| Public Health Service Food and Drug Administration |
PHILADELPHIA DISTRICT Telephone: 215-597-4390 |
Department of Health and Human Services
WARNING LETTER
10-PHI-09
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
June 10, 2010
Mr. Nicholas Caggiano, Sr.
President
Nicola Pizza Incorporated
8 N. First Street
Rehoboth Beach, DE 19971-2116
Dear Mr. Caggiano:
This letter is in reference to the inspection of your facility located at the above address on November 9 and 20, 2009, by an investigator from the U.S. Food and Drug Administration (FDA). During the inspection,insanitary conditions were found at your facility that render your Nic-o-boli® products adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Our review of your product labels and other evidence collected during the inspection has determined that your Nic-o-boli® products are misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343]. The Current Good Manufacturing Practice regulations for foods are found in Title 21, Code of Federal Regulations, Part 110; regulations implementing the food labeling requirements of the Act are found in Title 21, Code of Federal Regulations, Part 101. You can find the Act and implementing regulations on FDA's home page www.fda.gov.
Current Good Manufacturing Practice Violations
You must clean and sanitize all food contact surfaces, including utensils and equipment, in a manner that protects against contamination of food, in order to comply with 21 CFR 110.35(d). However, your firm failed to clean and sanitize utensils and equipment as to protect against contamination of food, as evidenced by:
♦ The can opener in the food production area exhibited food debris accumulated on the cutting blade and the shaft. This can opener was used to open 6 lb. cans of pizza sauce, the contents of which were to be used in the production of your pizza sauce.
♦ The pizza dough mixer exhibited food debris where the dough hook would be inserted. The dough mixed in the mixer is used for Nic-o-boli® products.
♦ The dough portion and press machine exhibited food debris on the food conveyors rear panels, metal runners, cloth runner, and motor housing. This machine is sued for the production of your pizza dough and Nic-o-boli® products.
Pests must not be allowed in any area of a food plant, and effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). However, your firm failed to exclude pests from the kitchen and to protect against contamination of food by pests, as evidenced by:
♦ Live ants observed in a hole with dimensions approximately 2 inches wide and 6 inches long, located under the kitchen triple sink where the wall meets the floor.
♦ Two electronic lighted devices used for pest control hung immediately over food preparation areas in the kitchen. When an insect flies into one for these devices and is "zapped," parts of the insect can be ejected from the device and can land up to six feet away from the device.
Buildings, fixtures, and other physical facilities of the plant must be maintained in a sanitary condition and must be kept in repair sufficient to prevent food from becoming adulterated, to comply with 21 CFR 110.35(a). However, your firm failed to do so, as evidenced by:
♦ Accumulated food debris in a hole in the floor located under a pizza oven.
♦ Accumulated dust and debris on the ceiling and pipes above the pasta cooker.
♦ A gap in the floor around the drain pipe from the pasta cooker.
♦ Loose and missing tiles along the wall behind the pasta cooker.
♦ A cart exhibiting food debris on the underside of its shelves and wheels stored upside down on a metal table.
♦ Broken tiles and absence of grout between tiles in front of the automatic dishwashers.
♦ No cleanable threshold on the floor at the rear entrance doorway between the food production area and the room containing the ice machine.
Labeling Violations
During our inspection, we collected your product labels for your 4 pack and 12 pack containers used to pack and ship your Nic-o-boli® products. In addition, we reviewed your website, http://www.nicolapizza.com. Because it appears on the package of your products, your website is considered labeling and must comply with FDA labeling requirements. We have identified numerous violations of the Act and applicable regulations in your labeling that cause your Nic-o-boli® products to be misbranded, as discussed below:
1. Failure to declare all major food allergens.
Your Nic-o-boli® products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that their labels fail to declare all major food allergens present in the products, as required by section 403(w)(1) of the Act.
The labeling our investigators collected during the inspection indicates that your Nic-o-boli® products are manufactured from ingredients that contain major food allergens, which are not listed on the finished product labels. For example:
♦ Dough used for your Nic-o-boli® products contains High Gluten Spring Wheat Flour, which contains wheat.
♦ Cheese used for your Nic-o-boli® products 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:
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. "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)]).
The allergen labeling requirements of section 403(w) of the Act can be accessed on our website at http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/
GuidanceComplianceRegulatorylnformation/ucm106187.html. Further guidance and information on food allergens can be accessed on our website at http://www.fda.gov/Food/FoodSafety/FoodAllergens/default.htm.
