{"editorial":{"content_id":"be33d182-49f1-4efe-8703-4598900af1c1","slug":"anvisa-20261105-689654","content_type":"news","title":"巴西Anvisa：褪黑素贴片与软糖未获授权，仅限19岁以上每日0.21毫克","summary":"巴西国家卫生监督局（Anvisa）明确褪黑素贴片、膜剂和咀嚼软糖未获授权，仅允许19岁以上成年人以食品补充剂形式每日摄入不超过0.21毫克。","body":"巴西国家卫生监督局（Anvisa）表示，褪黑素以贴片、膜剂或咀嚼软糖形式在巴西未获授权，这些剂型从未经过安全性和有效性评估。自2021年起，Anvisa仅允许褪黑素作为食品补充剂销售，且仅限19岁以上成年人，每日限量0.21毫克。\n\nAnvisa指出，上述未授权剂型没有经过安全性、有效性评估，无法确认其吸收量和在体内的作用。该机构强调，在食品补充剂范畴内，舌下和舌下膜剂形式的褪黑素从未在Anvisa通过安全性、质量和有效性评估；相关研究应由生产企业提交，以防止补充剂带来过量风险等问题。\n\n褪黑素是人体自身产生的激素，主要在夜间增加分泌。它也在草莓、樱桃、葡萄、香蕉、番茄等蔬果以及部分谷物、肉类、牛奶和乳制品中以少量存在。\n\n根据Anvisa规定，褪黑素补充剂标签必须标注警示：孕妇、哺乳期妇女、儿童以及需要持续集中注意力的人员（如驾驶者）不应食用。Anvisa还表示，没有证据表明获准剂量能对睡眠调节产生直接效果；企业若要做此类宣称，须通过科学研究向Anvisa证明该剂量下可观察到有益效果。\n\n2026年2月，Anvisa第758号决议决定召回并暂停Vita Be Cosméticos Ltda.（Renova Be）生产的“百香果味舌下滴剂褪黑素”的制造、销售、分销、进口、广告和使用，原因是使用了未经舌下途径评估的成分，并宣传了未经批准的治疗承诺，如预防失眠和调节睡眠周期。Anvisa的理解是，舌下褪黑素补充剂需要专门的安全性评估，否则可能成为卫生措施的对象。\n\nAnvisa提醒消费者：警惕宣称“终结失眠”或“几分钟入睡”的产品；确认标签注明“食品补充剂”并遵守每日0.21毫克限量；避免购买来源不明的进口或销售产品，这类产品剂量常远高于巴西允许水平；长期睡眠不佳应寻求专业医疗人员帮助。","why_it_matters":null,"cbi_observation":null,"direction_tag":"巴西","primary_category":"科技平台","secondary_topics":["合规","政策","br-health"],"content_level":"编辑整理","event_type":"政策法规","audience_tags":[],"event_location":null,"verification_status":"source_verified","published_at":"2026-11-05T17:02:02.945Z","display_date":"2026-11-05","source_published_at":null,"source_url":"https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/uso-de-melatonina-em-fitas-ou-em-gomas-nao-e-autorizado-no-brasil","source_name":"Anvisa","source_language":"pt","author_name":"编辑部","risk_level":"low","risk_flags":["compliance_risk","regulatory_uncertainty","legal_risk"],"opportunity_flags":[],"trend_signals":["policy_tightening"]},"intelligence":{"intel_id":"118c93df-5848-40f7-94a1-7a7a30ed8fce","version":1,"event_type":"监管表态","event_date":null,"main_entities":[{"name":"巴西国家卫生监督局（Anvisa）","role":"发布褪黑素监管要求并实施召回","type":"regulator","country":"巴西","normalized_name":null},{"name":"褪黑素贴片、膜剂和咀嚼软糖","role":"未获授权且未经安全有效性评估的剂型","type":"product","country":"巴西","normalized_name":null},{"name":"褪黑素食品补充剂","role":"仅限19岁以上成年人、每日不超过0.21毫克的授权形式","type":"product","country":"巴西","normalized_name":null},{"name":"Vita Be Cosméticos Ltda.