As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some warning letters are not made public until weeks or months after they are sent. Employers must respond to FDA warning letters within 15 days. Warning letters are often not issued until companies have had months or even years to correct the problem.
Big Island Candies Co.
Hilo, Hawaii
A Hawaii food company has received a warning from 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 explained that Big Island Candies recalled Big Island Candies Makana Brownie Assortment Boxes on Jan. 10 after the company discovered that the boxes contained milk chocolate peanut butter brownies instead of milk chocolate macadamia nut brownies.
The label printed on the assortment box did not include any mention of peanut allergens or ingredients. The company realized the omission of peanuts after a consumer contacted them about a peanut allergic reaction they had after eating brownies from the Makana Brownie assortment box. In a document submitted to the Western Division 5 Recall Coordinator for the Office of Human and Animal Food Affairs on January 15, the company said that the milk chocolate covered peanut butter brownies were mistakenly packed in an assortment box labeled as brownies with macadamia nuts. The product was manufactured in (redacted by FDA). The company said the recall was due to human error, meaning an employee was not paying attention and unintentionally packed the peanut butter brownies in a different box.
Misrepresentation:
Peanuts are considered a “major food allergen.” If a food is not a raw agricultural commodity and contains a major food allergen, or contains an ingredient that contains a major food allergen, it is considered misbranded unless:
The word “Contains” is followed by the names of the food sources of the major food allergens printed immediately after or adjacent to the list of ingredients, or the common or usual name of the major food allergen in the ingredient list is followed by the name of the food source of the major food allergen in parentheses (e.g., “whey (milk)”). However, the name of the food source is not required if the name of the food source is used in the common or usual name of the ingredient or if the name of the food source appears elsewhere in the ingredient list (unless the name of a food source listed elsewhere in the ingredient list is listed as part of the name of an ingredient that is not a major food allergen).
The company's Big Island Candies Makana Brownie Assortment is misbranded because it does not list a major food allergen (peanuts) on the finished product label.
Additional comments:
Your facility is subject to the regulatory requirements of current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food. As such, your facility must identify and implement preventive controls to ensure that hazards requiring a preventive control (such as undeclared allergens) are significantly reduced or prevented and that food manufactured, processed, packed, or held at your facility is not adulterated or misbranded. Owners, operators, or persons in charge of a covered facility are prohibited from failing to comply with the preventive controls provisions of the CGMP and PC rules.
The full warning letter can be found here.
Cookies and Milk LLC
McKinney, Texas
A Texas food company has received a warning from the U.S. Food and Drug Administration for violating current good manufacturing practices, hazard analysis and risk-based preventive controls regulations for human food.
In its April 22 warning letter, the FDA explained that it plans to inspect Cookies-n-Milk, LLC's ready-to-eat (RTE) cookie dough manufacturing facility in McKinney, Texas, from October 3 to 19, 2023.
FDA investigators determined that RTE Peanut Butter Cups and Edible Cookie Dough manufactured at their facility were misbranded because the finished product's label did not list peanuts, a major food allergen. RTE Edible Cookie Dough and Peanut Butter Cups are also misbranded because the product labels do not list all of the common or usual names of each ingredient.
Following the inspection, FDA investigators issued Form FDA-483, “Inspection Observations,” listing deviations found at the facility.
Some of the more serious violations are:
Hazard Analysis and Risk-Based Preventive Controls
1. The Company's hazard analysis did not identify and evaluate all known or reasonably foreseeable hazards in its RTE edible cookie dough products to determine whether there are hazards requiring a preventive control. Specifically, the Company's hazard analysis did not identify and evaluate all known or reasonably foreseeable hazards in its RTE edible cookie dough products to determine whether there are hazards requiring a preventive control.
a. You did not identify and evaluate undeclared allergens as known or reasonably foreseeable hazards due to mislabeling and did not determine whether preventive controls are required at the packaging/labeling stage. This facility manufactures, packages, and distributes RTE edible cookie dough products that contain or do not contain peanuts and other allergens (soy, milk, wheat). Therefore, the allergens are known or reasonably foreseeable hazards. A knowledgeable person manufacturing/processing food in your situation would identify the allergens as hazards requiring preventive controls at the packaging/labeling stage. Food allergen controls include the procedures, practices, and processes used in labeling to ensure that all food allergens required to be declared are listed on the label.
b. The company did not identify mycotoxins as a known or reasonably foreseeable hazard and did not conduct an evaluation to determine whether a preventive control was required. The company's facilities manufacture RTE edible cookie dough products, including peanut butter, which are associated with mycotoxins, such as aflatoxins. A knowledgeable person manufacturing/processing food in the company's situation would identify mycotoxins as a hazard requiring preventive controls in peanut butter and peanut butter-containing ingredients. Additionally, facilities that identify raw materials and other ingredients requiring supply-chain applied controls, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients. The supply-chain program must include the use of approved suppliers and conducting supplier verification activities. The company has not conducted supplier verification activities for mycotoxins in peanut butter and peanut butter-containing ingredients.
Misrepresentation
The company's Cookies-n-Milk brand RTE Peanut Butter Cup Edible Cookie Dough, lot 3240, is misbranded because the finished product's label does not list peanuts, a major food allergen. Specifically, the company manufactured Cookies-n-Milk RTE Peanut Butter Cup Edible Cookie Dough, lot 3240 (which contains soy, milk, wheat, and peanuts as allergens) and packaged the product in cups labeled Cookies-n-Milk RTE Chocolate Chip Edible Cookie Dough (which contains soy, milk, and wheat). The product was packaged in mislabeled cups and did not list peanuts on the label. Peanuts are considered a major food allergen. A food is misbranded when it is an ingredient, other than a raw agricultural commodity, that accompanies or contains a major food allergen, unless:
• The word “Contains” following the name of the food that causes the major food allergy is printed immediately after or next to the list of ingredients or components.
• List the common or usual name of the major food allergen in the ingredient list, followed by the name of the food from which the major food allergen is derived (e.g., “peanut”) in parentheses, except that if a food name is used in the common or usual name of an ingredient or if the ingredient name appears elsewhere on the ingredient list, the food name does not need to be listed (unless the name of a food that appears elsewhere on the ingredient list is listed as part of an ingredient name that is not a major food allergen).
The company's Cookies-n-Milk brand Peanut Butter Cup Edible Cookie Dough peanut products are misbranded because the product label does not list the common or usual name of each ingredient used. The products are manufactured with milk powder (an allergen) and baking soda, which are added according to the ingredients list in the product formula, but are not listed as such in the ingredient statement on the product label. Additionally, the company adds salt directly as an ingredient to its Cookies-n-Milk brand Peanut Butter Cup Edible Cookie Dough products, but salt is not listed as an added ingredient separate from the margarine and Peanut Butter Chocolate Cups secondary ingredients.
The full warning letter can be found here.
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