FDA WARNING_LETTER - Schwan's Consumer Brands

The FDA issued a Warning Letter to Schwan's Consumer Brands North America, Inc. following a review of the label for their "Mrs. Smith's Classic Coconut Custard Pie" product. The FDA concluded that the product is misbranded under the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR Part 101. The core violation is that the product label features a nutrient content claim, "0g TRANS FAT PER SERVING," on its principal display panel. However, the product fails to meet the regulatory requirements for this claim, specifically by not including a mandatory disclosure statement, such as "See nutrition information for fat, saturated fat, and cholesterol content," as required by 21 CFR 101.13(h)(1). This omission is critical because the product exceeds the specified thresholds for total fat (17g), saturated fat (9g), and cholesterol (65mg) per serving. The company must take prompt action to correct these violations and submit a written response within 15 working days, detailing specific corrective actions, including revised labels, and outlining preventative measures. Failure to comply may lead to further regulatory actions, including product seizure or injunction.