《关于构建事前预防型监管模式的若干措施》已经海南省药品监督管理局局务会审议通过，现印发给你们，请遵照执行。海南省药品监督管理局2026年9月22日海南省药品监督管理局关于构建事前预防型监管模式的若干措施为深入贯彻落实国家药监局关于构建事前预防型监管新模式的要求，全面提升药品、医疗器械、化妆品（以下简称“两品一械”）质量安全保障能力，结合海南自由贸易港（以下简称自贸港）建设实际，强化全链条、全生命周期监管，变“被动应对”为“主动预防”，特制定如下措施。一、完善预防性工作机制，筑牢全生命周期监管防线（一）前移注册审批与备案关口。完善基于风险防控的审评审批机制。对特许药械实施“早期介入、全程指导”的服务模式。在药品、医疗器械创新产品研发过程中，提前开展合规性指导，避免系统性设计缺陷。完善化妆品备案前技术咨询机制，为企业安全性评估提供前置服务，防范产品因风险物质识别不充分等风险流入市场。（二）强化变更管理质量体系核查。督促企业将变更管理作为质量体系的核心。在日常监管中，重点核查企业工艺、物料变更等是否按规定开展验证和报告，对获批试点的重大变更实施“预防性技术评估”，防范因频繁变更带来的系统性质量安全风险。（三）健全药品安全风险会商体系。强化监管部门层级会商，定期综合分析研判药品安全风险形势。推动市县药品监管部门完善属地会商机制，实施靶向监管、精准施策。引导企业建立内部风险会商制度，运用产品质量趋势、偏差、变更、投诉举报、不良反应等数据开展分析研判，主动识别潜在质量风险并制定纠正预防措施。二、深化风险预警与排查，实现隐患早发现早处置（四）建立企业全链条风险图谱机制。整合审评审批、检查核查、检验检测、监测评价、投诉举报、稽查执法等数据，综合企业既往合规记录，运用大数据绘制“两品一械”区域性、系统性风险图谱，实施差异化监管。（五）拓展药物警戒监测广度。探索开展将乐城先行区特许药械的临床真实世界数据应用于上市后风险预防。推动化妆品不良反应监测哨点向医美机构延伸，构建覆盖生产、经营、使用全环节的哨点网络，确保风险信号及早捕获。（六）实施基于风险的分级分类监管。结合自贸港信用体系建设，深化“信用+风险”分级分类监管模式，对质量体系运行良好、信用等级高的企业依法给予监管便利；对集采中选药械产品、无菌和植入医疗器械、疫苗、血液制品、儿童用化妆品等高风险品种及低信用企业，实施高频次、深层次的预防性检查。三、创新事前监管方式，提升全链条穿透式监管效能（七）全面推行预防性合规体系建设。制定并发布“两品一械”企业合规管理指引，鼓励企业建立“首席质量合规官”制度。在审评、检查、许可等环节，更加注重对企业质量体系合理性和运行有效性的审查，引导企业在产品研发和工艺设计阶段识别潜在质量风险，动态更新全生命周期风险管理计划。（八）强化冷链物流与供应链穿透监管。针对海南岛屿地理特点及高温高湿气候，强化对药品、体外诊断试剂在常温、阴凉、冷藏、冷冻等运输条件下的温控监管。鼓励药品批发企业温湿度自动监测预警系统与药监部门智慧监管平台对接，实现药品温控断链时平台自动触发预警，督促企业即时开展处置，由事后核查转向事前防范，推动药品储运温控风险动态感知、主动防控。（九）加强重点领域和关键环节风险防范。对中药注射剂、特殊管理药品、集采中选品种、无菌和植入类医疗器械等，实施全链条、全周期重点监控。严控网络销售与新业态风险，针对跨境电商、离岛免税、特许药械等，建立“线上监测+线下溯源”预防机制。督促第三方平台建立违规产品“关键词拦截库”，在网络销售行为发生前切断风险传播链。（十）健全药品投诉举报闭环核查与风险监管机制。优化投诉举报渠道，实行分类引导、清单化填报，提高线索的针对性和可核查性。建立投诉举报快速核查和定期分析制度，与12315、12345平台数据互联互通，避免多头受理、重复办理；对同一企业、同一品种被反复举报的，及时纳入风险研判并开展针对性检查。四、强化源头质量管控，压实企业主体责任（十一）严格关键岗位人员管理。落实《药品管理法》《医疗器械监督管理条例》《化妆品监督管理条例》等要求，强化对企业法定代表人、企业负责人、质量负责人、管理者代表等关键人员的履职能力评估。建立关键人员信用档案和黑名单制度，对严重违法违规的人员，依法实施行业禁入。（十二）督促落实上市后风险消除责任。压实企业在“两品一械”上市后的质量安全主体责任，指导企业定期开展风险隐患排查。对于监测发现的风险信号，督促企业在规定时限内开展原因调查、风险评估并采取风险控制措施，对于未按时消除风险的，监管部门依法采取行政措施。（十三）建立企业风险主动报告激励机制。对主动排查发现、如实及时报告质量安全风险，主动召回并落实管控措施，积极消除或减轻危害后果，未造成严重危害的企业，依法从轻或者减轻行政处罚。五、强化技术支撑与智慧赋能，夯实预防监管基础（十四）推进“智慧药监”预警模型建设。全量归集“两品一械”全生命周期数据，开发基于大数据的风险预警模型，对不良反应报告、企业生产数据、流通数据、网络销售数据等进行关联分析和异常检测，及时发现聚集性风险信号和潜在违法线索。（十五）发挥检验检测的“雷达”作用。常态化开展基于风险目标的药品探索性研究。提前储备化妆品新型非法添加物质检验方法，开展靶向抽检，将检验关口前移至风险形成初期。（十六）加强监管队伍预防性检查能力建设。改变“查记录、看文件”的传统模式，开展“穿透式”“放大镜式”检查能力培训。培养一批精通工艺和质量管理体系的高级检查员，打造既懂业务又懂风险管理的监管队伍，提升风险早发现能力。六、加强组织领导与宣贯引导，凝聚社会共治合力（十七）创新社会共治方式。成立省药监局构建事前预防型监管模式工作专门力量，细化年度任务清单，将事前预防理念融入各类规章制度和操作规范。加强质量安全风险预防研讨，向行业传递预防监管导向。发布典型案例，警示企业落实预防义务，营造全社会共同关注质量安全的共治氛围。

为推动建立全国统一的长期护理服务管理标准，提升经办服务和协议管理规范化水平，助力长期护理保险经办高质量发展，国家医保局制定《长期护理保险服务管理文书（2026版）》。为规范文书使用，引导医疗保障经办机构准确规范填写相关内容，我们组织对国家版文书进行系列解读。《长期护理服务质量评价表》是对定点长护服务机构的护理服务质量开展专业评价的制式文书，用于对照服务要点规范逐项核查、量化评分，科学判定服务质量达标情况。本表由统筹地区医疗保障经办机构工作人员或其授权的专业人员根据实际情况填写。表格具体说明如下：《长期护理服务质量评价表》主要分为四个部分：表头信息、表1生活照护类服务评价、表2医疗护理类服务评价、表3其他类服务评价、评价结果。表头信息用于登记被评价服务机构、参保人员及服务信息。三类评价表分别对照服务要点逐项评分，最终计算得分率并确定评价结果。评价工作应严格对照服务操作规范开展，客观公正、标准统一，确保评价结果真实反映服务质量水平。请您按如下操作：一、表头信息表头信息用于登记被评价服务机构、参保人员及服务相关信息。定点长护服务机构名称、机构类型、参保人员姓名、身份证号码、上门服务地址应据实填写，其中定点长护服务机构名称应填写全称，上门服务地址应填写实际服务的详细地址。服务项目类别应根据实际服务项目勾选。填写信息应与《长期护理保险服务记录单》保持一致。二、分类评价这一部分是质量评价的核心内容，对机构的护理服务质量进行逐项量化评分。质量评价表将服务分为生活照护类（A类）、医疗护理类（B类）和其他类（C类）三个类别进行评价。其中，生活照护类和医疗护理类的评价项目与《长期护理保险护理服务计划表》中各类项目一致。其他类包括医疗护理适应性、服务协议履约合规性、家属沟通与反馈响应、应急处置预案与准备和记录规范性5项内容。每项服务均对应明确的“服务要点”，采用0—5分制进行逐项评分。每完成一个类别的评分后，即对该类别的“小计项目数”和“小计得分总和”进行统计，并依据以下公式计算该类别的得分率：评分过程中应严格依据各服务要点逐项打分，各评分员对同一项目的判定标准应保持一致，不得因评分对象不同而调整尺度，确保评价结果真实、准确、可比。三、评价结果根据三类评价得分率判定最终评价结果，评价结论对应勾选合格或不合格。A、B、C三类得分率均达到60%及以上为合格，有一类低于60%即视为不合格。出现“打骂参保人”“非持证人员提供医疗护理”情形的，直接判定为不合格。《长期护理服务质量评价表》是服务质量评价的工具，评价结果应当据实记录、规范归档，作为定点长护服务机构服务优化、管理的参考依据。相关事宜可咨询参保地医保经办机构，或关注当地医保部门官方发布渠道。

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Joo-Young YoonCEOUnilam Co., LTDUlju-gun UlsanSouth Korea (b)(6)@unilam.co.krIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #738562September 22, 2026Dear Mr. Yoon,During an inspection of your firm located in Ulju, Ulsan, South Korea, from 05/18/2026 through 05/22/2026, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures SUV 600-800/KT/GYU UV Sunlamp, Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.Quality System Regulation Violation(s)This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.We received a response from Young Boo Cho dated June 15, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to establish, implement, and maintain one or more processes for risk management in product realization, as required by ISO 13485:2016 Clause 7.1.For example: Your firm does not have a risk management procedure that addresses design controls. Additionally, your firm's DFMEA only addresses 4 risk line items, and the risk controls identified rely almost entirely on labeling or on actions only able to be undertaken by the downstream sunlamp bed manufacturer, such as use of a timer or UV filter, rather than design level controls within your firm's own manufacturing process. The limited scope of the DFMEA results in a failure of the DFMEA to include reasonably anticipated failure modes.Furthermore, your firm's DFMEA does not address foreseeable risks, such as chemical exposure in the event of lamp breakage. By relying only on risk control measures involving labeling or actions outside the manufacturer’s control, your firm cannot ensure that those control measures will effectively bring the associated residual risks to an acceptable level.We reviewed your firm’s response and conclude that it is not adequate. Your firm created three new risk management procedures (2D4-014, 2D4-014-01, and 2D4-007-10), updated its DFMEA to evaluate additional potential failure modes and risk controls for its SUV lamps, and trained personnel on ISO 13485 and ISO 14971. However, the updated DFMEA still does not address the foreseeable risk of chemical exposure in the event of lamp breakage. Additionally, several risks in the