| Public Health Service Food and Drug Administration |
| Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 758-7114 FAX: (612) 334-4142 |
Department of Health and Human Services
March 30, 2010
WARNING LETTER
Refer to MIN 10 - 12
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Charles Palmer-Ball
Owner
Wisconsin Brother's Bakery, Inc.
dba Lehmann's Bakery
9117 Durand Avenue
Sturtevant, Wisconsin 53177-2027
Dear Mr. Palmer-Ball:
This letter is in reference to your firm's manufacture, distribution, and labeling of your Kringle products identified during our inspection conducted on September 10, 14, 17, and 21, 2009, at your facility located at 9117 Durand Avenue, Sturtevant, Wisconsin. During the inspection, FDA investigators documented violations of the Federal Food, Drug, and Cosmetic Act (the Act) and its implementing regulations contained within Title 21 of the Code of Federal Regulations, Part 101 (21 CFR 101). These violations cause your Kringle products to be misbranded within the meaning of sections 403(a), 403(w), 403(i), and 403(q) of the Act [21 U.S.C. § 343(a), 343(w), 343(i), and 343(q)]. You may find the Act and CFR through links on our website, www.fda.gov.
Your Kringle products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that their labels and labeling are false or misleading. Your firm uses the same label on the packages of all Kringle varieties, and we have determined that your website, www.lehmann.com. is labeling under section 201(m) of the Act for your Kringle products because the website address appears on the product labels. Your product labels and website state that your Kringle products contain butter. However, our investigator determined that your Kringle products do not contain butter.
Your Almond Kringle product is further misbranded under 403(a)(1) of the Act because its label is false or misleading. The ingredient statement for this product states that the product is made with "Blanched Almonds;" however, our investigator determined that this product does not contain the ingredient "blanched almonds."
Your Kringle products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the labels fail to list the major food allergen milk. Our investigator determined that these products are made with margarine, which, according to the label of the margarine ingredient, contains milk. 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:
1. 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 (in a type size no smaller than the type size used in the list of ingredients) [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
2. 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 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)].
Your Almond Kringle product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the product label does not list the names of each ingredient in the food. Specifically, our investigator noted that this product contains the ingredient "kernel paste," but the label fails to list this ingredient as required by 21 CFR 101.4(a)(1).
Additionally, your Almond, Cheese, and Cherry Cheese Kringle products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients but the labels fail to list all sub-ingredients (ingredients of an ingredient in the finished product). For example:
• Our investigator noted that "(b)(4) Vegetable Margarine" is an ingredient in all Kringle varieties. The label for this ingredient shows
that it contains several sub-ingredients (e.g., partially hydrogenated soybean and cottonseed oil, mono and diglycerides, soy lecithin, whey, and Vitamin A palmitate) that are not declared in the ingredient list for your Almond Kringle as required by 21 CFR 101.4(b)(2).
• Our investigator noted that "(b)(4) Milk Replacer" is an ingredient in all Kringle varieties. The label for this ingredient shows that it contains several sub-ingredients (e.g., soya protein, malto dextrin, cerelose, alginates, "beta carateen [sic]," and lecithin) that are not declared in the ingredient list for your Almond Kringle as required by 21 CFR 101.4(b)(2).
• Our investigator noted that the ingredient "(b)(4) Egg" is an ingredient in all Kringle varieties. The label for this ingredient shows
that it contains several sub-ingredients (e.g., corn starch, canola oil, vegetable stabilizer, lecithin, and beta carotene) that are not declared in the ingredient list for your Almond Kringle as required by 21 CFR 101.4(b)(2).
• The ingredient statements for your Cheese and Cherry Cheese Kringle products declare cream cheese as an ingredient. However, our
investigator noted that the label for the cream cheese shows that it is composed of several sub-ingredients (milk, cream, cheese culture, and stabilizers (carob bean and/ or xanthan and/or guar gums)) that are not declared in the ingredient lists for your Cheese and Cherry Cheese Kringles as required by 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; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
You must ensure that your product labels list all ingredients in accordance with 21 CFR 101.4. We recommend that you review the ingredient statements for each variety of your Kringle products to ensure that they appropriately identify all ingredients contained in each product.
