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CRITICALNutrition / Supplements

EU Natural Inc.

FDA and FTC jointly issued a warning letter to EU Natural Inc. (President Vinay Amin) regarding its dietary supplement products 'CONCEPTION Female Fertility Prenatal' and 'CONCEPTION MEN Male Fertility.' The products' website and Instagram marketing made disease-treatment claims — including treating PCOS, endometriosis, diabetes, cancer, anxiety, and infertility — that caused the products to be classified as unapproved new drugs and misbranded drugs under the FD&C Act. The FTC separately flagged the efficacy claims as potentially unsubstantiated and warned that violations could result in civil penalties of up to $43,792 per violation, consumer refunds, injunctions, or cease-and-desist orders.

Top choices for those with endometriosis include…B6…Chaste Tree [both ingredients in "CONCEPTION Female Fertility Prenatal"]… If you are currently dealing with infertility as a result of endometriosis, try to find prenatal vitamins/supplements that include some of these natural remedies.

Myo-Insitol [sic] [an ingredient in "CONCEPTION Female Fertility Prenatal"] . . . When taken as a supplement, it can absolutely combat infertility issues.

[W]hen you add in the vitamin D [an ingredient in "CONCEPTION Female Fertility Prenatal"] you not only improve polycystic ovary syndrome, you also can improve the income [sic] on in-vitro fertilization.

Ashwagandha is also commonly linked to being a natural way to help overcome anxiety… taking Ashwagandha extract can be hugely beneficial for those living with anxiety.

Ashwagandha has been linked to increasing insulin secretion and improving insulin sensitivity in muscle cells and could help treat diabetes.

…[B]enefits that Ashwagandha is believed to have…include: …Helping with depression, Treating arthritis…Reducing blood sugar levels, Stopping cancer growth, Helping with insomnia

…natural source for safe anticancer medicine.

Ashwagandha extract had [sic] antidiabetic properties, including decreased blood glucose level, preventing hyperinsulinemia, and improved glucose tolerance.

Why did I start taking Conception from @eunatural you may ask... I possibly have PCOS and Myo Inositol [an ingredient in "CONCEPTION Female Fertility Prenatal"] has been shown to help regulate Insulin and regulate your cycle.

…[A]shwagandha selectively kills tumor cells.

…Ashwagandha demonstrates anti-cancer effects against several cancer cell lines.

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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