FDA WARNING_LETTER - Saputo Cheese USA Inc.

The FDA issued a Warning Letter to Saputo Cheese USA Inc. after reviewing the label for their "Treasure Cave? Reduced Fat Crumbled Blue Cheese" product. The FDA concluded that the product is misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101. The core violation is that the product label bears a "Reduced Fat" nutrient content claim but fails to include a required disclosure statement. Specifically, the product's sodium content (380 mg per serving, or 679 mg per 50g) and saturated fat content (3.5 g per serving, or 6.25 g per 50g) exceed the thresholds (480 mg sodium, 4 g saturated fat per RACC/serving/50g) specified in 21 CFR 101.13(h)(1). This regulation mandates a statement such as "See nutrition information for sodium and saturated fat content" in immediate proximity to the claim, which was absent. Saputo Cheese USA Inc. must take prompt action to correct these violations and prevent recurrence. A written response detailing specific corrective actions, prevention strategies, and supporting documentation like revised labels must be submitted within 15 working days. Failure to comply may lead to further regulatory actions, including product seizure or injunction.