updated DFMEA were accepted at medium-risk RPN levels without the design verification test data and technical manager approvals required by your firm's own procedure 2D4-007-10.2. Failure to adequately document design and development procedures, as required by ISO 13485:2016 Clause 7.3.1.For example: Your firm has not documented validation plans that include methods, acceptance criteria, rationale for sample size, rationale for choice of product, or confirmation that validation was conducted on a representative product. Your firm performed a lifetime test intended to serve as design validation following a change to its quartz tube supplier; however, the documents do not include the previously listed information and do not include results for UVC emissions over the full 800-hour expected lifetime of the device. Furthermore, your firm does not have procedures to control design and development changes. Specifically, your firm's quality manager stated that your firm does not have a design control procedure.We reviewed your firm’s response and concluded that it is not adequate. Your firm created a new procedure, 2D4-007-10 (SUV Design and Review Preparation Instruction, Ver. 00), outlining how to plan and document design validation, evaluate design changes, linked those changes to risk management, and performed risk assessments for the three design changes identified during the inspection. However, your firm has not provided test data showing that UVC emissions remain within acceptable limits over the full 800-hour lifetime of the device. Additionally, your firm's risk assessment for ECN 21-00472 states the 2021 post-fire change only involved resetting inspection values and did not affect lamp performance. However, this change also included modifications to the UVA and UVB product specifications, and your firm has not explained why those specifications changed or whether the change affected product safety. Finally, your firm has not provided evidence that 2D4-007-10 has been applied to any design changes made after its effective date of July 1, 2026, and it cannot be confirmed whether the existing change control process reliably triggers its use for all SUV medical device design changes.3. Failure to adequately establish criteria for the evaluation and selection of suppliers, as required by ISO 13485:2016 Clause 7.4.1.For example: Your firm's purchasing procedures (Purchasing Management Procedure, 2D3-001, Rev. 18; Supplier Management Procedure, 2D3-002, Rev. 16) do not establish criteria for initial evaluation and selection of suppliers prior to use.We reviewed your firm’s response and concluded that it is not adequate. Your firm completed initial supplier evaluations for its quartz tube, mercury, and krypton suppliers. However, the evaluation form for the quartz tube supplier ((b)(4)) scored 80 points, which is the minimum passing threshold, but was marked "Not Registered." This is contradictory and raises doubt about whether this supplier was approved. Furthermore, the evaluation form for the mercury supplier references both (b)(4), which is the supplier of record, and (b)(4), which makes it unclear which entity was evaluated.4. Failure to maintain written agreements requiring suppliers to notify the firm of changes to purchased product prior to implementation, as required by ISO 13485:2016 Clause 7.4.2.For example: Your firm has not established written change notification agreements with its suppliers of quartz tube, mercury, and krypton. These are key raw materials that directly affect the UV emission characteristics and safety performance of its sunlamp products. In the absence of such agreements, your firm has no assurance that it will be notified of supplier changes prior to those changes impacting the sunlamp products, and therefore no opportunity to assess whether requalification or updated certification testing is required before affected product is distributed.We reviewed your firm’s response and concluded that it is not adequate. Your firm updated its purchase order form to require suppliers to notify your firm before making changes. However, the change notification language added to the purchase order form is a one-sided request rather than a binding mutual agreement. This is less comprehensive than what your firm described in its response, which stated the purchase order form would cover changes to specifications, materials, manufacturing process, manufacturing location, and sub-suppliers.5. Failure to adequately document procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner consistent with monitoring and measurement requirements, as required by ISO 13485:2016 Clause 7.6.For example: Your firm did not include the actual range of use for the Integrating Sphere test equipment (OL770) in your firm's calibration acceptance criteria. Although your firm collects calibration data from 195–793 nm, the acceptance criteria for new calibration curves are based solely on the visible light spectrum (340–780 nm). However, this equipment is used to measure UVC (200–260 nm) and UVB (260–320 nm) emissions required by the performance standard. These wavelengths are excluded from your firm's acceptance criteria and exhibit substantially higher variation than the visible spectrum. Furthermore, after a fire at the factory in 2021, your firm did not perform an adequate requalification of the Integrating Sphere equipment (OL770). While a calibration record was generated after cleaning, there was no justification for the acceptability of the post cleaning irradiance reading, no documented basis for concluding that the cleaning did not adversely affect the instrument's functionality, and no additional equipment qualification was performed. Finally, the calibration procedures do not define how to