| Public Health Service Food and Drug Administration |
Kansas City District |
Department of Health and Human ServicesSeptember 20, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref: KAN 2011-15
Harvey R. Sergio, President and Owner
Heartland Products, Inc.
301 SW 14th Street
Des Moines, IA 50309
Dear Mr. Sergio:
Your
On 5/3-5/9,2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 301 SW 14th Street, Des Moines, IA, 50309. During this inspection, FDA investigators collected labels of your products and a sample of industrial grade (b)(4). We have determined that your products described below are adulterated within the meaning of section 402 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342] and misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343]. You can find the Act and FDA's implementing regulations through links on FDA's home page at http://www.fda.gov.
ADULTERATION VIOLATIONS:
Your (b)(4) products are adulterated within the meaning of Section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because they bear or contain a food additive that is unsafe within the meaning of section 409 of the Act [21 U. S.C. § 348]. (b)(4) may only be used as an aging and bleaching ingredient in cereal flour if it is used in an amount no greater than 2.05 grams per 100 pounds of flour (0.0045 percent; 45 parts per million), to comply with 21 CFR 172.806. In addition, under 21 CFR 172.5, regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice, which include the restriction that any substance intended for use in or on food must be of appropriate food grade. However, your products contain industrial grade (b)(4) and the amount of (b)(4) you use in your products, even if it was food grade, exceeds 2.05 grams per 100 pounds of flour. We also note that a sample of the (b)(4) you use collected during the inspection was analyzed by an FDA laboratory. Cyanuric acid was identified as an impurity.
Current Good Manufacturing Practice
Your firm failed to clean food-contact surfaces, including utensils and equipment food contact surfaces, as frequently as necessary to protect against contamination of food, as required by 21 CFR 110.3 5(d).
• On 05/03/2011, your employee stated the small (b)(4) Blender used to stage out ingredients such as FD&C Yellow No.5 (b)(4), Ascorbic Acid, Bromate, L-cysteine and Wheat Flour had not been cleaned since the previous week. The blender had brown material caked on the stirring paddle. Scoops used to stage ingredients and fill finished products to their specified weight were observed on a forklift and on a wooden pallet. Your employee stated the product scoops are cleaned about once a week.
Your firm failed to store raw materials in a manner that protects against contamination, as required by 21 CFR 110.80(a)1).
• On 05/03/2011 and 05/05/2011, boxes and bags of ingredients such as Fine Potato Flour, Fine Granulated Sugar, Food Grade Salt, and Dried Egg White Solids used to manufacture finished goods were observed open within the manufacturing area. Some of these products were placed directly on the floor. Allergens were not physically separated from each other during storage, which is likely to result in allergen contamination of products whose formulations do not contain allergens.
Your firm failed to store cleaned and sanitized portable equipment in a location and manner that protects food-contact surfaces from contamination, as required by 21 CFR 110.35(e).
• On 05/03/2011, clean white buckets, used to stage out ingredients for the finished product blend,were being stored on pallets immediately adjacent to a pile of litter and waste consisting of empty bags and boxes. The buckets had no protective covering from the environment.
MISBRANDING VIOLATIONS:
Your (b)(4) is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1) in that its labeling is false or misleading. The statement of identity for your (b)(4) includes the term butter. However, our investigators determined this product does not contain butter. In fact, the product's ingredient statement declares vegetable shortening, not butter.
Food Allergens
Your (b)(4) and (b)(4) 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 wheat. Our investigator determined that these products are made with wheat flour. 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)(l)(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., "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)].
Ingredient Statements
The (b)(4), and (b)(4)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 and the label fails to bear the common or usual name of each ingredient in accordance with 21 CFR 101.4(a)(1). For example:
a.(b)(4) is manufactured using azodicarbonamide. This ingredient is not in your ingredient statement.
b.(b)(4) and (b)(4) products declare vegetable shortening or vegetable oil, but fail to list specific components [21 CFR 101.4(b)(14)]. Each individual fat and or oil ingredient of a food intended for human consumption must be declared by its specific common or usual name (e.g. "beef fat," "cottonseed oil") in its order of predominance in the food, except that blends of fats and/or oils may be designated in their order of predominance in the foods as "_._ shortening" or "__blend of oils," the blank to be filled in with the word "vegetable," "animal," "marine," or combination of these, whichever is applicable if, immediately following the term, the common or usual name of each individual vegetable, animal, or marine fat or oil is given in parentheses, e.g., "vegetable oil shortening (soybean and cottonseed oil)."
The ingredient statement for your (b)(4) lists, among other ingredients, soda and gum, but does not provide the common or usual name for these ingredients.
Our inspection also determined that you utilize multiple wheat flours to manufacture your bakery mixes; however several of the flours that you use contain multiple ingredients. For example, the (b)(4) flour contains wheat flour, niacin, iron, thiamin mononitrate, riboflavin, and folic acid. You must ensure that all ingredients of the flours that you use are properly identified on your product label.
For ingredients that are themselves composed of two or more ingredients (e.g., mayonnaise), the requirement to list the component ingredients (or "sub-ingredients") may be met by either (1) For ingredients that are themselves composed of two or more ingredients (e.g., mayonnaise), the requirement to list the component ingredients (or "sub-ingredients") may be met by either (1) parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or (2) listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 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.
The above is not intended to be an all-inclusive list of violations. As a manufacturer of food products you are responsible for assuring your overall operation and the products you manufacture and distribute are in compliance with the Act and implementing regulations.
You should take prompt action to correct these violations. Failure to effect prompt and permanent corrective actions may result in regulatory and/or administrative sanctions including but not limited to seizure or injunction. This letter constitutes official notification under the law and provides you an opportunity to correct the deficiencies in your operations.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done to correct these violations. You should include in your response documentation, such as records, labels, or photographs, of the corrective and preventive actions taken by your firm, 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.
Your written reply should be addressed to the Food and Drug Administration, Attention: Tamara J. Umscheid, Compliance Officer, at the above address.
Sincerely,
/s/
John W. Thorsky
District Director
Kansas City District
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