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Limited State Registries Will Negatively Impact Consumers of Nicotine Products 

WASHINGTON, D.C. – In the first few months of 2024, more than a dozen bills have been introduced in US states calling for a state-based Premarket Tobacco Product Application (PMTA) registry for alternative nicotine products such as vaping devices, heaters, and nicotine pouches.

Although this type of legislation has already been passed in Oklahoma, Louisiana, and Alabama, it’s crucial that other states recognize the unintended consequences and course-correct before it is too late.

ELIZABETH HICKS, US Affairs Analyst at Consumer Choice Center, responded, “While the intention behind these bills is to manage consumer access to unregulated nicotine products on the illicit market, the reality is that the FDA is not approving enough new devices and products to create a competitive, regulated marketplace that meets consumer demand.”

While 26 million nicotine alternative products submitted PMTAs to the FDA, only 23 have been approved. Of those 23 approved products, 12 are simply tobacco-flavored e-liquid refills.

“The FDA is hiding the ball here on product approvals and how few new products are actually coming to market. If the goal is to improve public health across the country, then consumers deserve to choose from a variety of different nicotine alternatives,” added Hicks.

“The FDA’s flawed PMTA process needs reform. Instead of restricting consumer access to products that have been demonstrated to be 95 percent less harmful than combustible tobacco, state legislatures should refrain from adding to counterproductive federal policies and advance tobacco harm reduction through a competitive marketplace,” she concluded.

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The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Washington, D.C., Ottawa, Brussels, Geneva, and other hotspots of regulation and inform and activate consumers to fight for  Consumer Choice. Learn more at consumerchoicecenter.org

Checking in on Michael Bloomberg’s multi-million dollar global crusade against harm reduction

For years, we’ve covered the extent of former New York City mayor Michael Bloomberg’s multi-million dollar campaigns to try to shape the lives of ordinary consumers.

What began as an erstwhile nanny state campaign on Big Gulps in New York City has ballooned into a massively funded operation that uses grants and NGO funding on many tobacco issues, mostly on outlawing nicotine alternatives like vaping products.

In 2019, Bloomberg pledged $160 million to get US states and localities to ban flavored vaping products, mostly funneled to anti-tobacco groups who’ve pivoted from “stop smoking” campaigns to “stop consuming nicotine in all forms.”

Those efforts quickly scaled to the level of the World Health Organization, including funding US anti-tobacco groups in the millions to even go so far to completely outlaw nicotine alternatives in developing countries across Latin America, Asia, and more. While nations on these continents typically have larger smoking populations than in the US and Europe, they have thus far been deprived of the life-saving nicotine alternatives that would serve as a less harmful switch away from smoking.

In the name of “halting tobacco,” Bloomberg and the organizations he funds have actively sought to poison the well of tobacco harm reduction by miscasting vaping products as “just as bad” as combustible tobacco. Even though health agencies in nations such as the United Kingdom, New Zealand, and even Canada actively recommend vaping products to get smokers to quit, this option is kept off the table in developing nations where Bloomberg has influence.

In February of this year, Bloomberg’s commitment to severely restrict harm reduction increased significantly to nearly $420 million, hoping to drive a larger global campaign in 110 countries around the world to cut off citizens from nicotine alternatives that are less harmful.

Over $280 million of that money will focus on developing countries, offering grants to political groups, health agencies, and politicians to implement a zero-tolerance nicotine agenda.

The issue with Bloomberg’s approach, and by extension the dozens of health and anti-tobacco groups he funds, is their denial of the real scientific evidence on tobacco harm reduction.

Rather than endorse the market-derived alternatives that have been successful in getting adult smokers to quit – much more effectively than government education programs – they have created a false equivalence between the vape and the cigarette.

That not only harms public health, but continues to fester a narrative of misinformation that has captured many public health researchers and government agencies. We know this all too well from our cross-national survey of health practitioners in Europe, in which many doctors were simply unaware of the growing category of less harmful nicotine alternatives like vaping, heat-not-burn sticks, nicotine pouches, and more.

As Bloomberg continues his global crusade against harm reduction, and many groups pick up his baton to carry out policies to deny safer options to smokers who need them in developing countries, researchers and activists must continue to underscore the need for options and consumer choice when it comes to nicotine alternatives.

Consumers, political leaders, and community activists must uphold the both scientific and anecdotal evidence provided by the consumer-led revolution in harm reduction. Only then can we continue to save lives, influence better policy, and ensure a generation of people who will have more options to live their lives, not less.

