根据《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》和《药品经营和使用质量监督管理办法》等有关规定，海南省药品监督管理局依法注销海南奕昂医药有限公司的《药品经营许可证》。自注销之日起，该企业须立即停止药品经营活动，请社会各界监督。企业名称经营地址仓库地址经营范围许可证编号备注海南奕昂医药有限公司洋浦经济开发区D5B区内（浦馨苑）19栋9层903房1.海口市白龙北路8号华海大厦（海南泓泰医药物流管理有限公司仓库）;2.合肥市经济技术开发区芙蓉路368号（安徽九州通医药有限公司仓库）中成药；化学药（含原料药）（以上不含冷藏、冷冻药品）***琼AA898000037企业主动申请注销  特此公告。                         海南省药品监督管理局                           2026年6月24日（此件主动公开）

根据企业申请，依据《药品经营和使用质量监督管理办法》第二十七条的规定，湖南省药品监督管理局依法注销湖南源养天地大药房有限公司的《药品经营许可证》。自公告注销之日起，上述企业不得从事任何形式的药品经营活动。附件：注销《药品经营许可证》的企业名单湖南省药品监督管理局2026年6月25日   （公开属性：主动公开）

根据国家药监局2026年药品抽检工作安排，江西省药监局立足风险防控、聚焦监管实效，统筹省药检院及各设区市抽样力量，圆满完成年度国家药品抽样任务。一是科学筹划，高效推进。自2月27日国家药品抽样系统开放后，省药监局第一时间召开专项部署会，细化任务、统筹力量，组建13支“省队＋市队”抽样队伍，实行统一调度、分片推进、实时指导，构建了省市县三级联动、区域和环节全覆盖的抽样工作格局。我省国家药品抽样量连续三年位居全国前列，抽检工作质效居全国第一方阵。二是抓实培训，规范操作。结合年度国抽工作新要求，省药监局联合省药检院，通过集中授课、现场实操、线上教学相结合的方式，开展全省抽样业务培训。重点解读抽检方案，梳理实操重难点，解答共性问题、统一操作规范，有效提升一线抽样人员专业能力，保障全年抽样工作依规、有序开展。三是数字赋能，精准抽样。依托智慧药监体系，整合药品追溯、电商交易等平台，运用大数据智能筛选、精准锁定抽检品种。推行“线上研判＋线下核查”模式，补齐抽样短板、消除监管盲区，实现靶向抽检、应抽尽抽，为后续药品检验和质量风险研判提供坚实数据支撑。四是监检并重，提升效能。坚持抽样与日常监督、风险监测、隐患排查深度融合，落实“进一次门、办多项事”，切实减轻企业负担。在抽样同时，同步核验企业资质、药品来源、储存条件等关键信息，累计核验各类药品生产经营使用单位300余家，对发现的问题隐患及时转办，有效提升药品综合治理效能。下一步，省药监局将立足药品监管主责主业，紧盯高风险品种和重点监管领域，持续优化工作机制、规范抽样流程、细化操作标准，不断提升药品抽检科学化、规范化水平。（省药监局科技处、省药检院供稿）

为加快化妆品新原料研发创新，促进产业高质量发展，根据《化妆品监督管理条例》《化妆品注册备案管理办法》等有关规定，国家药监局组织制定《化妆品新原料注册备案及资料管理规定》，现予发布，自2026年7月15日起施行。《国家药监局关于发布〈化妆品新原料注册备案资料管理规定〉的公告》（2021年第31号）同时废止。特此公告。附件：化妆品新原料注册备案及资料管理规定　　国家药监局　　2026年6月25日

为推动疫苗国家监管体系建设，持续提升我国疫苗监管能力水平，6月12日，国家药监局在江苏常州举办疫苗监管质量管理体系（QMS）建设工作交流会议。会议现场调研了解江苏省药监局常州检查分局、审评核查常州分中心质量管理体系建设运行情况，通报国家药监局世界卫生组织疫苗列名机构（疫苗WLA）评估准备工作进展情况和推进工作安排。政法司详细介绍了疫苗QMS建设运行要求。北京、江苏、广州等省（市）药监局交流分享了QMS建设经验。参会人员就国家药监局与省级药监局QMS衔接协调等工作进行了讨论交流。国家药监局政法司、药品注册司、药品监管司，传媒集团和疫苗生产相关省级药监局人员参加会议。

