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Harm Reduction Campaign

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

E-Zigarette: Dem süßen Dampf eine Chance geben

E-Zigaretten und „Heat-not-burn“-Produkte erlauben weniger schädliche Wege Nikotin zu konsumieren, geraten allerdings zunehmend unter politischen Druck. Von unserem Gastautor Bill Wirtz.

Sie sehen aus wie USB-Sticks oder Feuerzeugasbehälter, riechen oft süß und stoßen manchmal große weiße Wolken aus. Viele Ex-Raucher machten den Sprung weg vom Glimmstängel zu E-Zigaretten. Dieses dampfende Produkt profitiert von motivierten Befürwortern und leidet unter uninformierten Politikern. Die Frage im Vordergrund bleibt, ob diese Alternative besser für Raucher ist.

Die Aussage, dass E-Zigaretten 95% weniger gesundheitsschädlich als konventionelle Zigaretten sind, stammt nicht aus einer Werbung von den Produzenten selbst, sondern von Public Health England (PHE). PHE ist Teil des britischen Gesundheitsministeriums und beschäftigt sich täglich mit den Gesundheitsfolgen von Konsumgütern.

Neuere Ergebnisse, die in den Annals of Internal Medicine veröffentlicht wurden, zeigen, dass langfristige E-Zigaretten-Nutzer, umgangssprachlich auch gerne Dampfer genannt, einen zwanzigmal niedrigeren Wert an krebserregenden Bestandteilen aufweisen. Dampfer zeigen auch viel niedrigere Werte für weitere tabakspezifische Giftstoffe, die zwei bis fünfmal unter denen der konventioneller Raucher liegen. Wer als Raucher Angst vor den möglichen Risiken einer Zigarette hat, kann E-Zigaretten-Flüssigkeiten (“e-liquids”) kaufen die lediglich Nikotin enthalten.

Doch wissenschaftliche Fakten schaffen es nicht immer in die öffentliche und politische Debatte. Für viele Gesundheitsaktivisten ist klar, dass auch bei diesen risikomindernden Produkten ein starkes Zeichen gesetzt werden muss. Resultat: Obwohl E-Zigaretten gänzlich andere Produkte sind, werden sie zunehmend wie Tabak reguliert. Der Kabinettschef des EU-Gesundheitskommissars Vytenis Andriukaitis, meint die Regulierung für E-Zigaretten in der Europäischen Union sollte gleich sein, wie die gewöhnlichen Tabaks. Er sagt dazu:

„Wir werden mit Fragen über gesündere Möglichkeiten etwas in die Lunge zu inhalieren bombardiert. Eine fremde Substanz in die Lunge zu bekommen, ist einfach nicht gesund.“

Oft wird bei Menge und Einnahmemedium kein Unterschied gemacht. So fallen ironischerweise auch die tabakfreien elektronischen Zigaretten unter die EU Tabakdirektive.

Bei der UN Welttabakkonferenz, die letztes Jahr in Genf stattfand, wurden E-Zigaretten explizit nicht als Alternative gepriesen. Ganz im Gegenteil, Anne Bucher, EU-Generaldirektorin für Gesundheit, sagte dort ebenfalls, dass es keinen Unterschied zwischen E-Zigaretten und konventionellen Zigaretten gibt.

Aus dem Nanny State Index on Nicotine des Institute of Economic Affairs geht hervor, dass Schweden, Großbritannien, Tschechien, Deutschland und die Niederlande die liberalste Politik gegenüber E-Zigaretten betreiben. Die Schweiz hingegen schneidet sehr schlecht ab, vor allem durch das Verbot gegen nikotinhaltige E-Zigaretten. Der Verkauf ist nicht erlaubt – importiert werden dürfen nur 150 ml alle 60 Tage. Norwegen wird diese Produkte demnächst erlauben (die Gesetzgebung ist hier bereits in Arbeit) und damit wird die Schweiz das einzige europäische Land sein, das ein komplettes Verbot pflegt.