Thailand police crackdown on tourists with vape devices shows they desperately need harm reduction policies

Harm reduction vs. smoking

If you happen to practice harm reduction and have a vape device in your pocket, it seems Thailand is the last place you’re going to want to visit.

In the last few days, it was revealed that police officers allegedly extorted a Taiwanese actress of more than 27,000 baht ($820) for…wait for it…having a vaping device.

Taiwanese actress Charlene An got into a taxi with friends after a night out in the Thai capital and was caught with a vape and was held by the police and not allowed to leave until she paid the steep fine.

The police officers have at last been transferred and may face their own charges, while the police have been forced to apologize to the Taiwanese tourist for the gross misstep.

This is not only an abuse of power and irresponsible in its own right, but it proves again why Thailand must modernize its policies on harm reduction and embrace alternatives to smoking like vaping and other products.

Before that, in 2019, a tourist from France was arrested, fined, jailed and deported just for vaping. She had to bear legal costs, expenses and fines of approximately 286,000 Baht ($8730) in just one week.

For any tourist, this can be unsettling, but it’s even more problematic that local residents don’t have access to legal harm reduction products. This is what happens when the government’s own policy sees vaping as a threat.

The Thai government must immediately re-evaluate their policy on vaping and take into account the proposal from Minister Thanakamanusorn to legalize the use of vaping as a way to give smokers the option to quit.

The government should replicate the implementation of policies in countries such as the United Kingdom that have succeeded in significantly reducing smoking rates through the recognition of harm reduction as the main strategy.

Based on data recently released by the United Kingdom’s Office for National Statistics, the number of smokers aged 18 and over has decreased from 14.0 percent in 2020 to 13.3 percent in 2021. In fact, this is the most effective decrease since it was first recorded in 2011 by 20.2 percent.

In August last year, Thailand’s Public Health Minister and Deputy Prime Minister Anutin Charnvirakul stated that e-cigarettes pose significant health risks to users and that vaping helps create new smokers, especially among young people in Thailand.

Based on a recent study by the Office for Health Improvement & Disparities United Kingdom stated vaping significantly lowered exposure to harmful substances compared to smoking, as shown by biomarkers associated with the risk of cancer, respiratory and cardiovascular conditions.

Besides, an analytical survey by Lee, Coombs dan Afolalu (2018) said the actual factors of vaping among youth have yet to be proven. In addition, according to the Royal College of Physicians, reports stating that teenagers who use vaping are at risk of potentially giving birth to a generation affected by nicotine are not based on evidence.

If policymakers took this into account, perhaps there would be more people with different options for harm reduction in Thailand, and perhaps less cases of abuse by police officers.

Tarmizi Anuwar is the Malaysia Country Associate of the Consumer Choice Center.

The case for permissionless innovation in tobacco harm reduction

By Yaël Ossowski

As a consumer advocate enamored with technology, there is nothing more satisfying than seeing a new product or service providing a solution to an old problem.

The entire world of Bitcoin — lightning nodes, censorship resistance, and frictionless cross-border payments — is doing wonders for financial freedom and security.

Ride-sharing and home-sharing apps are putting dormant property to use, providing income for drivers and homeowners and rides and places to stay for tourists and students.

And when it comes to tobacco harm reduction, innovation is picking up at breakneck speed, offering new and more effective ways to wean smokers off the harms of cigarettes. At another time, this is something public health organizations would have praised.

Pod vaping devices, open tanks, synthetic nicotine disposables, snus, heated tobacco products, and nicotine pouches are offering precisely what former smokers need without the same level of risk, all varied to some degree.

It is the permissionless innovation of this entire field — entrepreneurs large and small — that provides such hope to us technological optimists and harm reduction advocates. It excites us to the opportunities that progress can provide.

But for opponents of this particular shade of innovation — whether health groups, academics, or competing lobbies —  the very nature of how these products come to be is what so concerns them.

The vast majority of vaping products and alternative tobacco products are not spawned from public grants, university studies, or government programs, but rather from the process of entrepreneurial discovery, offering solutions to problems that exist in society.

This could be a former-smoker turned vaping entrepreneur with a thriving flavored liquids business run out of his garage, a multinational tobacco firm with thousands of employees, or a group of engineering students who just want to create a cool and safer alternative to the daily pack of cigarettes.

