Post-Marketing Surveillance of Cordyceps Products in Thailand

Post-Marketing Surveillance of Cordyceps Products in Thailand | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Post-Marketing Surveillance of Cordyceps Products in Thailand Lalita Wirasathien, Napatsorn Sriputhon, Mayuree Tangkiatkumjai This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7360734/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background The outbreak of acute kidney injury linked to Cordyceps products in Thailand prompted an assessment of their quality. The aims of this study were to identify the Cordyceps species contained in the dietary supplement and to evaluate legal compliance. Methods A survey and experimental studies were conducted, focusing on oral Cordyceps products selected through convenience sampling. Chemical and microscopic examinations were performed, and thin-layer chromatography was used to identify cordycepin and adenosine in the products. Steroid test kits were employed to detect corticosteroid adulteration. The products’ registration number and advertising approvals by the Thai FDA were verified. Results Sixty-five products were included in the study. The prevalence of products containing cordycepin and C. militaris was 53.8%. Among the products, 11% were unregistered, and 6.2% were adulterated with corticosteroids. 54.3% were mislabeled regarding the substitute or absence of the labeled species and the form of Cordyceps. The prevalence of products with legally compliant physical labeling was 78.5%. However, 72.3% of the products made disease claims through social media. Conclusions The study highlights that the regulation of dietary supplements containing Cordyceps in Thailand does not fully comply with legal standards. Therefore, the public should be aware of these issues with Cordyceps products. The Thai FDA should enhance its post-market surveillance system for health products to better protect consumers. Toxicology Cordyceps Dietary supplement Thailand Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Background Cordyceps are well-known as a Chinese herbal medicine that promote well-being and is popular for use worldwide. The Food division of the Food and Drug Administration (FDA) in Thailand has permitted dietary supplements containing Cordyceps militaris and Cordyceps sinensis since 2019.[ 1 ] Since then, the number of these dietary supplements has been increasing. In 2023, 473 products containing Cordyceps were registered as dietary supplements and food items, including tea, coffee, energy drinks, and chicken essence. Cordyceps extracts found in Cordyceps products in Thailand were not purified and contained a variety of compounds from Cordyceps. Cordyceps advertising in Thailand, promoting their use for the treatment of kidney disease and other chronic illnesses, has led to a high number of patients with chronic kidney disease or non-communicable diseases using Cordyceps products for self-care. Since 2020, Cordyceps products have been linked to cases of acute kidney injury (AKI) in Thailand, despite several studies suggesting that Cordyceps may have potential benefits in treat kidney diseases.[ 3 – 5 ] Cordycepin, a compound found in Cordyceps, has an anti-inflammatory effect through cyclooxygenase-2 (COX) inhibition.[ 6 ] However, COX-2 inhibition is known to cause vasoconstriction and reduce renal blood flow, which can adversely affect kidney function.[ 7 ] Additionally, adverse effects of Cordycepin-enriched products, such as nausea and diarrhea, may lead to kidney hypoperfusion, particularly in dehydrated patients.[ 8 ] Thai patients may overuse Cordyceps products, and high doses of Cordycepin could contribute to AKI. Other potential causes of Cordyceps-induced nephrotoxicity include arsenic contamination of natural C. sinensis [ 9 , 10 ] and the presence of mycotoxins, which may be produced during the large-scale cultivation of C. militaris .[ 8 , 11 ] Furthermore, corticosteroid adulteration in herbal products has been reported in Thailand and may also be linked to AKI.[ 12 , 13 ] Globally, the prevalence of herbal products adulterated with corticosteroids worldwide has been reported to range from 1.4–48%.[ 14 – 16 ] Due to the scarcity of C. sinensis and concerns about heavy metal contamination,[ 9 ] the mass production of cultivated C. militaris has increased worldwide, replacing natural C. sinensis . The primary different between these two species lies in their main compounds: adenosine is the key compound of C. sinensis , while cordycepin is predominant in cultivated C. militaris .[ 17 , 18 ] The natural form of C. sinensis contains only very low levels of cordycepin.[ 18 ] Globally, the adulteration of herbal products has been on the rise. In Thailand, 20% of herbal products were found to contain undeclared substitute species or none of the labeled species.[ 19 ] The high prevalence of Cordyceps products labeled as C. militaris in Thailand from 2020 to 2022 coincided with reports from healthcare providers of AKI linked to Cordyceps products.[ 3 ] Subsequently, most Cordyceps products on the market were labeled as C. sinensis rather than C. militaris . The literature suggests methods for differentiating these two species using microscopic techniques and chemical evaluation through thin-layer chromatography.[ 20 , 21 ] This study aimed to: 1) assess the Cordyceps species present in the products; 2) determine the prevalence of corticosteroid adulteration in Cordyceps products; 3) evaluate the prevalence of legally registered Cordyceps products and their compliance with labeling regulations; and 4) measure the rate of compliance with advertising law for Cordyceps products. Methods Sample and study design This study used a mixed-methods approach, combining survey and experiment studies. Oral dietary supplements containing Cordyceps as an active ingredient and sold in Thailand from May to October 2023 were included. The sample size of this study calculated using the Yamane formulary.[ 22 ] The total number of Cordyceps products registrations in Thailand were 473 in 2023, and the sampling error was set at 10%. The total sample size in this study was 83 products. Convenient sampling was applied to purchase the samples. The survey assessed the prevalence of legal Cordyceps products registrations, their labels, and advertising regulatory compliance. Meanwhile, the experiment tested whether C. militaris or C. sinensis were contained in the products as indicated on their labels. Tests of Cordyceps products 1. Chemical evaluation The preparation of samples involved extracting 500 milligrams (mg) of Cordyceps powder or one soft gelatin capsule using methanol assisted with ultrasonication and solvent was evaporated to obtain the extract, then redissolved with one milliliter of methanol. The sample extracts were tested using thin-layer chromatography (TLC).[ 21 ] Two authentic samples of C. sinensis and C. militaris were prepared as powders and extracted using the same method as the sample preparation. The samples labeled Cordyceps extracts were tested solely through chemical evaluation. Thin-layer chromatography was prepared using silica gel GF 254 as the stationary phase. The mobile phase consisted of two systems: mobile phase 1 with a ratio of ethyl acetate, methanol, and water at 10:1.5:1, and mobile phase 2 with a ratio of chloroform to methanol at 4:1.