FDA WARNING_LETTER - Hardy Peanuts, Inc. - May 09, 2011

On May 9, 2011, FDA investigators inspected Hardy Farms Peanuts' facility in Hawkinsville, Georgia, and collected labels for their Boiled Peanuts and Hot n' Spicy Boiled Peanuts. The FDA determined these products are promoted for disease prevention, mitigation, and treatment, specifically for lowering "bad" LDL cholesterol and maintaining HDL cholesterol. This claim, "Shown to lower bad LDL cholesterol while keeping good HDL cholesterol steady," causes the products to be considered unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), requiring prior FDA approval.

Furthermore, the products are misbranded drugs under section 502(f)(1) of the Act because adequate directions for layperson use cannot be provided for conditions not amenable to self-diagnosis. Even if considered foods, the products are misbranded under Section 403(r) of the Act due to unauthorized health claims. Specifically, the claim "Studies show one serving of peanuts a day can cut the risk of heart disease by ½ and diabetes by ½" is not an authorized health claim. Additionally, the claim "Four times more antioxidants than raw or roasted peanuts" is a misbranded nutrient content claim under Section 403(r)(1)(A) because it lacks quantitative information and fails to identify the specific antioxidant nutrients. The labels also incorrectly declare "