各有关单位：按照《江西省药品监督管理局关于开展第三批中药材GAP示范建设重点企业和品种遴选工作的通知》，根据企业提出的申请，经我局组织专家综合评审，确定江西省第三批中药材GAP示范建设单位及品种名单，现予公布（详见附件）。各示范建设单位要严格对照相关要求，切实抓好中药材GAP示范建设工作，适时组织开展自评，并在自评结束后及时提交自评报告。联系人：关龙彪，联系电话：0791-88158035。附件：江西省第三批中药材GAP示范建设单位及品种名单江西省药品监督管理局2025年9月3日附件：江西省第三批中药材GAP示范建设单位及品种名单序号企业名称品种名称中药材品种1江西景德中药股份有限公司茶芎中药饮片重点品种：茶芎2江西宜欣制药有限公司麸炒枳壳培育品种：枳壳3江西瑞龙药业有限公司炒栀子中药饮片、栀子/炒栀子配方颗粒重点品种：栀子4江西新绿色药业科技发展有限公司炒栀子中药饮片、栀子/炒栀子配方颗粒重点品种：栀子5江西南昌济生制药有限责任公司排石颗粒/肾宝胶囊重点品种：车前子

序号行政处罚决定书文号案件名称违法企业名称或违法自然人名称违法企业组织机构代码证/ 统一社会信用代码法定代表人/负责人姓名主要违法事实行政处罚内容决定机关名称处罚决定日期公示日期备注1渝药监药处罚〔2025〕4号重庆润医康医药有限公司未遵守药品经营质量管理规范经营药品案重庆润医康医药有限公司91500108MACUJLXL92        肖元娟当事人未遵守药品经营质量管理规范经营药品。当事人的行为违反了《中华人民共和国药品管理法》第五十三条第一款的规定。依据《中华人民共和国药品管理法》第一百二十六条、《中华人民共和国行政处罚法》第五条第二款的规定，责令当事人改正违法行为，并决定给予行政处罚如下：1.警告；2.罚款60万元。重庆市药品监督管理局2025.08.292025.09.03

行政处罚案件信息摘要行政处罚决定书文号湘药监械罚〔2025〕47号当事人株洲市忠艺牙科器材有限公司组织机构代码91430202320653692M法定代表人谭中桂违法类型未经许可从事第二类医疗器械生产活动案行政处罚内容1.没收违法生产的隐形义齿5颗、可摘局部义齿排牙113颗、大支架10个、可摘局部义齿2颗；2.处3万元罚款。作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2025年9月3日备注

按照《中华人民共和国药品管理法》《药品生产监督管理办法》《国家药监局关于实施新修订特此通告。附件：药品GMP符合性检查企业目录中药民族药监管处2025年8月28日

Delivery Method:Via EmailProduct:DrugsRecipient:Privacy Compliance OfficerGreen Vitality dba Gr33n1630 Peachtree Industrial BlvdSuwanee,GA30024United Statesinfo@shopgreenvitality.cominfo@gr33n.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 25, 2025RE: 710151Dear Privacy Compliance Officer:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.gr33n.com/ in June 2025. The FDA has observed that your websites offer “Jimerito Honey Eye Drops” for sale in the United States. We have also reviewed your social media account at https://www.instagram.com/trygr33n/ where you direct consumers to your https://www.gr33n.com/ website to purchase your product. 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).Your “Jimerito Honey Eye Drops” 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.Based on a review of your websites, your “Jimerito Honey Eye Drops” 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/or intended to affect the structure or any function of the body. Examples of claims from your websites that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:On your “Jimerito Honey Eye Drops” product page https://www.gr33n.com/products/jimeritohoney-eye-drops?variant=44243932217534:“Experiencing Declining Eye Health? Jimerito offers relief you can trust. Gr33n’s Jimerito Honey Eye Drops combat the effects of declining eye health with instant hydration and long-term support, keeping your eyes clear, refreshed, and protected.”Customer review: “Healthy Eyes, Happy Life ‘I was starting to struggle with early signs of cataracts, like blurry vision and eye discomfort. Since using Gr33n Jimerito drops, my eyes feel clearer and healthier, and my vision is more comfortable every day.’”Customer review: “My sight has improved! "I truly recommend this product if you have floaters and sight problems. I've being using it for a week and most of my floaters are gone and my sight is improved! I love it!”“Fight Off Eye Fatigue Instantly”“Improve & Sharpen Your Vision By providing essential hydration and lubrication, it can help your eyes focus more clearly.”“Help Protect Against Glaucoma & Cataracts Supports healthy blood flow and reduces eye pressure to help prevent serious vision issues.”“Clinically Proven to Improve Your Eye Health”“74% of People have reported clearer vision and sharper focus after regular use.”May 29, 2025, customer review: “I purchased the [J]imerito honey for my grandfather he has glaucoma and cataracts . . . he said that it is working for him.”On a post on your Instagram social media account at https://www.instagram.com/trygr33n/:February 26, 2025 video post: “Seeing floaters, struggling with blurry vision, or dealing with dry, irritated eyes? Jimerito Honey Eye Drops, powered by pure stingless bee honey, naturally hydrate, soothe, and protect your eyes—supporting clearer vision, cataract prevention, and overall eye health. Experience the power of nature!”March 10, 2025 video post: “[W]hen your vision was struggling for much you had to stop driving at night, and your phone gave you headaches…but then you found Jimerito Honey, and now everything just feels clearer.” “Struggling with eye strain, tired eyes, or trouble seeing clearly at night? [J]imerito honey is made with pure stingless bee honey, packed with natural nutrients to support eye health and clarity. experience the difference today!”Your “Jimerito Honey Eye Drops” 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 this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).