[ 21 ] The results of the TLC tests were read using ultraviolet light at 254 and 366 nanometers. Standard compounds of adenosine and cordycepin at a concentration of 1 mg/ml were used. Samples with a prominent adenosine band, matching the standard compound, were identified as C. sinensis , while those with a prominent cordycepin and adenosine band were identified as C. militaris (Fig. 1 ). The TLC findings, observed under ultraviolet light at 366 nanometers, confirmed the presence of a band consistent with C. militaris . 2. Microscopic methods Samples were stained with a glycerin-water solution, chloral hydrate solution and iodine test solution. Cordyceps products labeled as containing Cordyceps powder, except for Cordyceps extract, were tested using microscopic methods.[ 20 ] Fig. 2 indicated authentic C. sinensis and C. militaris stained with a glycerin-water solution. 3. Testing for corticosteroid adulteration The steroid test kit, using an immunochromatography technique, was used to test for corticosteroid adulteration in Cordyceps products.[ 23 ] The samples preparation included grinding the sample powders or preparing solutions, which were then extracted using the corticosteroid extraction solution provided by the test kit. Four drops of the extracted sample were placed in the oval channel of the kit plate. The test detected more than 1 microgram/ml of dexamethasone and 50 micrograms/ml of prednisolone. A positive result was indicated by a red line appearing on label C on the plate (Fig. 3 ). In case of an invalid result, the samples were re-tested. 4. Assessment of compliance with Labeling and online advertising standards for Cordyceps products Cordyceps products were legally checked their registration numbers and advertising approvals via the Thai FDA website ( https://porta.fda.moph.go.th/FDA_SEARCH_ALL/MAIN/SEARCH_CENTER_MAIN.aspx and https://alimentum.fda.moph.go.th/MAIN_SEARCH/MAIN/SEARCH_USER ). Their legal label must include: 1) name; 2) registration number; 3) address of manufacture or import; 4) amount of dietary supplement; 5) amount of active ingredients; 6) warning statements as follows: "No effect in preventing or treating diseases.", "The intake of various nutrients should come from consuming a variety of main foods, covering all five food groups, in appropriate proportions." and "Children and pregnant women should not consume."; 7) manufacturing and expiry dates; and 8) usage.[ 24 ] Statistical analysis Frequencies and percentages were reported, and descriptive statistics, including the median and range, were calculated. The prevalence of products containing cordycepin, legally compliant products, and those with corticosteroid adulteration in Thailand was also reported. The prevalence was defined as the rate of those occurrences over six months. Results Only 65 Cordyceps dietary supplements were included in the study, as many products were sold out, or their production, or importation had been discontinued. Characteristics of Cordyceps products based on their labels Forty percent of the products did not specify the species of Cordyceps. More than half of the products were labeled as C.sinensis (53.8%), while only four products were labeled as C. militaris . Most of them (58.5%) were labeled as containing Cordyceps extract. The median amounts of Cordyceps in extract and powder form were 325 and 350 mg per capsule, respectively. The median number of additional ingredients in the products were three (range: 0–14). The top three additional ingredients were vitamins, reishi, and ginseng (Fig. 4 ). Three products contained only Cordyceps. The maximum daily doses of extract and powder indicated on the labels were 1,200 and 2,675 mg per day, respectively (Table 1 ). Table 1 Characteristics of Cordyceps products based on their labels in Thailand (N = 65). Characteristics Number Dosage form Extract 38 (58.5%) Powder 21 (32.3%) Mixed extract and powder 1 (1.5%) Unspecified 5 (7.7%) Product label C. sinensis 35 (53.8%) C. militaris 4 (6.2%) Unspecified 26 (40.0%) Amount of Cordyceps* Extract (median and range) 325 (30–790) mg/capsule Powder (median and range) 350 (20–850) mg/capsule Other ingredients* Median (range) 3 (0–14) ingredients Daily dosage on the label*, ** Extract (median and range) 365 (30 − 1,200) mg/day Powder (median and range) 450 (20 − 2,675) mg/day * One product with a fake registration number did not provide details of its ingredients and daily dosage. ** Two products did not indicate the frequency of consumption. The prevalence of products containing cordycepin and those with corticosteroid adulteration The prevalence of Cordyceps products containing cordycepin was 53.8% (N = 35), while 6.2% (N = 4) of the registered products were found to be adulterated with corticosteroids. Additionally, 53.8% (N = 35) of the products were identified as C. militaris (Table 2 ). Of 39 products examined, 19 (48.7%) were mislabeled regarding the species of Cordyceps. Nearly half of the products labeled C. sinensis were identified as C. militaris . The labeled daily doses of Cordyceps powder and extract identified as C. militaris ranged from 200 to 900 mg per day and 229 to 1,200 mg per day, respectively. Table 2 Comparison of Cordyceps species: Labeled identification vs. microscopic and chemical analysis results (N = 65) Labeled identification Microscopic and chemical analysis results C. sinensis (N = 35) C. sinensis (N = 9, 25.7%) C. militaris (N = 19, 54.3%) Not detected (N = 6, 17.1%) Cannot identifies (N = 1, 2.9%) C. militaris (N = 4) C. militaris (N = 4, 100.0%) Unspecified (N = 26) C. sinensis (N = 9, 34.6%) C. militaris (N = 12, 46.2%) Not detected (N = 5, 19.2%) Eleven products (16.9%) did not contain detectable Cordyceps ingredients. Among these, two products (No.40 and 59) contained the lowest amounts of Cordyceps products, with 30 and 20 mg per unit, respectively. Other products contained Cordyceps ranging from 100–790 mg per capsule, with labels indicating on 3 as extract, 3 as powder, and 3 with unspecified Cordyceps forms. Three products were labeled as containing 100, 150 and 200 mg of Cordyceps, but no Cordyceps was detected in these products. In contrast, other products with similar characteristics did contain detectable amounts of Cordyceps. Among the eleven products, one product could not be identified as containing Cordyceps species due to interference from additional ingredients, such as magnesium oxide, vitamin C and vitamin B complex, during chemical analysis. Samples one and eleven were labeled as Cordyceps powder but did not show any Cordyceps tissues under microscopic examination. These two products may instead contain Cordyceps extract. Overall, 54.3% of the products were mislabeled regarding the substitute or absence of the labeled species, as well as the form of Cordyceps. The findings from the microscopic and chemical analyses are provided in the supplement table. The prevalence of legally compliant products Eleven percent (N = 7) of the products were not registered with the Thai FDA. Of these, three products lacked a registration number, while four displayed either a canceled registration number (N = 3) or a fake number (N = 1). One product was sold despite being expired. The prevalence of legally compliant physical labeling was 78.5%. Among the non-compliant physical labels, 11 products failed to display the required disclaimers, and three products were not registered with Thai FDA and carried illegal labels. Only one product (1.5%) advertised health claims permitted by the Thai FDA online and displayed its advertising license number. Forty-seven products (72.3%) made disease claims through online advertising. Seventeen products (26.2%) did not apply for an advertising license from the Thai FDA and did not make disease claims. The most common health claims were reducing blood glucose levels (11%), boosting immunity (11%), decreasing serum lipid levels (8%) and enhancing sexual performance (8%) (Fig. 5 ). The median number of health claims made online was five per product. Three products (4.6%) - one registered and two unregistered - were physically labeled with claims of treating diseases. Discussion This is the first paper to report on the quality of Cordyceps products in Thailand using post-marketing surveillance. The most concerning issues were that 6.2% of the products were adulterated with corticosteroids, and 11% were not registered with the health authority. However, the prevalence of Cordyceps products adulterated with corticosteroids in this study was lower than in previous studies in Thailand, which reported that 15–50% of herbal products were adulterated with corticosteroids.