LeRoche Benicoeur dba ConceiveEasy
FDA and FTC jointly issued a warning letter to LeRoche Benicoeur dba ConceiveEasy (Mary Whittaker, Seaside, CA) regarding their 'ConceiveEasy' dietary supplement marketed for fertility. The product's website and social media made disease-treatment claims — including treating PCOS, endometriosis, luteal phase defect, ovarian cysts, and preventing miscarriage — that caused it to be classified as an unapproved new drug under the FD&C Act and a misbranded drug for lacking adequate directions for use. The FTC separately flagged the efficacy claims as potentially unsubstantiated by competent and reliable scientific evidence, warning of potential civil penalties up to $43,792 per violation. The recipient was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure, injunction, or civil penalties.
Flagged claims (10)
Glycyrrhiza uralensis is … used to treat Polycystic Ovarian Syndrome for its abilities to help normalize adrenal function and reduce testosterone levels.
Katherine: We couldn't afford the expensive fertility drugs and fertility treatments..after taking the TTC Kit pill for 2 ½ months… I am pregnant.
[ConceiveEasy] does not treat only one cause of infertility, but tackles them all simultaneously: it regulates menstrual and ovulatory disorders; it helps eliminate luteal phase defects…
Sabina is used to help treat infertility for its effectiveness in preventing recurrent miscarriages during early stage pregnancy.
Apis mellifica is most widely used ... in the treatment of ovarian inflammation and ovarian cysts.
Women with PCOS – Polycystic Ovary Syndrome… the single most common cause of infertility in women
Viburnum opulus is used … for preventing miscarriages
Not only has Vitex [an ingredient in the "ConceiveEasy" product, also known as "agnus castus"] been proven to help treat mild endometriosis, it can also keep cases of endometriosis from advancing and becoming worse. …Vitex ... can help to reduce the size of uterine cysts. This can be incredibly helpful for fertility, since many women with uterine cysts have a hard time getting pregnant. … Vitex … can help to prevent miscarriage in women who are at risk of miscarriage due to low progesterone levels. … In a study of women who had absent periods (also known as amenorrhea), more than 70 percent of the women had actually resumed their menstrual periods after using Vitex for six months.
White Peony [an ingredient in the "ConceiveEasy" product, also known as "paeonia alba"] is another very popular fertility herb, ... has traditionally been used for ... treatment of PCOS, uterine fibriods [sic] and also for endometriosis.
This supplement ["ConceiveEasy"] is designed to help combat all of the problems that many women face when trying to conceive, including PCOS, endometriosis, ovulation problems, irregular menstrual periods and much more.
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.
With regard to the advertising claims discussed above, 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.
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).
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