| Public Health Service Food and Drug Administration |
| Cincinnati District Office 6751 Steger Dr. Cincinnati, OH 45237 |
Department of Health and Human ServicesVIA United Parcel Service
May 10, 2010
Rachel D. Torres, Owner
Dolce, L.L.C.
221 S. Hancock St.
Unit 2
Louisville, KY 40202-1101
WARNING LETTER CIN-DO 10-92404-9
Dear Ms. Torres:
We inspected your seafood processing facility, located at 221 S. Hancock St., Unit 2, Louisville, KY on December 17 - 18, 2009, and again on January 27 and February 11, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your tuna salad, tuna salad sandwiches and salmon cakes are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
During each inspection FDA also collected labels for subsequent review. Based on our review of the label for your "Grandma's Tuna Sandwich", "Salmon Cakes" and "Ooohmami Vegan Burger" products, we have found these products to be misbranded within the meaning of Section 403 of the Act [21 U.S.C. § 343] as outlined below.
Your significant violations follow:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a) and (b). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption. However, your firm does not have a HACCP plan for tuna salad and tuna salad sandwiches to control the food safety hazards of histamine (scombrotoxin) formation, pathogen growth and toxin formation and allergens. In addition, your firm does not have a HACCP plan for salmon cakes to control the food safety hazard of allergens and pathogen survival, pathogen growth and toxin formation.
For additional information related to the hazards of histamine (scombrotoxin) please refer to Chapter 7 of the Fish and Fisheries Products Hazards and Controls Guidance: 3rd Edition (the Hazards Guide). For information concerning the hazard of pathogens please refer to chapters 12, 15 and 16 of the Hazards Guide. For information concerning the hazard of allergenic substances, please refer to Chapter 19 of the Hazards Guide.
2. Your "Salmon Cakes" and "Ooohmami Vegan Burger" are misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare all major food allergens present in the products, as required by Section 403(w)(1) of the Act.
Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines 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, as "major food allergens." 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:
i. 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
ii. 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)].
3. Your food labels fail to declare the following major food allergens specified by the Act:
• Milk and Wheat: Your Salmon Cake product contains milk and wheat, which are components of sour cream and panko respectively.
• Soy: Your Ooohmami Vegan Burger product contains soy, which is a component of vegenaise.
4. Your "Grandma's Tuna Sandwich", "Salmon Cakes" and "Ooohmami Vegan Burger" 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 labeling fails to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight. Specifically, the finished product labels fail to declare all the sub-ingredients for the following ingredients, as required by 21 CFR 101.4(b)(2):
• Grandma's Tuna Sandwich label lists mayo in the ingredient statement but fails to list the sub-ingredients of that ingredient on your product's finished label.
• Salmon Cakes label lists mayo, panko and sour cream in the ingredient statement but fails to list the sub-ingredients on your product's finished product label.
• Ooohmami Vegan Burger label lists local wheat/oat/flax buns and veganaise in the ingredient statement but fails to list the sub-ingredients of these ingredients on your product's finished product label.
The requirement to list component ingredients (or "sub-ingredients") may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-con1ponent ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food [21 CFR 101A(b)(2)].
5. Your "Grandma's Tuna Sandwich", "Salmon Cakes" and "Ooohmami Vegan Burger" products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the packages do not contain the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The name of the business is declared but you fail to completely or accurately declare the street address, city, state and zip code.
During our label review we also noted these additional observations:
• Although formulation sheets were not collected during the inspection, several other ingredients appear to be multi-ingredient foods such as the tomato paste and spring mix in your "Ooohmami Vegan Burger" and the Dijon mustard and Old Bay Seasoning in your "Salmon Cakes."
• Several of the ingredients in your ingredient statement are not declared by their common or usual name. Some examples are "mayo" in your "Grandma's Tuna Sandwich" and "Salmon Cakes"; "TVP", "Vegenaise" and "Spring Mix" in your "Ooohmami Vegan Burger"; and "Old Bay
Seasoning" in the Salmon Cakes.
• The term "Local" on your "Grandma's Tuna Sandwich" and "Ooohmami" in the ingredient list is intervening material [21 CFR 101.2(e)].
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm is in compliance with the Act, the seafood RACCP regulation (21 CFR Part 123) and all applicable regulation including the Food Labeling regulations (21 CFR 101). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your reply should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. You should include in your response documentation such as HACCP plans, HACCP monitoring and verification records, 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.
If you have questions regarding any issue in this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 164.
Sincerely,
/S/
Teresa C. Thompson
District Director
Cincinnati District
cc: Mark M. Reed, Manager
Kentucky Food Safety Branch, HS1CF
Health Services Building
275 East Main Street
Frankfort, KY 40621
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