Silver Moon Springs LLC – FDA Warning Letter, Jul 20, 2011

An FDA inspection of Silver Moon Springs LLC's seafood processing facility in Elton, Wisconsin, on July 19-20, 2011, revealed significant deviations from food labeling regulations (21 CFR Part 101), causing their "Smoked Salmon Spread" to be misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: - **Misbranding (Section 403(i)(2)):** The "Smoked Salmon Spread" label failed to declare all sub-ingredients for "Cream cheese and Horseradish," and "salmon" (which is "smoked" salmon with undeclared sub-ingredients). The term "Lemon" was used instead of "lemon juice." Sub-ingredients must be listed parenthetically or in descending order of predominance. - **Misbranding (Section 403(e)(2)):** The outer container for products sold to individual customers lacked the net quantity of contents, violating 21 CFR 101.105.

Additional comments from the FDA include the failure to identify the specific species of fish in the "Contains" statement, and the false declaration of "paprika" as an ingredient on the label when it was not in the recipe.

The FDA requires a written response within 15 working days detailing specific corrective actions taken to achieve compliance and prevent recurrence. Failure to promptly correct these violations may result