WARNING LETTER
Cookies-n-Milk, LLC
MARCS-CMS 672621 —
April 22, 2024
Delivery Method:
Via Overnight Delivery
Return Receipt Requested
Product:
Food & Beverages
Recipient:
Recipient Name
Tyler F.B. Spragg
Recipient Title
Vice President and General Manager
Cookies-n-Milk, LLC
181 Industrial Blvd.
McKinney
,
TX
75069
United States
Issuing Office:
Division of Human and Animal Food West III Compliance Branch (HAFW3-CB)
United States
WARNING LETTER
April 22, 2024
CMS # 672621
Dear Mr. Spragg:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) cookie dough manufacturing facility located at 181 Industrial Blvd., McKinney, TX 75069 on October 3 -19, 2023. 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. 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 (CGMP and PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on FDA’s inspectional findings, we have determined that the RTE Peanut Butter Cup Edible Cookie Dough manufactured in your facility is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels did not declare a major food allergen (peanuts). The RTE Edible Cookie Dough Peanut Butter Cup is also misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare all the common or usual names of each ingredient used. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA’s home page at http://www.fda.gov.
At the conclusion of the inspection, the FDA issued a Form FDA 483 (FDA-483), Inspectional Observations. FDA received your written response, dated November 9, 2023, describing corrective actions taken and planned by your firm. After reviewing the inspectional findings and response that your firm provided, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility. We also address your response below.
Your significant violations are as follows:
Hazard Analysis and Risk Based Preventive Controls (21 CFR Part 117, Subpart C)
1.    Your hazard analysis did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are hazards requiring a preventive control for your RTE Edible Cookie Dough products, as required by 21 CFR 117.130(a)(1). Specifically:
a.    You did not identify and evaluate undeclared allergens due to incorrect labeling as a known or reasonably foreseeable hazard to determine whether they require a preventive control at the packaging/labeling step.  Your facility manufactures, packages, and distributes RTE Edible Cookie Dough products with and without peanuts, in addition to other allergens (soy, milk, wheat). Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify allergens as a hazard requiring a preventive control at the packaging/labeling step. Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR 117.135(c)(2)(ii)).
We note that your hazard analysis identifies undeclared allergens as a hazard requiring a preventive control at the “Receiving of Packaging Materials” step. Your allergen controls at this receiving step include “Pre-printed label review of ingredient statements and “contains:xxx” allergen(s) statement.” However, you do not monitor or verify that these preprinted labels are applied to the correct product during production (such as at the packaging/labeling step). Your firm’s investigation indicated that a lack of packaging controls resulted in containers of “Chocolate Chip Edible Cookie Dough,” which do not declare the allergen peanuts on the product label, being filled with Peanut Butter Edible Cookie Dough which contain peanuts. As a consequence, on September 27, 2023, your facility recalled 2,354 cases of 6oz cups of Cookies-n-Milk brand "Chocolate Chip Edible Cookie Dough" (lot # 3240), due to undeclared peanuts on the product label.
b.    You did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Your facility manufactures RTE edible cookie dough products containing peanut butter, which has been associated with mycotoxins such as aflatoxin.  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. 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 (see 21 CFR 117.405(a)(1)). The supply-chain program must include using approved suppliers and conducting supplier verification activities (see 21 CFR 117.410). You do not conduct supplier verification activities for mycotoxins in peanut butter and peanut butter-containing ingredients.
Your November 9, 2023 response included root cause analysis and corrective action reports; a photograph of the recalled product (i.e., Peanut Butter Edible Cookie Dough in Chocolate Chip Edible Cookie Dough container); a certificate of analysis for
(b)(4)
RTE wheat flour which includes a statement for mycotoxins; and part of a revised raw ingredient hazard analysis that identifies the mycotoxin hazard as a significant hazard for the flour ingredient. Your response stated that “The Edible Cookie Dough hazard analysis will be revised to identify undeclared allergens due to mislabeling/packaging as a potential hazard with controls at packaging implemented with monitoring and verification procedures defined” and “The Edible Cookie Dough hazard analysis will be revised to identify Mycotoxins as a potential hazard for Wheat Flour and Peanut Butter with controls at the supplier level implemented with monitoring and verification procedures defined.” 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.
Misbranding
Your Cookies-n-Milk brand RTE Peanut Butter Cup Edible Cookie Dough, lot 3240, is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product label fails to declare a major food allergen (peanuts). Specifically, you manufactured Cookies-n-Milk RTE Peanut Butter Cup Edible Cookie Dough, lot 3240 (containing allergens: soy, milk, wheat, and peanut) and placed this product into the preprinted labeled cup for the Cookies-n-Milk RTE Chocolate Chip Edible Cookie Dough (containing soy, milk, wheat). The product was placed in incorrectly labeled cups, which did not list peanut on the label. Under section 201(qq) of the Act [21 U.S.C. § 321(qq)], peanuts are considered a “major food allergen.” A food is misbranded under section 403(w) of the Act 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:
•    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
•    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 (e.g., “Peanuts”), except 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 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)].
Your Cookies-n-Milk brand Peanut Butter Cup Edible Cookie Dough Peanut product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.4. 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.  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 cups.
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
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.
Additional Comments:
We also offer the following comments regarding your Cookies-n-Milk RTE Peanut Butter Cup Edible Cookie Dough and your Cookies-n-Milk RTE Chocolate Chip Edible Cookie Dough product labels:
•    In accordance with 21 CFR 101.5(d), the statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory.
•    We note that the labels are missing the words “Net Weight” in accordance with 21 CFR 101.7(j)(3).
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to Dana Lewis, Compliance Officer, U.S. Food and Drug Administration at the following email: dana.lewis@fda.hhs.gov or you may mail a hard copy, addressed to Dana Lewis, Compliance Officer, U.S. Food and Drug Administration at 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any further questions, please contact me at (214) 253-5200 or by email.
Sincerely,
/S/
For:    Edmundo Garcia, Jr.
Program Division Director HAFW3 Dallas District Director
Cc:  Texas Department of State Health Services
Lori Woznicki, Food and Drug Inspections Branch Manager Division of Regulatory Services
Texas Department of State Health Services lori.woznicki@dshs.texas.gov
Content current as of:
05/21/2024
Regulated Product(s)
Food & Beverages