Sal Nature LLC/FertilHerb
FDA and FTC jointly issued a warning letter to Sal Nature LLC/FertilHerb (Hind Tatni, Cheyenne, WY) regarding their 'FertilHerb for Women' dietary supplement. The product's website made claims that it could treat PCOS, ovulatory infertility, endometriosis, amenorrhea, luteal phase defect, and reduce miscarriage risk, causing FDA to classify it as an unapproved new drug and a misbranded drug lacking adequate directions for use. The FTC separately flagged the efficacy claims as potentially unsubstantiated by competent and reliable scientific evidence. The recipient was required to respond within 15 working days with corrective steps, and faces potential seizure, injunction, and civil penalties up to $43,792 per violation.
Flagged claims (7)
Doctors use Vitex [an ingredient in "FertilHerb for Women"] to treat mild endometriosis or prevent its advancement. It has also been effective in treating amenorrhea, which is the lack of menstruation, as well as irregular menstruation, which can hinder fertility greatly.
Iron [an ingredient in "FertilHerb for Women"] – …[I]ron supplementation could decrease the risk of ovulatory infertility.
FertilHerb® supplements … are a perfect natural alternative to fertility drugs or invasive treatments.
A case study was carried out where German gynecologists evaluated 3602 women who were suffering from Polycystic Ovary Syndrome. They took Myo-inositol and folic acid [ingredients in "FertilHerb for Women"] every morning for 2-3 months... 2520 women restored to normal cycles while 545 of them got pregnant.
Vitamin B12 [an ingredient in "FertilHerb for Women"] .. reduces the chances of miscarriage.
Myo-inositol [an ingredient in "FertilHerb for Women"] –Many studies found Myo- inositol to be a simple and safe treatment capable of restoring ... fertility in most patients with PCOS.
[V]itamin B6 [an ingredient in "FertilHerb for Women"] is also helpful with the luteal phase defect.
Required actions (5)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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 pursuant to Section 5(m)(1)(B) of the FTC Act, 15 U.S.C. § 45(m)(1)(B)
may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b).
please notify Richard Cleland of the FTC via electronic mail at [email protected] within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns.
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