Tag: FDA
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Autoantibodies Tied to Rare Brain Inflammation After Live Vaccines
What the new findings show In recent years, rare neurological reactions have surfaced as a reminder that vaccines, while overwhelmingly safe, can interact with unique immune profiles in a small subset of people. A study published in PNAS points to autoantibodies — immune proteins that mistakenly attack the body’s own tissues — as a potential…
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FDA Faces Scrutiny as Tracy Beth Høeg Takes a Lead Role in U.S. Vaccination Policy
Background: A controversial figure threads into mainstream public health policy The U.S. FDA has long prided itself on evidence-based regulation, independent of partisan tides. But as vaccination guidance evolves amid a changing pandemic landscape, a new name has emerged from the fringes of public discourse into the epicenter of policymaking: Tracy Beth Høeg. A Danish…
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She Has No Expertise: How Tracy Beth Høeg’s FDA Tenure Is Stoking Debate in U.S. Medicine
Background The U.S. medical community is closely watching the appointment of Tracy Beth Høeg to a leadership position that intersects with vaccination policy and public health guidance. An epidemiologist and sports physician with a distinctive career path, Høeg rose to prominence in online conversations and policy circles for challenging conventional views on Covid-19 vaccines. As…
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US Medical Community Confronts Tracy Beth Høeg’s FDA Tenure
Background: A controversial rise aside a critical juncture in U.S. vaccination policy The U.S. health landscape is undergoing a wave of vaccination policy revisions, guided by a new administration and evolving public health data. Central to the debate is Tracy Beth Høeg, a Danish American sports physician and epidemiologist who first drew attention for challenging…
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Kratom and 7-OH: The Rising US Trend and FDA’s Addiction Concerns
Understanding the Kratom Surge Across the United States, Kratom and its derivative products containing 7-Hydroxymitragynine (7-OH) are increasingly available in smoke shops, head shops, and online retailers. Proponents argue that these botanical products offer a natural alternative for managing pain, anxiety, and opioid withdrawal symptoms. Critics, however, point to a growing body of evidence that…
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Kratom, 7-OH Products, and the FDA Warning: The Narrow Path Between Popularity and Risk
The Growing Popularity of Kratom and 7-OH Products Across the United States, a growing number of consumers are turning to kratom and products containing the active compound 7-hydroxy mitragynine (7-OH) as alternatives to traditional opioids. Sold in many smoke shops, vape shops, and online retailers, these products are often marketed as mood boosters, energy enhancers,…
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Kratom and 7-OH: FDA Addiction Risk in the US Today
Rising popularity of kratom and 7-OH products Across the United States, kratom and its metabolite 7-OH have moved from niche herbal markets into mainstream retail spaces. Fans tout the products as natural mood boosters, energy enhancers, or alternatives to traditional pain relief. They’re increasingly found in smoke shops, head shops, and online retailers, making them…
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RFK Jr. Targets the U.S. Vaccine Schedule: Safety in a Decades-Old Framework
RFK Jr. targets the U.S. vaccine schedule Robert F. Kennedy Jr. has renewed his push to scrutinize the U.S. childhood vaccine schedule, arguing for greater transparency and reform. The public health conversation around vaccines is often polarizing, but the debate surrounding the schedule—an arrangement of vaccines given from birth through adolescence to prevent serious infections—has…
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FDA Ditching Black Box Warnings on Low-Dose Estrogen: What It Means for Menopause Care
What Changed and Why It Matters The U.S. Food and Drug Administration (FDA) has announced a significant regulatory change: it will no longer require the strongest safety notice, the black box warning, on prescription, low-dose estrogen products used to treat perimenopause and menopause. This shift follows a nuanced assessment of the risks and benefits of…
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FDA Lifts Black Box Warning on Low-Dose Estrogen: What It Means for Menopause Care
Overview: A Shift in Menopause Care The U.S. Food and Drug Administration has announced a notable change in how low-dose estrogen products used to treat perimenopause and menopause are labeled. By removing the mandatory black box warnings—the most prominent safety alerts—the agency signals a move toward more nuanced, individualized discussions between patients and clinicians about…