| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142 |
Department of Health and Human Services
November 29, 2011
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Refer to MIN 12 – 11
Timothy Winkel
Owner
Silver Moon Springs LLC
W4852 State Highway 64
Elton, Wisconsin 54430-9740
Dear Mr. Winkel:
An investigator from the Minneapolis District Office of the Food and Drug Administration (FDA) inspected your seafood processing facility located at W4852 State Highway 64, Elton, Wisconsin, on July 19 to July 20, 2011. Our inspection found significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause the “Smoked Salmon Spread” distributed by your firm to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C § 343, in that it is not labeled with the mandatory information required by the Act. You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Your significant violations include:
- Your Smoked Salmon Spread product is misbranded within the meaning of section 403(i)(2) of the Act, 21 U.S.C. § 343(i)(2). Specifically:
- Your Smoked Salmon Spread label fails to properly declare the common or usual name of several ingredients as required by 21 CFR 101.4(a)(1). Your product label for the Smoked Salmon Spread contains the ingredients “Cream cheese and Horseradish;” however, all of the ingredients in the cream cheese and horseradish are not declared on the product label. In addition, your Smoked Salmon Spread is labeled to contain: “Lemon….” The term “Lemon” is not an appropriate common or usual name that describes the actual ingredient used in the Smoked Salmon Spread recipe, which is lemon juice.
- Your product label for the Smoked Salmon Spread lists the ingredient “salmon;” however, all of the ingredients in the salmon are not declared on the product label. Based on your recipe for the Smoked Salmon Spread, you use “smoked” salmon which includes several sub-ingredients in the recipe that are not declared on your finished product label, 21 CFR 101.4(b)(2).
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; under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
- Your Smoked Salmon Spread is misbranded within the meaning of section 403(e)(2), 21 U.S.C. § 343(e)(2), in that the outer container for your product sold to individual customers does not provide the net quantity of contents, as required under 21 CFR 101.105.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the food labeling regulations (21 CFR Part 101). You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
We provide the following comments:
- Your Smoked Salmon Spread is manufactured using salmon, milk, and soybean oil; however, your product label fails to identify the species of fish in the “Contains” statement when the species name is required. Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
- Your product label for the Smoked Salmon Spread lists the ingredient “paprika.” Paprika is not one of the ingredients identified in either your Smoked Salmon Spread recipe or the Smoked Salmon recipe and is falsely declared on your finished product label for the Smoked Salmon Spread.
Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining violations will be corrected.
Please send your reply to the Food and Drug Administration, Attention:
Tyra S. Wisecup, Compliance Officer, at the address on this letterhead. If you have questions regarding the issues in this letter, please contact Ms. Wisecup at (612) 758-7114.
Sincerely,
/S/
Elizabeth A. Waltrip
Acting Director
Minneapolis District
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