In a Surprise Move, the FDA Denies Approval for Juul Tobacco and Menthol Vapes

“After nearly two years of review, the Food and Drug Administration (FDA) is preparing to deny Juul’s application to keep its tobacco- and menthol-flavored vaping products on the market, according to reporting from The Wall Street Journal. The news is surprising; when compared to competitors’ applications, Juul’s was one of the most detailed and data-heavy, showing just how effective it was at transitioning smokers away from cigarettes, toward a safer alternative.”

“But what appeared to be a classic Silicon Valley success story soon became a victim of an intensely ideological war on nicotine. Unfortunately, Juul also for a time became the most popular product among minors who were experimenting with vaping. Youth vaping rates rose substantially. Current e-cigarette use, defined as taking a puff or more in the past 30 days, jumped from 11.7 percent in 2017 to 27.5 percent in 2019.

Juul was squarely blamed for the rise of youth vaping, with critics pointing to its initial marketing campaigns showing people in their early twenties enjoying the product. Critics alleged that flavors like mango and cucumber were especially appealing to the younger demographic. But what they forget is that in late 2016, the company switched to exclusively using models who are 35 or older in their advertising campaigns, as well as only using real customers who have switched from smoking to vaping. What anti-vaping campaigners also ignore is that the vast majority of adult vapers quit smoking using sweet or fruity flavors; such products are not just desired by teens.

The claim that Juul’s flavors were the underlying cause for the rise in youth vaping is highly dubious, considering there were thousands of different flavors for other e-cigarettes on the market years before Juul took off. Surveys of teenagers by the Centers for Disease Control and Prevention show that just 13.2 percent of young people who use e-cigarettes say they do so for the flavors. Experimentation with e-cigarettes mimics other behaviors like alcohol and illicit drug use, often with the same populations engaging in these types of activities. But to appease critics, Juul voluntarily removed all flavors other than tobacco and menthol from the market in 2019.”

“In 2020, the Cochrane Review, widely considered the gold standard for evaluating evidence-based medicine, concluded that e-cigarettes are more effective than traditional nicotine replacement therapies for helping smokers quit. By banning the most effective and popular e-cigarette on the market, there is no doubt that the FDA’s choice will force a portion of current Juul users to go back to smoking, and an unknown number of smokers to never make the healthier switch to vaping. What economist Alex Tabarrok calls the FDA’s “invisible graveyard” just got a whole lot bigger.”

The FDA’s Menthol Cigarette Ban Is a ‘Racial Justice’ Issue, but Not in the Way Its Supporters Mean

“Supporters of the ban on menthol cigarettes that the Food and Drug Administration (FDA) proposed today say it is “a racial justice issue.” They are right about that, but not in the way they mean.

What they mean is that 85 percent of black smokers prefer menthol cigarettes, compared to 30 percent of white smokers. “The number one killer of black folks is tobacco-related diseases,” Phillip Gardiner, a tobacco researcher and activist, told Slate’s Julia Craven after the FDA announced plans for the ban last year. “The main vector of that is menthol cigarettes and flavored cigars.”

The FDA’s proposed rule would ban both, which the agency says will “address health disparities experienced by communities of color.” Action on Smoking and Health welcomed the FDA’s ban, calling it “a major step forward in Saving Black Lives” and averring that “menthol advertising violates the right to health of Black Americans.”

Although menthol and nonmenthol cigarettes pose similar hazards, the FDA says menthol makes smoking more appealing and harder to quit. As Guy Bentley, director of consumer freedom at Reason Foundation (which publishes this website), noted this week, the evidence on the latter point is mixed. But even if it were clear that menthol smokers are less likely to quit, that would not necessarily mean menthol cigarettes are inherently more “addictive.” That debate tends to obscure the tastes, preferences, personal characteristics, and circumstances that are crucial to understanding why some people never smoke, some start but eventually quit, and others continue smoking.

