Inspections, Compliance, Enforcement, and Criminal Investigations
Bonita's Pizza, Inc. 27-Oct-06
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Minneapolis District Office
212 Third Avenue South
Minneapolis, MN 56401
Telephone: (612) 758-7114
FAX: (612) 334-4142
October 27, 2006
RETURN RECEIPT REQUESTED
Refer to MIN 07- 04
Betty J. Wahl
Bonita's Pizza, Inc.
924 Wheat Avenue, P.O. Box 3 A7
Hatton, North Dakota 58240
Dear Ms. Wahl:
An inspection of your facility, located at 924 Wheat Avenue, Hatton, North Dakota, was conducted by an investigator from the Food and Drug Administration (FDA) on July 24, 2006. This inspection verified that your firm manufactures and distributes ready-to-bake food products. Our review of your product labels and other evidence collected during our investigation found several violations of the Federal Food, Drug, and Cosmetic Act (the Act). First, your Bonita's Garlic Cheese Pizza product is misbranded within the meaning of sections 403(a), 403(i), and 403(w) of the Act [21 U.S.C. §§ 343(a), 343(i) and 343(w)] and FDA regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). In addition, (b)(3).
Your Bonita's Garlic Cheese Pizza product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare the common or usual name of each ingredient as specified under 21 CFR 101.4. Under 21 CFR 101.4(b)(2),"sub-ingredients" (i.e., component ingredients of multi-component foods used to make a finished food) must be declared in the ingredient statement of the finished food. For example, this product is manufactured with Bonici "PARBAKED PIZZA CRUST." The ingredient statement for the Bonici "PAR-BAKED PIZZA CRUST" declares "flour (wheat, malted barley)" ; however, the ingredient statement on your Bonita's Garlic Cheese Pizza product label fails to declare the wheat and malted barley components of the flour. In addition, the product label fails to declare the vegetable shortening ingredient in the pizza crust by its specific common or usual name, which must identify the type of shortening [21 CFR 101.4(b)(14)].
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.
Your Bonita's Garlic Cheese Pizza product is further misbranded under section 403(a)(1) of the Act (21 U.S.C. § 343(a)(1)) because the label falsely states that the product has been inspected and passed by the U.S. Department of Agriculture (USDA). In fact, this product is not regulated by USDA.
Your Bonita's Garlic Cheese Pizza product is further misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the label fails to declare wheat, a major food allergen present in your product, as required by section 403(w)(1). According to the ingredient statement for the Bonici "PARBAKED PIZZA CRUST" (used to manufacture the Bonita's Garlic Cheese Pizza),"wheat" is a sub-ingredient of the 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 (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)]).
As a responsible official of a facility that manufactures/ processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
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 comments concerning the labeling of your Bonita's Garlic Cheese Pizza:
The ingredient statement for the Bonici "PAR-BAKED PIZZA CRUST" used in this product lists soybean oil and soy lecithin. As previously stated, soy is a major food allergen and is therefore subject to the labeling requirements of the Food Allergen Labeling and Consumer Protection Act [section 403(w) of the Act]. We point out that FALCPA provides an exemption for highly refined oils; therefore, highly refined soybean oil would not be subject to the labeling requirements of FALCPA. It is your responsibility to determine whether this exemption applies to the soybean oil ingredients in your product. Regarding the labeling of soy lecithin under FALCPA, we note that FDA has issued guidance stating its intent to exercise enforcement discretion for a limited time for certain foods in which soy lecithin has been used as a component of a release agent; however, the guidance also states that FDA expects manufacturers of foods that use soy lecithin as a component of a release agent to revise the labels of their products to comply with FALCPA by the end of the enforcement discretion period. This guidance, along with other information about FALCPA and food allergens, is available on FDA's website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
Your reply should be directed to Compliance Officer Tyra S. Wisecup at the address indicated on the letterhead.
W. Charles Becoat