[ 12 , 13 ] More than 50% of the products in this study were mislabeled due to the substitute or absence of the labeled species, which is higher than the prevalence of mislabeling in general herbal products in Thailand (20%), as reported by Ichim (2019).[ 19 ] Among the products labeled as C. sinensis , 53.8% were identified as C. militaris . The substitution of C. sinensis with C. militaris has been reported globally.[ 25 ] The absence of the labeled species may be influenced by the poor quality of some Cordyceps products. Potential causes include the degradation of active compounds in Cordyceps due to high temperatures[ 26 ] or the complete absence of Cordyceps from the product. This issue requires closely monitoring and intervention by the health authorities. Most of the Cordyceps products (53.8%) in Thailand contained cordycepin and C. militaris . The labeled daily doses of products containing identified C. militaris in this study ranged from 200 to 900 mg per day for powder forms and from 229 to 1,200 mg per day for extract forms. In comparison, the Thai FDA’s recommended active ingredient levels for dietary supplements suggest a daily intake of 230 mg of C. militaris powder or no more than 0.3 mg of cordycepin per gram of dietary supplement. These levels are part of the positive list of Cordyceps products, allowing for expedited product registration.[ 27 ] The daily doses of these products raise concerns about the potential for individuals to consume high doses of Cordyceps. The Thai FDA’s policy on the positive list of active ingredient levels for dietary supplements shortens the approval period of these products. The findings from this study suggest that this policy should be implemented alongside robust post-marketing surveillance to ensure the sustained quality of dietary supplements. Forty percent of the Cordyceps products in this study did not label the species of Cordyceps, and 7.7% did not specify the form of Cordyceps, such as powder or extract. Each form is consumed at a different dose. The Thai FDA should revise regulations for herbal dietary supplements to mandate clear labeling in order to protect consumer rights. Most of the Cordyceps products in this study complied with physical labeling requirements (78.5%). However, nearly three-quarters of the products in this study made overclaims through online advertising and 4.6% were physically labeled with disease claims. Advertising dietary supplements on social media is more likely to spread misinformation.[ 28 ] To prevent misunderstanding about the benefits of dietary supplements, it is essential to improve health literacy and educate people on assessing the accuracy of health information. Health authorities should enforce regulations to address this issue. The limitation of this study was that the included products may not sufficiently represent all Cordyceps products available in Thailand. However, researchers purchased as many products as were accessible on the market. The findings of this study should therefore be interpreted with caution. The TLC method used in this study to detect chemical compounds in Cordyceps products had limited sensitivity for small amounts of adenosine and cordycepin. As a result, two products containing 20 and 30 mg of Cordyceps per unit were not detected. However, the TLC method is simple and cost-effective compared to DNA-based authentication techniques. Lastly, this study did not measure the quantities of Cordyceps present in the products. Conclusions This study raises awareness among consumers and health authorities about the quality of Cordyceps products in Thailand. The issues identified with Cordyceps products situations may reflect similar problems found in other dietary supplements. Key concerns include misleading product labels, exaggerated claims in online advertising, and some products posing risks to consumers due to lack of proper registration or corticosteroid adulteration, which are significant challenges for herbal and dietary supplements worldwide. Effective post-marketing surveillance is essential to ensure the quality and safety of dietary supplements. Abbreviations AKI Acute Kidney Injury C. Cordyceps COX Cyclooxygenase FDA The Food and Drug Administration TLC Thin-Layer Chromatography Declarations Ethics approval and consent to participate: No ethical approval was required as this study did not involve human participants or laboratory animals. Consent for publication: Not applicable Funding: This research was supported by the Faculty of Pharmacy, Srinakharinwirot University, Thailand, and grant number 538/2566. Author contributions: LW and MT conceptualized the study. LW, NS, and MT designed the study methods, coordinated the work, and analyzed the results. MT drafted the manuscript. All authors reviewed, revised, and approved the final manuscript. Acknowledgements: Not applicable Availability of data and materials: Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study. Competing interests: The authors declare that they have no conflicts of interest. 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Pharmacol Res - Mod Chin Med 7:100228 Positive lists of active ingredients for dietary supplements [ https://food.fda.moph.go.th/database-food/category/positivelists2?ppp=10& page=13&kw=] Ricke JN, Seifert R (2024) Disinformation on dietary supplements by German influencers on Instagram. Naunyn Schmiedebergs Arch Pharmacol Additional Declarations The authors declare no competing interests. Supplementary Files SupplementaryTable29072025.