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The FDA Takes Action

In 2008, the FDA sent warning letters to seven compounding pharmacies indicating that their claims about the safety and effectiveness of their so-called “bioidentical hormone replacement therapy” are unsupported by medical evidence and are considered false and misleading by the agency. As a result, US pharmacies may not compound drugs containing estriol without investigational new drug authorization. There is no scientific basis for using saliva testing to adjust hormone levels.

Read the full press release, letters, and the FDA’s advice about compounding here.

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The North American Menopause Society (NAMS) confirms its support of the US Food and Drug Administration (FDA) and other scientific organizations that have warned women about the potential harm from these products.

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