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Original article

Vol. 155 No. 12 (2025)

Quality assessment of Andrographis paniculata products reveals significant labelling inaccuracies and contaminations

Cite this as:
Swiss Med Wkly. 2025;155:4728
Published
11.12.2025

Summary

BACKGROUND: Andrographis paniculata products have gained in popularity for the management of respiratory infections since the COVID-19 pandemic. None of these products holds marketing authorisation and all are sold as herbal food supplements. Current herbal food supplement regulations generally do not impose quality assessments prior to commercialisation, such that the quality of herbal food supplements available to consumers is largely unknown.

STUDY AIM: To assess the quality, purity and labelling accuracy of A. paniculata-containing products, focusing on andrographolide content (the pharmaceutically active component) and the presence of contaminants and residues.

METHODS: Forty A. paniculata-containing products were purchased from 13 countries: 13 from pharmacies and 27 from online retailers readily accessible to consumers in Switzerland. Samples were analysed using ultra-high-performance liquid chromatography–ultraviolet (UHPLC-UV) and ultra-high-performance liquid chromatography–mass spectrometry (UHPLC-MS) based on the European Pharmacopoeia method. Contaminants and residues were assessed using inductively coupled plasma mass spectrometry and gas chromatography–mass spectrometry, respectively.

RESULTS: All samples except one contained A. paniculata. The measured daily dose of andrographolide was compared to the labelled dose. Andrographolide content ranged from 29% to 174% of the labelled dose, with only 2 products accurately labelled, while 20 were underdosed and 1 overdosed. Two products contained quercetin, which interfered with UHPLC-UV analysis. Additionally, three online-purchased products contained toxic contaminants, including a heavy metal (mercury) or pesticides (strychnine, butralin).

CONCLUSION: This study reveals widespread mislabelling and underdosing in A. paniculata-containing food supplements marketed internationally, along with the presence of impurities that pose risks to consumers in products bought online. Regulatory authorities must implement stringent quality controls to ensure consumer safety and product transparency.