assess the validity of previous testing results when testing equipment is found out of calibration, nor do they define how to handle any potentially affected product.The adequacy of your firm’s response cannot be determined at this time. Your firm established a Sampling Plan Validation Protocol (VAL-PRO-001, Rev. 0) and Validation Report (VAL-RPT-001, Rev. 0) to retroactively provide the documented statistical and manufacturing basis that was absent. However, the process capability analysis is not explicitly linked to the parameters and acceptance criteria required under the applicable performance standard. The rationale for limiting 100% verification to five lots is not documented. Your firm has not revised its AQL Inspection Level Setting Guideline (2S2-008-01) to require prospective statistical justification for future sampling plan selections. Finally, the validation report does not address whether the continued use of sampling based inspection is consistent with the regulatory expectation that all SUV lamps conform to the applicable performance standard.6. Failure to monitor and measure the characteristics of the product to verify that product requirements have been met, as required by ISO 13485:2016 Clause 8.2.6.For example: Your firm's sampling plan for certification testing of SUV lamps, as described in procedure AQL Inspection Level Setting Guideline, 2S2-008-01, is based on ISO 2859-1 at AQL 2.5 using Table S-3. However, your firm has not established a documented statistical or manufacturing basis for the selection of this sampling level.For example: Your firm's sampling plan for certification testing of SUV lamps, as described in procedure AQL Inspection Level Setting Guideline, 2S2-008-01, is based on ISO 2859-1 at AQL 2.5 using Table S-3. However, your firm has not established a documented statistical or manufacturing basis for the selection of this sampling level.We reviewed your firm’s response and concluded that it is not adequate. Your firm established a Sampling Plan Validation Protocol (VAL-PRO-001, Rev. 0) and Validation Report (VAL-RPT-001, Rev. 0) to retroactively provide the documented statistical and manufacturing basis that was absent. However, the process capability analysis is not explicitly linked to the parameters and acceptance criteria required under the applicable performance standard; the rationale for limiting 100% verification to five lots is not documented; your firm has not revised its AQL Inspection Level Setting Guideline (2S2-008-01) to require prospective statistical justification for future sampling plan selections and the validation report does not address the continued use of sampling based inspection with the regulatory expectation that all SUV lamps conform to the applicable performance standard.ELECTRONIC PRODUCT RADIATION CONTROL DEVICE VIOLATION(S)The Center for Devices and Radiological Health has determined the SUV 600-800/KT/GYU UV Sunlamp fails to comply with the federal requirements found in 21 Code of Federal Regulations (CFR) Part 1040 and 21 CFR Part 1010. In addition to being a "device," SUV 600-800/KT/GYU UV Sunlamps is an "electronic product" subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the general requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1010, and 1040.20. Your firm failed to comply with the regulations regarding the testing of the product for determination of compliance with the regulations, as follows:Per 21 CFR 1040.20(f), tests on which certification pursuant to 21 CFR 1010.2 is based shall account for all errors and statistical uncertainties in the process and, wherever applicable, for changes in radiation emission or degradation in radiation safety with the age of the product. Measurements for certification purposes shall be made under those operational conditions, lamp voltage, current, and position as recommended by the manufacturer. For these measurements, the measuring instrument shall be positioned at the recommended exposure position and so oriented as to result in the maximum detection of the radiation by the instrument. In response to Form FDA 483 issued at the conclusion of the inspection, your firm states that “the measurement method follows the measurement principles of CIE 127 and CIE S 025, and defines the measurement sequence, equipment configuration, operating conditions, aging/stabilization before measurement, data recording, and acceptance determination against the applicable specification.” However, even though document “2S2-008-05 SUV In-Process Inspection Work Instruction, Ver.00.pdf” presents a detailed test procedure based on CIE 127 and CIE S 025 international standards, it appears that key procedural details, such as measurement geometry, calibration, and stabilization criteria, are absent or not adequately documented. Also, several critical requirements such as temperature control, supply tolerances, calibration traceability, sphere correction factors, are not addressed in the measurement test procedure submitted by your firm. Additionally, the testing procedure mentions that aging is performed, but we could not find documented evidence on how the aging of the product is conducted.Documents “2D4-007-10 SUV Design and Review Preparation Instruction, Ver.00.pdf” and “SUV Design and Review Experimental Plan Form, Ver.00.pdf” do not appear to provide a clear justification for why this emissions set-up is the worst-case scenario for all models of UV lamps. Also, we could not find in your response any documented evidence providing justification of the sampling plan for the certification testing of your firm’s product along with statistical validation. We could not find the cited document “Sampling Plan Validation Protocol for SunLamps, VAL-PRO-001, Rev.OJ.pdf” in your firm’s