| Public Health Service Food and Drug Administration |
| San Francisco District 1431 Harbor Bay Parkway Alameda. CA 94502-7070 Telephone: 510/337-6700 |
Department of Health and Human ServicesWARNING LETTER
VIA UPS OVERNIGHT
SIGNATURE REQUESTED
Our Reference: 3001238989
April 18, 2011
Thomas F. Pagano, Owner
Tomaso’s Specialty Foods
201 Taylor Way
Blue Lake, CA 95525
Dear Mr. Pagano:
On December 2 and 3, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 201 Taylor Way Blue Lake, California. During this inspection, FDA investigators collected labels of your products. We have reviewed these labels and your proposed revisions to the labels provided to investigators during the inspection. Based on our review, we have determined that your Tomaso’s brand products described below are misbranded within the meaning of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 [21 CFR Part 101]. You can find the Act and FDA regulations through links on FDA's home page at http://www.fda.gov.
Food Allergens
Your Tomaso’s Classic Caesar Dressing is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that it fails to declare all major food allergens present in the product, as required by section 403(w)(1) of the Act [21 U.S.C. § 343(w)(1)]. Specifically, the product label fails to identify the major food allergens egg, milk, fish, and soy.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)] defines major food allergens as: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans; as well as any food ingredient containing 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 bearing or containing, a major food allergen, unless either:
(A) The word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [Section 403(w)(1)(A) of the Act; 21 U.S.C. § 343(w)(1)(A)]; or
(B) 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., “Worchester sauce (soy)”), except 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 from which the major food allergen is derived or the name of the food source from which the major allergen is derived appears elsewhere in the ingredient list (unless the name of the food source appearing 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
Your products, Classic Caesar Dressing and Black Olive Fresh Basil Garlic Pasta Sauce, are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients but the labels fail to list all required ingredients, in accordance with 21 CFR 101.4(a)(1). Specifically:
1. Your Classic Caesar Dressing product has an ingredient statement that lists mayonnaise, parmesan cheese, Dijon mustard. These ingredients are multi-component ingredients. For example:
• The mayonnaise ingredient is composed of several sub-ingredients (soybean oil, water, egg yolks, vinegar, contains 2% or less of spice, salt, high fructose corn syrup, extractives of paprika, corn syrup, citric acid, calcium disodium EDTA (to protect flavor)).
• You stated that the parmesan cheese ingredient is composed of several sub-ingredients (pasteurized cultured milk, enzymes, and salt).
• You stated that the Dijon mustard ingredient is composed of several sub-ingredients (vinegar, lemon juice from concentrate (water, concentrated lemon juice), sodium benzoate, sodium meta-bisulfate and sodium sulfate, lemon oil).
2. Your Black Olive Fresh Basil Garlic Pasta Sauce product has an ingredient statement that lists kalamata olives and capers. These ingredients are multi-component ingredients.
• The kalamata olives are composed of several sub-ingredients (kalamata olives, sunflower oil, extra virgin olive oil).
• The capers are composed of several sub-ingredients (capers, water, vinegar, salt).
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.
We acknowledge your response letter dated January 20, 2011 which states that you intend to make corrections to your product labels and provides proposed revised ingredient statements. You also provided hand-written proposed revised ingredient statements to the inspectors during the inspection. However, as explained below, the revised ingredient statements for the products discussed here are inadequate because they still do not comply with the Act and its regulations. Your proposed revised label for the Classic Caesar Dressing product does not list the sub-ingredients for Dijon mustard. Your proposed revised label for the Black Olive Fresh Basil Garlic Pasta Sauce product does not include the sub-ingredients for kalamata olives or capers. It is your responsibility to ensure that your labels list all ingredients in descending order of predominance to comply with 21 CFR 101.4(a)(1) and 21 CFR 101.4(b)(2), and that your labels comply with the Act and all other applicable FDA regulations.
