关于《假药靠肌肉男真人“赤膊上阵”，真药伟哥仅以小小 “老鼠作证”》一文，科伦药业回应→

Core Viewpoint - The controversy surrounding Kelun Pharmaceutical's product, Ergothioneine capsules, has intensified following public criticism from renowned biologist Rao Yi, who labeled the product as a "fake drug" due to its lack of regulatory approval [1][2]. Group 1: Product Controversy - Rao Yi's article questioned the legitimacy of Ergothioneine capsules, suggesting that if the product had genuine health benefits, it would have received regulatory approval [1]. - Kelun Pharmaceutical responded by asserting that Ergothioneine is classified as a dietary supplement and not a drug, thus challenging the notion of it being a "fake drug" [1][2]. Group 2: Regulatory Status - Ergothioneine has been recognized as a novel food supplement in developed countries, with the FDA granting it GRAS (Generally Recognized as Safe) status and the European Food Safety Authority approving it as a new food supplement [2]. - Kelun Pharmaceutical's application for Ergothioneine as a new food ingredient was accepted by the National Health Commission in 2024, although it is still under review [2]. Group 3: Company Stance - In response to accusations of misleading marketing, Kelun Pharmaceutical welcomed scrutiny from academia, regulatory bodies, and consumers, urging an objective evaluation of emerging technologies [2].