Charlemagnes Tree Farm Ltd dba Hudson Valley Homestead 4/22/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
April 22, 2014
WARNING LETTER NYK-2014-30
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. John B. King, Owner and President
Charlemagne’s Tree Farm, Ltd.
d/b/a Hudson Valley Homestead
102 Sheldon Lane
Craryville, NY 12521
Dear Mr. King:
The United States Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility, located at 102 Sheldon Lane, Craryville, New York, from January 16, 2014 through January 24, 2014. During the inspection of your facility, product labels for your Bushwhacker’s Savory Sauce products were collected. We have reviewed your product labels and find that your labels cause your products to be misbranded within the meaning of section 403 of the Act (21 U.S.C. § 343). You can find the Act and the regulations through links in FDA’s Internet home page at www.fda.gov
Your labeling violations are as follows:
1. Your Bushwhacker’s Hot & Spicy Savory Sauce and Bushwhacker’s Mild Sauce are misbranded under Section 403(w) of the Act, [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen; fish, as required by section 403(w)(1) of the Act. Specifically, your Bushwhacker’s Hot & Spicy Savory Sauce and Bushwhacker’s Mild Savory Sauce are manufactured using Worcestershire Sauce, which contains “anchovies”.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as “major food allergens”. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
- The word “Contains;” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. § 343(w)(1)(A)]; or
- The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “Whey (Milk)”), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
2. Your Bushwhacker’s Hot & Spicy Savory Sauce and Bushwhacker’s Mild Savory Sauce are misbranded within meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that each product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. For example:
- Your products are manufactured using the ingredients Worcestershire Sauce and Dijon Mustard; which are multicomponent ingredients in that they contain two or more ingredients; however, you fail to list all sub-ingredients on your finished product labels.
- The ingredient statement declares, “Blended Herbs and Spices,” which is not the proper common or usual name for such ingredients in accordance with 21 CFR 101.22.
The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
3. Your Bushwhacker’s Mild Sauce is misbranded within meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the label fails to declare trans-fat as required by 21 CFR 101.9(c)(2)(ii).
We also note the following comments about your products labels:
- You list the ingredient, mesquite oil, in the formulation for the savory sauce products; however, we do not recognize this as the common or usual name of the ingredient. This ingredient should be properly declared in the ingredient statement of the product labels with its common or usual name or a sufficiently descriptive term.
- The full footnote is not declared on the nutrition label for both your Bushwhacker’s Hot & Spicy Savory Sauce and Bushwhacker’s Mild Savory Sauce as required by 21 CFR 101.9(d)(9).
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not have listed all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 C.F.R. Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 USC 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent the Food and Drug Administration; Attention: LCDR Frank Verni, RPh; U. S. Food and Drug Administration; Compliance Branch; 158-15 Liberty Avenue, Room 4050; Jamaica, NY 11433.
If you have any questions about the content of this letter please contact: LCDR Verni at (718) 662-5702.
Ronald M. Pace
New York District