These entrepreneurial forces are reacting to a demand in the market, namely, millions of smokers who want to stub their last cigarette. For many of us, this is a positive example of permissionless innovation. For others, it is nothing more than greed and exploitation.

One can understand that the institutions and lobby groups that oppose efforts at tobacco harm reduction are threatened by private industries providing solutions more effective than the status quo. Or perhaps they even question their intentions.

But the fact remains that millions of former smokers, driven by their own conscious wants and needs, have found an alternative that works for them, provided by firms and entrepreneurs who did not ask for the permission of authorities. That is how our market economies should work.

To that end, new lines of nicotine pouches, vape mods, and disposable vapes are debuted on the market each day, some better than others.

Many of these innovators will fail: perhaps they will create a product that fails to gain customers or blur ethical lines on their advertising that eventually send them to court. Or, as in most cases, will vastly underestimate the cottage industry of governmental lobbying that can only be navigated by the most skilled and politically-connected industries, as the US Food & Drug Administration’s byzantine PMTA process has demonstrated.

That said, we should continue to cheer the innovators that provide us with solutions. And we should support them when their interests, and by extension, ours, are threatened by burdensome regulations and bureaucratic decrees.

When legislators are fed false narratives about lung illnesses and their connection to legal vaping products, as the 2019 EVALI crisis demonstrated, or perhaps are confronted with bombastic claims about a youth vaping epidemic, we must stand up for the people for precisely the people who will be hurt by spontaneous legislation: the adult users of the drug who just want a better option.

There are real externalities that must be dealt with: youth access, dangerous products laced with other compounds, and faulty devices that endanger users.

But we cannot kneecap the permissionless innovation in tobacco harm reduction that is saving lives and giving us solutions we couldn’t even imagine. If that remains a priority for consumer advocates like myself, it will have made all the difference.

Yaël Ossowski is deputy director of the Consumer Choice Center.

Congress wants to sneak in an effective ban on synthetic nicotine vaping that would harm consumers

WASHINGTON, D.C. – This week, it was revealed that several congressmen and US senators have added a provision in the upcoming emergency government funding bill that would relegate tobacco-free synthetic nicotine to the regulatory authority of the Food and Drug Administration and its premarket tobacco application process.

This would give vaping firms less than two months to file a lengthy and convoluted Premarket Tobacco Application (PMTA), which will ultimately lead to most small vaping firms and shops going out of business.

Yaël Ossowski, deputy director of the Consumer Choice Center, said this will actively harm adults who want to quit smoking.

“The byzantine process of asking permission to sell harm reducing vaping products in the 21st century is asinine in itself. But using sleight of hand during an emergency government funding bill to castigate millions of vapers and the entrepreneurs who make and sell the products they rely on is the definition of active harm,” said Ossowski.

“Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options. Many will be forced back to cigarettes.

“Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A back door bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit,” added Ossowski.

“The method of fattening up continuing resolution bills with laws that benefit special interests, without broader democratic debate or analysis of the costs and benefits, is shameful in our modern American Republic.

“We hope our elected representatives reject this particular provision on synthetic nicotine and go back to the drawing board to offer a more permanent, sane, and smart policy on the next generation of vaping products,” said Ossowski.

Smoking is up for the first time in a generation. The public health lobby is to blame

By Yaël Ossowski

It often takes a long time for health policy influencers, advocates, and proponents to admit fault. 

When it is about topics such as diet fads, saturated fats, food pyramids, and sugar consumption, long-held consensus beliefs and government actions later proved erroneous have had a lasting negative impact.

But nothing has been more egregious and harmful in our current age than the public health lobby’s persistent denialism of the harm reduction value of nicotine vaping products and other alternatives to cigarettes.

That denialism has come in many forms: public information campaigns demonizing vaping devices, misinformation on lung illnesses caused by tainted cannabis cartridges, bans, restrictions, and taxes on flavored nicotine products (especially those without tobacco), Kafkaesque market authorization applications handled by the drug regulators, and a never-ending crusade to deny adult consumers from having access to life-saving products because of illicit and risky behavior by teens.

These public health bodies, anti-smoking groups, and allied journalists, whatever their intent, have sought to convince the public that not only is smoking bad and dangerous — an easy admission — but also that alternative nicotine devices like vaping products, nicotine pouches, and heated tobacco are just as or even riskier than a pack of smokes.

