AOC Slams the FDA’s Harmful Overregulation of Sunscreen

“Sunscreen is regulated like a drug, which means the product is subject to byzantine FDA regulations that have largely thwarted innovation in the category for the last 20 years.
As the economist Alex Tabarrok has pointed out, European and Asian countries enjoy vastly superior options.

“Suncreens in Europe and Asia are better than in the United States because more ingredients are allowed and these create more effective and more pleasing suncreens,” he writes.

This is no accident, but rather the deliberate result of regulatory policy. The European Union, for instance, has approved 27 different compounds for use in sunscreen, whereas the FDA has only approved 17.

“The number of approved ingredients matters because not all filters can seamlessly be formulated into sunscreens or other suitable products for skin application,” writes the Cato Institute’s Gabriella Beaumont-Smith. “Moreover, some of the ingredients approved in the EU and Japan but not the US are more effective and long‐lasting.”

If the FDA won’t clear more sunscreen ingredients for use in the U.S., the agency should at the very least allow reciprocity: Foreign sunscreens could be made available with warning labels noting that they were approved by European health officials but not by the FDA. Of course, the best option would be for U.S. regulators to simply get out of the way and acknowledge that these products are obviously safe for human use. Indeed, not approving them is the greater danger, since using sunscreen is one of the best ways to prevent skin cancer.”

FDA Might Approve Over-the-Counter Sales of One Birth Control Pill. Now It’s Time To Approve All the Rest.

“For decades, the American College of Obstetrics and Gynecology, the American Academy of Family Physicians, the American Medical Association, and the vast majority of practicing reproductive physicians have called for the Food and Drug Administration (FDA) to make hormonal contraceptives (e.g., birth control pills) available over the counter (OTC) to women of all ages.
When experts in the field who get paid for prescribing hormonal contraceptives nonetheless keep telling patients, “You don’t need to see me for this,” government regulators should take notice. Women can get birth control pills OTC in over 100 countries, formally or informally, around the globe. It’s time for them to be OTC in the “land of the free.””

FDA eases restrictions on blood donation for men who have sex with men

“Screening questions asked of prospective blood donors will still recommend the deferral of individuals who report having a new sexual partner and have engaged in anal sex in the past three months, as well as of individuals who report having more than one sexual partner in the last three months and have also had anal sex.
The FDA said it “strongly believes” the new policy will not hurt the safety or availability of the nation’s blood supply.

Currently, men who have sex with men must abstain from sex for three months before giving blood. The new policy still limits people who have certain risk factors — such as a history of non-prescription injection drug use, those who have exchanged sex for money or drugs, or those who previously tested HIV-positive from donating.”

Is CBD in trouble?

“But CBD, a cannabis compound also known as cannabidiol, exists in a gray area under federal law, and its exact legality has long been tricky to define. Any substance marketed as a supplement or food additive has to meet safety standards issued by the Food and Drug Administration, and that’s where things have gotten hairy for CBD manufacturers and marketers. Food and drinks that contain CBD have never actually been FDA-approved.
For years, the FDA hasn’t come down one way or another with guidance on how to regulate, label, or market CBD in supplements and food products. So store shelves proliferated with quasi-legal tinctures and gummies and beverages, all taking advantage of the FDA gray area. The FDA has warned companies selling CBD products and consumers about unproven health claims made by manufacturers, steadfastly holding that CBD doesn’t meet the definition of a dietary supplement — a position that has been challenged by the industry and consumers as demand for CBD has boomed. Without regulation, however, there’s no way for a consumer to know what, exactly, is in that CBD they bought at the gas station — or if it contains any CBD at all.

In late January, the agency finally issued a decision on CBD, and it’s a potentially damning blow to the industry. The FDA announced that it was denying three citizen petitions requesting guidance on CBD; the agency’s existing safety standards for supplements or food additives, it ruled, aren’t sufficient to regulate CBD’s use. Further, it expressed concerns that CBD products could be dangerous, especially with long-term use. Essentially, the FDA has said that CBD is a headache that it doesn’t want to deal with, so it’s kicking things over to Congress to sort out the mess.”

New Survey Data Cast Further Doubt on the FDA’s Opposition to Flavored E-Cigarettes

“as survey data from the government-sponsored Monitoring the Future (MTF) study confirm, the surge in electronic cigarette use by teenagers that alarmed the FDA in 2018 and 2019 is already receding, even though adults can still buy flavored ENDS that remain on the market because the FDA has not yet decided whether to allow them or has not taken enforcement action against them. Those data also indicate that adolescent smoking continued to decline as vaping became more popular. The picture is similar for young adults: As vaping continued to rise among 19-to-30-year-olds in 2021, cigarette smoking hit a record low.

These trends suggest that we are seeing precisely the sort of harm-reducing substitution that the FDA claims to want. The data certainly are not consistent with the idea that the availability of ENDS has resulted in more smoking. Yet Judge Rosenbaum, who seems to think the FDA’s opposition to flavored ENDS is well-grounded, avers that “vaping has been shown to be a gateway to smoking combustible cigarettes.” She cites no evidence to support that claim, which seems highly implausible in light of the continuing decline in smoking among teenagers and adults.”

FDA Finally Admits It Caused the Baby Formula Shortage

“it’s the FDA’s unnecessary and protectionist rules that effectively ban foreign-made baby formula from being imported into the United States. On Wednesday, the agency announced plans to tweak those rules so foreign formula manufacturers can permanently import their goods into the U.S., giving American consumers greater choice in the marketplace and ensuring more robust supply chains.”

” When the Abbott Nutrition plant in Michigan was forced to close temporarily due to an FDA investigation into possible contamination, it created a supply shock that left store shelves empty and parents scrambling to find formula. Because of the FDA’s protectionist rules (and high tariffs levied on foreign-made formula), markets could not adapt quickly to the shortage here in America”

“In testimony to Congress, FDA officials admitted to botching the response to the contamination at the Abbott plant. But the real culprit of the recent shortage was a deeper and more pervasive one. No matter what nationalists like Sen. Josh Hawley (R–Mo.) might suggest, closing off the country to international trade is not a recipe for resilience. The baby formula crisis demonstrated that it is quite the opposite.
So it’s good to see the FDA admit those mistakes and crack open the door to allowing foreign formula into the U.S. on a permanent basis.

Unfortunately, the list of policy changes the FDA announced..mostly amounts to providing technical assistance to foreign firms that want to sell formula here. That is, offering help in navigating the complex approval process, rather than sweeping aside those regulations entirely. If a formula maker has passed muster under E.U. regulations, that should be good enough for the FDA.

There’s also the matter of tariffs on imported formula, which are so high that they effectively make any imported formula uncompetitive in the American market. Why would a foreign manufacturer like Holle or HiPP go through the complicated FDA approval process (even after the announced changes) if it knows in advance that its goods won’t be able to compete on a level playing field in America?”

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.””