FDA WARNING_LETTER - Dreyer's Ice Cream Inc.
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The FDA issued a Warning Letter to Dreyer's Grand Ice Cream, Inc. CEO and President, Mike Mitchell, regarding misbranded "Nestle Drumstick? Classic Vanilla Fudge" and "Dreyer's Dibs Bite Sized Ice Cream Snacks Vanilla Ice Cream with Nestle Crunch Coating?" ice cream products. The review, based on the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101, found the products misbranded under section 403(r)(1)(A) of the Act.
The violation stems from the products bearing the nutrient content claim "0 g Trans Fat" on the principal display panel. This claim characterizes the level of trans fat, a nutrient required in nutrition labeling, making it a nutrient content claim per 21 CFR 101.13(b). However, both products exceed the fat thresholds requiring a disclosure statement: the Nestle Drumstick? product has 19g total fat and 10g saturated fat per serving, and the Dreyer's Dibs product has 28g total fat and 20g saturated fat per serving.
According to 21 CFR 101.13(h)(1), foods with nutrient content claims that contain more than 13g total fat or 4g saturated fat per serving must include a disclosure statement, such as "See nutrition information for fat and saturated fat content," immediately
- Company
- Dreyer's Ice Cream Inc.
- Product Type
- Food
ID · 2d416107-4fb3-42e6-9762-26171566f533
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