In honor of this week being National Women’s Health Week, it is important to touch on the topic of infertility. Infertility affects millions of people each year, both female and male. Infertility in a woman is caused by many distinct factors. There are many known causes of infertility today, however, it is sometimes impossible to explain the causes of infertility. The most common causes of female infertility include, but are not limited to, abnormalities of the ovaries, fallopian tubes, endocrine system, and the uterus1.

The causes of female infertility can differ across the globe, due to differences in background, STI prevalence, and population age. Discussing infertility in a woman is important because although both men and women can experience infertility, the woman in a different-sex relationship is commonly perceived to suffer from infertility if they are infertile or not. The term infertility has significant negative social impacts on couples and women, especially those who experience emotional stress, divorce, depression, and violence. The fear of infertility has deterred both men and women from using contraceptives due to the social pressure of proving their fertility due to the social stigma around the term childbearing1.

The diagnosis and treatment of infertility are often not prioritized due to a lack of training, equipment, and infrastructure. Unfortunately, there are non-Food and Drug Administration (FDA) approved dietary supplements that claim to prevent, cure, mitigate and treat infertility and other reproductive health concerns. These unapproved new drugs could potentially harm consumers who use the products instead of giving effective treatment2. The FDA and Federal Trade Commission (FTC) have been advising companies for years to review all product claims and to ensure there is competent scientific evidence for their products or they could face legal actions.

While EMMA International cannot help directly with infertility issues, we can help your company achieve regulatory approval and optimize your quality systems for your new infertility drug applications and other new drug applications as well. Our team is here to guide on product claims for more information, give EMMA International a call at 248-987-4497 or email us at


1World Health Organization (September 2020), Infertility, Retrieve on May 10, 2022, from,on%20their%20families%20and%20communities.2Federal Trade Commission (May 2021), FDA Warn Five Companies That May Be Illegally Selling Dietary Supplements Claiming to Treat Infertility, Retrieved on May 10 from

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

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