The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued warning letters to five companies. The companies are illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders. This is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs said, "Dietary supplements that claim to cure, treat or prevent infertility and other reproductive health conditions can potentially harm consumers. Consumers could be using these products instead of seeking effective treatments, such as FDA-approved drugs or assisted reproductive technology. Protecting the health and safety of Americans is the FDA’s highest priority and we will remain vigilant in warnings about products and companies that place consumers at risk.”
Under the FD&C Act, products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.
Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances or whether they have dangerous side effects or other safety concerns.
Daniel Kaufman, Acting Director of the FTC’s Bureau of Consumer Protection said, “Women and families who face fertility issues deserve the best that science has to offer. The FTC is proud to work with the FDA to ensure that when companies make claims about fertility treatments and cures, those claims are backed by solid scientific evidence.”
Dr. Mario Vega Croker, Scientific Director at Panama Fertility said, “It is really important that both our male and female patients tell us all the supplements that they are taking at their first consultation. Sometimes certain supplements can cause more harm than good and actually hinder a couple’s chance of successful treatment. We treat a lot of couples from the USA, so welcome this intervention by both the FDA and the FTC.”
In general, consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases. The FDA advises consumers to talk to their doctor, pharmacist, or other health care provider before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Also, if claims sound too good to be true, they probably are.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.