submission.Please be advised that, by authority of the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C – Electronic Product Radiation Control, manufacturers of sunlamps are responsible for assuring their products comply with all applicable mandatory federal radiation safety performance standards prior to entry of those products into US commerce. The applicable performance standards are 21 CFR Parts 1010, and 1040.20. Additionally, manufacturers of these products are subject to all applicable requirements of 21 CFR 1000 – 1005, which includes the reporting and record keeping requirements found in 21 CFR 1002.Please provide the following information: (a) documented evidence on measurement geometry, calibration, stabilization criteria, temperature control, supply tolerances, calibration traceability, and sphere correction factors, (b) documented evidence on how the aging of the product is conducted, (c), a clear justification for why this emissions set-up is the worst-case scenario for all models of UV lamps. and (d) documented evidence on the justification of the sampling plan for the certification testing of your firm’s product along with statistical validation.Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to sunlamps are available on FDA’s web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm.Other federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. 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 as part of your response.Your firm’s response should be sent via email to Tanisha Hithe at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, CMS Case 738562 when replying. If you have any questions about the contents of this letter, please contact: Andrew Keys at Andrew.Keys@FDA.HHS.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Anton E. Dmitriev, PhD, MSc, FAIMBEDirectorOHT 4: Office of Surgical and Infection Control DevicesOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC:Soojung MoonAllura Medical Solution Inc.5485 Rathdrum WayAntioch, CA 94531CC: (b)(6)@allurameds.com

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsOver-the-Counter DrugsRecipient:Krystsina UradzimskayaCEOTerramed10731 Queen AveLa Mesa, CA 91941United States support@terramed.info info@puritycosmetics.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 20269310 Towne Center Dr Unit 72San Diego, California, 92121WARNING LETTERReference Number: 735070To Krystsina Uradzimskaya:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://terramed.info, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, the “Genital Herpes Intimate Wash,” “HerpCare Ointment,” “HerpCare Spray,” and “HerpCare Genital Wart Remover Ointment” products on your website are unapproved new drugs. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during a review of your website https://terramed.info/ in July 2026. Based on our review, “Genital Herpes Intimate Wash,” “HerpCare Ointment,” “HerpCare Spray,” and “HerpCare Genital Wart Remover Ointment” 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 your website, “Genital Herpes Intimate Wash,” “HerpCare Ointment,” “HerpCare Spray,” and “HerpCare Genital Wart Remover Ointment” 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:Genital Herpes Intimate WashOn the webpage https://terramed.info/products/genital-herpes-intimate-wash:“This genital herpes intimate wash is designed to support soothing relief for itching, tingling, burning, and irritation associated with genital herpes symptoms. The gentle cleansing formula helps maintain intimate hygiene while supporting skin comfort for sensitive intimate areas. The wash is suitable for daily intimate care for both men and women experiencing discomfort associated with herpes outbreaks.”“GENITAL HERPES INTIMATE WASHo Formulated for Herpes Relief”Supports Genital Herpes Comfort.”HerpCare OintmentOn the webpage https://terramed.info/products/genital-herpes-treatment-fast-acting-ointment:“This genital herpes relief ointment is designed to support soothing comfort for genital sores, itching, tingling, burning, and irritation associated with herpes outbreaks. The soothing formula helps calm sensitive skin while supporting comfort and relief for intimate areas. Each tube provides targeted topical support for genital herpes symptoms.”“GENITAL HERPES SYMPTOMSo Soothes and calms genital sores”HerpCare SprayOn the webpage https://terramed.info/products/genital-herpes-spray:“This genital herpes relief spray is designed to support soothing comfort for genital sores, itching, burning, tingling, and irritation associated with herpes outbreaks. The convenient spray format allows targeted application to sensitive areas while helping calm irritated skin.”“Fast-acting Genital Herpes Symptom Reliefo Soothes and calms genital sores.”HerpCare Genital Wart Remover OintmentOn the webpage https://terramed.info/products/genital-wart-remover-oitnment:“This genital wart remover ointment with salicylic acid is designed to support targeted treatment for genital warts, irritation, redness, itching, and discomfort. The formula helps soften and break down wart tissue while supporting gentle skin recovery. The ointment helps provide targeted wart treatment while supporting skin comfort for sensitive areas.”“HerpCare Genital Wart Remover Ointmento Targets Genital Warts”“Genital Wart Treatment Supporto Designed to support treatment for genital wart symptoms.”“Supports Genital Wart Removal”The above-referenced webpages for each product also provide the following:“Terramed Intimate Careo HerpCare – Proprietary Genital Herpes Care LineHerpCare is a proprietary and exclusively developed product line, fully owned and commercially distributed by Terramed Just Think Comfort, specifically created to support individuals managing genital herpes (HSV-2).”