2. Failure to meet the requirements for making a nutrient content claim.
Your Nic-o-boli® products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because their labeling makes a nutrient content claim but the products do not meet the requirements for making this claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the label or labeling of the food must be made in accordance with a regulations promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
Your Nic-o-boli® products claim "fat free dough and sauce." Under 21 CFR 101.62(b), to use the term "fat free," a food must contain less than 0.5 grams of fat per reference amount customarily consumed (RACC) and per labeled serving; must not contain an added ingredient that is a fat or that is generally understood to contain fat unless the ingredient statement lists the ingredient followed by an asterisk that refers to a statement indicting that the amount of fat added is insignificant; and must either be specially processed to remove fat from the food or is labeled to disclose that fat is not usually present in the food.
Your Nic-o-boli® products contain a blend of (b)(4) cheeses, which is an added ingredient generally understood to contain fat. Therefore, to use the term "fat free" in association with this product, you must indicate that the amount of fat added by your cheese blend is insignificant by placing an appropriate statement on the product label, in accordance with 21 CFR 101.62(b)(ii).
In addition, we question your use of the term "healthy heart" on your labeling. The labeling on your website claims "Healthy Heart Pizza... " and "Healthy Heart Nicoboli. ..." The term healthy may be used as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the following conditions for fat, saturated fat, cholesterol and other nutrients, in accordance with 21 CFR 101.65(d)(2)(i):
♦ The product contains 3g or less of total fat per 100g and not more that 30 percent of calories from fat; and if the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower fat content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (see 21 CFR 101.62(b)(3));
♦ The product contains 19 or less of saturated fatty acids per 100g and less than 10 percent calories from saturated fat; and if the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated fat content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (see 21 CFR 101.62(c)(3));
♦ The level of cholesterol is 90mg or less cholesterol per labeled serving (LS); and
♦ The product contains at least 10 percent of the referenced daily intake (see 21 CFR 101.9(c)(8)(iv)) or daily reference value (see 21 CFR 101.9(c)(9)) per LS of three of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, or fiber.
Therefore, if your products do not meet these criteria, they are misbranded under section 403(r)(1)(A) of the Act.
3. Failure to list sub-ingredients.
Your Nic-o-boli® products are misbranded under 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 their labels fail to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, s required by 21 CFR 101.4. For example:
♦ The labels for your Nic-o-boli® products fail to list the sub-ingredients of dough. For example, one ingredient of your dough is High Gluten Spring Wheat Flour, which has the following sub-ingredients that do not appear on the labels of your Nic-o-boli® products (b)(4)
♦ The labels for your Nic-o-boli® products fail to list the sub-ingredients of the cheese used to manufacturer your products. For example, one ingredient of your cheese is (b)(4) cheese, which has the following sub-ingredients that do not appear on the labels of our Nic-o-boli® products: (b)(4)
♦ The labels for your Nic-o-boli® products fail to list the sub-ingredients for the tomato sauce. For example, one ingredient of your tomato sauce is canned pizza sauce, which has the following sub-ingredient that do not appear on the labels of your Nic-o-boli® products: (b)(4)
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 [21 CFR 101.4(b)(2)(i)], or by 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; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
4. Failure to bear nutrition information
Your Nic-o-boli® products are misbranded within the meaning of section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)], because their labels or labeling fails to bear nutrition information as required by 21 CFR 101.9. Note that some food is exempt from the requirements in 403(q)(1) (see e.g., section 403(q)(5) of the act [21 U.S.C. § 343(q)(5)], but your products are not.
5. Failure to state net quantity of contents.
Your Nic-o-boli® products are also misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] in that the package for your products does not bear a label containing a statement of the net quantity of contents. This statement must be a distinct item in the bottom 30 percent of the principal display panel, in accordance with 21 CFR 101.105.
The above violations are not meant to be an all-inclusive list of deficiencies. It is your responsibility to ensure that all of your products are manufactured and labeled in accordance with all applicable laws and regulations.
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.
Additionally, we reviewed your processing method for your Hot Peppers packaged in 16 oz jars. FDA is concerned that the product may be an acidified food, governed by 21 CFR parts 108 and 114, or a low-acid food, and governed by 21 CFR parts 108 and 113. We recommend that you contact a processing authority familiar with acidification of foods in order to make this determination. If your Hot Peppers product, or any other product that you manufacture, is determined to be an acidified food or low-acid food, your firm is required to register and file scheduled process information with the FDA for those products.
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter. Your response should include the specific steps you have taken to correct the deviations. If you can not complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your response should be directed to: Ms. Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, U.S. Customhouse, 2nd & Chestnut Streets, Room 900, Philadelphia, PA 19106. If you have any questions, please do not hesitate to contact Ms. Rivers at (215)717-3076.
Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District Office
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