Ergothioneine Capsules: 'Fake Drug' or Legitimate Dietary Supplement? Kelun Responds to Rao Yi's Criticism Amid Synthetic Biology Boom

2025 Year 6 Month 6 On the day, facing Professor Rao Yi “Ergothioneine is a fake drug” in response to the sharp questioning, Kelun Pharmaceutical quickly responded via its official WeChat public account,Clearly state that ergothioneine is a dietary supplement, not a pharmaceutical drug, emphasizing its positioning as a health management tool.

Meanwhile, Kelun listed “Cell Metabolism” and other top-tier international journals have demonstrated that the core value and safety of ergothioneine have been scientifically validated, accusing Rao Yi’s article of containing “"Straw Man Fallacy"” Question, believing that it holds a bias against dietary supplements, and “Invalid without drug approval” The assertion is too arbitrary.

Professor Rao Yi believes that ergothioneine lacks sufficiently compelling evidence to be approved as a legitimate pharmaceutical drug, and its sale in the form of a dietary supplement is deceptive.He had already 2001 In that year, an article was published in Southern Weekly opposing the excessive hype by enterprises and business figures.“Nutritional supplements,” this time, through sharp wording and specific video screenshots, directly pointed to the endorsement behavior of Kelun Pharmaceutical and its chairman Liu Gexin.

It is understood that, Kelun Pharmaceutical used“Cellular-Level Age Defense” “Free Radical Scavenging Efficacy Far Exceeds That of Traditional Ingredients” VC with coenzyme Q10 "10 to 30 times"Such statements violate the prohibitions under the Implementing Regulations of the Food Safety Law and the Advertising Law against claiming health benefits for non-health food products. Although some promotional images were later removed, traces of suggestive language remain. Meanwhile, ergothioneine has not yet obtained domestic health food approval, and Kelun Pharmaceutical has only“Original Import from Japan”Circumventing policies, with high regulatory risks.

Amid the booming development of synthetic biology technologies, Kelun’s subsidiary, Chuanning Bio, has achieved green, large-scale production and commercial application of products such as ergothioneine through synthetic biology techniques, breaking the limitations of traditional production methods.

However, the application of synthetic biology in the health consumer goods sector faces numerous challenges, including difficulties in scaling up from pilot trials to mass production, cost control, market acceptance, and regulatory lag. The ergothioneine capsule incident not only plunged Kelun Pharmaceutical into a storm of public opinion but also highlighted the many dilemmas facing the health consumer goods market in areas such as product positioning, compliance in advertising, efficacy verification, and regulation, sparking profound reflection within and outside the industry on the future development of the entire market.

01  The Full Story of the Ergothioneine Controversy

2025 Year 5 In [Month], Liu Gexin, Chairman of Kelun Pharmaceutical, 75 An elderly individual, appearing shirtless in an endorsement for the company’s ergothioneine capsules, showcased his muscular physique and attributed it to long-term use of the capsules among other contributing factors. This bold marketing approach quickly captured public attention, turning ergothioneine capsules into an overnight sensation and setting the stage for the ensuing controversy.

Following Liu Gexin's endorsement, ergothioneine-related stocks have shown strong performance. Over the past month, the share prices of Kelun Pharmaceutical and its controlling subsidiary, Chuanning Biotechnology, have risen by respectively 16.75%、12.22%。Kelun’s ergothioneine products have achieved substantial sales on its official mini-program, with prices for different specifications ranging from 1199 Yuan to 4476 yuan, as of 6 Month 5 Sales exceeded on the evening of 1883 10,000 yuan.The market enthusiasm for this emerging product is surging, and investors are filled with high expectations for its future development.

6 Month 5 Recently, Rao Yi, former president of Capital Medical University and current deputy director of the Academic Committee and dean of the Faculty of Science at Peking University, published an article titled “Fake Drugs Rely on Muscular Men Going ‘Shirtless’ in Person, While Real Drug Viagra Is Backed Only by Tiny ‘Mice as Witnesses’” on his WeChat public account, “Rao Yi’s Science.” In the article, he claimed that “ergothioneine is a ‘fake drug,’” arguing that it lacks sufficient evidence for approval by drug regulatory authorities yet is marketed as a dietary supplement, thereby misleading consumers. He pointed out that if ergothioneine truly had life-extending and longevity-promoting effects, evidence would have long been provided to secure its approval as a pharmaceutical drug, rather than being sold through the supplement route. This statement sparked significant public controversy, undermining consumer confidence in ergothioneine capsules.

6 Month 6 Recently, Kelun Pharmaceutical responded that its ergothioneine capsules are positioned as dietary supplements rather than pharmaceutical drugs. Their value has been validated by papers in top-tier international journals and clinical trials. In developed countries and regions such as Europe, the United States, and Japan, ergothioneine has been listed as a novel food supplement or an ingredient in functional health foods. Its safety has been demonstrated through toxicity studies and randomized, double-blind, placebo-controlled trials. The core dispute between the two parties lies in whether ergothioneine should be classified as a dietary supplement or a pharmaceutical drug.

Following Rao Yi's post, the stock prices of Kelun Pharmaceutical and Chuanning Bio 6 Month 5 Daily Declines 4.96%、1.98%，6 Month 6 The stock opened lower and continued to decline. This reflects the market’s high sensitivity to expert opinions, with investors expressing doubts about the future prospects of ergothioneine capsules, thereby highlighting the impact of public opinion on the health consumer goods market.

From the perspective of the dispute between the two parties, Kelun emphasizes that ergothioneine is a dietary supplement, arguing that pharmaceuticals and nutritional supplements belong to different dimensions: the former are used for the treatment of specific diseases, while the latter focus on risk prevention and functional enhancement in healthy populations, such as vitamins. C Not approved for treating colds, but its value in immune support is recognized.

