July 9, 2019
When the topic of women’s health arises, a common area of focus is the reproductive system. Women’s health products face two hurdles that must be crossed when discussing their benefits: claims must be acceptable from a regulatory perspective (not just truthful), and they must be supported by evidence.
FDA maintains the position that menopause is not a disease nor an indication of one, so claims for supplements surrounding menopause should be allowed. Claims addressing symptoms resulting from menopause, however, can trigger regulatory issues. The claims brands can make for women’s health products are limited, despite recognition that the life stage of a woman is not a disease or dysfunctional state.
As with any claims, FDA recognizes the boundaries between dysfunctional states and life stages and, in fact, it may be argued that FDA grants greater leeway in this consideration toward women. These boundaries identify that a woman’s life stage matters as being a part of her life.. An example of a permissible claim is “support for a woman’s changing body during menopause,” while “suppresses menopausal hot flashes” likely crosses the line. While menopause itself is not a disease or dysfunctional state, the physiologic response from a woman’s body could be considered a dysfunction or, worse, signs of an underlying disease not amenable to self-diagnosis and, thus, outside the acceptable bounds for claims for dietary supplements.
This is an excerpt from the article, “Menopause is not a disease—not exactly,” originally published in INSIDER’s Women’s Health digital magazine. Download the digital magazine to read the complete article.
As chief operating officer, Jim Lassiter oversees all consulting operations at REJIMUS, formerly Ingredient Identity. He has more than four decades of experience in quality control (QC), and government and regulatory affairs throughout the pharmaceutical, dietary supplement and natural product industries with organizations such as Nutrilite, Robinson Pharma, Irwin Naturals, Chromadex, the American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN). A respected author and speaker, Lassiter has served on numerous industry and trade boards.
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