“The concept of nutritional and ingredient labeling is even more complex in the alcohol space since the TTB uses a pre-approval system for alcohol labeling, meaning that alcohol producers have to submit their proposed labels to the agency for approval before the product ever hits the market. No approval, no market access. This is in marked contrast to most food labeling, which the Food and Drug Administration enforces after a product goes to market.”
“while Americans are having more and more difficulty getting access to pain-relieving opioids, the FDA forces them to wait for an alternative to opioids that people in much of the developed world have been using for years.”
“As earlier threatened, the Food and Drug Administration (FDA) has just issued new rules that will significantly slow down the development of new diagnostic tests. Specifically, the agency requires that all laboratory-developed tests (LDTs) be submitted to its regulators before the tests can be offered to patients and physicians. As I explained earlier, LDTs are in vitro diagnostic (IVD) tests for clinical use that are designed, manufactured, and performed by individual laboratories. They can diagnose illnesses and guide treatments by detecting relevant biomarkers in saliva, blood, or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens. For example, some assess the risks of developing Alzheimer’s disease or guide the treatment of breast cancer.”
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” “Laboratory developed testing services are not medical devices and subjecting them to medical device regulation will harm patient access to needed testing and compromise innovations that drive personalized medicine,” said American Clinical Laboratory Association President Susan Van Meter in a statement. “The rule will limit access to scores of critical tests, increase health care costs, and undermine innovation in new diagnostics.””
“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.”
“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.””
“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.”
“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.”
“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.”
“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.”
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” 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”
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“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?”
“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.”
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“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.”
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“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.”