Inspections, Compliance, Enforcement, and Criminal Investigations
Square One Foods 3-20-2009
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142
March 20, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09-14
Ms. Wendi J. Harrison
Mr. Larry C. Salley
Square One Foods
23781 Third Avenue, P.O. Box 72
Siren, Wisconsin 54872
Dear Ms. Harrison and Mr. Salley:
An inspection of your facility located at 23781 Third Avenue, Siren, Wisconsin, was conducted by an investigator from the Food and Drug Administration (FDA) on November 3, 4 and 6, 2008. This inspection verified that your firm manufactures and distributes a variety of food products. Our review of your product labels reveals that several of your products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) in that several of your products are misbranded within the meaning of sections 403(w) and 403(i)(2) of the Act [21 U.S.C. §§ 343(w) and (i)(2)] and title regulations contained within Title 21, Code of Federal Regulations; Part 10 [21 CFR 101). You may find the Act and the CFR through links on FDA's home page at www.fda.gov.
Your HAM & CHEESE SANDWICH and GARLIC CHEESE BREAD 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 completely or accurately declare the presence of all the-major food allergens present in the food.
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)(l)(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., "flour (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)]:
Specifically, your HAM & CHEESE SANDWICH is manufactured in part with "(b)(4) Pasteurized Process Swiss and American Cheese" which contains cultured milk and skim milk, cream, and soy lecithin; and the standardized food "Enriched bun" [21 CFR 136.115], which contains wheat flour. However, your HAM & CHEESE SANDWICH fails to declare the presence of the major food allergens milk, soybeans, and wheat on its label. Your GARLIC CHEESE BREAD is manufactured in part with French Bread, which contains wheat flour;"(b)(4) Whipped Butter Blend Spread," which contains cream, whey solids, soy lecithin, and buttermilk solids; "(b)(4) Pure Vegetable Margarine," which contains soy lecithin and whey, and "(b)(4) Shredded Blend".(cheese blend), which contains part skim milk and pasteurized whole milk. However, your GARLIC, CHEESE BREAD fails to declare the presence of the major food allergens wheat, milk and soybeans on its label.
Your HAM & CHEESE SANDWICH and GARLIC CHEESE BREAD products are also misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the labels of these products have incomplete ingredient-statements. For example:
• The ingredient statement-for your HAM & CHEESE SANDWICH reads: "Fully cooked ham, Swiss American cheese, Enriched bun: flour, water; shortening, egg,. sugar, yeast, salt & sesame seeds." The label fails to include the component ingredients (or "sub-ingredients") of the ingredients that are themselves composed of more than one ingredient as required by 21 CFR 101.4(b)(2). For example, the Pasteurized Process Swiss and American Cheese used in your product (currently declared on the product label as "Swiss American Cheese") is composed of, in part, cultured milk and skim milk, cream, sodium citrate, citric acid, sorbic acid, sodium phosphate, enzymes, and soy lecithin. However, none of the sub-ingredients listed here are declared on your product label. Moreover, the name "Swiss American cheese" is not a proper "common or usual name" for this ingredient within the meaning of section 403(i)(2) of the"Act. We would not object to the name "Pasteurized Process Swiss and American Cheese." In addition, the ingredient "Fully cooked ham" is also composed of several sub-ingredients which are not included on your label [21 CFR 101.4(b)(2)].
• The ingredient statement for your GARLIC CHEESE BREAD reads: "French Bread, Garlic Butter, Margarine, Mozzarella Cheese, Monterey Jack Cheese, Provolone Cheese, Cheedar [sic] Cheese, Salt & Spices." The label does not include the sub-ingredients. of the ingredients that are themselves composed of more than one ingredient as required by 21 CFR 101.4(b)(2). Specifically, the French Bread, Garlic Butter, Margarine, Mozzarella Cheese, Provolone Cheese and Cheddar Cheese used in your product are all composed of several sub-ingredients which are not included on your label [e.g., the French Bread is composed of wheat flour (wheat flour, malted barley flour, potassium bromate), water, yeast, sugar, salt, partially hydrogenated soybean oil, and calcium propionate]. The investigator also noted that the cheese used in this product was a shredded blend of "part skim mozzarella cheese, provolone cheese, and colored cheddar cheese." Your ingredient statement declares "Monterey Jack Cheese" as an ingredient, but there is no evidence to suggest that Monterey Jack cheese is used in this product.
The requirement to list these component 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.
This letter is not meant to be an all-inclusive list of deficiencies that may exist in any of your product labeling. It is your responsibility as owners to ensure that your establishment is in compliance with all requirements of federal law and FDA regulations.
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence, including documentation that will help us assess the corrective actions you have taken. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Failure to promptly correct these deviations may result in legal action without further notice. Such actions include, without limitation, seizure and injunction.
We also note that the labels for your products show the firm's previous name of R & M Foods. To be in compliance with 21 CFR 101.5(b) the labels must reflect the current name of the firm. Additionally, if the firm is listed in a local telephone directory, it is permissible to exclude the street address from your label. However, there is no exemption which permits the exclusion of the zip code [21 CFR 101.5(d)]. Please also address these two items in your reply to this letter.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
W. Charles Becoat