The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) recently sent warning letters to five dietary supplement companies– LeRoche Benicoeur/ConceiveEasy; EU Natural Inc.; Fertility Nutraceuticals LLC; SAL NATURE LLC/FertilHerb; and NS Products, Inc. – warning them that advertising their products as treatments that could cure or treat infertility without substantiating evidence violates the FTC Act. Such claims also subject the products to FDA scrutiny as drugs under the Federal Food, Drug, and Cosmetic Act, which prohibits the introduction or sale of new drugs into interstate commerce without prior FDA approval. In each case, the agencies asserted that the companies promoted their products as able to “cure, treat, mitigate, or prevent disease.” Such assertions “establish that the product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act because it is intended for use in the cure, mitigation, treatment, or prevention of disease” and require FDA approval even if they are labeled as dietary supplements.
For example, NS Products promises on their website that by using their NaturaCure supplement “You will get pregnant very fast and give birth to healthy children regardless of . . . how severe or chronic your infertility disorder.” Similarly, Fertility Nutraceuticals assured customers that their CONFLAM Forte supplements are “[W]ell suited for women with infertility, a history of implantation failure, chemical pregnancies and miscarriages or with known inflammatory conditions, like obesity, polycystic ovary syndrome (PCOS), severe allergies and autoimmune conditions” and were the “best fertility supplements to boost your chance of pregnancy or improve your IVF success rate.”
Warning letters have been an important tool the agencies have used during the COVID-19 pandemic to address COVID treatment claims. Claims that a product can treat a medical condition, whether it involves infertility, a virus, or something else, must be substantiated by competent and reliable scientific evidence and comply with applicable registration or other regulatory obligations or face some potentially expensive consequences in the form of civil penalties or other enforcement actions.