Core Viewpoint - The controversy surrounding the product Ergothioneine from Kolun Pharmaceutical is primarily focused on its classification as a dietary supplement rather than a drug, which has led to accusations of it being a "fake drug" by a prominent biologist [1][2]. Group 1: Product Classification and Controversy - Kolun Pharmaceutical asserts that Ergothioneine is recognized internationally as a dietary supplement and not a drug, countering claims of it being a "fake drug" [1]. - The core of the dispute revolves around the product's qualifications, with Kolun responding to criticisms regarding the lack of drug approval by citing studies published in the high-impact journal "Cell Metabolism" that support its health benefits [1]. Group 2: Safety and Regulatory Status - Ergothioneine has been classified as a new type of food supplement or functional health food ingredient in developed countries, receiving GRAS certification from the FDA and approval from the European Food Safety Authority [2]. - Kolun Pharmaceutical has submitted an application for Ergothioneine as a new food ingredient to the National Health Commission, which is currently under review [2]. - The company welcomes scrutiny from the academic community, regulatory bodies, and consumers regarding its research and products, advocating for an objective perspective on emerging technologies [2].

Core Viewpoint - The core controversy revolves around whether the product Ergotioneine capsules from Kelun Pharmaceutical is a dietary supplement or a "fake drug" as claimed by Peking University’s Rao Yi [1][4]. Group 1: Company Position - Kelun Pharmaceutical asserts that Ergotioneine is recognized internationally as a dietary supplement and not a drug, thus challenging the notion of it being labeled as a "fake drug" [1][4]. - The company emphasizes that the value and safety of Ergotioneine have been scientifically validated through various studies, including those published in top journals [2][3]. - Kelun Pharmaceutical calls for an objective industry perspective on emerging technologies to shift the nutrition and health industry from a marketing-driven approach to a science-driven one [1][6]. Group 2: Scientific Evidence - The company cites two studies published in "Cell Metabolism" demonstrating that Ergotioneine can significantly extend the lifespan of model organisms and improve their physical performance [2]. - Additional clinical research indicates that Ergotioneine may help reduce sleep difficulties, improve cognitive functions in patients with mild cognitive impairment, decrease skin wrinkles, and lower the risk of coronary artery disease [3]. - The safety of Ergotioneine has been established in toxicity tests and randomized controlled trials, with its acceptance as a new food supplement in developed countries [3]. Group 3: Market Performance - Despite the controversy, Kelun Pharmaceutical's Ergotioneine products continue to be sold, with prices ranging from 1,199 yuan to 4,476 yuan, and sales exceeding 18.83 million yuan as of June 5 [5].