FDA WARNING_LETTER - Goetze's Candy Company Inc

The FDA issued a Warning Letter to Goetze's Candy Co., Inc. regarding their Goetze's Caramel Creams Double Chocolate, 9 oz product, found to be misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act. The product label bears the nutrient content claim "Fortified With Calcium" on the principal display panel. This claim is a nutrient content claim under 21 CFR 101.13(b) but does not meet the requirements of 21 CFR 101.54(e)(1)(ii) because the product, being candy, does not comply with the policy on fortification of foods in 21 CFR 104.20, which states that fortifying snack foods like candy is inappropriate.

Additionally, the FDA noted several other issues: the serving size and nutrition information are not based on the established Reference Amount Customarily Consumed (RACC) of 40 grams for candies, as the label uses "3 pieces" (34g) instead of an approximate "4 pieces" (45g); the declared 7.5 servings per container should be rounded to the nearest whole number (8 servings) per 21 CFR 101.9(b)(8)(i); and the term "Double Chocolate" is misleading as the product is flavored only with cocoa, requiring qualification with "flavored"