Tag: FDA
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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…
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FDA’s New Labeling: No More Black Box Warnings for Menopause Hormone Therapy
Overview: A Shift in How Menopause Hormone Therapy Is Labeled The FDA has announced a major update to the labeling of menopause hormone therapies, removing the long-standing black box warnings about potential risks such as breast cancer, heart disease, and dementia. The change aims to provide clearer, more balanced information to patients and clinicians, emphasizing…
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FDA Moves to Remove Black Box Warnings From Menopause Hormone Therapies
FDA Announces Removal of Black Box Warnings From Menopause Hormone Therapies The U.S. Food and Drug Administration (FDA) has announced plans to remove the black box warnings associated with menopause hormone therapies. These warnings, once highlighted as the most serious safety information on medication labels, detailed potential risks related to breast cancer, heart disease, and…
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FDA Softens Stance on Menopause Hormone Therapies: What Changed and Why
What the FDA decision means for menopause treatment The U.S. Food and Drug Administration has announced a pivotal update to the labeling of menopause hormone therapies (HRT). Historic labels carried a black box warning about several serious health risks, including breast cancer, heart disease, and dementia. The FDA’s new approach no longer uses that singular,…
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Cops on Ketamine: Unregulated Mental Health Treatments for First Responders
Ketamine and the push to help first responders When mental health crises collide with high-stress public service, innovative treatments often move faster than policy and regulation. Ketamine-assisted psychotherapy—combining a dissociative drug with guided talk therapy—has emerged as a potential option for police officers, firefighters, and military personnel who carry heavy trauma loads. In rural western…