Cholesterol supplement raises red flags
This article was originally published in The Tan Sheet
Executive Summary
During an inspection of Wellspring International's Anoka, Minn.-facility, FDA discovered the firm promotes its Eniva Cholesterol Reducer Dietary Supplement with claims that make it an unapproved new drug. The claims, including "Eniva Cholesterol Reducer" and "Naturally Lower Your Cholesterol Up to 15% in 8 weeks" suggest the product is intended to prevent, mitigate or treat a disease, the agency notes in a Nov. 20 warning letter to CEO Andrew J. Baechler. Though Wellspring committed to correct labels in a Sept. 22 letter to the agency, FDA says the revised labels do not correct all of the violations, and the firm did not say when the new labels would be in use