The Federal Trade Commission has joined the U.S. Food and Drug Administration (FDA) in sending warning letters to five companies that may be making false or unsubstantiated claims that their products can cure, treat, mitigate, or prevent infertility and other reproductive disorders in violation of the FTC Act, and that are unapproved and misbranded. The warning letters were issued to: LeRoche Benicoeur/ConceiveEasy; EU Natural Inc.; Fertility Nutraceuticals LLC; SAL NATURE LLC/FertilHerb; and NS Products, Inc.
"Women and families who face fertility issues deserve the best that science has to offer,” said Daniel Kaufman, Acting Director of the FTC’s Bureau of Consumer Protection. “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.”
“Dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health conditions are unapproved new drugs that can potentially harm consumers who use these products instead of seeking effective treatments, such as FDA-approved drugs or assisted reproductive technology,” said Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs. “Protecting the health and safety of Americans is the FDA’s highest priority, and we will remain vigilant in communicating about products and companies that place U.S. consumers at risk.”
The FTC Act
The letters state that the Commission is concerned that one or more of the efficacy claims in the companies’ advertisements may not be substantiated by competent and reliable scientific evidence, as required by the FTC Act. The agency strongly urges the companies to review all claims for their products and ensure they are supported by such evidence or potentially face legal action seeking an injunction in federal district court or an administrative cease and desist order. In addition, the letters state, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of a disease may be subject to a civil penalty of up to $43,792 per violation. They also may be required to pay refunds to consumers who purchased the deceptively marketed products.
The letters instruct the recipients to notify the FTC by email within 15 working days of receipt of the specific actions they have taken to address the agency’s concerns.
The FD&C Act
Under the FDA’s Federal Food, Drug, and Cosmetic Act (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 today 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.
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