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Andy JassyCEOAmazon.com, Inc.P.O. Box 81226Seattle, WA 98108-1226United StatesRegulatory-inquiries@amazon.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 17, 2026WARNING LETTERReference number: 728814To Andy Jassy:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of drug products that were purchased on your website, www.amazon.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during review of the product labeling of products purchased on your website www.amazon.com in May 2026. FDA purchased “Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream,” through your website and these products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.1 Based on our review, “Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream” 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).This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of the product labeling, “Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream” 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 observed on the labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Vajraang Phimosis Mini Combo“FOR PHIMOSIS”“Phimosis & Paraphimosis cream”“Coconut Oil for Phimosis”Penile Heal Cream“Daily Phimosis Cream”Beilloso Balanitis Relief Cream2“Helps relieve redness, itching & irritation from balanitis”“Balanitis Relief Cream”“Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. 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). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “728814” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration______________________1 Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products discussed below was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a program that lets you outsource order fulfillment to Amazon and offer customers free, two-day shipping through Prime. By enrolling in FBA, you can send your products into Amazon’s global network of fulfillment centers, and we’ll pick, pack, and ship orders, as well as handle customer service and returns. FBA is part of a fully automated set of services we call Supply Chain by Amazon.” (See https://sell.amazon.com/fulfillment-by-amazon).2 The only permitted indications under “Over-the-Counter (OTC) Monograph M005: Topical Antifungal Drug Products for Over-the-Counter Human Use” (M005) are for the treatment of athlete’s foot, jock itch, ringworm and for relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch. Your product, “Beilloso Balanitis Relief Cream,” is intended to provide relief from balanitis symptoms, which goes beyond the permissible claims under M005. “Beilloso Balanitis Relief Cream” does not conform to M005 or any other final administrative order, thus there is no basis under section 505G of the FD&C Act under which this product could be legally marketed without an approved application. (see https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTC%20Monograph_M005-Topical%20Antifungal%20drug%20products%20for%20OTC%20Human%20Use%2012.16.2021.pdf).

