FDA WARNING_LETTER - Gorton's, Inc.

The FDA issued a Warning Letter to Gorton's, Inc. regarding their "Gorton's Beer Batter Crispy Battered Fish Fillets" product. The letter, dated CFSAN-OC-10-03, states that the product is misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act [21 USC § 343(r)(1)(A)] and 21 CFR Part 101.

The violation stems from the product label bearing the nutrient content claim "0 grams TRANS FAT SAME GREAT TASTE!" on the principal display panel. While "0 grams TRANS FAT" is a nutrient content claim, the product's Nutrition Facts panel declares 19g total fat, 4.5g saturated fat, and 680mg sodium per serving. According to 21 CFR 101.13(h), a food bearing a nutrient content claim that exceeds 13g total fat, 4g saturated fat, or 480mg sodium per serving must include a disclosure statement, such as "See nutrition information for fat, saturated fat, and sodium content," immediately adjacent to the claim. Gorton's product label fails to include this required disclosure statement.

Gorton's, Inc. is required to take prompt action to correct these violations. Failure to do so may result in regulatory actions like seizure