FDA WARNING_LETTER - Wellspring International, Inc. - September 11, 2009

The FDA conducted an inspection of Wellspring International, Inc.'s facility in Anoka, Minnesota, on September 1, 8, 10, and 11, 2009. The inspection and subsequent review of the label and labeling for their "Cholesterol Reducer Dietary Supplement" revealed significant violations. The FDA determined that the product is promoted with claims, such as "promotes a reduction in cholesterol" and "may reduce your risk of heart challenges," which cause it to be an unapproved new drug under section 505 of the Act (21 U.S.C. § 355). Specifically, the product is deemed a drug because its intended use is for the prevention, mitigation, and treatment of disease. As it is not generally recognized as safe and effective for these uses, it is considered a new drug under section 201(p) of the Act (21 U.S.C. § 321(p)) and cannot be legally marketed without prior FDA approval per section 505(a) (21 U.S.C. § 355(a)). Although the firm submitted revised labels, these did not correct all identified violations. Furthermore, the firm failed to provide a timeline for implementing new labels or a plan for the disposition of existing violative stock. Wellspring International, Inc. is required to respond within 15 days, detailing specific corrective actions, supporting documentation, and a timeline for completion, to avoid potential enforcement actions like product seizure or injunction.