Lone Candle
Champion of Truth
“at the Food and Drug Administration, the Trump administration is backpedaling on some of its terminations, reinstating workers in the agency’s medical devices division after realizing they were responsible for approving and monitoring the safety of life-saving equipment like pacemakers and defibrillators.”
https://www.politico.com/news/2025/02/26/musk-silicon-valley-ethos-washington-00206293
“There are many reasons a person could find themselves homeless, but severe mental illness is a major contributor. Last month, Esquire ran a first-person account of Patrick Fealey, an award-winning journalist who found himself unable to hold a job after he was diagnosed with Bipolar I disorder in 1997; after struggling for years, he became homeless in October 2023. While admitting that his particular cocktail of drugs is not ideal and negatively affects other parts of his body, Fealey writes that it also “enables me to function and has kept me alive for twenty-seven years.”
A 2019 meta analysis of 31 studies, encompassing nearly 52,000 homeless people in both developed and developing countries, found that more than 10 percent had schizophrenia or related disorders.
“While ensuring drug safety is essential,” Singer and Bloom write, “the REMS program has unintentionally created barriers that disproportionately affect individuals with severe mental illnesses like schizophrenia, further compounding the significant challenges they already face, including unemployment, substance abuse, heightened suicide risk and homelessness.””
https://reason.com/2024/12/05/fda-policy-worsens-homelessness-by-limiting-access-to-antipsychotics/
“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.”
https://reason.com/2024/08/24/transparency-mandate-would-burden-small-brewers-and-distilleries/
“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.”
https://reason.com/2024/06/20/if-opiates-are-killing-americans-why-wont-the-fda-let-us-try-an-alternative/
“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.”
…
” “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.””
https://reason.com/2024/04/29/fda-once-again-stands-athwart-biomedical-innovation-yelling-stop/
“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.”
https://reason.com/2023/08/11/aoc-sunscreen-fda-regulation-tiktok-europe/
“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.”