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7360734","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":499708047,"identity":"709749fc-f2f1-48da-ad55-c78664b59b4f","order_by":0,"name":"Lalita Wirasathien","email":"","orcid":"https://orcid.org/0009-0006-4985-0446","institution":"Department of Pharmacognosy, Faculty of Pharmacy, Srinakharinwirot University, Nakhon Nayok, Thailand","correspondingAuthor":false,"prefix":"","firstName":"Lalita","middleName":"","lastName":"Wirasathien","suffix":""},{"id":499708048,"identity":"0ec6e835-f18d-4417-8c20-fd1953bdb0a8","order_by":1,"name":"Napatsorn Sriputhon","email":"","orcid":"https://orcid.org/0009-0008-8952-1051","institution":"Faculty of Pharmacy, Srinakharinwirot University, Nakhon Nayok, Thailand","correspondingAuthor":false,"prefix":"","firstName":"Napatsorn","middleName":"","lastName":"Sriputhon","suffix":""},{"id":499708049,"identity":"f554e387-fbc2-4d96-a578-011634072096","order_by":2,"name":"Mayuree Tangkiatkumjai","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA3UlEQVRIiWNgGAWjYDADfiQ2G1E6JCQb4GxmIrUYHCBWi277GTPpigqbOuPzC5g/87YxyPM38B97gE+L2ZkcM8kzZ9IkzG48YJMGajGccYCZ3QCvlgNALY1th4FaDrAx57YxMG4AOkwCr5bzb4Ba/v2XMAaa/hmoxZ6wlhsgWxoOSBjwNzBIA7UkEqHlWbFlw7FkyRk3GNuk/5yTSJ5xmNmMgMOSN95sqLHj5+8/fPjjjDIb2/72xmd4tTAwcECDRyKxAUQCowW/eiBgfwCh+Q8QVDoKRsEoGAUjFAAATs5DH5GIsAcAAAAASUVORK5CYII=","orcid":"","institution":"Department of Clinical Pharmacy, Faculty of Pharmacy, Srinakharinwirot University, Nakhon Nayok, Thailand","correspondingAuthor":true,"prefix":"","firstName":"Mayuree","middleName":"","lastName":"Tangkiatkumjai","suffix":""}],"badges":[],"createdAt":"2025-08-13 04:39:17","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false},"doi":"10.21203/rs.3.rs-7360734/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7360734/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":89046166,"identity":"d51ec7c1-2fc6-4925-8736-11bf1a36ce47","added_by":"auto","created_at":"2025-08-14 06:50:10","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":110113,"visible":true,"origin":"","legend":"\u003cp\u003eThe findings of the TLC analysis compared authentic samples of \u003cem\u003eC. sinensis\u003c/em\u003e and \u003cem\u003eC. militaris\u003c/em\u003e with standard compounds of adenosine and cordycepin.\u003c/p\u003e\n\u003cp\u003eFigure note. Figure A and B display the results of TLC analysis under ultraviolet light at 254 and 366 nanometers, respectively. Abbreviations: A= Adenosine, C = Cordycepin, CS = \u003cem\u003eC. sinensis\u003c/em\u003e, and CM = \u003cem\u003eC. militaris\u003c/em\u003e.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7360734/v1/00b4a8627e7a0a27690483ae.png"},{"id":89046168,"identity":"ea596a2a-c8d4-4863-b131-7864aaaf47d8","added_by":"auto","created_at":"2025-08-14 06:50:10","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":959031,"visible":true,"origin":"","legend":"\u003cp\u003eMicroscopic results of authentic \u003cem\u003eC. sinensis\u003c/em\u003e and \u003cem\u003eC. militaris\u003c/em\u003e stained with a glycerin-water solution at 400x magnification\u003c/p\u003e\n\u003cp\u003eFigure note. A and B represent the tissues of \u003cem\u003eC. sinensis\u003c/em\u003e and \u003cem\u003eC. militaris\u003c/em\u003e, respectively.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7360734/v1/653611a6da029f2860068788.png"},{"id":89046171,"identity":"c6afd0f5-afda-485b-96ae-cf1bad5ea3ef","added_by":"auto","created_at":"2025-08-14 06:50:10","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":374387,"visible":true,"origin":"","legend":"\u003cp\u003eThe steroid kit test\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7360734/v1/457ede416bbbc8195d60bdb8.png"},{"id":89047242,"identity":"199c2cea-895e-4ae6-a9bc-1dada072a685","added_by":"auto","created_at":"2025-08-14 06:58:10","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":74079,"visible":true,"origin":"","legend":"\u003cp\u003eThe percentage of additional ingredients\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7360734/v1/d227c60186b094fe5f1cbfd9.png"},{"id":89046170,"identity":"c2fee58b-0a66-4f5a-a643-889da152e6f9","added_by":"auto","created_at":"2025-08-14 06:50:10","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":105224,"visible":true,"origin":"","legend":"\u003cp\u003eThe percentage of each health claim made by Cordyceps products advertising online\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-7360734/v1/09d2425be1b18ee6e2400878.png"},{"id":89048426,"identity":"3ac6f0d8-9dda-4734-b4e8-b49a008fc32c","added_by":"auto","created_at":"2025-08-14 07:14:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2549618,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7360734/v1/33767a88-d9d2-4c06-8e48-75839a4a1b49.pdf"},{"id":89046167,"identity":"ce18106d-b9d4-42f5-89d9-511e2edac093","added_by":"auto","created_at":"2025-08-14 06:50:10","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":25282,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryTable29072025.docx","url":"https://assets-eu.researchsquare.com/files/rs-7360734/v1/8f7ada8af55441271a9e33c7.docx"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003ePost-Marketing Surveillance of Cordyceps Products in Thailand\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Background","content":"\u003cp\u003eCordyceps are well-known as a Chinese herbal medicine that promote well-being and is popular for use worldwide. The Food division of the Food and Drug Administration (FDA) in Thailand has permitted dietary supplements containing \u003cem\u003eCordyceps militaris\u003c/em\u003e and \u003cem\u003eCordyceps sinensis\u003c/em\u003e since 2019.[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] Since then, the number of these dietary supplements has been increasing. In 2023, 473 products containing Cordyceps were registered as dietary supplements and food items, including tea, coffee, energy drinks, and chicken essence. Cordyceps extracts found in Cordyceps products in Thailand were not purified and contained a variety of compounds from Cordyceps. Cordyceps advertising in Thailand, promoting their use for the treatment of kidney disease and other chronic illnesses, has led to a high number of patients with chronic kidney disease or non-communicable diseases using Cordyceps products for self-care.\u003c/p\u003e\u003cp\u003eSince 2020, Cordyceps products have been linked to cases of acute kidney injury (AKI) in Thailand, despite several studies suggesting that Cordyceps may have potential benefits in treat kidney diseases.[\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] Cordycepin, a compound found in Cordyceps, has an anti-inflammatory effect through cyclooxygenase-2 (COX) inhibition.[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] However, COX-2 inhibition is known to cause vasoconstriction and reduce renal blood flow, which can adversely affect kidney function.[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] Additionally, adverse effects of Cordycepin-enriched products, such as nausea and diarrhea, may lead to kidney hypoperfusion, particularly in dehydrated patients.[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] Thai patients may overuse Cordyceps products, and high doses of Cordycepin could contribute to AKI.\u003c/p\u003e\u003cp\u003eOther potential causes of Cordyceps-induced nephrotoxicity include arsenic contamination of natural \u003cem\u003eC. sinensis\u003c/em\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] and the presence of mycotoxins, which may be produced during the large-scale cultivation of \u003cem\u003eC. militaris\u003c/em\u003e.[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] Furthermore, corticosteroid adulteration in herbal products has been reported in Thailand and may also be linked to AKI.[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] Globally, the prevalence of herbal products adulterated with corticosteroids worldwide has been reported to range from 1.4\u0026ndash;48%.[\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/p\u003e\u003cp\u003eDue to the scarcity of \u003cem\u003eC. sinensis\u003c/em\u003e and concerns about heavy metal contamination,[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] the mass production of cultivated \u003cem\u003eC. militaris\u003c/em\u003e has increased worldwide, replacing natural \u003cem\u003eC. sinensis\u003c/em\u003e. The primary different between these two species lies in their main compounds: adenosine is the key compound of \u003cem\u003eC. sinensis\u003c/em\u003e, while cordycepin is predominant in cultivated \u003cem\u003eC. militaris\u003c/em\u003e.