FDA WARNING_LETTER - Charlemagnes Tree Farm Ltd dba Hudson Valley Homestead - January 24, 2014

The FDA conducted an inspection of Charlemagne's Tree Farm, Ltd. d/b/a Hudson Valley Homestead's food manufacturing facility from January 16-24, 2014. The inspection revealed that product labels for Bushwhacker's Savory Sauce products were misbranded under Section 403 of the Act (21 U.S.C. § 343).

Key violations include: 1. **Undeclared Major Food Allergen (Fish):** Bushwhacker's Hot & Spicy Savory Sauce and Bushwhacker's Mild Savory Sauce are misbranded under Section 403(w) of the Act because they contain Worcestershire Sauce, which includes anchovies (fish), a major food allergen, but fail to declare fish on the labels as required by Section 403(w)(1). 2. **Failure to Declare Sub-Ingredients:** Both savory sauces are misbranded under Section 403(i)(2) of the Act because they use multi-component ingredients like Worcestershire Sauce and Dijon Mustard, but fail to list all sub-ingredients. Additionally, "Blended Herbs and Spices" is not a proper common or usual name for ingredients per 21 CFR 101.22. 3. **Failure to Declare Trans-Fat:** Bushwhacker's Mild Sauce is misbranded under Section 403(