[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-my-holistic-honey-co-shenzhen-qanhai-wanb-express-supply-chain-co-ltd-712052-08252025":3,"fda-latest-sync-dates":29},{"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":27,"updated_at":28},677,"my-holistic-honey-co-shenzhen-qanhai-wanb-express-supply-chain-co-ltd-712052-08252025","Warning Letter","My Holistic Honey c\u002Fo Shenzhen Qanhai Wanb Express Supply Chain Co., LTD",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FOphthalmic Drug Products","2025-09-02","2025-08-25","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmy-holistic-honey-co-shenzhen-qanhai-wanb-express-supply-chain-co-ltd-712052-08252025","712052","Drugs","Via Email","Bingbing Feng","\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\">Via Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \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\">Bingbing Feng\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>My Holistic Honey c\u002Fo Shenzhen Qanhai Wanb Express Supply Chain Co., LTD \u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2452 Gillingham Circle\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Thousand Oaks\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">91362\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:support@myholistichoney.com\"> support@myholistichoney.com\u003C\u002Fa>\u003C\u002Fdd>\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>Center for Drug Evaluation and Research (CDER)\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>\u003Cp>August 25, 2025\u003C\u002Fp>\u003Cp class=\"text-align-center\">RE: 712052\u003C\u002Fp>\u003Cp>Dear Bingbing Feng:\u003C\u002Fp>\u003Cp>This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your product label and your website at the Internet address https:\u002F\u002Fmyholistichoney.com\u002F in July 2025. The FDA has observed that your website offers “Holistic Honey EYE DROP” (also referred to on your website as “Jimerito Honey Eye Drops”) for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>Your “Holistic Honey EYE DROP” product is especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.\u003C\u002Fp>\u003Cp>Based on a review of your product label and website, your “Holistic Honey EYE DROP” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body. Examples of claims that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:\u003C\u002Fp>\u003Cp>From your product label:\u003C\u002Fp>\u003Cul>\u003Cli>“HOLISTIC HONEY EYE DROP OPTIMAL VISION”\u003C\u002Fli>\u003Cli>“It can quickly releve [sic] eye dryness and fatigue and restore eye comfort.”\u003C\u002Fli>\u003Cli>“\u003Cstrong>Noticeable relief & soothing comfort\u003C\u002Fstrong>\u003Cbr>My optometrist recommended Holistic Honey for my chronic dry eye condition, and I'm so glad they did. I finally have relief without having to rely on prescription medications!”\u003C\u002Fli>\u003Cli>“Naturally promotes healing, reduces inflammation, and soothes irritation.”\u003C\u002Fli>\u003Cli>“\u003Cstrong>Fight Off Eye Fatigue Instantly\u003C\u002Fstrong>\u003Cbr>Provides immediate comfort & moisture to tired, strained eyes, making them feel refreshed & alert.”\u003C\u002Fli>\u003Cli>“\u003Cstrong>Give Your Eyes a Natural Boost\u003C\u002Fstrong>\u003Cbr>Crafted with natural ingredients to help your eyes feel their best. It addresses dryness, irritation, and discomfort.”\u003C\u002Fli>\u003Cli>“\u003Cstrong>Experience Newfound Clarity\u003C\u002Fstrong>\u003Cbr>By providing essential hydration and lubrication to your eyes.”\u003C\u002Fli>\u003Cli>“\u003Cstrong>Supports Overall Eye Comfort\u003C\u002Fstrong>\u003Cbr>Supports healthy blood flow and helps maintain comfortable vision.”\u003C\u002Fli>\u003Cli>“\u003Cstrong>Modern Life Takes a Toll on Your Eyes. Holistic Honey Fights Back\u003C\u002Fstrong>.\u003Cbr>Our eyes work hard in today's digital world, and many of us experience dryness, strain, and discomfort—issues that can contribute to more serious conditions like cataracts or glaucoma over time. Holistic Honey is crafted with the power of nature (honey!) to address these very issues.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Unlike traditional eye drops, Holistic Honey goes beyond just moisture. They provide a natural solution to promote healthier, more comfortable eyes and help reduce the risk of long-term vision problems.”\u003C\u002Fp>\u003Cp>Your “Holistic Honey EYE DROP” is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). There is no FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist 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.