Senna Leaf and Laxatives: Key Regulatory Differences Buyers Must Know

Summary

Senna leaf and the senna extract used in laxatives share the same active ingredients, sennosides A and B. Their regulatory treatment varies by market: China allows them in pharmaceuticals and health foods with the Blue Hat mark, but bans them in ordinary foods. The industry standard T/CNHFA 111.104-2024 has taken effect.

The US FDA recognises them as OTC ingredients, while Australia requires TGA registration with an AUST L/R number.

Commentary

Senna extract originates from the same source as traditional Chinese medicine decoction pieces, but its regulatory status dictates market access. In China, it is restricted to pharmaceuticals and Blue Hat health foods, with ordinary foods prohibited. The US regulates it as an OTC or dietary supplement, while Australia requires TGA registration.

For Australian and New Zealand brands entering China, the cross-border ordinary food channel is not an option; they must complete health food registration and comply with the T/CNHFA 111.104-2024 raw material standard. TGA registration is not mutually recognised in China, so separate compliance efforts are needed. The new raw material standard is set to eliminate non-compliant extract suppliers, driving an industry upgrade.

New Zealand SMEs should prioritise suppliers with multi-country certifications to mitigate customs clearance and channel risks.

Keywords: Senna leaf, laxatives, regulation, health foods, OTC, TGA, ARTG, industry standard, compliance

Summary in Chinese | 摘要

番泻叶与通便产品中的番泻叶提取物本质相同，有效成分为番泻苷A和B。监管因品类而异：中国允许用于药品和保健食品（蓝帽子），普通食品禁用，行业标准T/CNHFA 111.104-2024已实施；美国FDA认可为OTC成分；澳大利亚需经TGA登记，标注AUST L/R编号。

Commentary in Chinese | 评论

番泻叶提取物与中药饮片同源，但监管身份决定市场准入。中国仅允许药品和蓝帽子保健食品添加，普通食品禁止；美国按OTC/膳食补充剂管理；澳洲需TGA登记。澳新品牌若进入中国，不能走普通食品跨境渠道，须完成保健食品注册并符合2024年T/CNHFA 111.104原料标准。

TGA登记不获中国互认，需单独投入合规。新原料标准实施将淘汰不合规提取物供应商，倒逼行业升级，建议新西兰SME优先绑定多国认证的供应商，避免清关与渠道风险。

关键词: 番泻叶, 通便产品, 监管, 保健食品, OTC, TGA, ARTG, 行业标准, 合规

Source: Sina