Andrea Zovi, Antonio Vitiello, Michela Sabbatucci, Umberto Maria Musazzi, Gianni Sagratini, Carlo Cifani, Sauro Vittori
{"title":"Food Supplements Marketed Worldwide: A Comparative Analysis Between the European and the U.S. Regulatory Frameworks.","authors":"Andrea Zovi, Antonio Vitiello, Michela Sabbatucci, Umberto Maria Musazzi, Gianni Sagratini, Carlo Cifani, Sauro Vittori","doi":"10.1080/19390211.2024.2389397","DOIUrl":"10.1080/19390211.2024.2389397","url":null,"abstract":"<p><p>In recent decades, a new health paradigm emerged which increasingly places diet and nutrition at the center of citizens' healthcare. The resulting evolution of the food market has prompted country governments to adapt their regulatory frameworks to ensure product safety and preserve the health of citizens. Dietary supplements (DS) are products which are increasingly occupying a significant market share in Western countries, contributing to meeting the nutritional and physiological needs of a large portion of the global population. Food supplements must be safe for use by the final consumer who has access to the global market, but currently they are framed by a different legislation worldwide. This search aimed of comparing the legislative frameworks currently in force in the European Union (EU) and in the United States (USA), the two main markets in which DS are purchased, to focus on the strengths, similarities and possible shortcomings, against the backdrop of a global market which often transcends the regulatory barriers of individual countries. Both in the EU and the USA, food supplements are governed by specific regulations to ensure their safety and quality. However, the regulatory approaches differ sharply in some cases. It is expected that more and more operators will launch new DS in Western markets. As a result, it is crucial for competent authorities in food safety to deepen and develop additional regulatory tools aimed to control and safeguard the DS market.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"25-40"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142107961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sepideh Barzin Tond, Sara Abolghasemi, Seyyed Hossein Khatami, Sajad Ehtiati, Tayebe Zarei, Somayyeh Shateri, Somayeh Mahmoodi Baram, Sahar Yarahmadi, Soudabeh Fallah, Farzaneh Salmani, Mohammad Reza Shahmohammadi, Nasim Khajavirad, Abbas Tafakhori, Ali Riazi, Saeed Karima
{"title":"Boswellic Acids Reduce Systemic Inflammation in Patients with Moderate COVID-19 Through Modulation of NF-κB Pathway.","authors":"Sepideh Barzin Tond, Sara Abolghasemi, Seyyed Hossein Khatami, Sajad Ehtiati, Tayebe Zarei, Somayyeh Shateri, Somayeh Mahmoodi Baram, Sahar Yarahmadi, Soudabeh Fallah, Farzaneh Salmani, Mohammad Reza Shahmohammadi, Nasim Khajavirad, Abbas Tafakhori, Ali Riazi, Saeed Karima","doi":"10.1080/19390211.2025.2468484","DOIUrl":"10.1080/19390211.2025.2468484","url":null,"abstract":"<p><p>Prevention and/or management of the dysregulated immune response in patients with COVID-19 is expected to help in the treatment of COVID-19. Boswellic acids (BAs) have great therapeutic potential because they have anti-inflammatory and immunomodulatory effects. Here, we aimed to investigate the mechanism of action of a BA formulation, Inflawell syrup, which was previously shown to be effective in reducing disease symptoms in patients who suffer from mild to moderate COVID-19. Patients with mild to moderate COVID-19 were treated with either Inflawell containing boswellic acids or a placebo for 14 days. The serum levels of inflammatory cytokines, including tumor necrosis factor-alpha (TNF-α), interleukin (IL)-8, IL-1α, IL-17, IL-1Ra, and Monocyte Chemoattractant Protein-1 (MCP-1), were measured both at study onset and on day 14 after treatment started. In addition, to further investigate the signaling pathway(s) underlying the changes in cytokine levels, we evaluated the expression of tumor necrosis factor receptor 1 (TNFR1), tumor necrosis factor receptor 2 (TNFR2), and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) p65 mRNAs and phospho-inhibitor of nuclear factor kappa B (IκB) and IκB proteins. In our study, a significant decrease in the serum levels of IL-1α (<i>p</i> < .009), IL-8 (<i>p</i> < .04), TNF-α (<i>p</i> < .0001), and MCP-1 (<i>p</i> < .007) was detected in patients treated with Inflawell. Additionally, our data revealed a decrease in phospho-IκB protein levels (<i>p</i> < .02) and NF-κB p65 mRNA levels (<i>p</i> < .002), whereas the amount of IκB protein (<i>p</i> < .01) in the Inflawell group was significantly greater than that in the placebo group. Furthermore, despite the decreasing trend in the expression of TNFR1 and TNFR2 in the Inflawell group, there was no statistically significant difference compared with that in the placebo group. In general, treatment with Inflawell syrup led to a lower level of proinflammatory cytokines and a decrease in the activity of the TNF-α/NF-κB signaling pathway.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"365-381"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143515778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maren C Podszun, Ahmad Samer Alawad, Shilpa Lingala, Nevitt Morris, Wen Chun A Huang, Yaron Rotman