“Genital Herpes Intimate Wash,” “HerpCare Ointment,” “HerpCare Spray,” and “HerpCare Genital Wart Remover Ointment” 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.1 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. 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. Identify your response with reference number “735070” in the subject line of the email.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 We recognize that the “HerpCare Ointment” and “HerpCare Spray” labeling describes the products as being “homeopathic.”First, we note that 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.In addition, FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States that potentially pose a higher risk to public health. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” Your “HerpCare Ointment” and “HerpCare Spray” include the active ingredient, lemongrass, which is not listed in the HPUS. Thus, your “HerpCare Ointment” and “HerpCare Spray” products fall outside the scope of products addressed in this guidance.Notwithstanding, even if your above listed products were considered “homeopathic drug products" under this guidance, these products would fall under the guidance’s category of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsOver-the-Counter DrugsRecipient:Jake CarterChief Executive OfficerDesBio/Deseret Biologicals, Inc.469 West Parkland DriveSandy, UT 84070United States practitionersupport@desbio.com (b)(6)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 2026WARNING LETTERReference Number: 735464To Jake Carter:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://desbio.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, the “CHLA:10M” product available for purchase on your website is an unapproved new drug. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during a review of your website https://desbio.com/ in July 2026. Based on our review, “CHLA:10M” 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).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 your website, “CHLA:10M” 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 product label:“Chlamydia 10M”“Chlamydia trachomatis 10M . . . Burning Sensation During Urination, Testicular Tenderness or Pain, Vaginal Discharge, Painful Sexual Intercourse”On the webpage https://desbio.com/product/chlamydia-series-symptom-relief-series-kit-10m/:“chlamydia, series symptom relief”“CHLA:10M is for the temporary relief of symptoms related to Chlamydia infection. Male: burning sensation during urination and testicular tenderness or pain. Female: vaginal discharge, burning sensation during urination, and painful sexual intercourse.”“CHLA:10M” 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this product.1 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 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. 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. Identify your response with reference number “735464” in the subject line of the email.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 We recognize that the “CHLA:10M” labeling describes the product as being “homeopathic.”First, we note that 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.In addition, FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States that potentially pose a higher risk to public health. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” Your product contains Chlamydia trachomatis 10M which is not listed in the HPUS; thus, this product falls outside the scope of products addressed in this guidance.Notwithstanding, even if your above listed product is considered “homeopathic drug product" under this guidance, the product would fall under the guidance’s category of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsOver-the-Counter DrugsRecipient:Jamey HaganCEOThe Platinum Healthcare LLC1019 N 1st StreetPulaski, TN 38478United States office@platinumwellnesscenter.orgIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 2026WARNING LETTERReference Number: 735147To Jamey Hagan:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://platinumwellnesscenter.org/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, the “Sycosis” and “Syphillinum” products available for purchase on your website are unapproved new drugs. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during a review of your website https://platinumwellnesscenter.org/ in July 2026. Based on our review, “Sycosis” and “Syphillinum” 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 your website, “Sycosis” and “Syphillinum” 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:SycosisOn the webpage https://platinumwellnesscenter.org/store/sycosis/:“Oral antigen for desensitizing and stimulating the body’s immune defense mechanism against problems caused by the Gonorrhea miasm.”SyphillinumOn the webpage https://platinumwellnesscenter.org/store/syphilinum/:“Oral antigen for desensitizing and stimulating the body’s immune defense mechanism against problems caused by the Syphilis miasm.”“Sycosis” and “Syphillinum” 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).We recognize that your “Sycosis” and “Syphillinum” 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.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. 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. Identify your response with reference number “735147” in the subject line of the email.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:DrugsOver-the-Counter DrugsRecipient:Guy SiversonIrene SiversonGraceful Touch, LLC2040 West Main Street, #209Rapid City, SD 57702United Statesguy@gracefultouch.org irene@gracefultouch.orgIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 2026WARNING LETTERReference Number: 735272To Guy and Irene Siverson:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://gracefultouchproducts.org/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during a review of your website https://gracefultouchproducts.org/ in July 2026. Based on our review, “Herpes B Gone” 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).