Natürlich kann man sagen, dass man am Besten einfach ganz mit dem Rauchen aufhört. Doch komplette Abstinenz ist für viele Raucher einfach nicht möglich. Entweder weil sie es nicht wollen, oder weil die Aufgabe von Nikotin zu schwierig ist. Sogar in extremen Situationen, wie die erzwungene Einstellung des Rauchens im Gefängnis, zeigt sich, dass Inhaftierte auch nach mehreren Monaten in Haft, in der Freiheit wieder mit dem Rauchen anfangen. Wenn man „einfach aufhören“ könnte, würde die Empfehlung einen Arzt zur Rauchentwöhnung zu befragen (so wie es heute auf vielen Zigarettenschachteln steht), nicht sonderlich viel Sinn ergeben. Wir wissen inzwischen ebenfalls, dass das “vaping” bei der Rauchentwöhnung besser abschneidet als konventionelle Methoden wie z.B. Nikotin-Pflaster.

Wer nikotinhaltige E-Zigaretten verbietet, muss damit rechnen, dass Raucher wieder auf die normale Zigarette umsteigen. Und das kann ja nicht das Ziel moderner Gesundheitspolitik sein. Verbote von E-Zigaretten führen dazu, dass viele Verbraucher sich wieder dem altbewährten Glimmstängel zuwenden. Gerade Großbritannien zeigt, dass eine liberale Dampfpolitik die klassische Zigarette besser abgewöhnt. Zwischen 2011 und 2017 ist die Raucherzahl in Großbritannien von 19,8% auf 14,9% gesunken. Gleichzeitig stieg die Zahl der E-Zigaretten Nutzer: Fast die Hälfte dieser Verbraucher nutzen E-Zigaretten als Mittel zur Rauchentwöhnung.

Der Markt bietet Rauchern nun eine Alternative, die bezahlbar und angenehm ist und zudem noch weitaus geringere Risiken mit sich bringt. Anstatt alles zu tun, um diese Alternative mit Überregulierung zu überschütten, sollte die Politik Verbrauchern erlauben Zugang zu diesen innovativen Nikotinprodukten zu haben.

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 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.

Originally published here.

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.

The Deep State Will Challenge the New FDA Head

FDA

If we are to realize the kind of aggressive, innovation-promoting deregulation called for by President Trump, Stephen Hahn (FDA) will need to disrupt the agency’s built-in bias for overregulation.

Now that the Trump Administration’s new FDA commissioner, Dr. Stephen Hahn, has been confirmed, he’ll find he has one of the most difficult and important jobs in government. The FDA’s purview is wide, regulating pharmaceutical and other medical, food, and vaping products that account for more than 25 cents of every consumer dollar, over a trillion dollars annually.

Government regulation offers some reassurance to the public, to be sure, but when it is wrong-headed or merely fails to be cost-effective, it actually costs lives—directly by withholding life-saving and life-enhancing products, and also indirectly by diverting societal resources to gratuitous regulatory compliance.

Dr. Hahn is inheriting an organization that is huge, critical, and dysfunctional. The stakes are high. For example, FDA has pushed the average cost (including out-of-pocket expenses and opportunity costs) to bring a new drug to market to over $2.5 billion. That ensures that many new drugs will have a hefty price tag, and that others will never be developed at all.

Putting FDA on the right track will require toughness and discipline at an agency where more than 99.9 percent of the employees are civil servants who cannot be fired even for incompetence or insubordination. (Did we hear someone mutter, “deep state?”)

Government regulators have vast power and wide discretion; unfortunately, the incentives that guide them are perverse.

The late, great economist Milton Friedman observed that to gain insight into the motivation of an individual or organization, look for the self-interest. So, where does the self-interest of regulators lie? Not necessarily in serving the public interest, alas, but in expanded responsibilities, bigger budgets and grander bureaucratic empires for themselves.

Former FDA Commissioner Frank E. Young once quipped that “dogs bark, cows moo, and regulators regulate.” Consistent with that propensity, FDA has sometimes exceeded its congressional mandate. Regulators have concocted additional criteria for marketing approval of a new drug—above and beyond the statutory requirements for demonstrating safety and efficacy—that could inflict significant damage on both patients and pharmaceutical companies.

For example, they have arbitrarily demanded that a new drug be superior to existing therapies, although the Food, Drug and Cosmetic Act requires only a demonstration of safety and efficacy. And Phase 4 (postmarketing) studies are now routine, whereas the FDA used to reserve them for rare situations, as when there were subpopulations of patients for whom data were insufficient at the time of approval.

The effects of FDA regulators’ self-serving actions range from the creation of disincentives to research and development (which inflates their costs) to significant threats to public health, such as the years-long delay in approval of a much-needed meningitis B vaccine.

