FDA WARNING_LETTER - Nature's Way Products, Inc. - September 14, 2007

An FDA inspection of Nature's Way Products, Inc. in Springville, Utah, from September 10-14, 2007, revealed significant violations regarding their Red Yeast Rice product. The FDA's laboratory analysis determined the product contains substantial levels of lovastatin, the active ingredient in the FDA-approved drug Mevacor, exceeding the lowest recommended daily dose. Traditional red yeast rice contains only trace amounts of lovastatin, if any. Consequently, the lovastatin-enhanced Red Yeast Rice cannot be marketed as a dietary supplement, as articles approved as new drugs before being marketed as dietary supplements are excluded from the dietary supplement definition (21 U.S.C. § 321(ff)).

The product is deemed an unapproved new drug (21 U.S.C. § 321(g)(1) and § 321(p)) because its labeling claims (e.g., "support cardiovascular health," "Good for Hearts") indicate intended use for disease treatment or affecting body structure/function, and it is not generally recognized as safe and effective for these uses. The sale of this product without an FDA-approved application violates sections 301(d) and 505(a) of the Act. Furthermore, the product is misbranded under 21 U.S.C. § 352(f)(1) due to inadequate directions for use, as its intended conditions are not amenable to self-diagnosis. The FDA also stated the product cannot be lawfully marketed as food, as it would be adulterated (21 U.S.C. § 342(a)(1)) by containing a poisonous substance (lovastatin) that may render it injurious to health.

Nature's Way Products, Inc. is required to take prompt corrective action and notify the FDA within fifteen working days, detailing steps taken to correct violations, prevent recurrence, and address distributed product. Failure to comply may result in legal action, including seizure and injunction.