FDA WARNING_LETTER - Millennium Health LLC

The FDA issued a Warning Letter to Millennium Health LLC after reviewing their website, www.ellagicdirect.com, and determining that their product "Ellagic Acid 1000mg" is promoted as a drug. The FDA cited therapeutic claims on the website, such as "Ellagic Acid may slow the growth of some tumors" and "may prevent binding of carcinogens to DNA," which establish the product's intended use in the cure, mitigation, treatment, or prevention of disease, violating section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The letter also noted that the "Cancer Information and Prevention" page cited scientific publications, like "Preventing Cancer" by Ricki Lewis, to promote the product for disease treatment or prevention, which, in context, implies such uses. A metatag "alternative medicine for cancer prevention" further supported this.

The FDA determined that "Ellagic Acid 1000mg" is a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for the claimed conditions and lacks prior FDA approval as required by section 505(a). Additionally, the product is misbranded under section 502(f)(1) of the Act due to inadequate directions for use.

Millennium Health LLC was advised to review all their websites, product labels, and promotional