KELUN PHARMA(SZ:002422) Xin Hua Wang·2025-08-12 05:38Core Viewpoint - The controversy surrounding Kelun Pharmaceutical's product "Ergothioneine Capsules" continues, primarily due to its advertising methods and product claims, raising questions about regulatory compliance and potential legal violations [1][4]. Group 1: Product and Sales Information - Kelun Pharmaceutical's "Ergothioneine Capsules" are marketed as a cross-border product, developed in collaboration with a century-old Japanese company, with a current retail price of 1499 yuan per 60-capsule bottle, leading to estimated sales exceeding 38 million yuan [2]. - The product contains 30mg of ergothioneine per capsule and is sold through a mini-program linked to the company's WeChat account, which is operated by its wholly-owned subsidiary [2]. Group 2: Regulatory Compliance Issues - The "Ergothioneine Capsules" have not been registered with the National Market Supervision Administration or obtained drug approval, and while a new food raw material application was accepted in 2024, it is still under review [2]. - The sales model employed by Kelun, which involves exporting raw materials to Japan for production and then importing them as personal use items, raises concerns about circumventing domestic safety assessments required by the Food Safety Law [3]. Group 3: Advertising and Legal Concerns - The product's marketing claims, including references to anti-aging benefits, may violate advertising laws, as the term "dietary supplement" lacks a legal definition in China, and the product's claims suggest health benefits that are not substantiated [4][5]. - Legal experts indicate that the promotional content constitutes a clear violation of the Advertising Law and Food Safety Law, particularly due to claims of health benefits and the use of a celebrity endorsement that may mislead consumers [5].