FDA warns candy and cookie dough manufacturers about misbranding and undeclared allergens

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not made visible to the public until weeks or months after they are sent. Business owners have 15 days to respond to warning letters from the FDA. Warning letters are often only issued after a company has been given months or years to resolve problems.

Big Island Candies Inc.
Hi Hi

A food company in Hawaii has been issued a warning by the U.S. Food and Drug Administration (FDA) for violating the Federal Food, Drug, and Cosmetic Act.

In a May 29 warning letter, the FDA described the Big Island Candies Inc. recall. on Jan. 10 from the Big Island Candies Makana Brownie Assortment Box after the company discovered that the box contained milk chocolate-covered peanut butter brownies instead of milk chocolate-covered macadamia nut brownies. .

The printed label on the range box did not contain an allergen statement or ingredient declaration for peanuts. The company became aware of the undeclared peanut after a consumer informed them that he had experienced an allergic reaction to peanuts after consuming a brownie from the Makana brownies range. In documentation provided to the Office of Human and Animal Food Operations West Division 5 Recall Coordinator on January 15, the company indicated that the milk chocolate-covered peanut butter brownies were inadvertently packaged in the assortment box, which was labeled as containing macadamia nut brownies. sat. This product was manufactured on (edited by FDA). They stated that the recall was due to human error, namely employees not paying attention and unintentionally packing a peanut butter brownie in the wrong box.

Misbranding:
Peanuts are considered a ‘major food allergen’. A food is misbranded if it is not a raw agricultural product and it is or contains an ingredient that carries or contains a major food allergen, unless:

• The word “Contains”, followed by the name of the food source from which the major food allergen is derived, appears immediately after or next to the list of ingredients or
• The common or common 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. “Whey (Milk)”), except the name of the food source is not required when the common or customary name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredients list (unless the name of the food source appears elsewhere in the ingredients list appears as part of the name of an ingredient that is not is a major food allergen).

The company’s Big Island Candies Makana Brownie range is misbranded because the finished product label fails to declare a major food allergen (peanuts).

Additional comments:
The company’s facilities are subject to current regulations for good manufacturing practices, hazard assessments and risk-based preventive controls for human food. As such, the company is required to identify and implement preventive controls to provide assurance that any hazard requiring a preventive control (for example, undeclared allergens) will be significantly minimized or prevented and that the food produced by their facilities , processed, packaged or stored, shall not be adulterated or misbranded. It is prohibited by the owner, operator, or agent in charge of a covered facility to comply with the preventive control provisions of the CGMP & PC Rule.

You can view the full warning letter here.

Cookies-n-Milk LLC
McKinney, TX

A Texas food company has been notified by the U.S. Food and Drug Administration of violations of current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food regulations.

In an April 22 warning letter, the FDA described an Oct. 3 to Oct. 19, 2023, inspection of Cookies-n-Milk, LLC’s ready-to-use cookie dough plant in McKinney, Texas.

FDA investigators have determined that RTE Peanut Butter Cup Edible Cookie Dough manufactured at their facility is misbranded because the finished product labels did not list the major food allergen peanuts. The RTE Edible Cookie Dough, Peanut Butter Cup, is also misbranded because the product label does not list all the common or common names of each ingredient.

Following the inspection, the FDA investigator issued a form FDA-483, Inspectional Observations, which noted the abnormalities found at the facility.

Some of the most important violations:

Hazard analysis and risk-based preventive controls

1. The Company’s hazard analysis has not identified and evaluated all known or reasonably foreseeable hazards to determine whether there are any hazards that require preventative control for your RTE Edible Cookie Dough products, as required. Specifically:

A. They failed to identify and evaluate undeclared allergens due to improper labeling as a known or reasonably foreseeable hazard to determine whether they require preventative control during the packaging/labeling step. Their factory produces, packages and distributes RTE Edible Cookie Dough products with and without peanuts and other allergens – soy, milk, wheat. Therefore, allergens represent a known or reasonably foreseeable hazard. A knowledgeable person who produces/processes food in your circumstances will identify allergens as a hazard requiring preventative control during the packaging/labeling step. Food allergen controls include procedures, practices and processes used for labeling to ensure that all food allergens required to be declared are listed on the label.

B. The Company has not identified and evaluated mycotoxins as a known or reasonably foreseeable hazard to determine whether they require preventative control. Their factory produces RTE edible cookie dough products that contain peanut butter, which has been linked to mycotoxins such as aflatoxin. A knowledgeable person manufacturing/processing food in his/her circumstances would identify mycotoxins as a hazard requiring preventive control of peanut butter and peanut butter-containing ingredients. Further, a facility that identifies raw materials and other ingredients that require supply chain controls, such as mycotoxins, must establish and implement a risk-based supply program for those raw materials and ingredients. The supply chain program should include using approved suppliers and conducting supplier verification activities. They do not conduct supplier verification activities for mycotoxins in peanut butter and peanut butter-containing ingredients.

Wrong branding
The Cookies-n-Milk brand RTE Peanut Butter Cup Edible Cookie Dough, lot 3240, is misbranded because the finished product label fails to declare a major food allergen of peanuts. Specifically, they manufactured Cookies-n-Milk RTE Peanut Butter Cup Edible Cookie Dough, lot 3240 – containing the allergens soy, milk, wheat and peanut – and placed this product in the pre-printed labeled cup for the Cookies-n-Milk RTE Chocolate Chip Edible Cookie dough with soy, milk and wheat. The product was placed in mislabeled cups that did not have peanuts on the label. Peanuts are considered a major food allergen. A food is misbranded if it is not a raw agricultural product and it is or contains an ingredient that carries or contains a major food allergen, unless:

• The word “Contains” followed by the name of the food source from which the major food allergen is derived shall be printed immediately after or next to the list of ingredients or

• The common or common name of the major food allergen in the ingredients list is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., “peanuts”), except the name of the food source. is not required if the common or customary name of the ingredient uses the name of the food source or if the name of the food source appears elsewhere in the ingredients list (unless the name of the food source appears elsewhere in the ingredients list as part of the name of a ingredient that is not a major food allergen).

The company’s Cookies-n-Milk brand Peanut Butter Cup Edible Cookie Dough Peanut is misbranded because the product label does not list all the common or common names of each ingredient used. The product is manufactured using milk powder (an allergen) and baking soda; However, the product label does not list these ingredients in the ingredient statement even though these ingredients have been added according to the list of ingredients on the product formulation sheet. Additionally, the company adds salt directly as an ingredient to their Cookies-n-Milk brand Peanut Butter Cup Edible Cookie Dough product; however, salt is not listed as an added ingredient, separate from the sub-ingredients of the margarine and peanut butter chocolate cups.

You can view the full warning letter here.

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