Another egregious example of the impact of excessive risk-aversion is the sorry saga of a drug called pirfenidone, used to treat a pulmonary disorder called idiopathic pulmonary fibrosis (IPF), which used to kill tens of thousands of Americans annually. The FDA unnecessarily delayed approval of the drug for years, although it had already been marketed in Europe, Japan, Canada, and China. During the delay, more than 150,000 patients died of IPF in the United States, many of whom could have benefited from the drug.

Many years of fat budgets have enabled the FDA to waste resources. In 2017, for example, the agency sought public comments about its use of focus groups, claiming they “provide an important role in gathering information because they allow for a more in-depth understanding of patients’ and consumers’ attitudes, beliefs, motivations, and feelings.” FDA officials seem to have forgotten that their mission is to make science-based decisions—primarily about product safety, efficacy, and quality—as expeditiously as possible, whatever the public’s beliefs, motivations, and feelings may be.

A particularly dubious policy is the FDA self-declared jurisdiction over all “genetically engineered” animals. Subsequently, the agency then took more than 20 years to approve the first one—an obviously benign, fast-growing salmon—and then made a colossal mess of the five-year review of a single field trial of a mosquito to control the mosquitoes that transmit the Zika, yellow fever, dengue fever, and chikungunya viruses. Eventually, the FDA relinquished jurisdiction over that mosquito and other animals with pesticidal properties to the EPA, where they belong.

We need structural, policy, management, and cultural changes that create incentives for FDA to regulate in a way that is evidence-based and imposes the minimum burden possible. A number of possible approaches and remedies to accomplish that have been described, ranging from radical to more conservative.

Significant legislative changes, or even meaningful congressional oversight, would go a long way toward reining in an agency so culturally invested in more regulation. But political realities make this unlikely anytime soon.

If we are to realize the kind of aggressive, innovation-promoting deregulation called for by President Trump, Hahn will need to disrupt the agency’s built-in bias for overregulation.

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

Vaping ban in Alberta would harm public health

Alberta should rise above the vaping hysteria and follow harm reduction principles when developing regulations on e-cigarettes.

There’s a panic brewing about the use of e-cigarettes following reports by the Centre for Disease Control and Prevention (CDC) that hundreds vapers in the US have contracted severe lung injuries, with a handful of fatalities. Politicians responded quickly to the reports, and several states moved forward with vaping regulations. These ranged from bans on flavoured vaping products in New York to a four month ban on all vaping products in Massachusetts. However, a later report by the CDC in November revealed that none of the recent patients with lung injuries had used conventional nicotine vapes, but instead used black-market THC products – many in states where marijuana is illegal. 

Unfortunately, various Canadian provinces have put further vaping regulations on the agenda. Nova Scotia has banned all flavoured e-cigarettes and vaping juice as of April 1st, and Ontario is considering a similar ban. So far, it looks like Alberta is headed down a similar path. Health Minister Tyler Shandro has committed to developing regulations on vaping products as part of a review of the province’s tobacco and smoking laws, with the hope that any amendments will be in place by spring 2020. It would be misguided for Alberta to follow the bad policies that have been proposed and implemented in the US, in Canada, and abroad.

If our goal is to save lives, it is important to compare the harms caused by vaping products with their closest substitute: cigarettes. Acomprehensive report by Public Health England suggests that while e-cigarettes are not risk-free, they are comparatively much safer than traditional cigarettes. While it is nicotine that causes cigarette addiction, it is the thousands of other chemicals contained in cigarettes that causes almost all of the harm. E-cigarette vapour does not contain tar or carbon monoxide, which are two of the most harmful components of tobacco smoke. While e-cigarette vapour does contain some of the chemicals also found in tobacco smoke, they are present at much lower levels. Additionally, Public Health England reports that in a recent study, cancer potencies of e-cigarettes were under 0.5 per cent of the risk of smoking. For these reasons, Public Health England’sadvice on vaping remains unchanged: “There is no situation where it would be better for your health to continue smoking rather than switching completely to vaping”.

This is especially important considering that most people who use e-cigarettes are current or former smokers. Arecent survey administered by Statistics Canada found that among people who had used e-cigarettes in the past 30 days, 65 per cent were current smokers and 20 per cent were former smokers. If vaping products were banned or regulated in a way that made them difficult to access, it is reasonable to suggest that these people would increase their use of traditional cigarettes. For this reason, stock prices of cigarette manufacturers jumped when India announced they would enact a vape ban. This response is in large part because there is evidence that e-cigarettescan be used as a cessation mechanism. Restricting access to e-cigarettes may be in effect taking away a tool that helps people quit smoking.

