FDA, FTC warn 5 companies over supplements sold to treat infertility, reproductive disorders

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced Wednesday that they sent warning letters to five companies accusing them of illegally selling dietary supplements that allegedly treat infertility and reproductive health disorders. 

The agencies issued the cautionary letters to the companies last week, saying that they violated federal laws by selling their products without FDA approval and by advertising the products’ abilities without evidence. 

The five companies that received the warnings were LeRoche Benicoeur/ConceiveEasy, Eu Natural Inc., Fertility Nutraceuticals LLC, SAL NATURE LLC/FertilHerb and NS Products Inc.

In the letters, the FDA said it reviewed their websites in March, and the FTC examined advertising claims on the sites this month.

The FDA noted that any products that companies claim can “cure, treat, mitigate, prevent” a disease are considered drugs, “even if they are labeled as dietary supplements.” The agency said it has not analyzed the products in question, specifically their effectiveness, appropriate dosage, interaction with other approved drugs and side effects or other concerns. 

The letters alleged that these products are “not generally recognized as safe and effective.” The FDA also considered the drugs to be “misbranded,” since the products are supposed to treat diseases that require a medical professional’s diagnosis and treatment, yet the directions are for a layperson. 

The FTC also asserted the companies violated the FTC Act, which mandates advertisements be backed up by “competent and reliable scientific evidence.” The agency called on the firms to review all claims about the products, saying those who advertise “deceptive claims” could face up to $43,792 per violation and requirements to pay refunds. 

“Women and families who face fertility issues deserve the best that science has to offer,” Daniel Kaufman, acting director of the FTC’s Bureau of Consumer Protection, said in a statement. “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.”

Eu Natural President Vinay Amin said in a statement that the company plans to respond to both agencies “in a timely manner to address the concerns that have been raised.”

“Eu Natural is committed to consumer health and wellbeing and takes its obligations with respect to truthful and non-misleading communication seriously,” Amin said in an email. 

The four other companies did not immediately return a request for comment.

The FDA and FTC both requested the firms to respond within “15 working days” addressing their concerns, noting that “failure to correct violations promptly” could lead to legal action, including product seizure and/or injunction.

The FDA cautioned consumers to talk to medical professionals about any products sold online that say they treat diseases.  

“If claims sound too good to be true, they probably are,” the FDA said in a press release.

Updated at 4:45 p.m.