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 your website, “Herpes B Gone” 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://gracefultouchproducts.org/products/herpes-b-gone:“Herpes B Gone” and images of what appears to be cold sores on the lips.“Say No to Sores on Your Mouth or Genitals”“Lower the dangers of herpes virus”“Herpes B Gone is a certified organic, plant-based cream formulated specifically to soothe herpes sores, calm irritated skin, and support your body's natural healing process— so you can get through an outbreak with less discomfort and more confidence.”“Herpes B Gone” 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is 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 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. 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. Identify your response with reference number “735272” in the subject line of the email.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:DrugsOver-the-Counter DrugsRecipient:Andy JassyCEOAmazon.com, Inc.P.O. Box 81226Seattle, WA 98108-1226United States (b)(6)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 2026WARNING LETTERReference Number: 736006To 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, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, the “FemiClear,” “Hclear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” products available for purchase on your website are unapproved new drugs. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during review of the product labeling of products purchased on your website www.amazon.com in July 2026. FDA purchased, “FemiClear,” “HClear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” 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, “FemiClear,” “HClear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” 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, “FemiClear,” “Hclear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,”2 “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” 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 product 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:FemiClear“Genital Herpes Symptoms”“Fast-acting ointment for recurring outbreak symptoms”“>90% OF USERS REPORTED LESS SEVERE OUTBREAKS”“[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.”“[B]est used at first sign of outbreak. Early use ensures the best results.”HClear for him“GENITAL HERPES SYMPTOMS”“>90 of USERS REPORTED LESS SEVERE OUTBREAKS”“FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING”“[I]ntended to relieve symptoms associated with diagnosed genital herpes, including itching, burning and/or pain.”“[B]est used at first sign of outbreak. Early use ensures the best results.”HerpCare Ointment“FAST-ACTING GENITAL HERPES SYMPTOM RELIEF”“Soothes and calms genital sores”“Purpose:o Anti-Fungalo Anti-microbial”“Provides temporary relief from skin inflammation, irritation, and/or tingling caused by genital herpes.”HerpCare Spray“Relief on the Go:o Fast-acting formula in a convenient spray format . . .o Herpes Symptoms”“To maintain optimal hygiene and support skin health, incorporate the HerpCare Genital Wash into your daily routine. Formulated specifically for sensitive skin, it helps maintain a balanced environment and supports the natural healing process . . . help manage symptoms effectively throughout the day and night.”“Gentle & effective care for intimate areas”“Soothes irritation, burning & itching quickly”Genital Herpes Intimate Wash“Formulated for Herpes Relief”“Antiviral Action . . . reduce viral activity . . . powerful antimicrobial properties”“Pain Relief . . . numbs pain and soothes itching by targeting nerve endings, providing fast and lasting relief during flare-ups”“Anti-Inflammatory . . . reduce redness, swelling, leaving your skin feeling refreshed.”“Healing Support . . . hydrates and promotes skin repair, aiding in faster recovery”Herstat GST“Genital Sore Treatment”“Soothes and calms genital sores”“[R]elieves pain and itching associated with genital sores.”Genital Herpes Ointment“FAST ACTING GENITAL HERPES RELIEF”“Soothes Genital Sores.”“Purpose:o Anti-Fungalo Anti-Microbial”“[R]elief of inflammation, irritation, and tingling caused by genital herpes.”RoyceDerm Herpes Relief Cream“Helps relieve the symptoms of rashes or blisters, itchy, redness and pain.”“FIGHTS OUTBREAKS”“SOOTHES & COOLS”“REDUCES RECURRENCE”“[S]pecifically formulated to help relieve the symptoms of Herpes, rashes or blisters, redness & pain.”Terragen HG Formula“Uses . . . relief of swelling and pain associated with genital sores.”“FemiClear,” “Hclear for him,” “HerpCare Ointment,” “HerpCare Spray,” “Herstat GST,” “Genital Herpes Ointment,” “RoyceDerm Herpes Relief Cream,” “Terragen HG Formula,” and “Genital Herpes Intimate Wash” 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).We recognize that the “Terragen HG Formula” product available for purchase on your website is labeled as a homeopathic drug with active ingredients 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.3ConclusionAs 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. 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. Identify your response with reference number “736006” in the subject line of the email.