Your Kringle products are misbranded within the meaning of 403(q) of the Act [21 U.S.C. § 343(q)] in that their labels fail to comply with the nutrition labeling requirements of 21 CFR 101.9, and your firm is not exempt from these requirements. For example:
• The serving size declaration is not expressed in the common household measure appropriate to the food [21 CFR 101.9(b)(5)(ii)] based on the reference amount customarily consumed (RACC) for the product category provided in 21 CFR 101.12(b).
• The nutrition information required to be presented on your Kringle product labels does not meet the requirements of 21 CFR 101.9(d). For example:
1. The nutrition information is not presented under the identifying heading of "Nutrition Facts" as required by 21 CFR 101.9(d)(2), and the nutrition facts panel does not include the subheading "Amount Per Serving" as required by 21 CFR 101.9(d)(4).
2. Your labels do not bear the footnote required under 21 CFR 101.9(d)(9). This footnote, preceded by an asterisk, must include the information specified by 21 CFR 101.9(d)(9)(i) and must be placed beneath the list of vitamins and minerals and separated from that list by a hairline.
3. Your Kringle product labels do not meet the bolding requirements in 21 CFR 101.9(d)(1)(iv).
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/ or injunction against the manufacturers and distributors of violative products.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
We also have the following comments for your information when revising your labeling:
You should ensure that your package labels provide the net quantity of contents statement as a distinct item in the bottom 30 percent of the principal display panel as required by 21 CFR 101.105.
As discussed above, your Almond Kringle products do not contain almonds. Because the name of the food is "Almond Kringle," almond is considered the characterizing flavor of the food, and this flavor must be declared in accordance with 21 CFR 101.22(i). For example, if the food contains any artificial flavor that simulates, resembles, or reinforces the characterizing flavor, the name of the food must be accompanied by the common or usual name of the characterizing flavor, and the name of the characterizing flavor must be accompanied by the word(s) "artificial" or "artificially flavored" (e.g., "artificial almond"), [21 CFR 101.22(i)(2)].
As discussed above, your firm uses the same label on each variety of your Kringle products. This label declares the ingredients in your Almond, Apple, Apricot, Blueberry, Cheese, Cherry, Cherry Cheese, Chocolate, Mixed Berry, Pecan, Raspberry, and Walnut Kringles only. Your firm sells additional Kringle varieties, including your Pineapple, Strawberry, Almond Macaroon, Apple Cinnamon, Apple Walnut, Blueberry Cheese, Chocolate-Custard, Cranberry Walnut, Custard Chocolate Chip, Custard Pecan, German Chocolate, Maple Walnut, Pineapple Pecan, Poppyseed, Cranberry, Chocolate Chip, and Bavarian Custard Kringles, but does not use an additional label on packages containing these varieties. You must ensure that the label of each product lists all ingredients that the product contains, as required by section 403(i) of the Act [21 U.S.C. § 343(i)] and 21 CFR 101.4(a)(1).
Additionally, it was noted during the inspection that your firm routinely uses donuts, manufactured by your firm, as an ingredient in each variety of your Kringle products. These donuts may be of many different varieties and may contain ingredients not declared in the ingredient statements for your Kringle products. Such a practice could result in the introduction of ingredients, including allergens, not declared on the labels of the finished products. Although your Kringle product label bears the disclaimer statement "Manufactured on the same equipment as peanut and other varieties of tree nut products," if you continue to use donuts in your Kringles, you must ensure that all Kringles containing donuts declare all ingredients, as well as any major food allergens, introduced by the donuts, on their labels.
Your reply should be sent to the attention of Compliance Officer Tyra S. Wisecup at the address on the letterhead.
Sincerely,
/s/
W. Charles Becoat
Director
Minneapolis District
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