FDA WARNING_LETTER - Nature's Health Company, LLC - April 01, 2017

On February 6, 2017, the FDA inspected Nature's Health Company, LLC, and subsequently reviewed its website in April 2017. The review found serious violations of the Federal Food, Drug and Cosmetic Act. The company's products, including Ojibwa Herbal Tea Formula, Acai-Acai Berry Fruit, Blood Sugar Support, Graviola, Maca, and Super Strength Prostate Formula, are marketed with claims that establish them as unapproved new drugs under Section 201(g)(1)(B) of the Act, as they are intended for disease cure, mitigation, treatment, or prevention.

Examples of drug claims include: Ojibwa Herbal Tea Formula's "anecdotal history" for cancer treatment; Acai-Acai Berry Fruit for preventing cancer and heart problems; Blood Sugar Support for balancing blood sugar levels in diabetes; Graviola for cancer studies, claiming it's "10,000 times stronger in killing colon cancer than Adriamycin"; Maca for sexual dysfunction and menstrual pain; and Super Strength Prostate Formula for prostate cancer, BPH, and urinary tract infections. The letter also cites the use of scientific publications, like the Harvard Medical School study on lycopene and prostate cancer, as evidence of intended drug use.

These products are considered "new drugs" under Section 201(p) of the Act, lacking FDA approval for safety and effectiveness. Furthermore, Ojib