The enforcement action was announced yesterday. Warning letters were sent to the following five companies: LeRoche Benicoeur/ConceiveEasy, EU Natural Inc., Fertility Nutraceuticals LLC, Sal Nature LLC/FertilHerb and NS Products, Inc.
Infertility is treated by a variety of pharmaceutical and medical device-based interventions. As such, it is condition or set of conditions that according to the regulatory bodies are “not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.”
Range of disease/conditions mentioned
Among the diseases or conditions that the five companies were allegedly claiming to treat are:
- Luteal phase defect
- Polycystic Ovary Syndrome
The supplements made by the five firms including ingredients such as Apis mellifica (a homeopathic remedy derived from honey bees), ashwagandha, CoQ10Viburnum opulus (rose)
"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,” 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 warnings about products and companies that place consumers at risk.”
The companies were given 15 days to respond to the warning letters.
Compliant claims possible in fertility category
The companies above are not alone in marketing dietary supplements to consumers who are concerned about fertility. Among the companies not subject to the joint FDA/FTC action are UK-based firm Cambridge Diagnostic Imaging, which markets a product called Lycofertilic. In that case the company claims the product, based on an algal form of DHA, provides anti aging support for a woman’s reproductive system and boosts what the company calls a woman’s “ovarian reserve” via a “reduction in markers of inflammatory damage” that boosts “peripheral tissue oxygenation and respiration.”
Highly sensitive area ripe for abuse
Loren Israelsen, president of the United Natural Products Alliance, said the emotion (and expense) surrounding consumers’ search for infertility answers makes this a highly sensitive area and one ripe for exploitation by potentially unethical marketers.
“Infertility is a deeply personal and sensitive matter, and the increase in male and female infertility is rising at a troubling rate. Unsupported claims to assure or improve fertility are out of bounds, and inappropriate,” Israelsen said.
“While encouraging sound nutrition and avoidance of chemicals known to affect fertility are important to consumers, selling false hope is not OK,” he added.
“As is often the case, these warning letters were directed to companies unknown to the responsible dietary supplement industry, which is source of concern to the many companies that work at a high level of integrity and regulatory compliance,” Israelsen concluded.