Those conclusions are easily debunked by the millions of passionate vapers who have long since put down cigarettes and taken up customized tanks, vaporizers, and flavored liquids that give them a familiar nicotine sensation without the tar and combustible byproducts of tobacco.

David Butow for Rolling Stone

The public health mission to muddy the popular perception of nicotine alternatives such as vaping — even though it is scientifically proven to be 95% less harmful than cigarettes — is causing actual damage to American public health. And now we have the proof.

That proof is found both in the increased sales of cigarettes nationwide and also in a highly concentrated study on teen smoking in a jurisdiction where flavored nicotine vaping was outlawed.

According to the sales figures collected by the Federal Trade Commission for its 2020 Cigarette Report, Americans bought more cigarettes in 2020 than they have in more than a generation.

“The total number of cigarettes reported sold by the major manufacturers, 203.7 billion units in 2020, increased by 0.8 billion units (0.4 percent) from 2019, the first increase in cigarettes sold in twenty years,” cites the report.

Americans could be buying more cigarettes for a multitude of reasons: lockdowns, stress from both the pandemic and the government responses to the pandemic, job losses, closed schools, and more. Or perhaps because they’ve been told repeatedly by trusted public health sources and news outlets that vaping, an alternative that millions of adult consumers are now using to quit smoking, is just as dangerous.

Whatever your conclusion, the trend that lowered the percentage of US smokers down to 14 percent in 2019 (when the last complete nationwide survey was completed) is halting. And that should concern us all.

We see anecdotal echoes of this in a recent style piece in the New York Times, highlighting the “comeback” of cigarettes among the bourgeois hipster crowd in Brooklyn, New York. 

“I switched back to cigarettes because I thought it would be healthier than Juuling,” claimed one woman. It seems the public health lobbies have done their job.

On the more evidentiary side, an extensive May 2021 article published in JAMA Pediatrics found that after San Francisco’s ban on flavored vaping and tobacco products, more teens took up smoking.

“San Francisco’s ban on flavored tobacco product sales was associated with increased smoking among minor high school students relative to other school districts,” concludes the paper.

As tobacco harm reduction advocates have claimed for several years, the persistent public health campaigns, echoed by headline-grabbing media outlets, to demonize and restrict access to vaping has led to a predictable rise in smoking rates, both among adults and teens.

Whatever your view on whether vaping devices, heated tobacco, snus, or nicotine pouches are the most attractive and effective gateway away from smoking, this recent uptick in smoking demonstrates actual harms result when politically-charged health lobbies seek to extinguish market alternatives. And we must ask why they persist.

The opposition of these groups, along with affiliated journalists and researchers, to the rise of nicotine alternatives may have less to do with quantitative questions of science and health and more to do with how these products were created and are delivered: by entrepreneurs providing solutions in the market.

These entrepreneurs are vape shop owners, makers of vape liquids, gas station owners, vaping technology firms, tobacco firms pivoting to alternative products, and an entire creative class of vaping influencers both on and offline who are trying to give smokers a second chance at a long life. These are the true heroes of harm reduction in the 21st century.

The fact that spontaneous markets can deliver helpful and healthier solutions because of consumer demand, rather than by edicts, funding, and programs directly controlled by public health bureaucracies and agencies, runs counter to much of the ideology in the tobacco control space. 

It is the former, therefore, that is the true American innovative spirit that has helped make this country so prosperous and competitive, while the latter has failed us again and again.

If we want to reclaim a true public health victory and help smokers quit to give them long and fruitful lives, it is time to cast aside this aversion to the innovations of the market. The future health of our nation depends on it.

Yaël Ossowski is deputy director at the Consumer Choice Center

The Myth of the Vaping Crisis is Sparking a New War on Flavored Nicotine Products – And That Harms Consumers

In the backdrop of a very busy Congress, members of the U.S. House are pushing a bill that would eradicate entire categories of flavored nicotine products.

This sweeping ban would directly harm consumers who use menthol tobacco, flavored cigars, snus, and vaping products by outlawing the products they use and pushing them to the black market.

The proposed law comes in the wake of the much-hyped “vaping crisis” that transpired over the summer, in which thousands of individuals suffered lung damage from inhaling vapor products, also called e-cigarette, or vaping, product use-associated lung injury (EVALI).

In the end, the culprit was revealed to be illegal cannabis vaping cartridges loaded with Vitamin E acetate and not nicotine vaping products, according to the Centers for Disease Control.

