Fertility Nutraceuticals LLC
FDA and FTC jointly issued a warning letter to Fertility Nutraceuticals LLC (New York, NY) regarding three products — CONFLAM-Forte™, FERTINATAL® DHEA, and OVOENERGEN™ CoQ10 — marketed on two websites. The regulators found that website and product-insert claims characterizing these supplements as reducing miscarriage risk, treating inflammatory diseases, improving IVF success, and addressing conditions like PCOS and autoimmune disease rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The FTC separately flagged the efficacy claims as potentially unsubstantiated under the FTC Act, warning that deceptive disease-treatment claims could trigger civil penalties of up to $43,792 per violation plus consumer refunds. Both agencies required written corrective responses within 15 working days, and FDA warned that failure to comply could result in seizure or injunction.
Flagged claims (10)
Egg Health Power Pack I [which combines FERTINATAL® DHEA with OVOENERGEN ™ CoenzymeQ10] is recommended for:… Women who have low ovarian reserve . . . Women . . . with high miscarriage risk
[W]ell suited for women with infertility, a history of implantation failure, chemical pregnancies and miscarriages or with known inflammatory conditions, like obesity, polycystic ovary syndrome (PCOS), severe allergies and autoimmune conditions.
POTENTIAL BENEFITS: Studies have suggested that calming the immune system by modulating inflammation can enhance female fertility, improve pregnancy chances with. . . IVF, and lower miscarriage risks
Fertinatal Fertility DHEA has been show in multiple studies to . . . reduce miscarriage risk.
CONFLAM-Forte™ . . . is recommended for: Women with evidence of inflammation. . . Women with inflammatory diseases including autoimmune diseases . . . Women with severe allergies . . . Women with PCOS and with obesity…
[B]est fertility supplements to boost your chance of pregnancy or improve your IVF success rate…include… FERTINATAL® Women's DHEA 25 mg… "OVOENERGEN™ Women's CoQ10 333mg….
[C]omprehensive Inflammation-Modulating Nutritional Supplement for Fertility
Since excessive inflammation is very frequent, CONFLAM-Forte™ . . . is especially recommended for . . . women with evidence of inflammation . . . women with inflammatory diseases including autoimmune diseases . . . women with severe allergies, PCOS and obesity.
…Fertility Doctors Recommend Conflam-Forte . . . Alleviates overactive inflammation
[O]ne 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. A 2007 study demonstrated that DHEA decreases the miscarriage rate of women
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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