However, experts such as Rao Yi argue that the absence of drug approval equates to inefficacy, and marketing these products as health supplements is deceptive. This discrepancy in positioning confuses consumers, making it difficult for them to accurately assess the nature and efficacy of the products.

Moreover, it is undeniable that Kelun’s ergothioneine products indeed face challenges regarding compliance in promotional activities. When promoting its ergothioneine capsules, Kelun once used“Cellular-Level Age Defense” “Combat Signs of Aging”Such statements violate the prohibitions under the Implementation Regulations of the Food Safety Law of the People’s Republic of China and the Advertising Law against attributing health benefits to non-health food products. Although some promotional images were later removed, traces of suggestive language remained, exposing the company to significant compliance risks in its marketing efforts. This also highlights a prevalent industry misconduct wherein certain health consumer goods companies engage in borderline practices in their advertising to pursue commercial interests.

Meanwhile, ergothioneine also faces challenges in efficacy validation and regulatory dilemmas.

Although ergothioneine has demonstrated antioxidant properties in cellular and animal studies, comprehensive benefits in humans lack support from large-scale, high-quality clinical trial data. Current research suggests that its purported effects, such as life extension and improved athletic performance, are largely based on animal models or small-scale human trials, making it difficult to fully substantiate its broad health benefits for humans. This leaves companies with insufficient evidence to support their efficacy claims, thereby raising consumer skepticism about its actual effectiveness.

Ergothioneine is not included in the "Catalog of Raw Materials for Health Foods" nor has it obtained health food filing approval in China, resulting in regulatory gaps and uncertainties. Companies leverage cross-border e-commerce channels to bypass stringent domestic approvals for health supplements, marketing these products as cross-border goods. While this approach offers some room for justification under e-commerce regulations, it essentially raises suspicions of circumventing domestic regulations on functional claims for health supplements, thereby posing challenges to regulatory authorities.

02 Synthetic Biology Reshaping the Health Consumer Goods Market

As the core technology of the third biotechnology revolution, synthetic biology is reshaping the health consumer goods market. Taking Kelun Pharmaceutical’s subsidiary, Chuanning Biology, as an example, it has achieved green, large-scale production and commercial application of products such as ergothioneine through synthetic biology technologies. This breakthrough overcomes the limitations of traditional production methods, enhances production efficiency and product quality, reduces costs, and provides more innovative products and solutions for the health consumer goods market.

Compared with other technologies, synthetic biology has unique advantages in the production of health consumer products.It enables the precise design and engineering of biological systems to achieve efficient synthesis of specific products, thereby enhancing product purity and quality. For instance, in the production of ergothioneine, it can optimize microbial metabolic pathways to improve both yield and quality.

According to Arthur D. Little Analysis,2022-2030 Global Synthetic Biology Market Size CAGR Ke Da 24%, its application prospects in the healthcare and life sciences sectors are broad, driving health consumer products toward personalization, precision, and high efficiency.

Moreover, it is worth noting that with technological advancements, the cost of synthetic biology continues to decline.As recently as not long ago, a UK-based pet food startupMeatlyAnnounced a major breakthrough in its cultured meat production technology, successfully reducing production costs to bring them closer to the price level of conventional chicken. The company developed a new type of bioreactor and optimized protein-free culture media, thereby lowering production costs.95%, the company has become the first to be approved for the sale of cultured meat in Europe, and 2 Last month, cultivated meat for dogs hit the market for the first time. Currently, traditional dog food may be three times cheaper than cultivated meat, but this situation could soon change.

The domestic synthetic biology market is fiercely competitive, with companies such as Cathay Biotech, Huaheng Biotechnology, and Bloomage Biotech actively establishing their presence. These enterprises possess distinct advantages in technological R&D, product applications, and market expansion, continuously launching innovative products to meet the diverse demands of the market.

In the future, with technological advancements and growing market demand, the application of synthetic biology in the health consumer goods sector will become more extensive and profound, leading to intensified market competition. Enterprises need to increase R&D investment, enhance their technical capabilities and innovation capacity, strengthen brand building and marketing efforts, and thereby improve their market share and competitiveness. Meanwhile, emphasis must be placed on product quality and safety, with strengthened regulation and standardization to ensure the healthy development of the market.

However, despite the broad prospects of synthetic biology technology, its application in the health consumer goods sector also faces numerous challenges.

From a technical perspective, there are challenges in scaling up from laboratory-scale trials to mass production, necessitating solutions to ensure the stability and consistency of biological systems, thereby improving production efficiency and product quality. In terms of cost, the relatively high production costs associated with synthetic biology technologies have limited their large-scale application and market adoption; therefore, enterprises must optimize process workflows to reduce production costs and enhance economic viability.

In terms of market acceptance, consumer awareness of synthetic biology technology remains limited, accompanied by skepticism and concerns. Companies need to strengthen science popularization efforts to enhance consumer awareness and acceptance. Regarding regulation, the rapid development of synthetic biology technology has outpaced relevant laws and regulations, resulting in regulatory gaps and uncertainties. Governments need to strengthen oversight, improve regulatory standards, and ensure market compliance and the protection of consumer rights.

In summary, the controversy surrounding ergothioneine capsules reflects numerous issues in the health consumer goods market, including product positioning, regulatory compliance in advertising, efficacy verification, and supervision. With the development of synthetic biology technologyAs the market evolves, the health consumer goods sector faces new opportunities and challenges. Enterprises must strike a balance between innovation and compliance, regulatory authorities should strengthen oversight, and consumers ought to view product promotions rationally, thereby jointly promoting the healthy development of the market.

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