Read the Consumer Choice Center Policy Primer: Myths and Facts on Vaping: What Policymakers Should Know

Though scientific experts correctly identified the cause of the injuries – black market THC cannabis vape cartridges – that hasn’t stopped legislators from using that pretext to introduce new prohibitions on flavored tobacco products used responsibly by adult consumers.

H.R. 2339, named the Reversing the Youth Tobacco Epidemic Act of 2019, proposes several sweeping changes to flavored consumer products and is expected to soon hit the House floor for a vote.

The bill would outlaw the following:

  • Menthol products
  • Flavored cigars and cigarillos
  • Flavored smokeless tobacco, known as snus or dip.
  • Some flavored vaping products

The goal is to significantly reduce or eliminate youth use of these products, which is a noble pursuit.

But youth smoking is at an all-time low

Fewer young people than ever are using traditional tobacco products – less than 2.3%. That’s a significant decline since the year 2000, where nearly 15% of minors smoked cigarettes, according to the CDC.

  • This represents a public health victory, and one that has been achieved with sensible education, regulation, and innovation. The same is true for adult smokers. Just 13.7% of adults currently smoke, the lowest number ever recorded.
  • The latest CDC figures show that 20.8 percent of high schoolers have vaped at least once in the last 30 days. But 7 to 8% of those were vaping cannabis rather than nicotine.
  • A total flavor ban on all tobacco products and vaping products for adults would do little to curb use among youth.
  • It may even exacerbate the problem and only punish lawful adult consumers and deprive them of their choice, not to mention devastate the communities that rely on tobacco taxes to fund important social programs.

What’s more, by categorizing non-tobacco vapor products as tobacco products, House members are attacking the very innovation that has led to the lowest-ever figure of recorded tobacco use.

Prohibition Hasn’t Worked

The 100-year anniversary of the passage of Prohibition of alcohol took place last month.

  • All these years later, we know that outlawing certain consumer products does not eradicate their existence. Rather, it moves them from the legal, regulated market to the illicit and unregulated black market.
  • This makes the products themselves less safe, and the trade around those products even more dangerous.

After an entire nation had awoken to the disaster of Prohibition, it was successfully repealed in 1933.

Minorities are more likely to use menthol products

According to the CDC, African-Americans who use tobacco are 90% more likely to favor menthol products and represent the vast majority of consumers in the flavored tobacco market.

  • A ban would create an illicit market without regulations or ID checks
  • Such bans would then force police officers to crack down on illicit menthol cigarette trade, further straining relations between the African-American community
  • As seen in the case of Eric Garner, who was choked out by a police officer and later died in New York City for selling loose cigarettes on the street, bans and restrictions that create illegal markets can lead to devastating consequences.
  • If a law bans menthol and flavored tobacco products, the demand wouldn’t disappear.

Rather, it would be pushed into the unregulated market, siphoning away tobacco taxes and incenting police officers to use their power to enforce laws in minority communities.

Age-restriction by law is a powerful means of dissuading youth use

By penalizing convenience retailers that sell to minors, regulators have already created a significant barrier to youth access.

  • This allows law enforcement to prosecute bad actors and focus their efforts on illicit markets where dealers don’t ask for ID.
  • Recently, Congress’ raising of the age to purchase tobacco and vaping products to 21 years old also dissuades youth use, ensuring no high schooler will be able to legally purchase these products.
  • Nearly half of tobacco and vape shops don’t ID young customers.

Enforcing existing laws on youth access, including prosecuting shops that don’t check ID, are a powerful means of keeping youth away from tobacco products.

Bans Deny the Science on Harm Reduction by Vaping and Smokeless Products

For many adult smokers looking to quit, vaping products have been proven key to harm reduction.

  • About 4.4% of adults, nearly 11 million, are now using vaping devices
  • National health bodies around the world, including Public Health England, the New Zealand Ministry of Health, and Health Canada have endorsed vaping as a smoking cessation method.
  • The U.K.’s top health body has repeatedly said that vaping and e-cigarettes are 95 percent less harmful than smoking.
  • Bans that include flavored vaping products would deprive adult smokers of a less harmful method of consuming nicotine

We all have an interest in eliminating the number of young people who take up smoking. But counterintuitive bans would make that goal harder, not easier to achieve.

And depriving adult consumers of harm reducing technologies like flavored vaping products will reserve the decades of public health successes.

Let’s hope our members of Congress consider these facts before they vote on H.R. 2339.