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 permitted indications under OTC Monograph M017: External Analgesic Drug Products for OTC Human Use (M017) are for the treatment of pain, itching, and minor skin irritation generally and for the prevention of premature ejaculation. The “Herstat GST” product available for purchase on your website is intended to provide relief from genital sores and their associated symptoms, which goes beyond the permissible indications under M017. “Herstat GST” therefore does not conform to M017 or any other final OTC administrative order. Accordingly, there is no basis under section 505G of the FD&C Act under which “Herstat GST” could be legally marketed without an approved application. (see https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTC%20Monograph_M017-External%20Analgesic%20Drug%20Products%20for%20OTC%20Human%20Use%2005.02.2023.pdf).3 We recognize that the “FemiClear,” “HClear for him,” “HerpCare Ointment,” “HerpCare Spray,” and “Genital Herpes Ointment” products available for purchase on your website are also labeled as being “homeopathic.” FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for certain categories of homeopathic drug products that potentially pose a higher risk to public health. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” These products do not meet the definition of a “homeopathic drug product” because they include lemongrass, which is not listed in the HPUS as an active ingredient. Therefore, these products fall outside the scope of products addressed in this guidance.Notwithstanding, even if the above listed products were considered “homeopathic drug products" under this guidance, these products would fall under the guidance’s category of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsOver-the-Counter DrugsRecipient:Caroline GoodnerChief Executive OfficerOrganiCare, LLC / OrganiCare Nature’s Science, LLC3900 Drossett Dr., Bldg 5, Suite GAustin, TX 78744United Stateshello@femiclear.com (b)(6)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 2026WARNING LETTERReference Number: 734925To Caroline Goodner:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://femiclear.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.As discussed below, the “HClear for him” and “FemiClear Genital Herpes Symptoms” products available for purchase on your website are unapproved new drugs. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during a review of your website https://femiclear.com/ in July 2026. We have also reviewed your Facebook and Instagram accounts at https://www.facebook.com/FemiClear and https://www.instagram.com/femiclear,External Link Disclaimer respectively, where you direct consumers to your https://femiclear.com/ website to purchase your products. Based on our review, “HClear for him” and “FemiClear Genital Herpes Symptoms” 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 allinclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your website, “HClear for him” and “FemiClear Genital Herpes Symptoms” 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 and social media accounts, 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:HClear for himOn the webpage https://femiclear.com/products/hclear-for-him-for-genital-herpes-symptoms-24-ea?selling_plan=3741548730:On the image of the producto “>90% OF USERS REPORTED LESS SEVERE OUTBREAKS”o “GENITAL HERPES SYMPTOMS”o “FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING”“Try the FemiClear topical ointment for men that kills 99.9% of the herpes simplex I & II viruses”On a September 10, 2024, post on your Facebook page https://www.facebook.com/FemiClear/posts/pfbid02GZLSvy4rJUch7SvLwKcZbP8r5aAipKeCruw7qjkDnjKVLigQPhSu8i7CroLJf6cjl:“Say goodbye to the discomfort of genital herpes symptoms with HClear for Him! This all-natural, organic ointment is designed specifically for men, targeting itching, tingling, and burning caused by herpes outbreaks. With a powerful formula that kills 99.9% of herpes simplex viruses (HSV1 & HSV2), you can trust HClear to bring fast relief. Over 90% of users reported milder symptoms, and over 50% experienced no blisters when used at the first sign.”“Explore The Benefits HClear for Him for Genital Herpes Symptoms”FemiClear Genital Herpes SymptomsOn the webpage https://femiclear.com/products/femiclear-herpes-treatment-multi3symptom?selling_plan=3740434618:On the image of the producto “Fast-acting ointment for recurring outbreak symptoms”o “>90% OF USERS REPORTED LESS SEVERE OUTBREAKS”“Looking for genital herpes symptom relief? Try the FemiClear topical ointment that kills 99.9% of the herpes simplex I & II viruses (HSV1 & HSV2) and works fast to relieve Itching & Tingling + Pain & Burning symptoms caused by a herpes outbreak.”On a January 29, 2026, post on your Facebook page https://www.facebook.com/photo.php?fbid=1343141094494950&set=pb.100063972160769.-2207520000&type=3:On the image of the producto “GENITAL HERPES SYMPTOMSFast-acting ointment for recurring outbreak symptoms”On an April 4, 2025, post on your Instagram page https://www.instagram.com/p/DICmMYfOANa/:“Herpes Relief for Less”“Genital Herpes Symptoms”“We know managing outbreak symptoms can be tough. The last thing you need is a price tag standing between you and relief. That’s why we dropped the price of FemiClear for Genital Herpes Symptoms.”Additionally, your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the treatment of disease and/or to affect the structure or function of the body. Examples of such testimonials include, but are not limited to, the following from the Reviews section of the “FemiClear Genital Herpes Symptoms” product webpage https://femiclear.com/products/femiclear-herpes-treatment-multisymptom?selling_plan=3740434618:“Works like magic!I have had genital herpes for 35 years, and in the past 15 years, the outbreaks have been horrible and hard to get rid of. I won't take meds because they mess up my stomach. However, this ointment effectively eliminates the blisters within 24 hours. I have tried EVERYTHING, and this product truly works.”