麦角硫因究竟是不是“假药”？科伦药业公开回应饶毅多条质疑

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].