Download the full policy note here.

Yes, The FDA Is In Trouble, But The New York Times’ Prescription Would Make It Worse

The FDA’s failures are a result of too much regulatory dithering and bureaucracy. Yet the Times’ prescriptions for change would just increase the dose.

A recent New York Times editorial about the Food and Drug Administration (FDA) reflects a systematic weakness at the once-venerable Gray Lady: The members of the editorial board often rely on sloganeering and popular wisdom instead of substantive evidence.

The editorial was headlined, “The FDA Is in Trouble. Here’s How to Fix It.” The agency is in trouble. But it’s due to the very kinds of “fixes” the Times recommends.

The FDA is highly bureaucratic and risk averse, leading to a slow and expensive drug approval process—at last count, more than $2.5 billion to bring a new drug to market. Yet the armchair quarterbacks at the Times want to slow it down even more and increase the cost and risks of innovating.

Supposedly, too many drugs are being approved “with too little data on how safe or effective they are,” according to the editorial. More specifically, regulators have supposedly made “compromises” by accepting “surrogate evidence” of efficacy.

In fact, there are good reasons that the clinical testing of new drugs can be accomplished with fewer and smaller trials. We are entering the era of precision, or personalized, medicine, the mantra of which is “the right dose of the right drug for the right patient at the right time.”

It reflects that treatments are gradually shifting from a relatively imprecise one-size-fits-all approach to a more personalized one, so patients can be matched to the best therapy based on their genetic makeup, the specific characteristics of their illness, and other predictive factors. This enables doctors to avoid prescribing a medication that is unlikely to be effective or that might cause serious side effects in certain patients.

How Smaller Trials Can Be More Accurate

The editorial ignores that those factors make possible drug testing in smaller, better-targeted populations. That is not a completely new concept. Under appropriate circumstances, the FDA has long used fewer and smaller clinical trials as the basis for approval.

What makes that possible is that medical research is increasingly discovering biological indicators, or “biomarkers”—such as variants of DNA sequences, the levels of certain enzymes, or the presence or absence of drug receptors—that can dictate how patients should be treated and to predict the likelihood that the intervention will be effective or elicit dangerous side effects.

Using biomarkers enables drug companies to better select patient populations for clinical trials to demonstrate efficacy. The reason is related to the statistical power of clinical studies: In any kind of experiment, a fundamental principle is that the greater the number of subjects or iterations, the greater the confidence in the results. Conversely, small studies generally have large uncertainties about results—and that is where biomarkers can make a difference.

By better defining the experimental groups, such as limiting the trial only to patients with a certain mutation in their genome or tumor, they can help drugmakers design clinical studies that will show “a high relative treatment difference” between the drug and whatever it is being compared to (often a placebo, but sometimes another treatment).

For example, a 2018 study of patients with certain rare pancreatic or gastrointestinal cancers found that analyzing the “protein-signaling networks” in the tumors could identify regulators of tumor survival. The researchers were then able to test the effect of various drugs on these regulators. That enabled them to predict in many patients which drugs would be effective in the tumors—the kind of precision oncology that makes possible smaller clinical trials.

Whiffing on Needed Critiques of the FDA

The Times editorial faulted the FDA for “its roles in the opioid epidemic (regulators allowed too many opioids on the market without properly flagging them as addictive or deadly),” but, in fact, the regulators did ensure that the drugs were safe and effective when used according to the labels, which do, in fact, warn about addiction potential. Analogously, can the Bureau of Alcohol, Tobacco, Firearms and Explosives be blamed for many Americans suffering from alcoholism?

Criticizing the FDA for its handling of e-cigarettes is easy. But the Times editorial even got that wrong, echoing the calls of prohibitionists to ban the sale of these products to adult smokers, rather than aggressively enforcing the existing ban on sales to minors.

The Times could have landed a powerful science-based critique of the agency for perpetuating the activist-created myth that nicotine e-cigarettes had anything to do with the past year’s lung disease outbreak, which was caused by adulterated THC oils, not nicotine vapes. By incorrectly blaming e-cigarettes for the illnesses, the FDA’s misinformation prevented countless adult smokers from switching to a truly less harmful alternative. The Times failed to hold the agency accountable for not telling the truth when it mattered most.

