FDA WARNING_LETTER - Fairfield Gourmet Food Corp

The FDA issued a Warning Letter to David's Cookies, specifically to CEO Ari Margulies, regarding their "David's Chocolate Marble Truffle Cake" product. The letter, dated CFSAN-OC-10-22, states that the product's label is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101, rendering it misbranded under section 403(r)(1)(A) of the Act [21 USC § 343(r)(1)(A)].

The core violation is the nutrient content claim "0 grams TRANS FAT" displayed on the principal display panel. While this phrase characterizes the level of trans fat, a nutrient required in nutrition labeling, the product is misbranded because it lacks the mandatory disclosure statement: "See nutrition information for fat, saturated fat, and cholesterol content." This disclosure is required by 21 USC § 343(r)(2)(B) and 21 CFR 101.13(h)(1) for foods bearing a nutrient content claim that contain more than 13g total fat, 4g saturated fat, or 60mg cholesterol per serving. The product's Nutrition Facts panel declares 32g total fat, 20g saturated fat, and 135mg cholesterol per serving, exceeding these thresholds.

The FDA emphasizes that this is