LeRoche Benicoeur/ConceiveEasy, EU Natural, Fertility Nutraceuticals, SAL NATURE/FertilHerb, and NS Products received warning letters
The US FDA Centre for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration/Wikipedia.)
The US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have warned five companies over the illegal sale of dietary supplements, claimed to treat infertility and other reproductive health disorders.
The companies LeRoche Benicoeur/ConceiveEasy, EU Natural, Fertility Nutraceuticals, SAL NATURE/FertilHerb, and NS Products received warning letters for violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).
According to the FD&C Act, products intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to the regulatory requirements that apply to drugs, even if they are labelled as dietary supplements.
The FDA has not evaluated the products subject to the warning effectiveness, appropriate dosage, their interaction with approved drugs, and any side effects or safety concerns.
FDA regulatory affairs associate commissioner Judy McMeekin said: “Dietary supplements that claim to cure, treat or prevent infertility and other reproductive health conditions can potentially harm consumers who use 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.”
The US FDA has advised the public to be vigilant of products sold online with unproven claims to prevent, treat, mitigate or cure diseases.
Consumers are urged to discuss with their doctor, pharmacist, or other health care provider before purchasing or using any dietary supplement or drug.
Also, those who think that a product has caused a reaction or an illness, should immediately stop using the product and contact their health care provider.
The US FDA has requested health care providers and consumers to report adverse reactions related to FDA-regulated products to the agency.
It has invited responses from the companies within 15 working days, asserting how they will address the issues, and provide information supporting the products not violating the law.
Any entity failing to correct violations may result in legal action, including product seizure or injunction, said the US regulator.
FTC bureau of consumer protection acting director Daniel Kaufman 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.”
In February this year, the US FDA has warned ten companies that are illegally selling dietary supplements that claim to treat depression and other mental health disorders.