The Times editorial accuses the agency of having become “too susceptible to outside pressure,” which most FDA-watchers find to be groundless. If FDA has favored any special interests, they are “progressive” ones, including the organic food industry, which has systematically violated regulations concerning “absence claims” on labels (such as “GMO free”), and by acceding to the demands of “public health advocates” who reject harm reduction policies toward e-cigarettes. The remedy for such failings is better, smarter management.

The FDA Needs a Diet, Not More Money

The Times editorial claims the FDA “has too few resources and too little power to fulfill its key responsibilities.” The facts argue otherwise. According to the Congressional Research Service:

Between FY2015 and FY2019, FDA’s enacted total program level increased from $4.507 billion to $5.725 billion. Over this time period, congressionally appropriated funding increased by 21%, and user fee revenue increased by 35%. The Administration’s FY2020 budget request was for a total program level of $5.981 billion, an increase of $256 million (+4%) over the FY2019 enacted amount ($5.725 billion).

More important than the raw numbers is how FDA’s resources are being used. The agency has become extremely top-heavy, with ever more boxes appearing at the top of the organizational chart, even though the vast majority of day-to-day oversight and regulatory actions are taken at the level of FDA’s various “centers”—the Center for Drug Evaluation and Research, Center for Food Safety and Nutrition, and so on. The FDA needs to be put on a diet, not to have additional “resources.”

The Times editorial endorsed a recent proposal to convert FDA from a component of the Department of Health and Human Services to an independent agency. That would be a prescription for disaster. Political meddling with the agency’s decisions has been extremely rare in recent years, and the genuine calamities in which the FDA has been involved have been self-inflicted wounds that might have been avoided with more, not less, accountability and oversight.

Three distinguished former federal officials presented in the journal Health Affairs compelling procedural arguments against making FDA an independent agency. As an independent agency, they said, FDA would not be bound by the policies of the Department of Justice, potentially leading to inconsistent positions being taken by different parts of the government on issues that could include foreign policy.

Furthermore, they point out, applying a consistent approach to rulemaking as required by working within Health and Human Services and Office of Management and Budget strictures is a useful check on highly expensive or wrong-headed regulation. “It’s also a way that Congress and the president can ensure consistency across government in the application of expertise in regulatory policy,” they wrote.

The FDA’s failures are a result of too much regulatory dithering and bureaucracy. Yet the Times’ prescriptions for change would just increase the dose.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

Trump’s Vape Pod Flavor Ban is Just Another New Year’s Hangover

Trump’s Vape Pod Flavor Ban is Just Another New Year’s Hangover


Washington, D.C. – As millions of Americans awoke on New Year’s Day, we learned the Trump Administration and the FDA will soon present a ban on all flavors except tobacco and menthol in pod-based vaping devices.

Though the ban is not as sweeping as first rumored, it will still deprive millions of adults of the harm-reducing flavors they have enjoyed to switch away from using cigarettes.

Yaël Ossowski, deputy director of the D.C.-based Consumer Choice Center, said a ban of this magnitude is still bad public policy, and deprives adults of more options for harm reduction.

“To be clear, the new policy is less egregious than a blanket ban or a ban on the open systems favored by advanced vapers. But it still denies the science on harm reduction and the reality of using flavors to convince adults to switch to less harmful methods of consuming nicotine,” said Ossowski.

“Pod-based devices are popular among former smokers because they’re portable, easy to maintain, and provide just the right amount of nicotine and taste to keep them away from normal combustible cigarettes. Flavors are instrumental to that equation.

“The debate on flavors has been framed by the radical tobacco control groups who need a new enemy. It’s unfortunate that vaping, which has been proven to be 95% less harmful than smoking, will now become less available to the people who need it the most.

“The facts are on the side of those who champion harm reduction and consumer choice. And in this case, because of the myths peddled by well-funded tobacco control groups, an innovative technology that has saved and will save millions of people has been demonized.

“We have a system in our country to age-prohibit certain goods like alcohol and tobacco. Rather than taking away options from adult consumers, we should investigate why kids are getting their hands on their devices and pods in the first place, and concentrate resources there instead of resorting to outright bans.

“It’s more a question of enforcement than a question of whether flavors should exist at all.

“Yet more prohibitions will only embolden sellers and dealers on the black market, who were the main culprits in the much-hyped vaping “crisis” of last year, and unlike traditional retailers and vape shops, don’t ask for ID.

“We need to continue fighting for effective harm reduction, and that won’t end here,” said Ossowski.

Check out the CCC’s Top Myths and Facts on Vaping here.

