Ken's Foods, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Ken's Foods, Inc. regarding misbranded products. The FDA reviewed labels for Ken's Healthy Options® Parmesan & Peppercorn, Sweet Vidalia® Onion Vinaigrette, and Raspberry Walnut Dressings. These products are deemed misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act [21 USC § 343(r)(1)(A)] because they bear the nutrient content claim "healthy" but do not meet the regulatory requirements in 21 CFR 101.65(d)(2).

Specifically, the "Healthy Options" brand name, associated with calorie, fat, and sodium claims, constitutes a nutrient content claim. However, all three products exceed the "low fat" definition (3g or less per 50g of food) as per 21 CFR 101.62(b)(2). For example, Parmesan & Peppercorn Dressing contains 6g of fat per 30g, Sweet Vidalia Onion Vinaigrette has 4g per 30g, and Raspberry Walnut Dressing has 3g per 30g. Additionally, none of the products contain at least 10% of the Daily Value of specified nutrients (vitamin A, C, calcium, iron, protein, or fiber) as required by 21 CFR 1