Natural Zing, LLC – FDA Warning Letter, Apr 29, 2010
On December 21, 2010, the FDA issued a Warning Letter to Natural Zing, LLC, following an inspection from April 27-29, 2010, and a website review in December 2010. The firm, a distributor, labeler, and relabeler of foods and dietary supplements, was found to be in violation of the Federal Food, Drug, and Cosmetic Act.
Key violations include: 1. **Unapproved New Drugs:** Products like Milk Thistle Seed Powder, Rice Bran Solubles, Acai Powder, and Yacon Syrup are promoted with therapeutic claims on the website (e.g., "curing jaundice," "protecting against cancer," "anti-inflammatory," "safeguards against colon cancer"), causing them to be unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Act. These products lack FDA approval for their claimed uses. 2. **Unauthorized Nutrient Content Claims:** Authentic Tibetan Goji Berries and Wildcrafted Mesquite Pod Meal bear unauthorized nutrient content claims (e.g., "superb source of vitamin A," "rich source of germanium," "rich in calcium") that do not meet the requirements of 21 CFR 101.54(b)(1). Specifically, some products do not contain the required 20% DV, or claims are made
- Company
- Natural Zing, LLC
- Inspection date
- April 29, 2010
- Product type
- Drugs
ID · be9bdd8d-2d60-4679-8cc8-e0d789731a16
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