CONTACT:
Yaël Ossowski
Deputy Director
Consumer Choice Center
yael@consumerchoicecenter.org

###

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. 

We represent consumers in over 100 countries across the globe and closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org.

Vaping is a more effective smoke reduction tool than government policies

Middle schoolers, high schoolers, and university students have increased their use of e-cigarettes, despite rising public concern. While underage nicotine consumption and smoking-related lung disease deaths are a real problem, legal vaping products, and accurate consumer information can combat instead of worsen these effects. We should welcome the presence of alternatives to tobacco, and endorse safe, and legal options.

At the beginning, there were the strange cigarette look-alikes that light up as you took a drag. Now, the e-cigarette market has expanded to include safer alternatives, ranging from popular Juul products to vapes the size of a pistol grip. In Europe, the so-called “heat-not-burn” also constitutes a new type of vape, by heating up the tobacco instead of burning it, thus avoiding the more unhealthy effects of tobacco combustion. The idea that these alternatives are a good thing will raise eyebrows for many, and rightfully so. If you’ve followed the health scare surrounding vaping, you’d think that the mere thought of encouraging e-cigarettes is problematic.

While no potentially harmful product should ever be encouraged, we should recognize its harm-reducing effects. The UK’s Department of Health and Social Care, Public Health England, assessed in 2015–confirmed since then–that vaping is at least 95% less harmful than smoking conventional cigarettes. Between 2011 and 2017, the number of smokers in the UK fell from 19.8% to 14.9%. At the same time, the number of e-cigarette users rose: almost half of these consumers use e-cigarettes as a means of quitting smoking. The UK is an example that shows how a permissive vaping policy is better at helping those who want to quit smoking.

On the other hand, the US Food and Drug Administration, as well as most European nations, have released serious public health warnings regarding vaping. A recent spike in vaping-related lung illnesses has made officials afraid of the rise of e-cigarettes. Symptoms of those affected by recent illnesses include trouble breathing, chest pain, fatigue, and vomiting. About half the patients are teenagers or young adults.

Here is where giving the full picture is important.

The two main ingredients used in vape liquids, propylene glycol (PG) and vegetable glycerin (VG), are used to form their vapor and add flavor. Added to these two ingredients is a third, usually a common food flavoring found in cakes, oils, and other food items. All of these compounds are common food ingredients that are deemed healthy and safe by regulatory bodies including the FDA. Other variable ingredients include the stimulant alkaloid nicotine. Although not all vape liquids contain nicotine, the addictive chemical is the main draw for smokers that want to quit smoking. Compared to other alternatives, like the Nicotine Replacement Therapy patches and drugs, vaping has been found to be more effective.

On Dec. 6, the Center for Disease Control (CDC) released a report which uncovered that none of the patients affected in recent cases had used conventional nicotine vapes. Most of the affected consumers had used black-market THC products—many in states that have not legalized marijuana. In most of these terrible cases of vaping-related lung disease, Vitamin E has been found in these moonshine liquids. Vitamin E is very harmful when inhaled.

In Europe, more countries are approaching the issue from a different direction. Portugal’s Directorate-General for Health released a statement saying users should refrain from modifying their e-cigarette liquids or add any substances that aren’t legally marketed and labeled. That is certainly a more consumer information-based approach than the state of Michigan, which decided to ban flavored vaping outright (at least as a temporary measure).

If we want to combat deaths arising from black market products, we have to embrace safe legal products. A legal and regulated market is the best method for rooting out bad products and actors. A ban on flavored liquids will only drive those who wish to use flavored vaping products to the black market, or back to cigarettes. Recent studies have shown that if vaping products are outlawed, current vapors are more likely to return to smoking. That would be very consequential for public health.

A lot of myth-busting needs to be done on the issue of e-cigarettes. More than that, however, let’s just consider what harm-reducing products have actually done. The government has tried for decades to get people to stop smoking. In order to do that, it has utilized paternalistic policies, like taxation, restrictions on packaging and sales, which have all been shown to be ineffective. All reduction in cigarette sales has been offset by a spike in black market sales. In this shadow economy, consumers are being misled, and people get hurt.

We need to encourage the marketing and branding of safe and legal vaping products. Consumer information is necessary in order to crowd out dangerous black market products.

Vaping has achieved what decades of government policies couldn’t–gave consumers a viable alternative. This type of innovation should be celebrated, not reprimanded.

Originally published here.

The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

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