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] The natural form of \u003cem\u003eC. sinensis\u003c/em\u003e contains only very low levels of cordycepin.[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] Globally, the adulteration of herbal products has been on the rise. In Thailand, 20% of herbal products were found to contain undeclared substitute species or none of the labeled species.[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/p\u003e\u003cp\u003eThe high prevalence of Cordyceps products labeled as \u003cem\u003eC. militaris\u003c/em\u003e in Thailand from 2020 to 2022 coincided with reports from healthcare providers of AKI linked to Cordyceps products.[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] Subsequently, most Cordyceps products on the market were labeled as \u003cem\u003eC. sinensis\u003c/em\u003e rather than \u003cem\u003eC. militaris\u003c/em\u003e. The literature suggests methods for differentiating these two species using microscopic techniques and chemical evaluation through thin-layer chromatography.[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/p\u003e\u003cp\u003eThis study aimed to: 1) assess the Cordyceps species present in the products; 2) determine the prevalence of corticosteroid adulteration in Cordyceps products; 3) evaluate the prevalence of legally registered Cordyceps products and their compliance with labeling regulations; and 4) measure the rate of compliance with advertising law for Cordyceps products.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eSample and study design\u003c/h2\u003e\u003cp\u003eThis study used a mixed-methods approach, combining survey and experiment studies. Oral dietary supplements containing Cordyceps as an active ingredient and sold in Thailand from May to October 2023 were included. The sample size of this study calculated using the Yamane formulary.[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e] The total number of Cordyceps products registrations in Thailand were 473 in 2023, and the sampling error was set at 10%. The total sample size in this study was 83 products. Convenient sampling was applied to purchase the samples.\u003c/p\u003e\u003cp\u003eThe survey assessed the prevalence of legal Cordyceps products registrations, their labels, and advertising regulatory compliance. Meanwhile, the experiment tested whether \u003cem\u003eC. militaris\u003c/em\u003e or \u003cem\u003eC. sinensis\u003c/em\u003e were contained in the products as indicated on their labels.\u003c/p\u003e\u003cp\u003e\u003cb\u003eTests of Cordyceps products\u003c/b\u003e\u003c/p\u003e\u003cp\u003e1. Chemical evaluation\u003c/p\u003e\u003cp\u003eThe preparation of samples involved extracting 500 milligrams (mg) of Cordyceps powder or one soft gelatin capsule using methanol assisted with ultrasonication and solvent was evaporated to obtain the extract, then redissolved with one milliliter of methanol. The sample extracts were tested using thin-layer chromatography (TLC).[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] Two authentic samples of \u003cem\u003eC. sinensis\u003c/em\u003e and \u003cem\u003eC. militaris\u003c/em\u003e were prepared as powders and extracted using the same method as the sample preparation. The samples labeled Cordyceps extracts were tested solely through chemical evaluation.\u003c/p\u003e\u003cp\u003eThin-layer chromatography was prepared using silica gel GF\u003csub\u003e254\u003c/sub\u003e as the stationary phase. The mobile phase consisted of two systems: mobile phase 1 with a ratio of ethyl acetate, methanol, and water at 10:1.5:1, and mobile phase 2 with a ratio of chloroform to methanol at 4:1.[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] The results of the TLC tests were read using ultraviolet light at 254 and 366 nanometers. Standard compounds of adenosine and cordycepin at a concentration of 1 mg/ml were used. Samples with a prominent adenosine band, matching the standard compound, were identified as \u003cem\u003eC. sinensis\u003c/em\u003e, while those with a prominent cordycepin and adenosine band were identified as \u003cem\u003eC. militaris\u003c/em\u003e (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The TLC findings, observed under ultraviolet light at 366 nanometers, confirmed the presence of a band consistent with \u003cem\u003eC. militaris\u003c/em\u003e.\u003c/p\u003e\u003cp\u003e2. Microscopic methods\u003c/p\u003e\u003cp\u003eSamples were stained with a glycerin-water solution, chloral hydrate solution and iodine test solution. Cordyceps products labeled as containing Cordyceps powder, except for Cordyceps extract, were tested using microscopic methods.[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e indicated authentic \u003cem\u003eC. sinensis\u003c/em\u003e and \u003cem\u003eC. militaris\u003c/em\u003e stained with a glycerin-water solution.\u003c/p\u003e\u003cp\u003e3. Testing for corticosteroid adulteration\u003c/p\u003e\u003cp\u003eThe steroid test kit, using an immunochromatography technique, was used to test for corticosteroid adulteration in Cordyceps products.[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] The samples preparation included grinding the sample powders or preparing solutions, which were then extracted using the corticosteroid extraction solution provided by the test kit. Four drops of the extracted sample were placed in the oval channel of the kit plate. The test detected more than 1 microgram/ml of dexamethasone and 50 micrograms/ml of prednisolone. A positive result was indicated by a red line appearing on label C on the plate (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). In case of an invalid result, the samples were re-tested.\u003c/p\u003e\u003cp\u003e4. Assessment of compliance with Labeling and online advertising standards for Cordyceps products\u003c/p\u003e\u003cp\u003eCordyceps products were legally checked their registration numbers and advertising approvals via the Thai FDA website (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://porta.fda.moph.go.th/FDA_SEARCH_ALL/MAIN/SEARCH_CENTER_MAIN.aspx\u003c/span\u003e\u003cspan address=\"https://porta.fda.moph.go.th/FDA_SEARCH_ALL/MAIN/SEARCH_CENTER_MAIN.aspx\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e and \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://alimentum.fda.moph.go.th/MAIN_SEARCH/MAIN/SEARCH_USER\u003c/span\u003e\u003cspan address=\"https://alimentum.fda.moph.go.th/MAIN_SEARCH/MAIN/SEARCH_USER\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e). Their legal label must include: 1) name; 2) registration number; 3) address of manufacture or import; 4) amount of dietary supplement; 5) amount of active ingredients; 6) warning statements as follows: \"No effect in preventing or treating diseases.\", \"The intake of various nutrients should come from consuming a variety of main foods, covering all five food groups, in appropriate proportions.\" and \"Children and pregnant women should not consume.\"; 7) manufacturing and expiry dates; and 8) usage.[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003eStatistical analysis\u003c/h2\u003e\u003cp\u003eFrequencies and percentages were reported, and descriptive statistics, including the median and range, were calculated. The prevalence of products containing cordycepin, legally compliant products, and those with corticosteroid adulteration in Thailand was also reported. The prevalence was defined as the rate of those occurrences over six months.