{"title":"Development of Subtle Iron Deficiency During Vitamin E Treatment For Metabolic Dysfunction-Associated Steatotic Liver Disease.","authors":"Maren C Podszun, Ahmad Samer Alawad, Shilpa Lingala, Nevitt Morris, Wen Chun A Huang, Yaron Rotman","doi":"10.1080/19390211.2025.2465414","DOIUrl":"10.1080/19390211.2025.2465414","url":null,"abstract":"<p><p>Vitamin E is an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) but associated with hemorrhagic complications when used for other indications. We aimed to determine the risk of developing iron deficiency during treatment of metabolic dysfunction-associated steatotic liver disease (MASLD) with vitamin E. Iron status was monitored prospectively in 20 people with MASLD treated with 200 - 800 IU/d vitamin E (https://clinicaltrials.gov/study/NCT01792115). To gain mechanistic insights liver histology, hepatic gene expression, hepatic 4-hydroxynonenal, haptoglobin genotype and plasma vitamin E levels were assessed. We found iron deficiency to occur in 11/20 subjects (55%) after a median 11 weeks (range 4-13) of vitamin E treatment, and anemia to occur in 6 of the 11 (30% of study population) after 23 weeks (16-36). Ferritin (84.5 ± 85.2 to 47.8 ± 54.9μg/L, <i>p</i> < 0.001) and mean corpuscular volume (MCV, 86.2 ± 4.9 to 84.3±4.3fL, <i>p</i> = 0.003) significantly decreased, with a concomitant rise in red-cell distribution width (RDW, 13.4 ± 1.3 to 14.4 ± 1.9%, <i>p</i> = 0.003). A gastrointestinal bleeding source was found in 75% of subjects with complete work-up. Iron deficiency occurred in all diabetics vs. 47% of non-diabetics (<i>p</i> 0.007). Iron deficiency risk was not associated with cirrhosis, platelet count, prothrombin time, haptoglobin genotype, or plasma vitamin E level. Changes in hepatic gene expression and oxidative stress were suggestive of an extrahepatic effect. Iron deficiency resolved with appropriate care even with continued vitamin E treatment. We conclude that occult gastrointestinal bleeding and iron deficiency were frequently observed during vitamin E treatment, possibly reflecting an effect on platelet function. Close monitoring is warranted during the first months of treatment, especially in diabetics and subjects with risk factors for gastrointestinal bleeding.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"284-299"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11851352/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143441065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ruma G Singh, Fumiki Aoki, Maria Rodriguez-Palmero Seuma, Meritxell Aguilo, Motohisa Washida, Jordi Espadaler-Mazo, Huda Al-Wahsh, David C Crowley, Najla Guthrie, Malkanthi Evans, Marc Moulin, Erin D Lewis
{"title":"Efficacy of Probiotic Supplementation with <i>Lactiplantibacillus plantarum</i> Strains on Gastrointestinal Tract Function - A Randomized Controlled Trial.","authors":"Ruma G Singh, Fumiki Aoki, Maria Rodriguez-Palmero Seuma, Meritxell Aguilo, Motohisa Washida, Jordi Espadaler-Mazo, Huda Al-Wahsh, David C Crowley, Najla Guthrie, Malkanthi Evans, Marc Moulin, Erin D Lewis","doi":"10.1080/19390211.2025.2507610","DOIUrl":"10.1080/19390211.2025.2507610","url":null,"abstract":"<p><p>Gastrointestinal (GI) dysfunction in older adults may be associated with gut microbiota activity or composition changes. <i>Lactiplantibacillus plantarum</i> strains KABP031 and KABP032 have been shown to beneficially influence the frequency of bowel movements (BMs) and nutritional status in older adults. This study investigated the efficacy of this probiotic blend on defecation/stool consistency, GI symptoms, nutrient uptake, and mental well-being in older adults with occasional constipation. Subjects 50-85 years of age with infrequent BMs, straining during defecation and hard stool consistency, were randomized to either the Probiotic or Placebo group for 84 days. Changes in bowel function, GI symptoms, and stress were assessed by the daily bowel habits diary, Gastrointestinal Symptoms Rating Scale (GSRS) and the Perceived Stress Scale (PSS), respectively. Improvements in bowel movement frequency (<i>p</i> = 0.027, 95% CI: 0.22-2.39) and stool consistency (<i>p</i> = 0.002; 95% CI: 0.32-1.30) with the Probiotic were significantly greater compared to Placebo after 42 days. There was also significant decrease in the percentage of weekly BMs with a Bristol Stool Scale score of ≤2 with Probiotic vs. Placebo (-28.6% vs. -3.2%, <i>p</i> < 0.001). A significantly lower proportion of participants in the Probiotic group reported moderate stress following 84 days of supplementation compared to the Placebo group (9.4% vs. 37.9%, <i>p</i> = 0.013). Further, within-group significant improvements in stool consistency and BM frequency from baseline at days 42 and 84 were observed with the Probiotic (<i>p</i> < 0.001), but not the Placebo. The findings suggest the probiotic blend alleviated constipation symptoms and improved the mental well-being in older adults with occasional constipation.</p><p><strong>Clinical trial registry number and website: </strong>NCT04147923; https://clinicaltrials.gov/study/NCT04147923.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"549-570"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144225665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bill J Gurley, Amar G Chittiboyina, Mahmoud A ElSohly, C Ryan Yates, Bharathi Avula, Larry A Walker, Shabana I Khan, Ikhlas A Khan
{"title":"The National Center for Natural Products Research (NCNPR) at 30: A Legacy of Pioneering Research in Natural Products and Dietary Supplements.","authors":"Bill J Gurley, Amar G Chittiboyina, Mahmoud A ElSohly, C Ryan Yates, Bharathi Avula, Larry A Walker, Shabana I Khan, Ikhlas A Khan","doi":"10.1080/19390211.2024.2410758","DOIUrl":"10.1080/19390211.2024.2410758","url":null,"abstract":"<p><p>Since its establishment in 1994, the National Center for Natural Products Research (NCNPR) at the University of Mississippi has made notable contributions to the field of natural product research, coinciding with the passage of the Dietary Supplement Health and Education Act. Over the past three decades, the Center has focused on studying plants, herbs, and other natural materials for applications in medicine, agriculture, and nutraceuticals, particularly in the area of botanical dietary supplements. NCNPR scientists have been actively engaged in developing and improving quality control measures to help ensure the safety of dietary supplements in response to a growing market. The Center's research efforts have led to its designation as a U.S. Food and Drug Administration Center of Excellence, reflecting its role in advancing scientific understanding of natural products. Through collaborations with various stakeholders and regulators, NCNPR has contributed to shaping the regulatory landscape for botanical dietary supplements, highlighting both their potential health benefits and associated risks, such as product adulteration. The Center's influence is also evident internationally, as demonstrated by its annual International Conference on the Science of Botanicals, which will mark its 26th year in April 2025. This overview outlines NCNPR's role in supporting research, regulation, and safety in the natural products field.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"193-218"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Regulatory Challenges of Placing Dietary Ingredients on the European and US Market.","authors":"M J Tallon, D S Kalman","doi":"10.1080/19390211.2024.2308261","DOIUrl":"10.1080/19390211.2024.2308261","url":null,"abstract":"<p><p>The DSHEA is 30 years old and its place in providing legitimate protections for public health through relevant agency oversight has created a patchwork of legal and scientific requirements. In contrast, the European Union has rules on supplements and permitted ingredients. Given the context of a global supply chain for food ingredients any conflict between the legality of ingredients between the U.S/EU can inhibit the economic viability of international trade. The purpose of this review is to contrast these different systems of legislative oversight. The analysis of both markets demonstrates a fragmentation in what are considered legal food ingredients between country wide harmonization and state rules and related interpretation. There are many commonalities in this regard between the U.S/EU, from borderline medicinal classifications to their resultant preclusion from food use. However, the codified legal system existing within the EU and excessive guidance can be viewed as time consuming and inflexible, especially for placing new ingredients on the market. The US in contrast is in a holding pattern for legislative interpretation regarding NDIs, GRAS and possible drug preclusion laws. As we hit the anniversary of the DSHEA recent commentary from U.S./EU central authorities point to increased international co-operation in ingredient safety assessments but whether this results in friction-free access between markets is to be determined.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"9-24"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139545716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alexander J Layman, Scott M Alsbrook, Igor K Koturbash, Mitchell R McGill