As the menthol ban’s proponents see it, even the choice to start smoking is not really a choice, because consumers—in this case, black consumers in particular—are no match for Big Tobacco’s persuasive wiles. Gardiner cites the industry’s history of “predatory marketing,” while the anti-smoking Truth Initiative condemns “relentless profiling of Black Americans and vulnerable populations” by brands like Kool, Salem, and Newport.

That’s one way of looking at it. Here is another: The federal government is targeting the kind of cigarettes that black smokers overwhelmingly prefer, precisely because black smokers overwhelmingly prefer them. The FDA also worries that menthol cigarettes appeal to teenagers, another “vulnerable population.” Public health officials are thus treating African Americans like children in the sense that they don’t trust either to make their own decisions.

“The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” says Secretary of Health and Human Services Xavier Becerra. “Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities.” The FDA notes “particularly high rates of use by youth, young adults, and African American and other racial and ethnic groups.”

The federal government is implicitly denying the moral agency of black people, suggesting that they, like adolescents, are helpless to resist the allure of “predatory marketing” or the appeal of menthol’s minty coolness. In the FDA’s view, persuasion is not enough to break Big Tobacco’s spell; force is required.”

Biden’s Baby Formula Airlift Stunt Should Never Have Been Necessary

“America’s current shortage of baby formula is a crisis created, in significant part, by the failures of government policy aimed at protecting domestic companies from foreign competition.

But rather than sweep aside the rules and regulations that have contributed to this mess, the Biden administration and Congress are gearing up to address a problem created by industrial policy with…more industrial policy. We’re now weeks into the crisis, but the best response that our political leaders have been able to muster is an attempt to use public resources to duplicate the market response that would have solved (or at least eased) the mess if it had merely been allowed to operate. The entire saga is a sad and infuriating commentary about the entirely predictable failures of central planning.

Take the White House’s latest idea for addressing the shortage as a perfect example. On Wednesday, President Joe Biden announced plans to send military aircraft to Europe—”Operation Fly Formula,” as the White House is calling it—to bring back formula for American parents.”

“The baby formula shortage isn’t the result of there not being enough planes to transport baby formula from Europe to the U.S.; it’s the result of the federal government making it nearly impossible to transport baby formula from Europe to the U.S.

As Reason’s Elizabeth Nolan Brown explained earlier this week, the Food and Drug Administration’s (FDA) rules that prohibit many baby formulas made in Europe from being imported to the U.S. have nothing to do with health or nutritional safety issues. Often, those brands are banned because they fail to meet the FDA’s labeling requirements.

In addition, the U.S. imposes huge tariffs—technically tariff-rate quotas, which are designed to make it completely unprofitable to import more than a small amount of a certain product—on imported formula. Those tariffs exist for no reason other than to protect domestic formula manufacturers and the American dairy industry that supplies them. As a result, about 98 percent of the formula sold in the United States is produced here as well.”

“Rather than moving to ease those regulations, however, the House of Representatives approved a bill on Wednesday that throws $28 million at the FDA to “boost the part of the workforce focused on formula, as well as FDA inspection staff,” according to CBS News. As if the FDA deserves to be rewarded for its incompetence and over-regulation of baby formula. This crisis demands less from the FDA, not more.”

Mail-Order Abortion Pills, Now Officially Authorized by the FDA, Pose an Insoluble Problem for Legislators Who Want To Ban the Procedure

“The Food and Drug Administration (FDA)..announced that it is permanently loosening restrictions on the abortion-inducing drug mifepristone, allowing women to receive it by mail after a telemedicine session. The FDA had already used its enforcement discretion to allow that practice for the duration of the COVID-19 pandemic. The new policy preserves the option, which will play an increasingly important role as many states impose new restrictions on abortion, especially if the Supreme Court decides that the Constitution does not protect access to the procedure after all.
The FDA first approved mifepristone, a.k.a. RU-486 and Mifeprex, in 2000. The standard protocol for a medical abortion currently involves a dose of mifepristone, which thins the lining of the uterus by blocking the effects of progesterone, followed one or two days later by a dose of misoprostol, which causes uterine contractions. The FDA has approved the use of that regimen up to 10 weeks into a pregnancy. In 2019, according to the Centers for Disease Control and Prevention (CDC), 79 percent of abortions in the United States were performed at nine weeks or earlier.

