The Federal Trade Commission and the Food and Drug Administration sent letters to five companies, warning them that they may be making false or unsubstantiated claims that their products can treat infertility and other reproductive issues.
The warning letters, which were sent to LeRoche Benicoeur/Conceive Easy, EU Natural, Fertility Nutraceuticals, SAL NATURE/FertilHerb, and NS Products, raise concerns that the companies are making efficacy claims in their advertising that are not supported by competent and reliable scientific evidence. The letters also assert that the products, which are being promoted as drugs, have not been properly authorized for sale by the FDA.
For example, in its letter to Fertility Nutraceuticals, the regulators pointed to claims made by the company such as:
- "best fertility supplements to boost your chance of pregnancy or improve your IVF success rate"; and
- one of the best defenses against miscarriage is to make sure your body is ready for conception and pregnancy at the cellular level. Our supplements are designed to do just that."
Although the FTC's ability to obtain damages in some cases has been curtailed, that's not the case here. The letters warn the companies that if they make deceptive disease treatments claims, they may be subject to civil penalties of up to $43,792 per violation and may also be required to pay restitution to consumers.
In a statement, Daniel Kaufman, the 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.”
Health-related claims continue to be a top priority at the FTC. There's no doubt that we'll continue to see more attention on these issues, with the FTC emphasizing the importance of having competent and scientific evidence to support any advertising claims that are being made. And, with questions still looming about the extent of the FTC's authority to seek monetary relief, we'll also no doubt continue to see the FTC highlighting areas where it still has the ability to do so.
"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" -- Daniel Kaufman, Acting Director, FTC Bureau of Consumer Protection