{"title":"Natural Products That Protect Against Acetaminophen Hepatotoxicity: A Call for Increased Rigor in Preclinical Studies of Dietary Supplements.","authors":"Alexander J Layman, Scott M Alsbrook, Igor K Koturbash, Mitchell R McGill","doi":"10.1080/19390211.2024.2335573","DOIUrl":"10.1080/19390211.2024.2335573","url":null,"abstract":"<p><p>Acetaminophen (APAP) overdose is one of the most common causes of acute liver injury. The current standard-of-care treatment for APAP hepatotoxicity, <i>N</i>-acetyl-<i>l</i>-cysteine, is highly effective when administered early after overdose, but loses efficacy in later-presenting patients. As a result, there is interest in the identification of new treatments for APAP overdose patients. Natural products are a promising source of new treatments because many are purported to have hepatoprotective effects. In fact, a great deal of research has been done to identify natural products that can protect against APAP-induced liver injury. However, serious concerns have been raised about the rigor and human relevance of these studies. Here, we systematically reviewed the APAP-natural product literature from 2013 to 2023 to determine the veracity of these concerns and the scope of the potential problem. The results substantiate the concerns that have been previously raised and point to concrete steps that can be taken to improve APAP-natural product research.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"105-122"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11442681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140335846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jenil Patel, Omobola O Oluwafemi, Maria D Politis, Wendy N Nembhard
{"title":"The Association Between Dietary Supplement Use and COVID-19 Symptoms.","authors":"Jenil Patel, Omobola O Oluwafemi, Maria D Politis, Wendy N Nembhard","doi":"10.1080/19390211.2025.2450457","DOIUrl":"10.1080/19390211.2025.2450457","url":null,"abstract":"<p><p>The scientific evidence supporting recommendations for dietary supplement use to prevent or treat coronavirus disease 2019 (COVID‑19) is not well‑established. This cohort study investigates the relationship between dietary supplement usage and COVID‑19 symptoms among 27,181 adults tested for COVID‑19. Using data from surveys following COVID‑19 testing, conducted by the University of Arkansas for Medical Sciences, associations between dietary supplement usage, symptomatology, and COVID‑19 status were explored. The prevalence of supplement consumption among symptomatic individuals was significant, with non‑Hispanic (NH)‑White individuals showing higher usage rates. Among those testing positive for COVID‑19, mainly asymptomatic cases, dietary supplement usage was increased (7.8%), suggesting a proactive approach to supplementation. Symptomatic individuals with confirmed COVID‑19 also showed heightened dietary supplement usage (37.9%), indicating a response to perceived therapeutic benefits. Notably, respiratory symptoms such as cough (46.2%), fever (31.4%), and shortness of breath (8.9%) correlated consistently with increased dietary supplement usage across different time points. Despite limitations such as varying test sensitivities and potential selection biases, this study offers valuable insights into individual health‑seeking behaviors during the pandemic. Findings emphasize the importance of targeted public health interventions and education to address disparities in dietary supplement usage and promote evidence‑based approaches to dietary supplementation. Further research is warranted to understand better the motivations and implications of dietary supplement usage in the context of the pandemic.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"262-273"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hee-Sung Chae, Nessma H Ahmed, Olivia R Dale, Bharathi Avula, Ikhlas A Khan, Shabana I Khan