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.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.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 products are 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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “710151” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:Via EmailProduct:DrugsRecipient:Bingbing FengMy Holistic Honey c/o Shenzhen Qanhai Wanb Express Supply Chain Co., LTD2452 Gillingham CircleThousand Oaks,CA91362United Statessupport@myholistichoney.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning LetterAugust 25, 2025RE: 712052Dear Bingbing Feng: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://myholistichoney.com/ 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).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.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/or 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:From your product label:“HOLISTIC HONEY EYE DROP OPTIMAL VISION”“It can quickly releve [sic] eye dryness and fatigue and restore eye comfort.”“Noticeable relief & soothing comfortMy 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!”“Naturally promotes healing, reduces inflammation, and soothes irritation.”“Fight Off Eye Fatigue InstantlyProvides immediate comfort & moisture to tired, strained eyes, making them feel refreshed & alert.”“Give Your Eyes a Natural BoostCrafted with natural ingredients to help your eyes feel their best. It addresses dryness, irritation, and discomfort.”“Experience Newfound ClarityBy providing essential hydration and lubrication to your eyes.”“Supports Overall Eye ComfortSupports healthy blood flow and helps maintain comfortable vision.”“Modern Life Takes a Toll on Your Eyes. Holistic Honey Fights Back.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.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.”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).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.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.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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office 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.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:Via EmailProduct:DrugsRecipient:Dana UllmanOwnerHomeopathic Educational Services dba Homeopathic Family Medicine812Camelia Street, Suite CBerkeley,CA94710-1418United Statesemail@homeopathic.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 25, 2025RE: 708635Dear Dana Ullman:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://homeopathic.com/ in May 2025. The FDA has observed that your website offers “Cineraria Maritima 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).Your “Cineraria Maritima Eye Drops” 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.Based on a review of your website, your “Cineraria Maritima Eye Drops” product 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/or intended to affect the structure or any function of the body. Examples of claims from your website that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:Cineraria Maritima Eye DropsOn the webpage https://homeopathic.com/product/cineraria-maritima-eye-drops-without-alcohol-10ml-qcin/:“The most common indicaton [sic] for Cineraria Maritima is cataracts.”Your “Cineraria Maritima Eye Drops” is not generally recognized as safe and effective (GRASE) for its above referenced use 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 this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your “Cineraria Maritima Eye Drops” is labeled as a homeopathic drug with active ingredient(s) measured in homeopathic strengths (i.e., Cineraria Maritima D2). Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.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.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. In addition, please note that unapproved new drugs are subject to refusal of admission into the United States, and such products may be subject to detention without physical examination. For more information about detention without physical examination, see Import Alert 66-41.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 products are 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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.Please include your firm name and the unique identifier “708635” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:Via EmailProduct:DrugsRecipient:Josue CariasCEOMel Honey US152 Wapiti LoopHyrum,UT84319-2012United Statesjosuedcarias@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 25, 2025RE: 709535Dear Josue Carias:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://melhoney.us/ in June 2025. We have also reviewed your social media account at https://www.instagram.com/melhoney_us, which directs consumers to your above-mentioned website to purchase your product. The FDA has observed that your websites offer “Jimerito (Melipona) Honey” 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).Your “Jimerito (Melipona) Honey” 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.Based on a review of your websites, your “Jimerito (Melipona) Honey” 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/or intended to affect the structure or any function of the body. Examples of claims from your website https://melhoney.us/ that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:“. . .Melipona honey is used as a natural remedy for eye infections, such as conjunctivitis, and for treating other eye issues like cataracts. Its antimicrobial properties help reduce infections, and it is said to promote clearer vision.”“Experience natural relief with Melipona Honey Eye DropsWhen used as an eye drop, it serves as a natural moisturizer, providing relief for dry eyes and improving overall hydration and comfort.On the Instagram social media account https://www.instagram.com/melhoney_us/reels/:October 30, 2024, posting:o “Melipona honey contains natural enzymes and antioxidants that can soothe and protect your eyes, reducing irritation and promoting overall eye health. Try Mel Honey Eye Drops Today!”Your “Jimerito (Melipona) Honey” 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 are no FDA-approved applications 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 this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).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.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.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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “709535” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration

Delivery Method:Via EmailProduct:DrugsRecipient:Supply Center USA30 N Gould St Ste RSheridan,WY82801United Statesinfo@supplycenterusa.comsupport@supplycenterusa.reamaze.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 25, 2025RE: 710859Dear Supply Center USA:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://supplycenterusa.com in May 2025. The FDA has observed that your website offers “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” for sale in the United States. Based on our review, these products are unapproved new drugs 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 these products 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).Your unapproved “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” drug products are 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.Based on a review of your website, your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims from your website https://supplycenterusa.com that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:Similasan Allergy Eye Relief (all variations)On the webpages https://supplycenterusa.com/products/similasan-allergy-eye-relief-eye-drops-20-sterile-single-use-droppers-0-014-fl-oz-0-4-m and https://supplycenterusa.com/products/similasan-allergy-eye-relief-sterile-eye-drops-0-33-fl-oz-10-ml:“[T]emporarily relieve minor allergy symptoms such as:ItchingBurningExcessive wateringRedness of eye and lids”Similasan Complete Eye ReliefOn the webpage https://supplycenterusa.com/products/similasan-complete-eye-relief-sterileeye-drops-0-33-fl-oz-10-ml:“When your eyes need multi-symptom relief reach for Similasan Complete Eye Relief sterile eye drops. It stimulates the body's natural ability to temporarily relieve and address eye symptoms like dryness, burning, watering, grittiness, irritation, and redness.”“Uses: According to homeopathic principles, the active ingredients in this medication temporarily relieve minor symptoms such as:Redness of eyes and eye lidsDry eyeReflex watering secondary to dry eyeSensation of grittinessSensation of burning”Similasan Computer Eye ReliefOn the webpage https://supplycenterusa.com/products/similasan-computer-eye-relief-sterileeye-drops-0-33-fl-oz-10-ml:“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:Aching eyesBurningRednessStrained eyes (Computer, TV, reading, driving)”Similasan Pink Eye ReliefOn the webpage https://supplycenterusa.com/products/similasan-pink-eye-relief-sterile-eyedrops-0-33-fl-oz-10-ml:“Use As Often As NeededRednessBurningWatery DischargeSensation of Grittiness”Similasan Redness & Itchy Eye ReliefOn the webpage https://supplycenterusa.com/products/similasan-redness-itchy-eye-relief-0-33-fl-oz-10-ml:“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms such as:itchingredness of eyes and lidsexcessive wateringburningstingingirritation”Similasan Stye Eye ReliefOn the webpage https://supplycenterusa.com/products/similasan-stye-eye-relief-sterile-eyedrops-0-33-fl-oz-10-ml:“Uses: According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:RednessBurningEyelid RednessTearing”Similasan Aging Eye ReliefOn the webpage https://supplycenterusa.com/products/similasan-aging-eye-relief-0-33-fl-oz-10-ml:“Uses: According to homeopathic principles, the active ingredients in this medication help temporarily relieve minor symptoms such as:DrynessBurningIrritationFor protection against further irritation”Boiron Optique 1 Eye Irritation ReliefOn the webpage https://supplycenterusa.com/products/boiron-optique-1-eye-irritation-relief-30-doses-0-013-fl-oz-each:“Uses:Temporarily relieves minor eye irritation due to fatigue or airborne irritants such as ragweed, other pollens and dustSoothes red, dry, itchy, gritty, burning or tired eyes”Your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” 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 are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for these products. 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).We recognize that your “Similasan Allergy Eye Relief” (all variations), “Similasan Complete Eye Relief,” “Similasan Computer Eye Relief,” “Similasan Pink Eye Relief,” “Similasan Redness & Itchy Eye Relief,” “Similasan Stye Eye Relief,” “Similasan Aging Eye Relief,” and “Boiron Optique 1 Eye Irritation Relief” products are labeled as homeopathic drugs with active ingredient(s) measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.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.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. You should also refer to the FDA warning letters previously sent to Similasan AG1and Boiron, Inc.2about these unapproved ophthalmic drug products.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 products are 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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “710859” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration____________________1See the Warning Letter issued to Similasan AG on September 11, 2023.2See the Warning Letter issued to Boiron, Inc. on September 11, 2023.

Delivery Method:Via EmailProduct:DrugsRecipient:Sheelah GolligleePresidentTrew Balance11200 W. Michigan Ave. Suite #3Youngtown,AZ85363United Statesyoungtownclinic@gmail.cominfo@trewbalance.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 25, 20257558 W. Thunderbird Rd. Suite 1-489Peoria, AZ 85381RE: 709880Dear Sheelah Golliglee:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://trewbalance.com/ in May 2025. The FDA has observed that your website offers “Trew Vision CBD 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).Your “Trew Vision CBD Eye Drops” 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 this product bypasses some of the body’s natural defenses.Based on a review of your website, your “Trew Vision CBD Eye Drops” 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/or intended to affect the structure or any function of the body. Examples of claims from your website, https://trewbalance.com/, that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:On your “Trew Vision CBD Eye Drops” product page https://trewbalance.com/product/trew-vision-cbdeye-drops/:“Protects from macular degenerationReduces the risk of diabetic retinopathyProtects against computer radiation exposureActs as an optic nerve tonic to protect the eyesGreat antibacterial and antiseptic propertiesReduces stress and fatigueExcellent eye drops for relaxationProtects from glaucomaHelps in treating pink eyeHelps in treating sore eyes”Your “Trew Vision CBD Eye Drops” 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 this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We recognize that your “Trew Vision CBD Eye Drops” is labeled as a homeopathic drug with active ingredient(s) measured in homeopathic strengths. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.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.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.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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “709880” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration