[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-big-island-candies-inc-681107-05292024":3,"fda-latest-sync-dates":31},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":29,"updated_at":30},1433,"big-island-candies-inc-681107-05292024","Warning Letter","Big Island Candies, Inc.",null,"Division of Human and Animal Food Operations West V","CGMP Food Labeling\u002FMisbranded\u002FAdulterated","2024-06-11","2024-05-29","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbig-island-candies-inc-681107-05292024","681107","Food & Beverages","United States Postal Service","Sherrie Holi","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">United States Postal Service\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Food & Beverages                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Sherrie Holi\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">President\u002FCOO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Big Island Candies, Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">585 Hinano St.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Hilo\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">HI\u003C\u002Fspan> \u003Cspan class=\"postal-code\">96720-4428\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd> Division of Human and Animal Food Operations West V\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>May 29, 2024\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WL 681107\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Ms. Holi:\u003C\u002Fp>\n\n\u003Cp>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:\u002F\u002Fwww.fda.gov.\u003C\u002Fp>\n\n\u003Cp>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 \u003Cstrong>(b)(4)\u003C\u002Fstrong> (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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>\u003Cu>Misbranding:\u003C\u002Fu>\u003Cbr>\nPeanuts 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:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>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\u003C\u002Fli>\n\t\u003Cli>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)].\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>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).\u003C\u002Fp>\n\n\u003Cp>\u003Cu>Additional comments:\u003C\u002Fu>\u003Cbr>\nYour 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)].\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>Your written response should be directed to:\u003C\u002Fp>\n\n\u003Cp>Sergio Chavez, Director Compliance Branch\u003Cbr>\nFood and Drug Administration\u003Cbr>\nOffice of Human and Animal Foods Division West 5\u003Cbr>\nSan Francisco District Office\u003Cbr>\n1201 Harbor Bay Parkway\u003Cbr>\nAlameda, CA 94502\u003C\u002Fp>\n\n\u003Cp>or emailed to ORAHAFWEST5FirmResponses@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Refer to the Unique Identification Number CMS 681107 when replying.\u003C\u002Fp>\n\n\u003Cp>If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Darla R. Bracy\u003Cbr>\nProgram Division Director\u003Cbr>\nOffice of Human and Animal Food Operations- West Division 5\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nUnited States Postal Service\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nSherrie Holi\n\nRecipient Title\n\nPresident\u002FCOO\n\nBig Island Candies, Inc.\n\n585 Hinano St.\n\nHilo, HI 96720-4428\n\nUnited States\n\nIssuing Office:\n\nDivision of Human and Animal Food Operations West V\n\nUnited States\n\nWARNING LETTER\n\nMay 29, 2024\n\nWL 681107\n\nDear Ms. Holi:\n\nThe 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:\u002F\u002Fwww.fda.gov.\n\nOn 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.\n\nOn 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.\n\nMisbranding:\n\nPeanuts 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:\n\nThe 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\n\nThe 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)].\n\nYour 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).\n\nAdditional comments:\n\nYour 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)].\n\nThis 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.\n\nWithin 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.\n\nYour written response should be directed to:\n\nSergio Chavez, Director Compliance Branch\n\nFood and Drug Administration\n\nOffice of Human and Animal Foods Division West 5\n\nSan Francisco District Office\n\n1201 Harbor Bay Parkway\n\nAlameda, CA 94502\n\nor emailed to ORAHAFWEST5FirmResponses@fda.hhs.gov.\n\nRefer to the Unique Identification Number CMS 681107 when replying.\n\nIf you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.\n\nSincerely,\n\n\u002FS\u002F\n\nDarla R. Bracy\n\nProgram Division Director\n\nOffice of Human and Animal Food Operations- West Division 5","2026-08-20T00:02:46.597+00:00",[23,24,25,26,27,28,28,28],"\u003Ctime datetime=\"2024-06-11T13:20:00Z\">06\u002F11\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-05-29T04:00:00Z\">05\u002F29\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbig-island-candies-inc-681107-05292024\">Big Island Candies, Inc.\u003C\u002Fa>"," Division of Human and Animal Food Operations West V","CGMP Food Labeling\u002FMisbranded\u002FAdulterated\u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]