WARNING LETTER
Big Island Candies, Inc.
MARCS-CMS 681107 —
May 29, 2024
Delivery Method:
United States Postal Service
Product:
Food & Beverages
Recipient:
Recipient Name
Sherrie Holi
Recipient Title
President/COO
Big Island Candies, Inc.
585 Hinano St.
Hilo
,
HI
96720-4428
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
May 29, 2024
WL 681107
Dear Ms. Holi:
The United States Food and Drug Administration (FDA) has determined that your recalled Big Island Candies Makana Brownie Assortment Box (sold in 10 oz. boxes with 8 assorted brownies wrapped in plastic) is misbranded within the meaning of section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)], in that the finished product label did not declare the major food allergen, peanuts. The introduction or delivery for introduction into interstate commerce of any food that is misbranded is prohibited by section 301(a) of the Act [21 U.S.C. § 331(a)]. 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.
On January 10, 2024, your firm recalled Big Island Candies Makana Brownie Assortment Box after you discovered the box contained Milk Chocolate Covered Peanut Butter Brownies instead of Milk Chocolate Covered Macadamia Nut Brownies. The printed label on the assortment box did not contain an allergen statement or ingredient declaration for peanut. You became aware of the undeclared peanut after a consumer notified you that they experienced an allergic reaction to peanuts after consuming a brownie packed from the assortment box of Makana brownies. In documentation provided to the Office of Human and Animal Food Operations West Division 5 Recall Coordinator on January 15, 2024, you indicated that Milk Chocolate Covered Peanut Butter brownies were unintentionally packed into the assortment box which was labeled to contain brownies containing macadamia nuts. This product was manufactured on
(b)(4)
(Batch Code RFFIC 326760). You stated the recall was due to human error of workers who were not paying attention and unintentionally packed a peanut butter brownie in the wrong box.
On January 15, 2024, you provided information pertaining to corrective actions to be taken which included no longer producing any products that contain peanuts and removing all peanut ingredients from the facility. Additionally, you noted that should you reintroduce peanut products again the following additional measures will be put into effect: crates of food products labeled to bear or contain an ingredient containing peanuts will be identified with a color code plaque, all items containing peanuts will be stored on separate pallets in a designated area, additional training will be conducted to alert staff on any and all changes, and the food safety plan will be updated in writing. We will verify implementation of any corrective actions during FDA’s next inspection of your facility.
Misbranding:
Peanuts are considered a “major food allergen” under section 201(qq) of the Act [21 U.S.C. § 321(qq)]. 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., “Whey (Milk)”), 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 Big Island Candies Makana Brownie Assortment 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).
Additional comments:
Your facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule) (21 CFR Part 117). As such, you are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facilities will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 CFR 117.135(a)(1) and (c)(2)). The 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 (subparts A, C, D, E, F, and G) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)].
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.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 fifteen (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 written response should be directed to:
Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
San Francisco District Office
1201 Harbor Bay Parkway
Alameda, CA 94502
or emailed to ORAHAFWEST5FirmResponses@fda.hhs.gov.
Refer to the Unique Identification Number CMS 681107 when replying.
If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.
Sincerely,
/S/
Darla R. Bracy
Program Division Director
Office of Human and Animal Food Operations- West Division 5
Content current as of:
06/11/2024
Regulated Product(s)
Food & Beverages