{"title":"Damiana (<i>Turnera diffusa</i>) Reduces Adipocyte Cell Differentiation and Ameliorates Myocyte Glucose Uptake.","authors":"Hee-Sung Chae, Nessma H Ahmed, Olivia R Dale, Bharathi Avula, Ikhlas A Khan, Shabana I Khan","doi":"10.1080/19390211.2025.2480582","DOIUrl":"10.1080/19390211.2025.2480582","url":null,"abstract":"<p><p><i>Turnera diffusa</i> Willd. ex Schult. leaf has been used in traditional medicine as an aphrodisiac, tonic, and in the management of diabetes. Based on the traditional use and recent evidence of antidiabetic activity, we investigated the effects of a 95% ethanolic extract of <i>T. diffusa</i> leaf (TDE) on a series of ligand-activated transcription factors, namely PPARα, PPARγ, LXR and NRF2, which are involved in the regulation of metabolic pathways associated with obesity, diabetes and inflammation. Further, the effects of TDE on α-glucosidase enzyme, lipid accumulation in adipocytes (adipogenesis) and glucose uptake in myocytes were also evaluated. Phytochemical analysis of TDE was performed by mass spectrometry. TDE (50 μg/mL) demonstrated a strong agonistic effect on LXR (2.7-fold) and NRF2 (21.6-fold), while the activation of PPARα, and PPARγ was in the range of 1.4-1.8-folds under similar experimental conditions. At a concentration of 100 μg/mL TDE decreased lipid accumulation in adipocytes by 55.3% and increased glucose uptake in muscle cells by 91.3%. The adipogenic effect induced by a full PPARγ agonist (rosiglitazone) was antagonized by TDE showing a decrease of 57.6% in lipid accumulation. This is the first report to reveal the agonistic action of TDE on multiple nuclear receptors along with its glucose uptake enhancing and antiadipogenic effects. The results indicate the potential utility of TDE in alleviating the symptoms of metabolic syndrome and in preventing the undesired adipogenic effects of antidiabetic drugs of the glitazone class. Phytochemical analysis of TDE indicated the presence of flavonoids as major constituents. Further studies in animal models of type II diabetes and obesity are warranted to explore its utility as an anti-diabetic and anti-obesity supplement.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"401-416"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143692228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"DSHEA 1994 - Celebrating 30 Years of Dietary Supplement Regulation in the United States.","authors":"Taylor C Wallace, Igor Koturbash","doi":"10.1080/19390211.2024.2419434","DOIUrl":"10.1080/19390211.2024.2419434","url":null,"abstract":"<p><p>The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined the FDA's statutory authority to regulate dietary supplement products as a category of food in the United States. As we celebrate 30 years post-DSHEA, it is important to reflect on its significance for public health, influence on the continuously evolving and expanding product category, the current regulatory framework, and potential opportunities or modernizing oversight to ensure a strong and well-regulated marketplace. An estimated three-fourths of U.S. consumers report use of dietary supplements, and the product market has grown substantially since the passage of DSHEA, from approximately 4,000 products in 1994 to 80,000+ present day. This growth represents a current $60 billion domestic and $200 billion international market for dietary supplements. Scientists, public health officials, health care providers, patients, consumer advocacy organizations, and the U.S. Food and Drug Administration have all called for reform to what has been described as 'outdated' regulation of dietary supplements. Advancing at an even faster rate is published scientific evidence in the space. This special issue of the Journal of Dietary Supplements comprises a collection of articles authored by academicians, legal scholars, representatives of U.S. government agencies, and industry scientists that critically examine the successes, challenges, and opportunities for improving specific aspects of DSHEA and domestic health policy. This editorial provides historical context and milestones of dietary supplement regulation in the U.S. post-DSHEA and offers an overview of the research contained within the special issue. Advancing toward a more transparent and safer marketplace requires trustworthy supply chains, increased adherence to quality standards, additional labeling requirements, and enhancement of post-market surveillance. This special issue seeks to contribute to the broader understanding of dietary supplement regulation and its future direction.</p>","PeriodicalId":15646,"journal":{"name":"Journal of Dietary Supplements","volume":" ","pages":"1-8"},"PeriodicalIF":1.9,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142501632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}