FDA WARNING_LETTER - Ip-6 International Inc. - August 29, 2013

On April 23, 2014, the FDA issued a Warning Letter to IP-6 International Inc. following an inspection from August 26-29, 2013, of their dietary supplement distribution facility. The FDA determined that the firm's "Red Yeast Rice Gold" product is an unapproved new drug and a misbranded drug.

Laboratory analysis revealed the product contains approximately 1 mg of lovastatin per capsule, the active ingredient in the FDA-approved drug Mevacor. Traditional red yeast rice contains only trace amounts of lovastatin, if any. Because the product contains enhanced or added lovastatin, it is excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act, as lovastatin was approved as a new drug before being marketed as a dietary supplement or food.

Furthermore, the product's website (www.OrganicRedYeastRice.com) and product label promote claims such as "Cholesterol Support" and link to scientific publications regarding cholesterol, inflammation, and cancer, indicating the product's intended use as a drug for disease treatment or prevention. These claims establish the product as a "new drug" under section 201(p) of the Act, requiring prior FDA approval.

The product is also misbranded under section 502(f)(1) because it is offered for conditions not amenable to self-diagnosis