohol — is detrimental to youthful physical and intellectual development.

Time to go big, especially for kids’ sake?

Parents, educators, politicians, and regulators should err on the cautious side in safeguarding our young, acting with vigor to do so. That’s a big takeaway from the regulator mess of e-cigarettes and vaping, in which a focus on reducing tobacco’s harms for grownups led to other consequences, notably for youths. Regulators have been too permissive before with Big Tobacco and Big Sugar and how they target the young. Why did the FDA fail to see the onrushing e-cigarette and vaping calamity? Partly because like many parents and teachers, the agency’s experts were not listening enough to kids and understanding the influences in their lives, including peer and other pressures, as well as the huge influence of social and other new media.

Good luck to the regulators if they try to poke, piece by piece, at controlling the harms that Big Tobacco and its allies inflict on us all. It’s a nightmare to try to restrict products so adults have access them while younger folks don’t. Perhaps, though, the FDA can fix its miscues and try something it has not before — why not outright ban e-cigarettes, vaping and its products, as well as flavored tobacco cigarettes, cigars, and other byproducts? Where’s the conclusive proof of the powerful benefit of e-cigarettes or vaping, especially as opposed to other smoking cessation options?

Or maybe the FDA looks hard at the data and pulls off regulatory jiu-jitsu: Why not ban all burned tobacco products, especially cigars, cigarettes, pipes, and the like, and, if e-devices and vaping are less harmful, allow them for adults only and with tough restrictions on their advertising and marketing?

At the individual level, of course, if you don’t smoke (tobacco or pot) or vape (nicotine or marijuana-related substances, aka THC), please don’t start. If you’ve started with either of these injurious pastimes, please talk to your doctor and try one or more quitting strategies until you find the ones that get you unhooked. Here’s hoping you and yours stay on the right side of substances of all kinds and that you are happy and healthy throughout 2021 and beyond!