The FDA has issued a warning letter to a cookie manufacturer after their cookie dough product was found to contain "undeclared peanuts."
The "Chocolate Chip Edible Cookie Dough," produced by Cookies-n-Milk, was recalled last fall after it was found to contain peanuts that had not been declared on the packaging, putting people with peanut allergies at risk of an allergic reaction.
Now, the FDA has stated in a warning letter that Cookies-n-Milk made "serious violations" in their misbranding of the product, as well as not properly identifying and controlling other hazards such as mycotoxins. And 2,354 boxes of the cookie dough were recalled from across nine states after the mistake was noticed last year.
The FDA then investigated the manufacturer's factory.
"The inspection was initiated as a result of a Class 1 recall of your Cookies-n-Milk brand Chocolate Chip Edible Cookie Dough because of using incorrect packaging, which resulted in undeclared peanut allergen in the product, as containers of Chocolate Chip Edible Cookie Dough which do not declare the allergen peanuts were filled with Peanut Butter Edible Cookie Dough which contain peanuts," the letter from the FDA said.
"During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation."
Newsweek has contacted Cookies-n-Milk via email for comment.
Peanut allergies occur when the immune system mistakenly identifies proteins in peanuts as harmful. When a person with a peanut allergy is exposed to peanuts, their immune system releases chemicals such as histamines to protect the body, which can cause various symptoms, ranging from mild to severe, including hives, swelling, difficulty breathing, and anaphylaxis, which is a potentially life-threatening reaction.
According to the FDA letter, the company didn't identify that the product contained peanuts, and also didn't highlight that the milk powder contained was an allergen. It additionally didn't note that salt was an additional ingredient: while not dangerous, it underscores that ingredient labeling was a major weak spot.
"Your product is manufactured using milk powder (an allergen) and baking soda; however, the product label fails to declare these ingredients in the ingredient statement although those ingredients are added, as per the list of ingredients in the product formulation sheet," the letter reads.
"Furthermore, you directly add salt as an ingredient to your Cookies-n-Milk brand Peanut Butter Cup Edible Cookie Dough product; however, salt is not declared as an added ingredient separate from the sub-ingredients of the margarine and peanut butter chocolate cup."
"A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control at the packaging/labeling step," the FDA wrote.
Additionally, the letter describes how Cookies-n-Milk didn't evaluate the presence of mycotoxins—toxic compounds produced by fungi—in their products. Peanut butter has been previously associated with the mycotoxin aflatoxin, but no investigation into the presence of this toxin in Cookies-n-Milk was performed by the manufacturer.
"A knowledgeable person manufacturing/ processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control in peanut butter and peanut butter-containing ingredients," the letter said.
"Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients."
Despite corrective actions proposed by the company, the FDA found them insufficient and requested further detailed actions to comply with regulations and prevent future violations.
"However, the response did not contain sufficient supporting documentation for FDA to adequately evaluate your corrective actions. In addition, the response did not include a complete updated hazard analysis (to identify mycotoxins as a hazard requiring a preventive control for peanut butter and peanut butter-containing ingredients, and to identify undeclared allergens as a hazard requiring a preventive control at the packaging/labeling step) or revised food safety procedures," the letter said.
"This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction."
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