（Renova Be）","role":"被召回百香果味舌下滴剂褪黑素的生产企业","type":"company","country":"巴西","normalized_name":null},{"name":"Anvisa第758号决议","role":"决定召回并暂停相关舌下褪黑素产品的制造、销售、分销、进口、广告和使用","type":"policy","country":"巴西","normalized_name":null}],"main_action":"Anvisa明确褪黑素贴片、膜剂和软糖未获授权，重申每日0.21毫克限量","key_numbers":[{"unit":"毫克/天","label":"每日褪黑素摄入上限","value":"0.21"},{"unit":"岁","label":"允许作为食品补充剂的最低年龄","value":"19"},{"unit":"年","label":"食品补充剂授权起始年份","value":"2021"},{"unit":"号","label":"召回决议编号","value":"758"}],"facts":[{"verified":false,"statement":"Anvisa表示，褪黑素贴片、膜剂和咀嚼软糖在巴西未获授权，且从未经过安全性和有效性评估。","source_excerpt":null},{"verified":false,"statement":"自2021年起，Anvisa仅允许褪黑素作为食品补充剂销售，且仅限19岁以上成年人，每日限量0.21毫克。","source_excerpt":null},{"verified":false,"statement":"Anvisa规定褪黑素补充剂标签须警示孕妇、哺乳期妇女、儿童以及需要持续集中注意力的人员（如驾驶者）不应食用。","source_excerpt":null},{"verified":false,"statement":"Anvisa表示没有证据表明获准剂量能对睡眠调节产生直接效果。","source_excerpt":null},{"verified":false,"statement":"2026年2月，Anvisa第758号决议决定召回并暂停Vita Be Cosméticos Ltda.（Renova Be）生产的“百香果味舌下滴剂褪黑素”的制造、销售、分销、进口、广告和使用。","source_excerpt":null},{"verified":false,"statement":"Anvisa称召回原因是使用了未经舌下途径评估的成分，并宣传了未经批准的治疗承诺，如预防失眠和调节睡眠周期。","source_excerpt":null}],"assessments":[{"statement":"Anvisa对褪黑素非授权剂型采取从严监管，相关产品在巴西面临下架、召回和处罚风险。","confidence":"high","basis_fact_index":null},{"statement":"在巴西销售褪黑素食品补充剂需严格遵守剂型、年龄、每日限量和标签警示要求，并避免未经证实的睡眠疗效宣称。","confidence":"high","basis_fact_index":null},{"statement":"企业若拟推出舌下、贴片或软糖等剂型，需先向Anvisa提交安全性和有效性研究，否则难以合法进入市场。","confidence":"medium","basis_fact_index":null}],"actions":[{"target":"user","priority":"high","description":"核查在售褪黑素产品的剂型、每日0.21毫克限量、年龄限制和标签警示，立即下架未授权贴片、膜剂和软糖。"},{"target":"both","priority":"high","description":"监测Anvisa第758号决议及后续召回名单，评估供应链中是否涉及Renova Be相关产品。"},{"target":"user","priority":"normal","description":"对拟在巴西上市的褪黑素剂型准备安全性和有效性评估资料，并审查营销宣称。"},{"target":"system","priority":"normal","description":"向消费者发布风险提示，避免购买来源不明或宣称快速入睡、终结失眠的进口产品。"}],"affected_audience":["巴西消费者","褪黑素补充剂生产商","进口商和经销商","跨境电商平台","孕妇、哺乳期妇女、儿童及需持续集中注意力人员"],"risk_flags":["compliance_risk","regulatory_uncertainty","legal_risk"],"opportunity_flags":[],"trend_signals":["policy_tightening"],"follow_up_needed":true,"follow_up_questions":["Anvisa第758号决议的全文及涉事产品召回批次和流通范围是什么？","Anvisa是否计划对褪黑素软糖、贴片或膜剂启动专门评估或制定新规？","每日0.21毫克限量是否适用于所有褪黑素食品补充剂及跨境进口产品？","已获授权的褪黑素食品补充剂在标签和营销宣称方面还有哪些具体限制？"],"related_topics":["褪黑素","Anvisa","食品补充剂","舌下滴剂","产品召回","睡眠保健品","巴西监管"],"verification_status":"unverified","confidence_score":0.7,"generated_at":"2026-11-05T17:02:25.219Z"},"meta":{"canonical_url":"https://chinabrazilinsight.com/news/anvisa-20261105-689654","api_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261105-689654","markdown_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261105-689654?view=markdown","json_url":"https://chinabrazilinsight.com/api/public/content/anvisa-20261105-689654?view=json","last_updated":"2026-11-05T17:02:25.296Z","platform":"China Brazil Insight","platform_url":"https://chinabrazilinsight.com"}}