FDA Warning Letters 32031

FDA Warning Letters

WASHINGTONFDA continues itsoversight of natural products companies, and has issued several warning lettersin the past month for companies allegedly making claims outside of the allowanceof the Dietary Supplement Health and Education Act (DSHEA).

Garden of Life received an FDA warning letter concerningclaims on several of its products, including Q-Zyme, Primal Defense, FungalDefense, Fruits of Life and RevivAll Classic. The agency alleges the claims forthe products are unsubstantiated and position the products as unapproved newdrugs, rather than dietary supplements. FDA also targeted the book PATIENTHeal Thyself, by company founder Jordan Rubin, forreferencing diseases and recommending Garden of Life products to treatconditions including Alzheimers disease, cardiovascular disease andautoimmune diseases.

FDA investigated several nasal sprays and homeopathicformulas from Healthy World Distributing that are positioned as SARS cures. Theagency said the products are misbranded and unapproved new drugs, given theirclaims as a natural defense and effective treatment for coronavirusinfections.

Several products from Scientific Botanicals Co. weresingled out in a warning letter for containing significantly less of the labeledamount of nutrients (specifically folic acid), making the products adulterated.In addition, the agency claims the products are misbranded as they are notlabeled as dietary supplements nor do their labels contain a Supplement Factspanel.