Inspections, Compliance, Enforcement, and Criminal Investigations
Bradley Industries, Inc. 11/14/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
November 14, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 13 - 09
Christopher J. and Suzanne M. Bradley
Bradley Industries, Inc.
520 E. Church Street
Libertyville, Illinois 60048
Dear Mr. and Mrs. Bradley:
The United States Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 3840 N. Fratney Street, Milwaukee, Wisconsin, on June 5, 12-13, 2012. Our inspection found significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause your Stoneridge pasta products to be adulterated within the meaning of section 402 and to be misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§ 342 and 343. You may find the Act and the referenced regulations through links on FDA’s homepage at www.fda.gov.
Your significant violations are as follows:
1. Your OLD WORLD STONERIDGE GOURMET FETTUCCINE, TRI-COLOR FETTUCCINE, BASIL & TOMATO LINGUINE, SPINACH FETTUCCINE, and GARLIC & BASIL PESTO LINGUINE products are adulterated within the meaning of section 402(a)(2)(C) of the Act, 21 U.S.C. § 342(a)(2)(C), because the products bear or contain a food additive which is unsafe within the meaning of section 409(a) of the Act, 21 U.S.C. § 348(a). Section 409(a) of the Act, 21 U.S.C. § 348(a), deems a food additive to be unsafe if its use or intended use is not in conformity with the food additive listing regulations. Specifically, your pasta products are manufactured from a semolina-manufactured good which is enriched with folic acid. The folic acid regulation at 21 CFR 172.345(c) defines the foods to which folic acid may be included, which does not include semolina flour.
2. Your OLD WORLD STONERIDGE GOURMET FETTUCCINE, TRI-COLOR FETTUCCINE, BASIL & TOMATO LINGUINE, SPINACH FETTUCCINE, and GARLIC & BASIL PESTO LINGUINE products are misbranded within the meaning of section 403(w) of the Act, 21 U.S.C. § 343(w), in that the labels for these products fail to declare the known major food allergen wheat, as specified by the Act.
Specifically, your OLD WORLD STONERIDGE GOURMET FETTUCCINE, TRI-COLOR FETTUCCINE, BASIL & TOMATO LINGUINE, SPINACH FETTUCCINE, and GARLIC & BASIL PESTO LINGUINE product labels contain 100% Durum Semolina Flour Enriched or 100% Organic Durum Flour; however, the product labels fail to declare the presence of the major food allergen wheat.
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines as “major food allergens” 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. A food is misbranded 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., “(wheat)”), except that 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).
Further guidance and information on food allergens can be accessed on FDA’s website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
3. Your OLD WORLD STONERIDGE GOURMET LINGUINE, TRI-COLOR LINGUINE, SPINACH LINGUINE, BASIL & TOMATO LINGUINE, GARLIC & BASIL PESTO LINGUINE, WHOLE WHEAT LINGUINE, and FETTUCCINE products are misbranded within the meaning of section 403(q) of the Act, 21 U.S.C. § 343(q), because the Nutrition Facts information is not in an appropriate format as defined within 21 CFR 101.9. Specifically,
A. The labels for your pasta products declare the serving size as “2 oz.” In accordance with 21 CFR 101.9(b)(7), the serving size must be expressed in common household measure, 21 CFR 101.9(b)(5), and shall be followed by the equivalent metric quantity in parentheses. The reference amount customarily consumed per eating occasion for this product category (Pastas, plain) is 55 g dry according to 21 CFR 101.12(b), Table 2; therefore, the product serving size for your product might be declared as “2 oz (___ g dry).”
B. The labels for your pasta products fail to declare Trans Fat on the Nutrition Facts information panel, as required by 21 CFR 101.9(c)(2)(ii).
C. The labels for your pasta products fail to declare the list of vitamins and minerals in the correct order in accordance with 21 CFR 101.9(c)(8)(ii).
D. The labels for your pasta products fail to declare the footnote completely and in the proper format, as required by 21 CFR 101.9(d)(9). The abbreviated footnote is only provided for labels with 40 square inches or less of space available to bear labeling, 21 CFR 101.9(j)(13)(ii)(C).
For additional information on General Food Labeling requirements go to http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm.
4. Your DOOR COUNTY SWEET POTATO CHIPS product is misbranded within the meaning of section 403(q)(2)(A) of the Act, 21 U.S.C. § 343(q)(2)(A), because the nutrition label for this product does not include the amounts of polyunsaturated and monounsaturated fats present in the product, as required by 21 CFR 101.9(c)(2)(iii) and (iv) when claims about fatty acids are made. Since your product label bears the claim “[Z]ero grams trans fat,” which is a fatty acid, the label must also declare the amounts of polyunsaturated and monounsaturated fats present in your sweet potato chips.
5. Your OLD WORLD STONERIDGE GOURMET LINGUINE, TRI-COLOR LINGUINE, SPINACH LINGUINE, BASIL & TOMATO LINGUINE, GARLIC & BASIL PESTO LINGUINE, WHOLE WHEAT LINGUINE, and FETTUCCINE products are misbranded within the meaning of section 403(e)(1) of the Act, 21 U.S.C. § 343(e)(1), because they fail to declare the place of business as required by 21 CFR 101.5. Specifically, the labels in use at the time of the inspection for your pasta products state “MFG. BY STONERIDGE PRODUCTS, INC., MILWAUKEE, WI.” However, the name and location of business declared on your product labels are not listed in a current city or telephone directory. Additionally, you failed to list the street address and ZIP code as required by 21 CFR 101.5.
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturer and distributor of violative products.
Please notify this office in writing within 15 working days of receiving this letter of the specific steps you are taking to correct the violations described above, and in particular, what methods and controls you will implement to prevent their recurrence. Please include any documentation that demonstrates the corrections have been implemented. If corrective action cannot be completed within 15 working days of receiving this letter, please state the reason for the delay and the time frame in which they will be completed.
We also have the following comments:
• You must list in the ingredient statement all of the sub-ingredients for the ingredients in your products. For example, your OLD WORLD STONERIDGE TRI-COLOR FETTUCCINE and your BASIL & TOMATO LINGUINE product labels include “Tomato Conentrate [sic]” in the ingredient list; however, the ingredient statement does not list all of the component ingredients (or “sub-ingredients”) in the tomato concentrate (e.g., water, tomato paste, and citric acid).
• The website below your manufacturer declaration, www.stoneridgepasta.com, is not an active website.
• Your ALL NATURAL DOOR COUNTY KETTLE CHIPS SWEET POTATO CHIPS product lists “POTATOES” as the primary ingredient rather than “sweet potatoes.” A chip made from potatoes is a different food and would need to bear a different statement of identity.
• The Sprecher BEER Flavored KETTLE CHIPS product is made using the ingredient Beer Chip Seasoning which includes sugar, maltodextrin, beer (malted barley, corn syrup solids, hops, yeast), salt, honey (honey, maltodextrin), yeast extract. The finished product label fails to declare all of the sub-ingredients.
Further, section 743 of the Act, 21 U.S.C. § 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 non-compliance 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 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your reply should be directed to Acting Compliance Officer Marie A. Fadden at the address indicated on the letterhead. You can contact Ms. Fadden at (612) 758-7172 with any questions regarding this letter.
Michael Dutcher, DVM