Continental Mills/True Bliss Confections – FDA Warning Letter

On November 24, 2014, the FDA issued a Warning Letter to Continental Mills regarding their TrueBliss Confections Dark Chocolate Covered Coconut product, based on a label review conducted in June 2014. The product is deemed misbranded under the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101 due to several violations.

Firstly, the claim "Experience a healthy temptation with the truly indulgent taste of TrueBliss Confections" is misleading under section 403(a)(1) of the Act. The product contains 7g of saturated fat per 30g serving, exceeding the 4.0g limit per reference amount customarily consumed (RACC) or labeled serving, which FDA considers the threshold for increasing disease risk.

Secondly, the product is misbranded under section 403(e)(1) of the Act because the statement of the name and place of business, "Prepared For: True Bliss Confections, P.O. Box 1493, Owasso, OK 74055, U.S.A," lacks a street address, preventing determination of the firm's physical location as required by 21 CFR 101.5.

Thirdly, the product is misbranded under section 403(q) of the Act due to an incorrect serving size. The label states "6