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eOnly 65 Cordyceps dietary supplements were included in the study, as many products were sold out, or their production, or importation had been discontinued.\u003c/p\u003e\n\u003ch3\u003eCharacteristics of Cordyceps products based on their labels\u003c/h3\u003e\n\u003cp\u003eForty percent of the products did not specify the species of Cordyceps. More than half of the products were labeled as \u003cem\u003eC.sinensis\u003c/em\u003e (53.8%), while only four products were labeled as \u003cem\u003eC. militaris\u003c/em\u003e. Most of them (58.5%) were labeled as containing Cordyceps extract. The median amounts of Cordyceps in extract and powder form were 325 and 350 mg per capsule, respectively. The median number of additional ingredients in the products were three (range: 0\u0026ndash;14). The top three additional ingredients were vitamins, reishi, and ginseng (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). Three products contained only Cordyceps. The maximum daily doses of extract and powder indicated on the labels were 1,200 and 2,675 mg per day, respectively (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eCharacteristics of Cordyceps products based on their labels in Thailand (N\u0026thinsp;=\u0026thinsp;65).\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacteristics\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNumber\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDosage form\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExtract\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e38 (58.5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePowder\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e21 (32.3%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMixed extract and powder\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e1 (1.5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUnspecified\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e5 (7.7%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eProduct label\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eC. sinensis\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e35 (53.8%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eC. militaris\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (6.2%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUnspecified\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e26 (40.0%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAmount of Cordyceps*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExtract (median and range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e325 (30\u0026ndash;790) mg/capsule\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePowder (median and range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e350 (20\u0026ndash;850) mg/capsule\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOther ingredients*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMedian (range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e3 (0\u0026ndash;14) ingredients\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDaily dosage on the label*, **\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eExtract (median and range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e365 (30\u0026thinsp;\u0026minus;\u0026thinsp;1,200) mg/day\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePowder (median and range)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e450 (20\u0026thinsp;\u0026minus;\u0026thinsp;2,675) mg/day\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e* One product with a fake registration number did not provide details of its ingredients and daily dosage.\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"2\"\u003e** Two products did not indicate the frequency of consumption.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\n\u003ch3\u003eThe prevalence of products containing cordycepin and those with corticosteroid adulteration\u003c/h3\u003e\n\u003cp\u003eThe prevalence of Cordyceps products containing cordycepin was 53.8% (N\u0026thinsp;=\u0026thinsp;35), while 6.2% (N\u0026thinsp;=\u0026thinsp;4) of the registered products were found to be adulterated with corticosteroids. Additionally, 53.8% (N\u0026thinsp;=\u0026thinsp;35) of the products were identified as \u003cem\u003eC. militaris\u003c/em\u003e (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Of 39 products examined, 19 (48.7%) were mislabeled regarding the species of Cordyceps. Nearly half of the products labeled \u003cem\u003eC. sinensis\u003c/em\u003e were identified as \u003cem\u003eC. militaris\u003c/em\u003e. The labeled daily doses of Cordyceps powder and extract identified as \u003cem\u003eC. militaris\u003c/em\u003e ranged from 200 to 900 mg per day and 229 to 1,200 mg per day, respectively.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eComparison of Cordyceps species: Labeled identification vs. microscopic and chemical analysis results (N\u0026thinsp;=\u0026thinsp;65)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLabeled identification\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMicroscopic and chemical analysis results\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eC. sinensis\u003c/em\u003e (N\u0026thinsp;=\u0026thinsp;35)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eC. sinensis\u003c/em\u003e (N\u0026thinsp;=\u0026thinsp;9, 25.7%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eC. militaris\u003c/em\u003e (N\u0026thinsp;=\u0026thinsp;19, 54.3%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot detected (N\u0026thinsp;=\u0026thinsp;6, 17.1%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCannot identifies (N\u0026thinsp;=\u0026thinsp;1, 2.9%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eC. militaris\u003c/em\u003e (N\u0026thinsp;=\u0026thinsp;4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eC. militaris\u003c/em\u003e (N\u0026thinsp;=\u0026thinsp;4, 100.0%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUnspecified (N\u0026thinsp;=\u0026thinsp;26)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eC. sinensis\u003c/em\u003e (N\u0026thinsp;=\u0026thinsp;9, 34.6%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u003cem\u003eC. militaris\u003c/em\u003e (N\u0026thinsp;=\u0026thinsp;12, 46.2%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot detected (N\u0026thinsp;=\u0026thinsp;5, 19.2%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eEleven products (16.9%) did not contain detectable Cordyceps ingredients. Among these, two products (No.40 and 59) contained the lowest amounts of Cordyceps products, with 30 and 20 mg per unit, respectively. Other products contained Cordyceps ranging from 100\u0026ndash;790 mg per capsule, with labels indicating on 3 as extract, 3 as powder, and 3 with unspecified Cordyceps forms. Three products were labeled as containing 100, 150 and 200 mg of Cordyceps, but no Cordyceps was detected in these products. In contrast, other products with similar characteristics did contain detectable amounts of Cordyceps. Among the eleven products, one product could not be identified as containing Cordyceps species due to interference from additional ingredients, such as magnesium oxide, vitamin C and vitamin B complex, during chemical analysis.\u003c/p\u003e\u003cp\u003eSamples one and eleven were labeled as Cordyceps powder but did not show any Cordyceps tissues under microscopic examination. These two products may instead contain Cordyceps extract. Overall, 54.3% of the products were mislabeled regarding the substitute or absence of the labeled species, as well as the form of Cordyceps. The findings from the microscopic and chemical analyses are provided in the supplement table.