3. In addition, your Classic Caesar Dressing product and Black Olive Fresh Basil Garlic Pasta Sauce product have ingredient statements that fails to list all ingredients. Specifically our investigator noted that the label for your Classic Caesar Dressing product fails to list Worchester sauce (or any of its sub-ingredients, distilled vinegar, molasses, corn syrup, water, salt, caramel color, sugar, spices, anchovy puree, natural flavor (contains soy) and tamarind) and your Black Olive Fresh Basil Garlic Pasta Sauce product does not list tomato paste, red chili flakes, water and vinegar, which are all listed on your formulation sheets collected by our investigator.
We acknowledge your response letter dated January 20, 2011 which states that you intend to make corrections to your product labels and provides proposed revised ingredient statements. You also provided hand-written proposed revised ingredient statements to the inspectors during the inspection. Your proposed revised label for the Classic Caesar Dressing product is inadequate because it does not list Worchester sauce or any of its sub-ingredients. It appears that your proposed revised label for your Black Olive Fresh Basil Garlic Pasta Sauce product would correct this violation. We will verify this correction during your next inspection. You must also ensure that your labels list all ingredients in descending order of predominance to comply with 21 CFR 101.4(a)(1) and 21 CFR 101.4(b)(2), and that your labels comply with the Act and all other applicable FDA regulations.
Nutrition Facts Information
Your products “Classic Caesar Dressing” and “Pasta Sauce Black Olive Fresh Basil Garlic” are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not declared in accordance with the Act and FDA regulations. Specifically:
• The product labels fail to declare the amount of trans fat, as required by 21 CFR 101.9(c)(2)(ii).
• The product labels fail to round the amounts of calories and calories from fat to the appropriate increments, in accordance with 21 CFR 101.9(c)(1) and 21 CFR 101.9(c)(1)(ii) respectively.
• The product label for your Classic Caesar Dressing does not declare the unit of measure (grams) for total carbohydrate, dietary fiber, and sugar, as required in 101.9(c)(6), 101.9(c )(6)(i), and 101.(c )(6)(ii) respectively.
Manufacturer Information
Your products Puttanesca Tomato Fresh Basil, Olive & Caper Sauce and Black Olive Fresh Basil Garlic Pasta Sauce products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that their labeling does not bear the proper name and place of business of the manufacturer, packer, or distributor. Specifically, the products declare they are produced by your company located at Arcata, CA; however, your firm is located in Blue Lake, CA. According to 21 CFR 101.5(a), the label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.
We acknowledge your response letter dated January 20, 2011 which states that you intend to make corrections to your product labels. However, you did not provide documentation of your intended corrections, except for proposed revised ingredient statements, which we addressed above.
This letter is not intended to be an all-inclusive list of violations that may exist at your facility or with respect to your products. You are responsible for ensuring that your facility and your products are in compliance with the Act and all applicable regulations. Failure to implement lasting corrective action of these violations and prevent their recurrence may result in regulatory action by FDA without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products, and the seizure of such products, under sections 302 and 304 [21 U.S.C. §§ 332 and 334].
Additional Labeling Comments
In regard to your product labels, we also note that a UPC bar code is improperly placed within the Nutrition Facts panel on the Black Olive Fresh Basil Garlic Pasta Sauce label. The inclusion of the UPC bar code within the Nutrition Facts panel is not provided for in 21 CFR 101.9(d). The Nutrition Facts panel must be set off in a box by use of hairlines, to comply with 21 CFR 101.9(d)(1)(i).
Also, the term “fresh” is used to describe the garlic and basil ingredients in the ingredient statement on your “Pasta Sauce Black Olive Fresh Basil Garlic” and “Puttanesca Tomato, Fresh Basil, Olive & Caper Sauce” labels. Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name and without intervening material [21 CFR 101.4(a)(1) and 101.2(e)]. The word “fresh” is considered to be intervening material because it is not part of the common or usual name of the ingredient.
Within fifteen (15) working days of your receipt of this letter, please notify this office in writing of the current status of your corrective actions and the specific steps that you have taken to correct the noted violations. You should include documentation 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 your delay and state the time within which you will complete the remaining corrections.
Please send your reply to the Food and Drug Administration, Attention: Juliane K. Jung-Lau, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have
questions regarding any issue in this letter, please contact Compliance Officer Jung-Lau at (510) 337-6793.
Sincerely,
/s/
Barbara J. Cassens
San Francisco District Director
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