Even if e-cigarettes were as dangerous as their critics say, there is no reason to believe that restricting access to them would be good public policy. One of the main lessons from the war on drugs is that if there is demand for a product, it will be sold regardless of its legal status. Banning flavoured e-liquids or significantly limiting access will only create an unregulated black market for the product, exacerbating any existing safety concerns. E-cigarette users will no longer be able to have confidence in the safety of their products. 

In fact, the very hospitalizations that inspired the recent panic over vaping products are a testament to the dangers of drug prohibition. In November, the CDC linked the hospitalizations to vitamin E acetate, which is not found in legal e-cigarettes. However, it is often used by drug dealers to cut THC vape cartridges in an attempt to increase their profits. These products are illicit and thus unregulated in the United States. In Canada, THC vaping products were only just legalized, and nothing legally for sale in Canada contains vitamin E acetate. If vaping products are banned, we should only expect more harmful additives in an unregulated black market. 

Despite the facts, political responses to the CDC’s report have been anything but measured, and it would be misguided for Alberta to follow suit. Moving to ban flavoured e-liquids, or even worse, e-cigarettes in general, is a trigger-happy response that flies in the face of existing evidence about vaping as a harm reduction tool. Blanket bans on vaping are bad public policy and bad science, and will only serve to harm millions of vapers and harm public health. Alberta should rise above the vaping hysteria and follow harm reduction principles when developing regulations on e-cigarettes. 


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

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

Banning Cannabis Vape May Lead to Bigger Black Market Problem, Warns Consumer Choice Center

The Consumer Choice Center says the province’s cannabis vape ban is a dangerous mistake.

The provincial government on Wednesday announced that it is not going to allow the sale of cannabis vape products in Newfoundland and Labrador – at least for the time-being.

David Clement of the Consumer Choice Center, an anti-regulation non-profit organization, says the move to ban cannabis vape devices does more harm than good, and will put consumer safety at risk.

Clement says available evidence shows that severe lung illnesses from vaping are being caused by illegal vape products with harmful and prohibited additives, that are not in legal products.

He says the ban prevents legal and compliant products from stamping out the black market alternatives that are hurting people, making the problem worse.


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

Elizabeth Warren Outraged by Social Media Bans She Champions

In a tweet she published on Tuesday, Democratic Presidential Candidate Sen. Elizabeth Warren blasted Twitter’s new ad policy that won’t approve any political advertising.

The problem with Sen. Warren’s outrage is that she herself is a champion of breaking up social media networks as an end goal, and restricting political advertising in the meantime.

Therefore, when such policies are then implemented by social networks as a way to placate political interests and ensure good relationships with lawmakers, shouldn’t that be celebrated?

It seems Warren is upset that the policy affects more people than those she intended.

Here is a good lesson in advocating public policies and regulations that affect real people: they actually affect, and sometimes harm, real people.

Because regulations are rules that impact everyone and considering that these regulations are promoted as part of a candidate’s platform, it doesn’t take much to understand that ordinary groups, charities, and organizations will actually end up getting penalized. Noble intentions are great, but the actual impact is what matters.

This is something we’ve discussed before, and we’d advocate against.

The Consumer Choice Center, the consumer organization I work for, now won’t be allowed to make ads because Twitter’s algorithms consider our content “political advertising,” even though we do not endorse candidates. We discuss ideas and advocate for ideas that promote consumer choice.

Bans on political advertising, as promoted by Warren, are effectively an attempt to regulate speech, albeit in the private sphere. And not just the speech of the fossil fuel companies or political candidates from parties she deplores.

It also affects environmental groups, pro-LGBT groups, political clubs, NGOs, and everyday civil society organizations like ours.

Let that be a warning to those who promote tech regulation that stifles speech. It won’t just be speech that you don’t like that will end up censored, but all political speech. That’s bad for ordinary social media users, and it’s bad for well-meaning organizations who are just trying to spread a message.

For more, check out this Consumer Choice Center poll that shows that 77% of Americans believe government should not interfere with newer tech-enabled businesses where possible to ensure consumers have the greatest possible choice of services.

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