\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eThe prevalence of legally compliant products\u003c/h2\u003e\u003cp\u003eEleven percent (N\u0026thinsp;=\u0026thinsp;7) of the products were not registered with the Thai FDA. Of these, three products lacked a registration number, while four displayed either a canceled registration number (N\u0026thinsp;=\u0026thinsp;3) or a fake number (N\u0026thinsp;=\u0026thinsp;1). One product was sold despite being expired. The prevalence of legally compliant physical labeling was 78.5%. Among the non-compliant physical labels, 11 products failed to display the required disclaimers, and three products were not registered with Thai FDA and carried illegal labels.\u003c/p\u003e\u003cp\u003eOnly one product (1.5%) advertised health claims permitted by the Thai FDA online and displayed its advertising license number. Forty-seven products (72.3%) made disease claims through online advertising. Seventeen products (26.2%) did not apply for an advertising license from the Thai FDA and did not make disease claims. The most common health claims were reducing blood glucose levels (11%), boosting immunity (11%), decreasing serum lipid levels (8%) and enhancing sexual performance (8%) (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). The median number of health claims made online was five per product. Three products (4.6%) - one registered and two unregistered - were physically labeled with claims of treating diseases.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis is the first paper to report on the quality of Cordyceps products in Thailand using post-marketing surveillance. The most concerning issues were that 6.2% of the products were adulterated with corticosteroids, and 11% were not registered with the health authority. However, the prevalence of Cordyceps products adulterated with corticosteroids in this study was lower than in previous studies in Thailand, which reported that 15\u0026ndash;50% of herbal products were adulterated with corticosteroids.[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e\u003cp\u003eMore than 50% of the products in this study were mislabeled due to the substitute or absence of the labeled species, which is higher than the prevalence of mislabeling in general herbal products in Thailand (20%), as reported by Ichim (2019).[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] Among the products labeled as \u003cem\u003eC. sinensis\u003c/em\u003e, 53.8% were identified as \u003cem\u003eC. militaris\u003c/em\u003e. The substitution of \u003cem\u003eC. sinensis\u003c/em\u003e with \u003cem\u003eC. militaris\u003c/em\u003e has been reported globally.[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e] The absence of the labeled species may be influenced by the poor quality of some Cordyceps products. Potential causes include the degradation of active compounds in Cordyceps due to high temperatures[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] or the complete absence of Cordyceps from the product. This issue requires closely monitoring and intervention by the health authorities.\u003c/p\u003e\u003cp\u003eMost of the Cordyceps products (53.8%) in Thailand contained cordycepin and \u003cem\u003eC. militaris\u003c/em\u003e. The labeled daily doses of products containing identified \u003cem\u003eC. militaris\u003c/em\u003e in this study ranged from 200 to 900 mg per day for powder forms and from 229 to 1,200 mg per day for extract forms. In comparison, the Thai FDA\u0026rsquo;s recommended active ingredient levels for dietary supplements suggest a daily intake of 230 mg of \u003cem\u003eC. militaris\u003c/em\u003e powder or no more than 0.3 mg of cordycepin per gram of dietary supplement. These levels are part of the positive list of Cordyceps products, allowing for expedited product registration.[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] The daily doses of these products raise concerns about the potential for individuals to consume high doses of Cordyceps. The Thai FDA\u0026rsquo;s policy on the positive list of active ingredient levels for dietary supplements shortens the approval period of these products. The findings from this study suggest that this policy should be implemented alongside robust post-marketing surveillance to ensure the sustained quality of dietary supplements.\u003c/p\u003e\u003cp\u003eForty percent of the Cordyceps products in this study did not label the species of Cordyceps, and 7.7% did not specify the form of Cordyceps, such as powder or extract. Each form is consumed at a different dose. The Thai FDA should revise regulations for herbal dietary supplements to mandate clear labeling in order to protect consumer rights.\u003c/p\u003e\u003cp\u003eMost of the Cordyceps products in this study complied with physical labeling requirements (78.5%). However, nearly three-quarters of the products in this study made overclaims through online advertising and 4.6% were physically labeled with disease claims. Advertising dietary supplements on social media is more likely to spread misinformation.[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] To prevent misunderstanding about the benefits of dietary supplements, it is essential to improve health literacy and educate people on assessing the accuracy of health information. Health authorities should enforce regulations to address this issue.\u003c/p\u003e\u003cp\u003eThe limitation of this study was that the included products may not sufficiently represent all Cordyceps products available in Thailand. However, researchers purchased as many products as were accessible on the market. The findings of this study should therefore be interpreted with caution. The TLC method used in this study to detect chemical compounds in Cordyceps products had limited sensitivity for small amounts of adenosine and cordycepin. As a result, two products containing 20 and 30 mg of Cordyceps per unit were not detected. However, the TLC method is simple and cost-effective compared to DNA-based authentication techniques. Lastly, this study did not measure the quantities of Cordyceps present in the products.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThis study raises awareness among consumers and health authorities about the quality of Cordyceps products in Thailand. The issues identified with Cordyceps products situations may reflect similar problems found in other dietary supplements. Key concerns include misleading product labels, exaggerated claims in online advertising, and some products posing risks to consumers due to lack of proper registration or corticosteroid adulteration, which are significant challenges for herbal and dietary supplements worldwide. Effective post-marketing surveillance is essential to ensure the quality and safety of dietary supplements.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eAKI\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eAcute Kidney Injury\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eC.\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCordyceps\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eCOX\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCyclooxygenase\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eFDA\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eThe Food and Drug Administration\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eTLC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eThin-Layer Chromatography\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e\u003cp\u003eNo ethical approval was required as this study did not involve human participants or laboratory animals.