The FDA originally required that mifepristone be dispensed in person by a medical provider. An FDA-approved research project launched in 2016, the TelAbortion Study, aimed to assess the safety and efficacy of prescribing the drug based on “a video evaluation over the internet.” The program expanded during the pandemic, eventually including 17 states and the District of Columbia. According to a TelAbortion report published last March, covering nearly 1,400 packages of pills mailed from May 2016 through September 2000, “this direct-to-patient telemedicine service was safe, effective, and acceptable, and supports the claim that there is no medical reason for mifepristone to be dispensed in clinics as required by the Food and Drug Administration.””

FDA’s At-Home Testing Screw-Up Is Undermining Promising New COVID Treatments

“On November 4, the United Kingdom’s regulatory authorities approved molnupiravir as a treatment for COVID-19 infections. Meanwhile, the U.S. Food and Drug Administration (FDA) continues to dawdle over approving medications that were so effective that independent Data Monitoring Committees ruled that it would be unethical to continue giving placebos to study participants.

Speaking of dawdling, the FDA has long stymied the development and roll out of another vital component for the effective use of these antiviral medications: namely, at-home COVID-19 testing. Both pills must be taken by people within 3 to 5 days of exposure or symptom onset to be most effective at preventing hospitalization and death. That means that people need to be able to test themselves quickly, easily, and cheaply.

Up until mid-October, the FDA had approved only two over-the-counter at-home COVID-19 diagnostic tests, one of which has now had to be recalled. In the last month and a half, agency regulators have finally gotten around to authorizing nine more.”

Why the Hell Has the FDA Not Approved Cheap Rapid COVID-19 Self-Tests Yet?

“a bin of at-home rapid Flowflex COVID-19 tests for sale for about $3.50 apiece at a supermarket in the Netherlands. The test is manufactured by a company headquartered in the U.S., but the Food and Drug Administration (FDA) has not approved it for sale here. In the bin below the Flowflex test, you’ll see another COVID-19 self-test offered by Roche. You can buy it in the Netherlands for about $5.90 per test. It too is not approved by the FDA.”

“From the beginning of the pandemic 20 months ago, hypercautious federal bureaucrats have massively bungled COVID-19 diagnostic testing. Way back in March 2020, I argued that the FDA should get out of the way of rapid at-home COVID-19 testing. Instead, the agency prevented private companies and academic labs from developing and deploying any COVID-19 tests. It especially took its sweet time approving at-home diagnostic tests. The first real at-home COVID-19 wasn’t finally approved until mid-December.”

“If cheap rapid COVID-19 self-tests are good enough for Europeans, surely they are good enough for Americans.”

The FDA Continues To Drag Its Feet on Vaccine Approval

“the FDA’s approval is coming nearly two weeks after British regulators greenlighted the same vaccine, and almost a month since Pfizer/BioNTech submitted its final data for the agency to review.

Had the FDA acted more swiftly—say by bumping up the December 10 meeting it held to recommend approval of the Pfizer vaccine—Monday’s good news could have arrived a few weeks earlier. Meanwhile, the advisory committee tasked with evaluating another vaccine developed by Moderna is not set to meet until Thursday.

Given the slow rollout of these vaccines (slow, at least, when considered against the number of people needing to be vaccinated), it’s easy to think that the delay of a few days or weeks isn’t all that consequential.

Not so, says George Mason University economist Alex Tabarrok, who deploys some back-of-the-envelope math to argue that a few thousand people will die for every day the FDA dawdles in approving new vaccines.”