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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Panini Ventures, LLC 30-Jan-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 756-7133
FAX: (612) 334-4142



January 30, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 07 -09

Sang T. Tran, Owner
Bart Hazlett, Owner
Panini Ventures, LLC
1702 Lexington Ave N
Roseville, Minnesota 55113-6514

Dear Ms. Tran and Mr. Hazlett:

On September 29, October 2 and 6, 2006, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 1702 Lexington Ave N, Roseville, MN. During this inspection, the investigator collected labels from several of your ready-to-eat food products. Our review, of your product labels reveals that several of your products violate the Federal Food, Drug, and Cosmetic Act (the Act) in that they are misbranded within the meaning of sections 403(i) and 403(w) of the Act [21 U.S.C. § 343(i) and (w)] and the regulations contained within Title 21, Code of Federal Regulations, Part 101 (21 CPR 101). You may find the Act and FDA regulations in the CFR through links in FDA's home page at www.fda.gov.

Ingredient Listing

Various products manufactured with your "Made by The Original Tomato" brand 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 all of the ingredients are not declared on the labels as specified under 21 CFR 101.4(b)(2). See below for examples:

  • Your Chicken Salad on Croissant, Ham & Swiss on Croissant, Egg Salad on Croissant, Ham, Turkey & Swiss on Croissant, and Turkey and Swiss on Croissant products list "Butter Croissant" on the ingredient label. However, the Butter Croissant label obtained during the inspection identifies sub-ingredients that are not listed on your finished product labels (i.e. [redacted] (and its sub-components)] .

  • Your Chicken Salad on Croissant, Egg Salad on Croissant, Smoked Chicken Breast on Cranberry-Orange Bread, Chicken, Dried Cherries Red Pepper Vinaigrette, Honey-Cured Ham with Aged Swiss, Egg Salad, and Tarragon Chicken Salad products list "Mayonnaise" on the ingredient label. The Mayonnaise label obtained during the inspection identifies sub-ingredients that are not listed on your finished product labels (i.e., [redacted]).

  • Your Ham and Swiss on Croissant, Ham, Turkey and Swiss on Croissant, Turkey and Swiss on Croissant, and Honey-Cured Ham with Aged Swiss products list "Swiss Cheese" on the ingredient label. The Swiss cheese label obtained during the inspection identifies sub-ingredients that are not listed on your finished product labels (i.e., [redacted]).

  • Your Chicken, Dried Cherries Red Pepper Vinaigrette and Greek Salad Wrap list, "Sour Cream" on the ingredient label. The Sour Cream label obtained during the inspection identifies sub-ingredients that are not listed on your finished product labels (i.e., [redacted]).

  • Your Egg Salad on Croissant and Egg Salad list "Sweet Pickle Relish" on the ingredient label. The Sweet Relish label obtained during the inspection identifies sub-ingredients that are not listed on your finished product labels (i.e. [redacted]).

The requirement to list sub-ingredients in the ingredient statement of the finished food may be met-either by 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-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.

Allergen Labeling

Your Chicken Salad on Croissant, Ham and Swiss on Croissant, Egg Salad on Croissant, Ham, Turkey, and Swiss on Croissant, Smoked Chicken Breast on Cranberry-Orange Bread, Turkey and Swiss on Croissant, Chicken, Dried Cherries Red Pepper Vinaigrette, Honey-Cured Ham with Aged Swiss, Tarragon Chicken Salad, and Greek Salad Wrap products are further 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 those products (i.e., wheat, milk, egg and soy), as required by section 403(w)(1). Section 201 (qq) of the Act [21 U.S.C. § 321(qq)] defines a major food allergen as 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. (section 403 (w)(1)(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, 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 from which the major food allergen is derived 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)]).

Guidance on the allergen labeling requirements in section 403(w) may be found on FDA's website at www.fda.gov.

For example, your products fail to declare the following major food allergens as specified by the Act:

  • Wheat, Milk and Soy (subcomponents of the croissant, Swiss cheese, and sour cream): Your Chicken Salad on Croissant, Ham and Swiss on Croissant, Egg Salad on Croissant, Ham, Turkey, & Swiss on Croissant, Chicken, Dried: Cherries Red Pepper Vinaigrette, Honey-Cured Ham with Aged Swiss, and Greek Salad Wrap contain butter croissants, Swiss cheese and/or sour cream as an ingredient in the product.

  • Egg (subcomponent of the mayonnaise): Your Chicken Salad on Croissant, Smoked Chicken Breast on Cranberry-Orange Bread, Dried Cherries Red Pepper Vinaigrette, Honey-Cured Ham with Aged Swiss, and Tarragon Chicken Salad include mayonnaise as an ingredient in the product.

This letter is not meant to be an all-inclusive list of deficiencies that may exist in your products and their labeling. It is your responsibility as top management to ensure that your establishment is in compliance with all requirements of the Act 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. Include any documentation necessary to show that correction has been achieved. 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 regulatory action without further notice. Such action may include seizure and injunction.

In addition to the violations described above, we have the following comment concerning the labeling of your sandwiches that include Seasonal Greens as an ingredient:

Your various sandwiches such as Ham and Swiss on Croissant, and Hummus with Fresh Veggies, Smoked Turkey with Tarragon Chevre declared "seasonal greens" in the ingredient statement. However, "seasonal greens" is not a standardized name for a food, or the common or usual name of an appropriately descriptive term. The specific name of the greens must be listed on the finished food label as required under 21 CFR 101.4(b)(2).

Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letter head.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District


MAF/cc1