\u003C\u002Fp>\u003Cp>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>\u003Cp>Please notify FDA in writing, within fifteen working days of receipt of this letter, 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 believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\u003C\u002Fp>\u003Cp>Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “712052” in the subject line of the email.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Tina Smith, M.S.\u003Cbr>Captain, U.S. Public Health Service\u003Cbr>Director\u003Cbr>Office of Unapproved Drugs and Labeling Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>Food and Drug Administration\u003C\u002Fp>\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\nVia Email\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nBingbing Feng\n\nMy Holistic Honey c\u002Fo Shenzhen Qanhai Wanb Express Supply Chain Co., LTD\n\n2452 Gillingham Circle\n\nThousand Oaks, CA 91362\n\nUnited States\n\nsupport@myholistichoney.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWarning Letter\nAugust 25, 2025\nRE: 712052\nDear Bingbing Feng:\nThis letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your product label and your website at the Internet address https:\u002F\u002Fmyholistichoney.com\u002F in July 2025. The FDA has observed that your website offers “Holistic Honey EYE DROP” (also referred to on your website as “Jimerito Honey Eye Drops”) for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nYour “Holistic Honey EYE DROP” product is especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.\nBased on a review of your product label and website, your “Holistic Honey EYE DROP” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body. Examples of claims that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:\nFrom your product label:\n“HOLISTIC HONEY EYE DROP OPTIMAL VISION”\n“It can quickly releve [sic] eye dryness and fatigue and restore eye comfort.”\n“Noticeable relief & soothing comfort\nMy optometrist recommended Holistic Honey for my chronic dry eye condition, and I'm so glad they did. I finally have relief without having to rely on prescription medications!”\n“Naturally promotes healing, reduces inflammation, and soothes irritation.”\n“Fight Off Eye Fatigue Instantly\nProvides immediate comfort & moisture to tired, strained eyes, making them feel refreshed & alert.”\n“Give Your Eyes a Natural Boost\nCrafted with natural ingredients to help your eyes feel their best. It addresses dryness, irritation, and discomfort.”\n“Experience Newfound Clarity\nBy providing essential hydration and lubrication to your eyes.”\n“Supports Overall Eye Comfort\nSupports healthy blood flow and helps maintain comfortable vision.”\n“Modern Life Takes a Toll on Your Eyes. Holistic Honey Fights Back.\nOur eyes work hard in today's digital world, and many of us experience dryness, strain, and discomfort—issues that can contribute to more serious conditions like cataracts or glaucoma over time. Holistic Honey is crafted with the power of nature (honey!) to address these very issues.\nUnlike traditional eye drops, Holistic Honey goes beyond just moisture. They provide a natural solution to promote healthier, more comfortable eyes and help reduce the risk of long-term vision problems.”\nYour “Holistic Honey EYE DROP” is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). There is no FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist 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.\nThis 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.\nPlease notify FDA in writing, within fifteen working days of receipt of this letter, 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 believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “712052” in the subject line of the email.\nSincerely,\n\u002FS\u002F\nTina Smith, M.S.\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs and Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nFood and Drug Administration","2026-08-19T16:27:24.345+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2025-09-02T04:00:00Z\">09\u002F02\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-08-25T04:00:00Z\">08\u002F25\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fmy-holistic-honey-co-shenzhen-qanhai-wanb-express-supply-chain-co-ltd-712052-08252025\">My Holistic Honey c\u002Fo Shenzhen Qanhai Wanb Express Supply Chain Co., LTD \u003C\u002Fa>","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:55.884391+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"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"]