“HClear for him” and “FemiClear Genital Herpes Symptoms” 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.1 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. 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. Identify your response with reference number “734925” in the subject line of the email.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 We recognize that the “HClear for him” and “FemiClear Genital Herpes Symptoms” labeling describes the products as being “homeopathic.”First, we note that 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.In addition, FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States that potentially pose a higher risk to public health. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” Your products include lemongrass, which is not listed in the HPUS; thus, these products fall outside the scope of products addressed in this guidance.Notwithstanding, even if your above listed products were considered “homeopathic drug products" under this guidance, these products would fall under the guidance’s category of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDProduct:DrugsOver-the-Counter DrugsRecipient:Kevin Aspinall NesslingCEOBioactive Services USA, LLC / Herstat Inc.1309 Coffeen Ave, STE 1200Sheridan, WY 82801United States contact@herstat.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesOctober 1, 2026Herstat (USA) Inc.680 S Cache StreetSuite 100 – 10219Jackson, WY 83001United StatesWARNING LETTERReference Number: 734784To Kevin Aspinall Nessling:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your websites, https://drsosnowski.com/ and https://www.herstat.com/, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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.As discussed below, the “Herstat GST” product on your website is an unapproved new drug. Unapproved drug products marketed for the treatment of sexually transmitted infections (STIs) and/or their symptoms and sold directly to consumers present a serious public health concern. Individuals who rely on these products may forgo timely, appropriate medical care, increasing their risk of severe complications such as infertility, sepsis, and death. Further, a false sense of having been adequately treated may lead individuals to unknowingly transmit infections to their partners. FDA has not approved any over-the-counter (OTC) drug product for the treatment, cure, mitigation, or prevention of any STI. Effective treatment requires diagnosis and supervision by a licensed healthcare professional.FDA ReviewViolations were identified and documented during a review of your websites, https://drsosnowski.com/ and https://www.herstat.com/ in July 2026. We have also reviewed your Facebook and Instagram accounts at https://www.facebook.com/DoctorSosnowski and https://www.instagram.com/drsosnowskis/ where you direct consumers to your website to purchase your products. Based on our review, “Herstat GST” 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).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 your website, “Herstat GST”1 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://drsosnowski.com/products/herstat-gst:On product label: “Genital Sore Treatment”“Herstat GST provides rapid and targeted relief of genital sores at tingle, blister or scab, getting to work from 1st use at any stage of an outbreak”“The formula is dual action, designed to provide effective relief of symptoms (itching, pain, irritation) and aid healing of skin during outbreaks by calming inflammation and balancing PH”On the webpage https://www.herstat.com/products/herstat-genital-sore-treatment?variant=52463728689494:“Dr Sosnowski’s Herstat GST is formulated to provide effective relief from the symptoms of genital sores.”“The carefully balanced formula of GST helps to soothe and calm the symptoms of genital sores and provides temporary relief of pain, itching and inflammation.”“Effective for the treatment of genital sores”On an October 12, 2022 post on your Facebook and Instagram page https://www.facebook.com/DoctorSosnowski and https://www.instagram.com/drsosnowskis/ respectively:On product label: “Genital Sore Treatment”“Herstat GST provides rapid, targeted relief from the symptoms of genital sores.”“[P]rovides targeted pain relief . . . soothing relief to calm the discomfort associated with genital sores.” . . .“[A]nalgesic action . . . penetrate deep into the epidermis.”“Herstat GST” 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is 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 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. 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. Identify your response with reference number “734784” in the subject line of the email.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 The permitted indications under OTC Monograph M017: External Analgesic Drug Products for OTC Human Use (M017) are for the treatment of pain, itching, and minor skin irritation generally and for the prevention of premature ejaculation. The “Herstat GST” product available for purchase on your website is intended to provide relief from genital sores and their associated symptoms, which goes beyond the permissible indications under M017. “Herstat GST” therefore does not conform to M017 or any other final OTC administrative order. Accordingly, there is no basis under section 505G of the FD&C Act under which “Herstat GST” could be legally marketed without an approved application. (see https://www.accessdata.fda.gov/drugsatfdadocs/omuf/monographs/OTC%20MonographM017-External%20Analgesic%20Drug%20Products%20for%20OTC%20Human%20Use%2005.02.2023.pdf).