References

  1. 1. Patriota P, Guessous I, Marques-Vidal P. Dietary patterns according to vitamin supplement use. A cross-sectional study in Switzerland. Int J Vitam Nutr Res. 2022 Oct;92(5-6):331–41. 10.1024/0300-9831/a000679
  2. 2. Health Products Regulatory Authority [Internet]. Herbal medicines: regulatory information Dublin (Ireland): HPRA; 2014 [cited 2025 Oct 14]. Available from: http://www.hpra.ie/homepage/medicines/regulatory-information/medicines-authorisation/herbal-medicines/information-for-the-public-thmps
  3. 3. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the Approximation of the Laws of the Member States Relating to Food Supplements. Off J Eur Union. L 183 No. 51-5 (2002).
  4. 4. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Off J Eur Union. L 136 No. 85-90 (2004).
  5. 5. Finnish Food Authority [Internet]. Establishing novel food status of a food Helsinki (Finland): Finnish Food Authority; 2023 [cited 2025 Oct 14]. Available from: https://www.ruokavirasto.fi/en/foodstuffs/food-sector/ainesosat-ja-sisalto/novel-foods/establishing-novel-food-status-of-a-food/
  6. 6. Orhan N, Gafner S, Blumenthal M. Estimating the extent of adulteration of the popular herbs black cohosh, echinacea, elder berry, ginkgo, and turmeric - its challenges and limitations. Nat Prod Rep. 2024 Oct;41(10):1604–21. 10.1039/d4np00014e doi: https://doi.org/10.1039/D4NP00014E
  7. 7. Gafner S, Blumenthal M, Foster S, Cardellina JH 2nd, Khan IA, Upton R. Botanical Ingredient Forensics: Detection of Attempts to Deceive Commonly Used Analytical Methods for Authenticating Herbal Dietary and Food Ingredients and Supplements. J Nat Prod. 2023 Feb;86(2):460–72. 10.1021/acs.jnatprod.2c00929
  8. 8. Coon JT, Ernst E. Andrographis paniculata in the treatment of upper respiratory tract infections: a systematic review of safety and efficacy. Planta Med. 2004 Apr;70(4):293–8. 10.1055/s-2004-818938
  9. 9. Hu XY, Wu RH, Logue M, Blondel C, Lai LY, Stuart B, et al. Andrographis paniculata (Chuān Xīn Lián) for symptomatic relief of acute respiratory tract infections in adults and children: A systematic review and meta-analysis. PLoS One. 2017 Aug;12(8):e0181780. 10.1371/journal.pone.0181780
  10. 10. Tanwettiyanont J, Piriyachananusorn N, Sangsoi L, Boonsong B, Sunpapoa C, Tanamatayarat P, et al. Use of Andrographis paniculata (Burm.f.) Wall. ex Nees and risk of pneumonia in hospitalised patients with mild coronavirus disease 2019: A retrospective cohort study. Front Med (Lausanne). 2022 Aug;9:947373. 10.3389/fmed.2022.947373
  11. 11. Puri A, Saxena R, Saxena RP, Saxena KC, Srivastava V, Tandon JS. Immunostimulant agents from Andrographis paniculata. J Nat Prod. 1993 Jul;56(7):995–9. 10.1021/np50097a002
  12. 12. Songvut P, Suriyo T, Panomvana D, Rangkadilok N, Satayavivad J. A comprehensive review on disposition kinetics and dosage of oral administration of Andrographis paniculata, an alternative herbal medicine, in co-treatment of coronavirus disease. Front Pharmacol. 2022 Aug;13:952660. 10.3389/fphar.2022.952660
  13. 13. Wagner L, Cramer H, Klose P, Lauche R, Gass F, Dobos G, et al. Herbal Medicine for Cough: a Systematic Review and Meta-Analysis. Forsch Komplementmed. 2015;22(6):359–68. 10.1159/000442111
  14. 14. Raynor DK, Dickinson R, Knapp P, Long AF, Nicolson DJ. Buyer beware? Does the information provided with herbal products available over the counter enable safe use? BMC Med. 2011 Aug;9(1):94. 10.1186/1741-7015-9-94
  15. 15. Karioti A, Timoteo P, Bergonzi MC, Bilia AR. A Validated Method for the Quality Control of Andrographis paniculata Preparations. Planta Med. 2017 Oct;83(14-15):1207–13. 10.1055/s-0043-113827
  16. 16. Fibigr J, Šatínský D, Solich P. Current trends in the analysis and quality control of food supplements based on plant extracts. Anal Chim Acta. 2018 Dec;1036:1–15. 10.1016/j.aca.2018.08.017
  17. 17. Anastassiades M, Lehotay SJ, Stajnbaher D, Schenck FJ. Fast and easy multiresidue method employing acetonitrile extraction/partitioning and “dispersive solid-phase extraction” for the determination of pesticide residues in produce. J AOAC Int. 2003;86(2):412–31. 10.1093/jaoac/86.2.412
  18. 18. Allen LV, Bassani GS, Elder EJ, Parr AF. Strength and stability testing for compounded preparations. Rockville (USA) [USP]. U S Pharmacop. 2015.
  19. 19. Kumar S, Singh B, Bajpai V. Andrographis paniculata (Burm.f.) Nees: traditional uses, phytochemistry, pharmacological properties and quality control/quality assurance. J Ethnopharmacol. 2021 Jul;275:114054. 10.1016/j.jep.2021.114054
  20. 20. Parker AJ, Lee JB, Redman J, Jolliffe L. Strychnine poisoning: gone but not forgotten. Emerg Med J. 2011 Jan;28(1):84. 10.1136/emj.2009.080879
  21. 21. Smith E, Azoulay D, Tuncak B. Lowest common denominator : how the proposed EU-US trade deal threatens to lower standards of protection from toxic pesticides. London, UK: Center for International Environmental Law; 2015.
  22. 22. Aghababaei F, Hadidi M. Recent Advances in Potential Health Benefits of Quercetin. Pharmaceuticals (Basel). 2023 Jul;16(7):1020. 10.3390/ph16071020
  23. 23. Avula B, Katragunta K, Tatapudi KK, Wang YH, Ali Z, Chittiboyina AG, et al. Phytochemical analysis of phenolics and diterpene lactones in Andrographis paniculata plant samples and dietary supplements. J Pharm Biomed Anal. 2025 Sep;262:116866. 10.1016/j.jpba.2025.116866
  24. 24. Ruan LJ, Yan BX, Song SS, Yun-Qiu W, Liu XH, Yao CY, et al. Harmonizing international quality standards for Andrographis paniculata: A comparative analysis of content determination methods across pharmacopeias. J Pharm Biomed Anal. 2024 Mar;240:115924. 10.1016/j.jpba.2023.115924
  25. 25. Booker A, Frommenwiler D, Reich E, Horsfield S, Heinrich M. Adulteration and Poor Quality of Ginkgo biloba Supplements. J Herb Med. 2016;6(2):79–87. 10.1016/j.hermed.2016.04.003
  26. 26. Sorng S, Balayssac S, Danoun S, Assemat G, Mirre A, Cristofoli V, et al. Quality assessment of Curcuma dietary supplements: complementary data from LC-MS and 1H NMR. J Pharm Biomed Anal. 2022 Apr;212:114631. 10.1016/j.jpba.2022.114631
  27. 27. Jalil B, Heinrich M. Pharmaceutical quality of herbal medicinal products and dietary supplements - a case study with oral solid formulations containing Lavandula species. Eur J Pharm Sci. 2025 May;208:107042. 10.1016/j.ejps.2025.107042
  28. 28. Booker A, Agapouda A, Frommenwiler DA, Scotti F, Reich E, Heinrich M. St John’s wort (Hypericum perforatum) products - an assessment of their authenticity and quality. Phytomedicine. 2018 Feb;40:158–64. 10.1016/j.phymed.2017.12.012
  29. 29. Booker A, Jalil B, Frommenwiler D, Reich E, Zhai L, Kulic Z, et al. The authenticity and quality of Rhodiola rosea products. Phytomedicine. 2016 Jun;23(7):754–62. 10.1016/j.phymed.2015.10.006
  30. 30. Filipiak-Szok A, Kurzawa M, Szłyk E. Determination of toxic metals by ICP-MS in Asiatic and European medicinal plants and dietary supplements. J Trace Elem Med Biol. 2015 Apr;30:54–8. 10.1016/j.jtemb.2014.10.008
  31. 31. Luo L, Wang B, Jiang J, Fitzgerald M, Huang Q, Yu Z, et al. Heavy metal contaminations in herbal medicines: determination, comprehensive risk assessments, and solutions. Front Pharmacol. 2021 Jan;11:595335. 10.3389/fphar.2020.595335
  32. 32. Genuis SJ, Schwalfenberg G, Siy AK, Rodushkin I. Toxic element contamination of natural health products and pharmaceutical preparations. PLoS One. 2012;7(11):e49676. 10.1371/journal.pone.0049676