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConsent for publication:\u003c/strong\u003e\u003cp\u003eNot applicable\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eFunding:\u003c/h2\u003e\u003cp\u003eThis research was supported by the Faculty of Pharmacy, Srinakharinwirot University, Thailand, and grant number 538/2566.\u003c/p\u003e\u003ch2\u003eAuthor contributions:\u003c/h2\u003e\u003cp\u003eLW and MT conceptualized the study. LW, NS, and MT designed the study methods, coordinated the work, and analyzed the results. MT drafted the manuscript. All authors reviewed, revised, and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgements:\u003c/h2\u003e\u003cp\u003eNot applicable\u003c/p\u003e\u003ch2\u003eAvailability of data and materials:\u003c/h2\u003e\u003cp\u003eData sharing is not applicable to this article as no datasets were generated or analyzed during the current study.\u003c/p\u003e\u003cp\u003eCompeting interests: The authors declare that they have no conflicts of interest.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGuidelines for \u003cem\u003eC. militaris\u003c/em\u003e food registration [\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://food.fda.moph.go.th/for-entrepreneurs/guidelines-cordyceps/]\u003c/span\u003e\u003cspan address=\"https://food.fda.moph.go.th/for-entrepreneurs/guidelines-cordyceps/]\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSearching for the registration of health products in Thailand [\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.fda.moph.go.th/?cate=DATA_ALL\u003c/span\u003e\u003cspan address=\"https://www.fda.moph.go.th/?cate=DATA_ALL\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u0026amp;type=\u0026amp;fi=1\u0026amp;ww=%E0%B8%96%E0%B8%B1%E0%B9%88%E0%B8%87%E0%B9%80%E0%B8%8A%E0%B9%88%E0%B8%B2]\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTangkiatkumjai M, Chaiyarak S, Sriprach S, Lumboot U, Absuwan W, Changsirikulchai S (2022) Acute kidney injury related to \u003cem\u003eCordyceps militaris\u003c/em\u003e: A case series. 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Drug Healthc Patient Saf 13:133\u0026ndash;140\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKibiki AE, Mpanyakavili AL, Mwankuna CJ, Mariki EE, Mabiki FP (2023) Rapid detection of corticosteroids in herbal medicines sold in Tanzania. Tanzan J Agricultural Sci 22(2):222\u0026ndash;241\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChiu C-P, Hwang T-L, Chan Y, El-Shazly M, Wu T-Y, Lo (2016) I-W, al e: Research and development of Cordyceps in Taiwan. 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Acta Pharm Sinica B 1(3):189\u0026ndash;195\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eThuy DTP, Anh TTN, Thuy NTT, Intaparn P, Tapingkae T, Mai NT (2021) Simple and Efficient Method for the Detection and Quantification of Cordycepin Content in Cordyceps. Chiang Mai J Sci 48(2):420\u0026ndash;428\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eYamane T (1967) Statistics: an introductory analysis, 2nd edn. Harper and Row, London\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSornchaithawatwong C, Tadtong S, Tangkiatkumjai M (2020) The prevalence of acceptable quality herbal products in Thailand. J Herb Med :100391\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGuidelines for the registration of dietary supplements [\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://food.fda.moph.go.th/public-information/supplement-guide/]\u003c/span\u003e\u003cspan address=\"https://food.fda.moph.go.th/public-information/supplement-guide/]\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLiu J, Sun J, He R, Xia J, He P (2024) The situation of counterfeited and mislabeled commercialized edible mushrooms in China and the development of possible controls. Foods 13(19):3097\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eShweta AS, Komal, Kumar A (2023) A brief review on the medicinal uses of Cordyceps militaris. Pharmacol Res - Mod Chin Med 7:100228\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePositive lists of active ingredients for dietary supplements [\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://food.fda.moph.go.th/database-food/category/positivelists2?ppp=10\u0026amp;\u003c/span\u003e\u003cspan address=\"https://food.fda.moph.go.th/database-food/category/positivelists2?ppp=10\u0026amp;\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003epage=13\u0026amp;kw=]\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRicke JN, Seifert R (2024) Disinformation on dietary supplements by German influencers on Instagram. Naunyn Schmiedebergs Arch Pharmacol\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Srinakharinwirot University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Cordyceps, Dietary supplement, Thailand","lastPublishedDoi":"10.21203/rs.3.rs-7360734/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7360734/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe outbreak of acute kidney injury linked to Cordyceps products in Thailand prompted an assessment of their quality. The aims of this study were to identify the Cordyceps species contained in the dietary supplement and to evaluate legal compliance.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e\u003cp\u003eA survey and experimental studies were conducted, focusing on oral Cordyceps products selected through convenience sampling. Chemical and microscopic examinations were performed, and thin-layer chromatography was used to identify cordycepin and adenosine in the products. Steroid test kits were employed to detect corticosteroid adulteration. The products\u0026rsquo; registration number and advertising approvals by the Thai FDA were verified.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e\u003cp\u003eSixty-five products were included in the study. The prevalence of products containing cordycepin and \u003cem\u003eC. militaris\u003c/em\u003e was 53.8%. Among the products, 11% were unregistered, and 6.2% were adulterated with corticosteroids. 54.3% were mislabeled regarding the substitute or absence of the labeled species and the form of Cordyceps. The prevalence of products with legally compliant physical labeling was 78.5%. However, 72.3% of the products made disease claims through social media.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe study highlights that the regulation of dietary supplements containing Cordyceps in Thailand does not fully comply with legal standards. Therefore, the public should be aware of these issues with Cordyceps products. The Thai FDA should enhance its post-market surveillance system for health products to better protect consumers.\u003c/p\u003e","manuscriptTitle":"Post-Marketing Surveillance of Cordyceps Products in Thailand","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-14 06:50:05","doi":"10.21203/rs.3.rs-7360734/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"42b22f51-251f-465f-93c9-f3771de622dd","owner":[],"postedDate":"August 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":53078188,"name":"Toxicology"}],"tags":[],"updatedAt":"2025-08-14T06:50:05+00:00","versionOfRecord":[],"versionCreatedAt":"2025-08-14 06:50:05","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7360734","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7360734","identity":"rs-7360734","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}