Tag Archives: fda guidelines

Peptides Rally: What’s New on the Regulatory Landscape for the Body’s Super Signalers

Peptides Rally: What’s New on the Regulatory Landscape for the Body’s Super Signalers

Peptides are powerhouses, the body’s versatile amino chains that play a part in tissue repair, hormone release, collagen production, metabolism optimization, infection fighting, and so much more. Yet even as science uncovers myriad therapeutic and cosmetic applications for these microscopic miracle workers, peptides remain highly regulated. That may be about to change.

An FDA advisory panel is set to meet in late July to determine the fate of seven peptides that are now restricted due to safety concerns, possibly expanding access and allowing compounding that will make the health and anti-aging properties of peptides legally available in the US. The FDA will also review five additional peptides by early 2027, and approvals are expected to pave the way for exciting breakthroughs in the health and longevity community.

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Destigmatizing Hormone Replacement Therapy, Improving Women’s Health

An evolution in menopausal hormone therapy (MHT) is officially underway. New interpretations of safety data from randomized trials and observational studies have resulted in the Food and Drug Administration (FDA)’s decision to remove the class-wide black box warnings for many systemic estrogen and combined estrogen-progestogen (EPT) products, and experts in women’s health are advocating to remove the barriers and improve access to MHT.

Life-Changing Medication

Throughout the human body, hormones support physical, mental, and metabolic health. As hormone levels decline with age, the risk of arthritis, heart disease, cancer, diabetes, and other chronic conditions rises, and many women experience the symptoms of menopause and perimenopause, including hot flashes, insomnia, and brain fog. HRT provides women with bioidentical estrogen and sometimes progesterone, but a controversial Women’s Health Initiative study in 2002 suggested that the therapies raise the risk of breast cancer, putting an end to HRT’s widespread use in the U.S.

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