Abstract:

This article review focused on the analysis of the journal article “More Information Needed on Probiotic Supplement Product Labels” by Merenstein et al., 2019, published in the Journal of General Internal Medicine. The aim of such a review was to communicate a short critique as well as highlighting the need for fieldwork in regulatory compliance. Here, the review started with a general summary of the article, but also in conjunction with the literature review that the authors established. This was necessary to understand the article in its field of expertise whilst giving a clearer purpose on the need for more fieldwork of this kind. Without such understanding, it would have been difficult to understand the regulatory compliance of dietary supplement label regulations in the US. Then, a thorough analysis and deconstruction of the articles structure, as well as article critique, were established. The authority of the paper and other topics such as authority, accuracy, relevance, etc., were examined for effectiveness in conveying the research question that the authors were concerned with; that more information may be needed for product labels in probiotic supplements in the US. Lastly, the graphs, tables, and figures were evaluated to make a conclusion about the study as well as a discussion on the recent advances related to the label compliance of probiotic supplements. The paper, albeit was on the shorter side, was effective and was also simple in establishing a need for more information on the label. Thus, more transparency on clinical substantiation is needed.

Keywords: Clinical Substantiations, Label Compliance, Probiotics, Review, Regulatory, Short Communication.

References:

[1] Merenstein, D., Guzzi, J., & Sanders, M. E. 2019. More information is needed on probiotic supplement product labels. Journal of general internal medicine, 34(12), 2735-2737. https://link.springer.com/article/10.1007/s11606-019-05077-5.

[2] Hill, C., Guarner, F., Reid, G., Gibson, G.R., Merenstein, D.J., Pot, B., Morelli, L., Canani, R.B., Flint, H.J., Salminen, S. and Calder, P.C., 2014. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nature reviews Gastroenterology & hepatology.

[3] Food & Drug Administration (FDA). 2020a. Dietary Supplements. Retrieved November 19th, 2020. https://www.fda.gov/consumers/consumer-updates/dietary-supplements.

[4] Food & Drug Administration (FDA). 2020b. Dietary Supplements 101. Retrieved November 19th, 2020. https://www.fda.gov/consumers/consumer-updates/dietary-supplements.

[5] Degnan, F.H., 2008. The US Food and Drug Administration and probiotics: regulatory categorization. Clinical infectious diseases, 46 (Supplement_2), pp. S133-S136.

[6] Food & Drug Administration (FDA). 2020c. Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials: Guidance for Industry. Retrieved November 19th, 2020. https://www.fda.gov/media/115730/download.

[7] Cohen, P.A., 2018. Probiotic safety—no guarantees. JAMA internal medicine, 178(12), pp.1577-1578.

[8] Dailey, Z., Sanders, M.E. and Merenstein, D., 2020. Retail refrigerated probiotic foods and their association with evidence of health benefits. Beneficial microbes, 11(2), pp.131-133.

[9] Gibson, G.R., Hutkins, R., Sanders, M.E., Prescott, S.L., Reimer, R.A., Salminen, S.J., Scott, K., Stanton, C., Swanson, K.S., Cani, P.D. and Verbeke, K., 2017. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nature Reviews Gastroenterology & hepatology, 14(8), pp.491-502.

[10] Scherer, R.W., Huynh, L., Ervin, A.M., Taylor, J. and Dickersin, K., 2013. Clinical Trials. Gov registration can supplement the information in abstracts for systematic reviews: a comparison study. BMC medical research methodology, 13(1), pp.1-9.

[11] Souza, M.T.D., Silva, M.D.D. and Carvalho, R.D., 2010. Integrative review: what is it? How to do it? Einstein (São Paulo), 8, pp.102-106.

[12] Harris, J.D., Quatman, C.E., Manring, M.M., Siston, R.A. and Flanigan, D.C., 2014. How to write a systematic review. The American Journal of sports medicine, 42(11), pp.2761-2768.

[13] Williams, N.T., 2010. Probiotics. American Journal of Health-System Pharmacy, 67(6), pp.449-458.

[14] Food & Drug Administration (FDA). 2020c. Good Clinical Practices. Retrieved September 13th, 2020. https://www.fda.gov/ScienceResearch.

[15] Saldanha, L.G., 2008. US Food and Drug Administration regulations governing label claims for food products, including probiotics. Clinical infectious diseases, 46 (Supplement_2), pp. S119-S121.

[16] Freedman, S.B., Williamson-Urquhart, S., Farion, K.J., Gouin, S., Willan, A.R., Poonai, N., Hurley, K., Sherman, P.M., Finkelstein, Y., Lee, B.E., and Pang, X.L., 2018. Multicenter trial of a combination probiotic for children with gastroenteritis. New England Journal of Medicine, 379(21), pp.2015-2026.

[17] Goldenberg, J.Z., Yap, C., Lytvyn, L., Lo, C.K.F., Beardsley, J., Mertz, D. and Johnston, B.C., 2017. Probiotics for the prevention of Clostridium difficile‐associated diarrhea in adults and children. Cochrane Database of Systematic Reviews, (12).

[18] Isolauri, E., Salminen, S. and Ouwehand, A.C., 2004. Probiotics. Best practice & research Clinical gastroenterology, 18(2), pp.299-313.

[19] Sung, V., D’Amico, F., Cabana, M.D., Chau, K., Koren, G., Savino, F., Szajewska, H., Deshpande, G., Dupont, C., Indrio, F. and Mentula, S., 2018. Lactobacillus reuteri to treat infant colic: a meta-analysis. Pediatrics, 141(1).

[20] Health Canada. 2020. Compendium of Monographs. Retrieved December 14^th, 2020. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/product-licensing/compendium-monographs.html.

[21] Sanders, M.E., Akkermans, L.M., Haller, D., Hammerman, C., Heimbach, J.T., Hörmannsperger, G. and Huys, G., 2010. Safety assessment of probiotics for human use. Gut microbes, 1(3), pp.164-185.

[22] Snydman, D.R., 2008. The safety of probiotics. Clinical infectious diseases, 46(Supplement_2), pp. S104-S111.