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:MantroForceRoom 701, Unit 127, 7/F Tower BNew Mandarin PlazaTsim Sha TsuiHong Kong SAR Chinainfo@mantroforce.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 17, 2026WARNING LETTERReference Number: 729021To MantroForce:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of your website https://mantroforce.com/en-us in May 2026. Based on our review, “Passion Pro Endurance Delay Spray,” “Complex Men’s Nasal Inhaler,” “ErectBoost Vitality Spray for Men,” “Prostate Care Gel,” and “Prostate Patches” 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).Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an allinclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “Passion Pro Endurance Delay Spray,” “Complex Men’s Nasal Inhaler,” “ErectBoost Vitality Spray for Men,” “Prostate Care Gel,” and “Prostate Patches” 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 from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Passion Pro Endurance Delay SprayOn the webpage https://mantroforce.com/en-us/products/long-lasting-confidence-delay-spray:“Master Your Performance and Last 5x Longer Starting Tonight”“IS PREMATURE EJACULATION DISRUPTING YOUR INTIMACY?”“FOR LONGER LASTING PERFORMANCE”“Why Choose Biancat™ Passion Pro Endurance Delay Spray?✓ Extended Pleasure✓ Delayed Climax✓ Premature Control✓ Optimized Sensitivity✓ Intense Satisfaction”Complex Men’s Nasal InhalerOn the webpage https://mantroforce.com/en-us/products/men-nasal-inhaler-get-a-rock-harderection-within-5-minutes-100-without-pills:“Designed to combat slow, weak erections and performance anxiety, it offers fast results, without pills or risks.”“Men Nasal Inhaler Get a rock-hard erection within 5 minutes, 100% without pills!”“Experience the Powerful Erection Boost”“APPLICABLE TO THE FOLLOWING GROUPS WITH MALE PROBLEMS. . .PREMATURE EJACULATION[,] DECREASED LIBIDO”ErectBoost Vitality Spray for MenOn the webpage https://mantroforce.com/en-us/products/vitality-spray-instant-power-get-a-rocksolid-erection-in-3-minutes-flat-copy:“ErectBoost Explosive Performance and Rock-Solid Power in 3 Minutes Flat”“Discover the ultimate solution for impotence with Vitality Spray!”An image of a physician next to the product with the testimonial: “As a urologist, I recommend Vitality Spray because of its immediate and long-lasting effect. The powerful formula stimulates blood circulation and supports a firm, stable erection.”“Reignite your PassionBoost your ConfidenceExperience LastingStamina”Images of male genitalia illustrating the before and after effect of using the product along with couples engaged in intimate interactions.Prostate Care GelOn the webpage https://mantroforce.com/en-us/products/reliefpro-herbal-gel:“Reduce the urge to urinate”“Facilitating bladder emptying”“Better SleepReduces nighttime urges for uninterrupted rest.”“Soothe painCalms pelvic discomfort so movement hurts less.”“BENEFITS OF INJECTING THROUGH THE RECTUM. . .High local drug concentration”Prostate PatchesOn the webpage https://mantroforce.com/en-us/products/daily-prostate-comfort-relief-patch:“Promote urine flow”“Enhance sexual function”“Better SleepReduces nighttime urgency so you sleep longer and wake refreshed.”“Improve prostate health and reduce uncomfortable symptoms”“Enhance urinary function and promote smooth urination.”“Improves your bladder and urinary tract system”“Helps maintain normal prostate function and relieve prostate-related discomfort.”“Reduce frequent waking up at night, improve urine flow”“Passion Pro Endurance Delay Spray,” “Complex Men’s Nasal Inhaler,” “ErectBoost Vitality Spray for Men,” “Prostate Care Gel,” and “Prostate Patches” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. 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). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729021” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:JJLBRORomvy E-Ticaret Limited SirketiOba Başaranlar Sk. No: 1607400 /AntalyaTurkeyeroxoninmed@gmail.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 17, 2026WARNING LETTERReference Number: 729873To JJLBRO and Romvy E-Ticaret Limited Sirketi:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of your website https://jjlbro.com/ in May 2026. We also reviewed your Amazon storefront in May 2026.1 Based on our review, “Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” 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).Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” 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 from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Men’s Foreskin Repair GelOn the webpage https://jjlbro.com/products/mens-extra-power-foreskin-repair-enhancement-gel?variant=41998671478878:“DOUBLE LINE CARE, DIRECT HIT PHIMOSIS”“ABSORPTION OF INTERNAL ADHESIONS”“TO PROMOTE THE VITALITY OF PRIVATE CELLS FROM THE CONGENITAL PHIMOSIS”Size’Up Chrono ErectOn the webpage https://jjlbro.com/products/mens-size-up-chrono-erect-enlargement-cream-extra-power-massage-gel-oil-for-huge-thickness-strength-and-prolonged-performance?variant=41998765916254:“Proven Size Enhancement: Clinically . . . shown to help promote blood flow and stimulate cell growth, leading to visible results in size enhancement with consistent use.”“Prolonged Performance: Men’s Size Up Chrono Erect Enlargement Cream supports prolonged performance by stimulating circulation and energy flow, improving stamina and endurance.”Penile Health CreamOn the webpage https://jjlbro.com/products/male-performance-med3000-enhancement-gel?variant=41998765850718:“BOOST MUSCLE STRENGTH”“ENHANCES LIBIDO AND PLEASURE”“INCREASE ENERGY AND STAMINA”“IMPROVE MALE REPRODUCTIVE HEALTH”“Naturally Boosts Energy, Libido, Fertility, Mood, and Hormonal Balance.”“Enhances intimacy, Improves Blood Flow, and Elevates Performance.”“Believed to Support Brain Health, Soothe Pain, and Reinforce Masculinity.”Men’s External Delayed SprayOn the webpage https://jjlbro.com/products/mens-best-external-delay-enhancement-spray:“Prolonged Performance: Allows for extended enjoyment and satisfaction”“Quick-Acting Formula: Starts working within minutes for immediate results, so you’re always prepared.”“PREMATURE EJACULATION MAKES MEN MISERABLE”“MAY STIMULATE CAVERNOUS BODIES, REPRODUCTIVE GLANDS, NERVOUS SYSTEM IT MAKES IT PLAY A NORMAL FUNCTION, NOT ONLY TO HELP WITH OVERTIME, BUT ALSO TO HELP THE ERECTION FUNCTION”Men’s Penis XXL Care CreamOn the webpage https://jjlbro.com/products/men-s-care-ultra-enlargement-cream-jjlbro-huge-xxl-extra-strength-growth-cream-for-mens-size-power-xxl-care?variant=41998751563870:“SEXUAL EXCITEMENT”“LAST LONGER”“LARGER SIZE”“HUGE”“Proven Size Enhancement: Clinically . . . shown to help promote blood flow and stimulate cell growth, leading to visible results in size enhancement with consistent use”“Prolonged Performance . . . by stimulating circulation and energy flow, improving stamina and endurance”“Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. 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). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729873” in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.fda.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration__________________________1 https://www.amazon.com/s?i=merchant-items&me=A327E0NFTQVK94&marketplaceID=ATVPDKIKX0DER&qid=1778778461&xpid=ogniWslo1h6zF&ref=sr_pg_1

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Hadassah Healing Oils Ltd14 Elm Street, City VillasIrenepark North West 2571South Africahadassahhealingoils@gmail.comadmin@hadassahheaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 17, 2026WARNING LETTERReference Number: 729191To Lechi van Rooyen:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of your website https://hadassahhealingoils.com/ in May 2026. Based on our review, “Prostate Blend” 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 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).Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “Prostate Blend” 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 from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:On the webpage https://hadassahhealingoils.com/product/prostate-oil-30ml-blend/:“Assists with prostate healing and prostate cancer healing.”“[H]elp relieve the urge to constantly urinate.”“Refer to the Benign Prostate Enlargement (BPE) Protocol.”“Prostate Blend” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. 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). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729191” in the subject line of the email.If you have information that you believe demonstrates that your product is not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsRecipient:Wild Arabic HerbsAlbaniaarabicnaturalcare@live.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesJune 17, 2026WARNING LETTERReference Number: 729192To Wild Arabic Herbs:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.FDA ReviewViolations were identified and documented during a review of your website https://wildarabicherbs.com/ in May 2026. Based on our review, “Edral-17t” 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 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).Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, your “Edral-17t” 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 from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:On the webpage https://wildarabicherbs.com/products/edral-17t-desert-herbs-formula-for-prostate--testicles-cancers-90-capsules:“Edral-17t – Desert Herbs Formula for Prostate & Testicules [sic] Cancers”“[S]pecifically designed to support patients suffering from prostate cancer, testicular malignancies, and other severe conditions of the male reproductive system.”“Anticancer and antiproliferative effects – inhibits uncontrolled cell division, blocks the cell cycle, promotes differentiation, and induces apoptosis.”“Anti-metastatic effects – suppresses malignant angiogenesis, prevents cell migration, and blocks metastasis.”“Anticancer and selective cytotoxicity – effective against prostate, testicular, colon, liver, breast, kidney, and lung cancers.”“Helps prevent the spread of malignant cells within the body.”“Edral-17t” is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. 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). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure sustained compliance so that these violations and any others do not occur.Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729192” in the subject line of the email.If you have information that you believe demonstrates that your product is not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note FDA posts warning letters on www.FDA.gov.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration