Reforming Food, Drug, and Nutraceutical Regulations to Improve Public Health and Reduce Healthcare Costs

DOI record: { "DOI": "10.3390/foods14132328", "ISSN": [ "2304-8158" ], "URL": "http://dx.doi.org/10.3390/foods14132328", "abstract": "<jats:p>Neglecting preventive healthcare policies has contributed to the global surge in chronic diseases, increased hospitalizations, declining quality of care, and escalating costs. Non-communicable diseases (NCDs)—notably cardiovascular conditions, diabetes, and cancer—consume over 80% of healthcare expenditure and account for more than 60% of global deaths, which are projected to exceed 75% by 2030. Poor diets, sedentary lifestyles, regulatory loopholes, and underfunded public health initiatives are driving this crisis. Compounding the issue are flawed policies, congressional lobbying, and conflicts of interest that prioritize costly, hospital-based, symptom-driven care over identifying and treating to eliminate root causes and disease prevention. Regulatory agencies are failing to deliver their intended functions. For instance, the U.S. Food and Drug Administration’s (FDA) broad oversight across drugs, devices, food, and supplements has resulted in inefficiencies, reduced transparency, and public safety risks. This broad mandate has allowed the release of unsafe drugs, food additives, and supplements, contributing to the rising childhood diseases, the burden of chronic illness, and over-medicalization. The author proposes separating oversight responsibilities: transferring authority over food, supplements, and OTC products to a new Food and Nutraceutical Agency (FNA), allowing the FDA to be restructured as the Drug and Device Agency (DDA), to refocus on pharmaceuticals and medical devices. While complete reform requires Congressional action, interim policy shifts are urgently needed to improve public health. Broader structural changes—including overhauling the Affordable Care Act, eliminating waste and fraud, redesigning regulatory and insurance systems, and eliminating intermediaries are essential to reducing costs, improving care, and transforming national and global health outcomes. The information provided herein can serve as a White Paper to help reform health agencies and healthcare systems for greater efficiency and lower costs in the USA and globally.</jats:p>", "alternative-id": [ "foods14132328" ], "author": [ { "ORCID": "https://orcid.org/0000-0003-1096-8595", "affiliation": [ { "name": "CardioMetabolic & Endocrine Institute, North Brunswick, NJ 08902, USA" } ], "authenticated-orcid": false, "family": "Wimalawansa", "given": "Sunil J.", "sequence": "first" } ], "container-title": "Foods", "container-title-short": "Foods", "content-domain": { "crossmark-restriction": false, "domain": [] }, "created": { "date-parts": [ [ 2025, 6, 30 ] ], "date-time": "2025-06-30T14:03:48Z", "timestamp": 1751292228000 }, "deposited": { "date-parts": [ [ 2025, 7, 2 ] ], "date-time": "2025-07-02T04:30:10Z", "timestamp": 1751430610000 }, "indexed": { "date-parts": [ [ 2025, 7, 3 ] ], "date-time": "2025-07-03T04:02:30Z", "timestamp": 1751515350402, "version": "3.41.0" }, "is-referenced-by-count": 0, "issue": "13", "issued": { "date-parts": [ [ 2025, 6, 30 ] ] }, "journal-issue": { "issue": "13", "published-online": { "date-parts": [ [ 2025, 7 ] ] } }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 6, 30 ] ], "date-time": "2025-06-30T00:00:00Z", "timestamp": 1751241600000 } } ], "link": [ { "URL": "https://www.mdpi.com/2304-8158/14/13/2328/pdf", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "1968", "original-title": [], "page": "2328", "prefix": "10.3390", "published": { "date-parts": [ [ 2025, 6, 30 ] ] }, "published-online": { "date-parts": [ [ 2025, 6, 30 ] ] }, "publisher": "MDPI AG", "reference": [ { "article-title": "Drivers of health care costs: A physicians foundation white paper—Second of a three-part series", "author": "Norbeck", "first-page": "113", "journal-title": "Mo. Med.", "key": "ref_1", "volume": "110", "year": "2013" }, { "DOI": "10.1080/17538068.2025.2469387", "article-title": "Evidence-based medicine concepts for patients: Improving shared decision-making", "author": "Faggion", "doi-asserted-by": "crossref", "first-page": "1", "journal-title": "J. Commun. Healthc.", "key": "ref_2", "volume": "6", "year": "2025" }, { "DOI": "10.1016/j.jnutbio.2013.02.009", "article-title": "Lifestyle and nutritional imbalances associated with Western diseases: Causes and consequences of chronic systemic low-grade inflammation in an evolutionary context", "author": "Pruimboom", "doi-asserted-by": "crossref", "first-page": "1183", "journal-title": "J. Nutr. Biochem.", "key": "ref_3", "volume": "24", "year": "2013" }, { "DOI": "10.3390/jcm11195950", "doi-asserted-by": "crossref", "key": "ref_4", "unstructured": "Elma, O., Brain, K., and Dong, H.J. (2022). The Importance of nutrition as a lifestyle factor in chronic pain management: A narrative review. J. Clin. Med., 11." }, { "DOI": "10.1016/j.mayocpiqo.2023.08.005", "article-title": "The burden of chronic disease", "author": "Hacker", "doi-asserted-by": "crossref", "first-page": "112", "journal-title": "Mayo Clin. Proc. Innov. Qual. Outcomes", "key": "ref_5", "volume": "8", "year": "2024" }, { "key": "ref_6", "unstructured": "Amin, K., Cox, C., Ortaliza, J., and Wager, E. (2024, December 12). Health Care Costs and Affordability: Health Policy 101. Available online: https://www.kff.org/health-policy-101-health-care-costs-and-affordability/?entry=table-of-contents-introduction." }, { "key": "ref_7", "unstructured": "Yong, P.L., and Olsen, L.A. (2010). Missed Prevention Opportunities: Roundtable on Evidence-Based Medicine, National Academies Press. Institute of Medicine (US)." }, { "key": "ref_8", "unstructured": "(2025, February 10). Why Healthcare Should Shift from Reactive to Proactive. Available online: https://essentialhealth.health/why-healthcare-should-shift-from-reactive-to-proactive/." }, { "DOI": "10.1002/cpt.1295", "article-title": "Health care evolves from reactive to proactive", "author": "Waldman", "doi-asserted-by": "crossref", "first-page": "10", "journal-title": "Clin. Pharmacol. Ther.", "key": "ref_9", "volume": "105", "year": "2019" }, { "DOI": "10.1186/s40001-023-01162-y", "article-title": "Nanocrystal-induced chronic tubular-nephropathy in tropical countries: Diagnosis, mitigation, and eradication", "author": "Wimalawansa", "doi-asserted-by": "crossref", "first-page": "221", "journal-title": "Eur. J. Med. Res.", "key": "ref_10", "volume": "28", "year": "2023" }, { "DOI": "10.3945/jn.114.194571", "article-title": "Inflammation and nutritional science for programs/policies and interpretation of research evidence (INSPIRE)", "author": "Raiten", "doi-asserted-by": "crossref", "first-page": "1039S", "journal-title": "J. Nutr.", "key": "ref_11", "volume": "145", "year": "2015" }, { "DOI": "10.1111/all.15972", "article-title": "Nutrition in chronic inflammatory conditions: Bypassing the mucosal block for micronutrients", "author": "Peroni", "doi-asserted-by": "crossref", "first-page": "353", "journal-title": "Allergy", "key": "ref_12", "volume": "79", "year": "2024" }, { "key": "ref_13", "unstructured": "NIEHS (2025, February 15). Nutrition, Health, and Your Environment, Available online: https://www.niehs.nih.gov/health/topics/nutrition." }, { "DOI": "10.3390/nu14163329", "doi-asserted-by": "crossref", "key": "ref_14", "unstructured": "Narimatsu, H., and Yaguchi, Y.T. (2022). The role of diet and nutrition in cancer: Prevention, treatment, and survival. Nutrients, 14." }, { "DOI": "10.1017/S0007114518002222", "article-title": "Nutrition and cancer: Prevention and survival", "author": "Wiseman", "doi-asserted-by": "crossref", "first-page": "481", "journal-title": "Br. J. Nutr.", "key": "ref_15", "volume": "122", "year": "2019" }, { "DOI": "10.3390/nu17020277", "doi-asserted-by": "crossref", "key": "ref_16", "unstructured": "Grant, W., Wimalawansa, S.J., Pludowski, P., and Cheng, R. (2025). Vitamin D: Evidence-based health benefits and recommendations for population guidelines. Nutrients, 17." }, { "DOI": "10.3390/nu16223969", "doi-asserted-by": "crossref", "key": "ref_17", "unstructured": "Wimalawansa, S.J., Weiss, S.T., and Hollis, B.W. (2024). Integrating Endocrine, Genomic, and Extra-Skeletal Benefits of Vitamin D into National and Regional Clinical Guidelines. Nutrients, 16." }, { "DOI": "10.1016/j.immuni.2022.01.004", "article-title": "Control of immunity via nutritional interventions", "author": "Collins", "doi-asserted-by": "crossref", "first-page": "210", "journal-title": "Immunity", "key": "ref_18", "volume": "55", "year": "2022" }, { "DOI": "10.1016/j.heliyon.2024.e39471", "article-title": "From inflammation to immune regulation: The dual nature of dietary lectins in health and disease", "author": "Konozy", "doi-asserted-by": "crossref", "first-page": "e39471", "journal-title": "Heliyon", "key": "ref_19", "volume": "10", "year": "2024" }, { "DOI": "10.3390/nu14142997", "doi-asserted-by": "crossref", "key": "ref_20", "unstructured": "Wimalawansa, S.J. (2022). Rapidly Increasing Serum 25(OH)D Boosts the Immune System, against Infections-Sepsis and COVID-19. Nutrients, 14." }, { "DOI": "10.3390/nu15173842", "doi-asserted-by": "crossref", "key": "ref_21", "unstructured": "Wimalawansa, S.J. (2023). Infections and autoimmunity-The immune system and vitamin D: A systematic review. Nutrients, 15." }, { "DOI": "10.3390/environments7010002", "doi-asserted-by": "crossref", "key": "ref_22", "unstructured": "Wimalawansa, S.J., and Dissanayake, C.B. (2019). Factors Affecting the Environmentally Induced, Chronic Kidney Disease of Unknown Aetiology in Dry Zonal Regions in Tropical Countries—Novel Findings. Environments, 7." }, { "DOI": "10.3390/nu17030454", "doi-asserted-by": "crossref", "key": "ref_23", "unstructured": "Razzaque, M., and Wimalawansa, S.J. (2025). Minerals and human health: From deficiency to toxicity. Nutrients, 17." }, { "DOI": "10.1177/21501319231186500", "article-title": "Unveiling the significance and challenges of integrating prevention Levels in healthcare practice", "author": "AbdulRaheem", "doi-asserted-by": "crossref", "first-page": "21501319231186500", "journal-title": "J. Prim. Care Community Health", "key": "ref_24", "volume": "14", "year": "2023" }, { "DOI": "10.1007/s00394-021-02507-1", "article-title": "Dietary fat intakes and cardiovascular disease risk in adults with type 2 diabetes: A systematic review and meta-analysis", "author": "Schwab", "doi-asserted-by": "crossref", "first-page": "3355", "journal-title": "Eur. J. Nutr.", "key": "ref_25", "volume": "60", "year": "2021" }, { "DOI": "10.1038/s41392-024-01771-x", "article-title": "Effects of dietary intervention on human diseases: Molecular mechanisms and therapeutic potential", "author": "Xiao", "doi-asserted-by": "crossref", "first-page": "59", "journal-title": "Signal Transduct. Target. Ther.", "key": "ref_26", "volume": "9", "year": "2024" }, { "key": "ref_27", "unstructured": "IFWH (2024, November 19). Primary, Secondary and Tertiary Prevention. Available online: https://www.iwh.on.ca/what-researchers-mean-by/primary-secondary-and-tertiary-prevention." }, { "DOI": "10.1177/0020731420966976", "article-title": "For-profit hospitals have thrived because of generous public reimbursement schemes, Not greater efficiency: A multi-country case study", "author": "Jeurissen", "doi-asserted-by": "crossref", "first-page": "67", "journal-title": "Int. J. Health Serv. Plan. Adm. Eval.", "key": "ref_28", "volume": "51", "year": "2021" }, { "DOI": "10.1016/S0140-6736(20)30925-9", "article-title": "Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: A systematic analysis for the Global Burden of Disease Study 2019", "author": "Diseases", "doi-asserted-by": "crossref", "first-page": "1204", "journal-title": "Lancet", "key": "ref_29", "volume": "396", "year": "2020" }, { "key": "ref_30", "unstructured": "Remington, R., Axelrod, D., Bingham, E., Boyle, J., Breslow, L., Citrin, T., Evans, J.R., Grumbach, M.M., Haggerty, R.J., and Harmon, R. (1988). The Future of Public Health: Public Health as a Problem-Solving Activity: Barriers to Effective Action, Institute of Medicine (US)." }, { "DOI": "10.5888/pcd21.230267", "article-title": "Chronic disease prevalence in the US: Sociodemographic and geographic variations by Zip code tabulation area", "author": "Benavidez", "doi-asserted-by": "crossref", "first-page": "230267", "journal-title": "Prev. Chronic Dis.", "key": "ref_31", "volume": "21", "year": "2024" }, { "article-title": "Vitamin D supplements appropriate for preventing osteoporosis?—Vitamin D supplements only in case of deficiency and as a partial aspect of osteoporosis prevention", "author": "Zittermann", "first-page": "416", "journal-title": "Dtsch. Med. Wochenschr.", "key": "ref_32", "volume": "139", "year": "2014" }, { "key": "ref_33", "unstructured": "Wimalawansa, S. (2024, June 05). Part 1-5: Vitamin D: Everything You Need Know… and More. Available online: https://www.grassrootshealth.net/blog/vitamin-d-everything-need-know/." }, { "DOI": "10.1146/annurev.food.102308.124147", "article-title": "Nutrigenomics and personalized diets: What will they mean for food?", "author": "German", "doi-asserted-by": "crossref", "first-page": "97", "journal-title": "Annu. Rev. Food Sci. Technol.", "key": "ref_34", "volume": "2", "year": "2011" }, { "key": "ref_35", "unstructured": "Hilzenrath, D. (2025, February 15). Drug Money: FDA Depends on Industry Funding; Money Comes with “Strings Attached”. Available online: https://www.pogo.org/investigations/fda-depends-on-industry-funding-money-comes-with-strings-attached." }, { "DOI": "10.3389/fpubh.2024.1339859", "doi-asserted-by": "crossref", "key": "ref_36", "unstructured": "Matthews, E.D., and Kurnat-Thoma, E.L. (2024). U.S. food policy to address diet-related chronic disease. Front. Public Health, 12." }, { "DOI": "10.1177/0141076818815510", "article-title": "Artificial intelligence-enabled healthcare delivery", "author": "Reddy", "doi-asserted-by": "crossref", "first-page": "22", "journal-title": "J. R. Soc. Med.", "key": "ref_37", "volume": "112", "year": "2019" }, { "DOI": "10.3390/bioengineering11040337", "doi-asserted-by": "crossref", "key": "ref_38", "unstructured": "Maleki Varnosfaderani, S., and Forouzanfar, M. (2024). The role of AI in hospitals and clinics: Transforming tealthcare in the 21st century. Bioengineering, 11." }, { "key": "ref_39", "unstructured": "Lee, H.-F. (2025, January 15). COVID-19 Will Accelerate the AI Health Care Revolution. Available online: https://www.wired.com/story/covid-19-will-accelerate-ai-health-care-revolution/?utm_source=chatgpt.com." }, { "DOI": "10.1186/s43556-024-00238-3", "doi-asserted-by": "crossref", "key": "ref_40", "unstructured": "Gawande, M.S., Zade, N., Kumar, P., Gundewar, S., Weerarathna, I.N., and Verma, P. (2025). The role of artificial intelligence in pandemic responses: From epidemiological modeling to vaccine development. Mol. Biomed., 6." }, { "DOI": "10.3390/nu12020334", "doi-asserted-by": "crossref", "key": "ref_41", "unstructured": "Cena, H., and Calder, P.C. (2020). Defining a healthy diet: Evidence for the role of contemporary dietary patterns in health and disease. Nutrients, 12." }, { "key": "ref_42", "unstructured": "Espinosa-Salas, S., and Gonzalez-Arias, M. (2025). Nutrition: Macronutrient intake, imbalances, and interventions. StatPearls, StatPearls." }, { "DOI": "10.3390/nu16162673", "doi-asserted-by": "crossref", "key": "ref_43", "unstructured": "Singar, S., Nagpal, R., Arjmandi, B.H., and Akhavan, N.S. (2024). Personalized nutrition: Tailoring dietary recommendations through genetic insights. Nutrients, 16." }, { "key": "ref_44", "unstructured": "Noah, L. (1999). Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies: Workshop Summary [Appendix A-Legal Aspects of the Food Additive Approval Process], Institute of Medicine (US) Food Forum." }, { "key": "ref_45", "unstructured": "United States Congress (2025, March 29). The Delaney Clause Is Incorporated into the Food and Color Additive Provisions of the Food, Drug, and Cosmetic Act (FDCA or the Act): FDCA § 409(c)(3)(A), 21 U.S.C. § 348(c)(3)(A) (Food Additives); FDCA § 721(b)(5)(B), 21 U.S.C. § 379e(b)(5)(B) (Color Additives), Available online: https://uscode.house.gov/view.xhtml?req=(title:21%20section:348%20edition:prelim)#:~:text=(A)%20by%20order%20establish%20a,reasons%20for%20such%20action;%20or." }, { "key": "ref_46", "unstructured": "Armstrong, S., and Dunaif, G.E. (2024, November 18). Food Additive Reform: Time to Repeal the Delaney Clause?. Available online: https://www.fdli.org/2019/02/food-additive-reform-time-to-repeal-the-delaney-clause/." }, { "key": "ref_47", "unstructured": "FDA (2025, February 04). FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs, Available online: https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs#:~:text=The%20FDA%20is%20amending%20its,a%202022%20color%20additive%20petition." }, { "key": "ref_48", "unstructured": "Goldstein, Z. (2025, February 10). Titanium Dioxide: Why FDA Should Ban This Harmful Additive. Available online: https://www.cspinet.org/cspi-news/titanium-dioxide-why-fda-should-ban-harmful-additive." }, { "key": "ref_49", "unstructured": "Knisely, A. (2025, March 31). Governor Signs Bill Banning SOME artificial Dyes in Food Sold in West Virginia. Available online: https://scdailygazette.com/2025/03/31/governor-signs-bill-banning-some-artificial-dyes-in-food-sold-in-west-virginia/#:~:text=West%20Virginia%20Gov.%20Patrick%20Morrisey,dyes%20are%20unnecessary%20and%20harmful." }, { "DOI": "10.1186/s12989-021-00421-2", "article-title": "Titanium dioxide particles from the diet: Involvement in the genesis of inflammatory bowel diseases and colorectal cancer", "author": "Barreau", "doi-asserted-by": "crossref", "first-page": "26", "journal-title": "Part. Fibre Toxicol.", "key": "ref_50", "volume": "18", "year": "2021" }, { "DOI": "10.3389/fnut.2019.00057", "doi-asserted-by": "crossref", "key": "ref_51", "unstructured": "Pinget, G., Tan, J., Janac, B., Kaakoush, N.O., Angelatos, A.S., O’Sullivan, J., Koay, Y.C., Sierro, F., Davis, J., and Divakarla, S.K. (2019). Impact of the food additive titanium gioxide (E171) on gut microbiota-host interaction. Front. Nutr., 6." }, { "key": "ref_52", "unstructured": "Sheikh, Z. (2024, November 09). What Is Titanium Dioxide?. Available online: https://www.webmd.com/diet/titanium-dioxide-in-food." }, { "key": "ref_53", "unstructured": "FDA (2014, November 08). Parabens in Cosmetics, Available online: https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics#:~:text=Parabens%20are%20a%20family%20of,both%20the%20products%20and%20consumers." }, { "key": "ref_54", "unstructured": "Minassian, L. (2025, March 05). 12 Banned Foods Americans Should Stop Eating. Available online: https://foodrevolution.org/blog/banned-ingredients-in-other-countries/." }, { "DOI": "10.1016/j.scitotenv.2024.176547", "article-title": "Parabens as the double-edged sword: Understanding the benefits and potential health risks", "author": "Chatterjee", "doi-asserted-by": "crossref", "first-page": "176547", "journal-title": "Sci. Total Environ.", "key": "ref_55", "volume": "954", "year": "2024" }, { "DOI": "10.1210/endocr/bqad007", "article-title": "Chronic exposure to low levels of parabens increases mammary cancer growth and metastasis in mice", "author": "Tong", "doi-asserted-by": "crossref", "first-page": "bqad007", "journal-title": "Endocrinology", "key": "ref_56", "volume": "164", "year": "2023" }, { "key": "ref_57", "unstructured": "Moreschio, A., and Aaron, N. (2025, March 10). Concern Over Food Additives Banned in Europe but Not US. Available online: https://cbsaustin.com/news/nation-world/concern-over-food-additives-banned-in-europe-but-not-us-health-fitness-eating-drinking-diet-ingredients-cancer-treatments-illness-sickness-chemicals-candy-groceries-shopping." }, { "key": "ref_58", "unstructured": "Conley, M. (2024, November 27). Potassium Bromate: 50 Years of Research Shows Serious Health Risks. Available online: https://usrtk.org/chemicals/potassium-bromate/." }, { "article-title": "Toxicity and carcinogenicity of potassium bromate—A new renal carcinogen", "author": "Kurokawa", "first-page": "309", "journal-title": "Environ. Health Perspect.", "key": "ref_59", "volume": "87", "year": "1990" }, { "key": "ref_60", "unstructured": "Anderson, E., and Zagorski, J. (2014, November 09). Trending Brominated Vegetable Oil (BVO). Available online: https://www.canr.msu.edu/news/trending-brominated-vegetable-oil-bvo#:~:text=Bromine%20is%20added%20to%20vegetable%20oil%20to,bromine)%20can%20accumulate%20in%20the%20body%20tissues." }, { "key": "ref_61", "unstructured": "FDA (2024, November 12). FDA Revokes Regulation Allowing the Use of Brominated Vegetable Oil (BVO) in Food, Available online: https://www.fda.gov/food/hfp-constituent-updates/fda-revokes-regulation-allowing-use-brominated-vegetable-oil-bvo-food." }, { "article-title": "Nitrosation of tertiary amines and some biologic implications", "author": "Lijinsky", "first-page": "1239", "journal-title": "J. Natl. Cancer Inst.", "key": "ref_62", "volume": "49", "year": "1972" }, { "DOI": "10.1016/S0309-1740(02)00270-X", "article-title": "Meat nitrosamine contamination level depending on animal breeding factors", "author": "Rywotycki", "doi-asserted-by": "crossref", "first-page": "669", "journal-title": "Meat Sci.", "key": "ref_63", "volume": "65", "year": "2003" }, { "DOI": "10.1038/225021a0", "article-title": "Nitrosamines as environmental carcinogens", "author": "Lijinsky", "doi-asserted-by": "crossref", "first-page": "21", "journal-title": "Nature", "key": "ref_64", "volume": "225", "year": "1970" }, { "DOI": "10.1016/0304-3835(95)03786-V", "article-title": "Role of N-nitroso compounds (NOC) and N-nitrosation in etiology of gastric, esophageal, nasopharyngeal and bladder cancer and contribution to cancer of known exposures to NOC", "author": "Mirvish", "doi-asserted-by": "crossref", "first-page": "17", "journal-title": "Cancer Lett.", "key": "ref_65", "volume": "93", "year": "1995" }, { "DOI": "10.1007/978-981-13-6260-6_2", "article-title": "Environmental aldehyde sources and the health implications of exposure", "author": "Sinharoy", "doi-asserted-by": "crossref", "first-page": "35", "journal-title": "Adv. Exp. Med. Biol.", "key": "ref_66", "volume": "1193", "year": "2019" }, { "key": "ref_67", "unstructured": "Gerhards, P. (2025, March 15). Unveiling the Aadvanced Workflow for PAH Analysis in Smoke Flavored Foods. Available online: https://www.thermofisher.com/blog/analyteguru/unveiling-the-advanced-workflow-for-pah-analysis-in-smoke-flavored-foods/." }, { "DOI": "10.3390/cells12060879", "doi-asserted-by": "crossref", "key": "ref_68", "unstructured": "Hikisz, P., and Jacenik, D. (2023). The tobacco smoke component, acrolein, as a major culprit in lung diseases and respiratory cancers: Molecular mechanisms of acrolein cytotoxic activity. Cells, 12." }, { "DOI": "10.1016/S1470-2045(15)00444-1", "article-title": "Carcinogenicity of consumption of red and processed meat", "author": "Bouvard", "doi-asserted-by": "crossref", "first-page": "1599", "journal-title": "Lancet Oncol.", "key": "ref_69", "volume": "16", "year": "2015" }, { "DOI": "10.1016/j.heliyon.2024.e34691", "article-title": "Unlocking insights: Navigating COVID-19 challenges and Emulating future pandemic Resilience strategies with strengthening natural immunity", "author": "Wimalawansa", "doi-asserted-by": "crossref", "first-page": "e34691", "journal-title": "Heliyon", "key": "ref_70", "volume": "10", "year": "2024" }, { "DOI": "10.53346/wjapls.2023.5.2.0080", "article-title": "The impact of withholding cost-effective early treatments, such as vitamin D, on COVID-19: An analysis using an innovative logical paradigm", "author": "Polonowita", "doi-asserted-by": "crossref", "first-page": "013", "journal-title": "World J. Adv. Pharma Life Sci.", "key": "ref_71", "volume": "5", "year": "2023" }, { "article-title": "Molecular quantum and logic process of consciousness—Vitamin D big-data in COVID-19—A case for incorporating machine learning in medicine", "author": "Polonowita", "first-page": "24", "journal-title": "Eur. J. Parenter. Pharm. Sci.", "key": "ref_72", "volume": "10", "year": "2023" }, { "DOI": "10.1016/j.socscimed.2017.12.005", "article-title": "Understanding and misunderstanding randomized controlled trials", "author": "Deaton", "doi-asserted-by": "crossref", "first-page": "2", "journal-title": "Soc. Sci. Med.", "key": "ref_73", "volume": "210", "year": "2018" }, { "DOI": "10.3390/nu16111666", "doi-asserted-by": "crossref", "key": "ref_74", "unstructured": "Wimalawansa, S.J. (2024). Physiology of Vitamin D-Focusing on Disease Prevention. Nutrients, 16." }, { "DOI": "10.1093/nutrit/nuae164", "article-title": "Enhancing the design of nutrient clinical trials for disease prevention—A focus on vitamin D: A systematic review", "author": "Wimalawansa", "doi-asserted-by": "crossref", "first-page": "1", "journal-title": "Nutr. Rev.", "key": "ref_75", "volume": "83", "year": "2025" }, { "DOI": "10.1111/jep.12960", "article-title": "The use of mechanistic evidence in drug approval", "author": "Aronson", "doi-asserted-by": "crossref", "first-page": "1166", "journal-title": "J. Eval. Clin. Pract.", "key": "ref_76", "volume": "24", "year": "2018" }, { "DOI": "10.3389/fmed.2025.1513119", "doi-asserted-by": "crossref", "key": "ref_77", "unstructured": "Pereza, N., Hauser, G., Devic Pavlic, S., Maric, I., Sotosek, V., Grgasovic, T., and Mrsic-Pelcic, J. (2025). How to create a faculty development program that transforms medical education according to actual institutional needs: Evidence-based approach and experience at the University of Rijeka, Faculty of Medicine, Croatia. Front. Med., 12." }, { "DOI": "10.3390/nu17030599", "doi-asserted-by": "crossref", "key": "ref_78", "unstructured": "Wimalawansa, S.J. (2025). Vitamin D deficiency meets Hill’s criteria for causation in SARS-CoV-2 susceptibility, complications, and mortality: A systematic review. Nutrients, 17." }, { "DOI": "10.3390/biomedicines11061542", "doi-asserted-by": "crossref", "key": "ref_79", "unstructured": "Wimalawansa, S.J. (2023). Physiological Basis for Using Vitamin D to Improve Health. Biomedicines, 11." }, { "key": "ref_80", "unstructured": "Sertkaya, A., Birkenbach, A., Berlind, A., and Eyraud, J. (2025, February 15). Examination of Clinical Trial Costs and Barriers for Drug Development, Available online: https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0." }, { "key": "ref_81", "unstructured": "Sears, R. (2025, January 07). How Evidence Based Medicine Became an Illusion. Available online: https://www.madinamerica.com/2022/03/evidence-based-medicine-became-illusion/." }, { "DOI": "10.53294/ijfstr.2024.6.2.0031", "article-title": "Decoding the paradox: Understanding elevated hospitalization and reduced mortality in SARS-CoV-2 variants", "author": "Wimalawansa", "doi-asserted-by": "crossref", "first-page": "1", "journal-title": "Int. J. Front. Sci. Technol. Res.", "key": "ref_82", "volume": "6", "year": "2024" }, { "DOI": "10.1016/S2589-7500(24)00115-8", "article-title": "The next generation of evidence synthesis for diagnostic accuracy studies in artificial intelligence", "author": "Guni", "doi-asserted-by": "crossref", "first-page": "e541", "journal-title": "Lancet Digit. Health", "key": "ref_83", "volume": "6", "year": "2024" }, { "DOI": "10.1111/nure.12090", "article-title": "Guidelines for optimizing design and analysis of clinical studies of nutrient effects", "author": "Heaney", "doi-asserted-by": "crossref", "first-page": "48", "journal-title": "Nutr. Rev.", "key": "ref_84", "volume": "72", "year": "2014" }, { "DOI": "10.1530/EC-18-0432", "article-title": "Vitamin D testing and treatment: A narrative review of current evidence", "author": "Pilz", "doi-asserted-by": "crossref", "first-page": "R27", "journal-title": "Endocr. Connect.", "key": "ref_85", "volume": "8", "year": "2019" }, { "DOI": "10.1016/j.jsbmb.2017.01.003", "article-title": "Seasonal variations of U.S. mortality rates: Roles of solar ultraviolet-B doses, vitamin D, gene expression, and infections", "author": "Grant", "doi-asserted-by": "crossref", "first-page": "5", "journal-title": "J. Steroid Biochem. Mol. Biol.", "key": "ref_86", "volume": "173", "year": "2017" }, { "DOI": "10.1016/S2213-8587(18)30265-1", "article-title": "Effects of vitamin D supplementation on musculoskeletal health: A systematic review, meta-analysis, and trial sequential analysis", "author": "Bolland", "doi-asserted-by": "crossref", "first-page": "847", "journal-title": "Lancet Diabetes Endocrinol.", "key": "ref_87", "volume": "6", "year": "2018" }, { "DOI": "10.3390/nu10050561", "doi-asserted-by": "crossref", "key": "ref_88", "unstructured": "Scragg, R. (2018). Emerging evidence of thresholds for beneficial effects from vitamin D supplementation. Nutrients, 10." }, { "article-title": "Evidence-based medicine: What it is and what it isn’t. 1996", "author": "Sackett", "first-page": "3", "journal-title": "Clin. Orthop. Relat. Res.", "key": "ref_89", "volume": "455", "year": "2007" }, { "DOI": "10.1097/TA.0b013e3182932bac", "article-title": "Evidence-based medicine: What it is, what it isn’t, and are we practicing it?", "author": "Metzdorff", "doi-asserted-by": "crossref", "first-page": "927", "journal-title": "J. Trauma Acute Care Surg.", "key": "ref_90", "volume": "75", "year": "2013" }, { "DOI": "10.1111/jep.12147", "article-title": "How evidence-based medicine is failing due to biased trials and selective publication", "author": "Howick", "doi-asserted-by": "crossref", "first-page": "908", "journal-title": "J. Eval. Clin. Pract.", "key": "ref_91", "volume": "20", "year": "2014" }, { "DOI": "10.3390/pharmaceutics13030302", "doi-asserted-by": "crossref", "key": "ref_92", "unstructured": "Gatti, M., and De Ponti, F. (2021). Drug repurposing in the COVID-19 era: Insights from case studies showing pharmaceutical peculiarities. Pharmaceutics, 13." }, { "DOI": "10.1038/s41591-023-02235-5", "article-title": "Optimal dietary patterns for prevention of chronic disease", "author": "Wang", "doi-asserted-by": "crossref", "first-page": "719", "journal-title": "Nat. Med.", "key": "ref_93", "volume": "29", "year": "2023" }, { "DOI": "10.1186/s13690-022-00817-2", "article-title": "Dietary patterns of persons with chronic conditions within a multi-ethnic population: Results from the nationwide Knowledge, Attitudes and Practices survey on diabetes in Singapore", "author": "Tan", "doi-asserted-by": "crossref", "first-page": "62", "journal-title": "Arch. Public Health", "key": "ref_94", "volume": "80", "year": "2022" }, { "DOI": "10.1007/s13679-016-0189-8", "article-title": "Weight-related dietary behaviors in young adults", "author": "Partridge", "doi-asserted-by": "crossref", "first-page": "23", "journal-title": "Curr. Obes. Rep.", "key": "ref_95", "volume": "5", "year": "2016" }, { "DOI": "10.1007/s00125-012-2677-z", "article-title": "Sedentary time in adults and the association with diabetes, cardiovascular disease and death: Systematic review and meta-analysis", "author": "Wilmot", "doi-asserted-by": "crossref", "first-page": "2895", "journal-title": "Diabetologia", "key": "ref_96", "volume": "55", "year": "2012" }, { "DOI": "10.1016/S0140-6736(16)30370-1", "article-title": "Does physical activity attenuate, or even eliminate, the detrimental association of sitting time with mortality? A harmonised meta-analysis of data from more than 1 million men and women", "author": "Ekelund", "doi-asserted-by": "crossref", "first-page": "1302", "journal-title": "Lancet", "key": "ref_97", "volume": "388", "year": "2016" }, { "DOI": "10.3945/ajcn.2010.29673", "article-title": "Accruing evidence on benefits of adherence to the Mediterranean diet on health: An updated systematic review and meta-analysis", "author": "Sofi", "doi-asserted-by": "crossref", "first-page": "1189", "journal-title": "Am. J. Clin. Nutr.", "key": "ref_98", "volume": "92", "year": "2010" }, { "DOI": "10.1093/advances/nmac077", "article-title": "Consumption of nuts and needs and health outcomes including cardiovascular disease, diabetes and metabolic disease, cancer, and mortality: An umbrella review", "author": "Balakrishna", "doi-asserted-by": "crossref", "first-page": "2136", "journal-title": "Adv. Nutr.", "key": "ref_99", "volume": "13", "year": "2022" }, { "DOI": "10.1016/S0140-6736(10)61929-0", "article-title": "Chronic diseases: Global action must match global evidence", "author": "Beaglehole", "doi-asserted-by": "crossref", "first-page": "1619", "journal-title": "Lancet", "key": "ref_100", "volume": "376", "year": "2010" }, { "article-title": "Medicalizing obesity: Individual, economic, and medical consequences", "author": "Blackburn", "first-page": "890", "journal-title": "Virtual Mentor", "key": "ref_101", "volume": "13", "year": "2011" }, { "DOI": "10.3390/nu15122749", "doi-asserted-by": "crossref", "key": "ref_102", "unstructured": "Clemente-Suarez, V.J., Beltran-Velasco, A.I., Redondo-Florez, L., Martin-Rodriguez, A., and Tornero-Aguilera, J.F. (2023). Global impacts of Western diet and its effects on metabolism and health: A narrative review. Nutrients, 15." }, { "DOI": "10.1093/ije/19.3.559", "article-title": "Myocardial infarction is inversely associated with plasma 25-hydroxyvitamin D3 levels: A community-based study", "author": "Scragg", "doi-asserted-by": "crossref", "first-page": "559", "journal-title": "Int. J. Epidemiol.", "key": "ref_103", "volume": "19", "year": "1990" }, { "DOI": "10.1016/S0140-6736(11)60393-0", "article-title": "Priority actions for the non-communicable disease crisis", "author": "Beaglehole", "doi-asserted-by": "crossref", "first-page": "1438", "journal-title": "Lancet", "key": "ref_104", "volume": "377", "year": "2011" }, { "DOI": "10.2147/PPA.S161151", "article-title": "Primary nonadherence to chronic disease medications: A meta-analysis", "author": "Lemstra", "doi-asserted-by": "crossref", "first-page": "721", "journal-title": "Patient Prefer. Adherence", "key": "ref_105", "volume": "12", "year": "2018" }, { "DOI": "10.1007/s40258-015-0164-7", "article-title": "The role of chronic disease, obesity, and Improved treatment and detection in accounting for the rise in healthcare spending between 1987 and 2011", "author": "Thorpe", "doi-asserted-by": "crossref", "first-page": "381", "journal-title": "Appl. Health Econ. Health Policy", "key": "ref_106", "volume": "13", "year": "2015" }, { "DOI": "10.3390/nu17020304", "doi-asserted-by": "crossref", "key": "ref_107", "unstructured": "Atieh, O., Daher, J., Durieux, J.C., Abboud, M., Labbato, D., Baissary, J., Koberssy, Z., Ailstock, K., Cummings, M., and Funderburg, N.T. (2025). Vitamins K2 and D3 improve long COVID, fungal translocation, and inflammation: Randomized controlled trial. Nutrients, 17." }, { "DOI": "10.3389/fnut.2023.1207237", "doi-asserted-by": "crossref", "key": "ref_108", "unstructured": "Doaei, S., Mardi, A., and Zare, M. (2023). Role of micronutrients in the modulation of immune system and platelet activating factor in patients with COVID-19; a narrative review. Front. Nutr., 10." }, { "DOI": "10.1111/j.1752-8062.2011.00295.x", "article-title": "Chronic diseases: The emerging pandemic", "author": "Terzic", "doi-asserted-by": "crossref", "first-page": "225", "journal-title": "Clin. Transl. Sci.", "key": "ref_109", "volume": "4", "year": "2011" }, { "DOI": "10.1001/jamanetworkopen.2024.45309", "article-title": "Prevalence of cardiovascular-kidney-metabolic syndrome stages by social determinants of health", "author": "Zhu", "doi-asserted-by": "crossref", "first-page": "e2445309", "journal-title": "JAMA Netw. Open", "key": "ref_110", "volume": "7", "year": "2024" }, { "key": "ref_111", "unstructured": "World Health Organization (2024, October 25). Global Health Observatory 2011. Available online: https://www.who.int/data/gho." }, { "key": "ref_112", "unstructured": "Yong, P.L., Saunders, R.S., and Olsen, L.A. (2024, October 25). The Healthcare Imperative: Lowering Costs and Improving Outcomes: Workshop Series Summary, Available online: https://www.ncbi.nlm.nih.gov/books/NBK53914/." }, { "DOI": "10.1001/virtualmentor.2014.16.02.pfor1-1402", "article-title": "The complex relationship between cost and quality in US health care", "author": "Burke", "doi-asserted-by": "crossref", "first-page": "124", "journal-title": "Virtual Mentor", "key": "ref_113", "volume": "16", "year": "2014" }, { "key": "ref_114", "unstructured": "(2025, March 11). National Institutes of Health. Available online: https://en.wikipedia.org/wiki/National_Institutes_of_Health#:~:text=In%201901%2C%20the%20Division%20of,to%20National%20Institutes%20of%20Health." }, { "key": "ref_115", "unstructured": "(2025, March 25). National Science Foundation: FY 2025 Budget Request to Congress, Available online: https://nsf-gov-resources.nsf.gov/files/00_NSF_FY25_CJ_Entire%20Rollup_web.pdf?VersionId=cbkdqD_UMweHEIsZwPjtVgcQRwMccgvu." }, { "DOI": "10.1038/d41586-025-00703-1", "article-title": "Exclusive: NIH to terminate hundreds of active research grants", "author": "Kozlov", "doi-asserted-by": "crossref", "first-page": "281", "journal-title": "Nature", "key": "ref_116", "volume": "639", "year": "2025" }, { "DOI": "10.7554/eLife.106710", "article-title": "The NIH is a sound investment for the US taxpayer", "author": "Gilpin", "doi-asserted-by": "crossref", "first-page": "106710", "journal-title": "eLife", "key": "ref_117", "volume": "14", "year": "2025" }, { "DOI": "10.1038/d41586-022-04577-5", "article-title": "‘Disruptive’ science has declined—And no one knows why", "author": "Kozlov", "doi-asserted-by": "crossref", "first-page": "225", "journal-title": "Nature", "key": "ref_118", "volume": "613", "year": "2023" }, { "article-title": "VITAL study: An incomplete picture?", "author": "Infante", "first-page": "3142", "journal-title": "Eur. Rev. Med. Pharmacol. Sci.", "key": "ref_119", "volume": "23", "year": "2019" }, { "DOI": "10.1136/bmj.h321", "article-title": "Vitamin D supplements and reasonable solar UVB should be recommended to prevent escalating incidence of chronic diseases", "author": "Grant", "doi-asserted-by": "crossref", "first-page": "h321", "journal-title": "Br. Med. J.", "key": "ref_120", "volume": "350", "year": "2015" }, { "key": "ref_121", "unstructured": "Wimalawansa, S.J. (2017, January 24–25). IOM recommendations vs. vitamin D guidelines applicable to the rest of the world. Proceedings of the 5th International Conference on Vitamin D, Abu Dhabi, United Arab Emirates." }, { "DOI": "10.1056/NEJMoa1809944", "article-title": "Vitamin D supplements and prevention of cancer and cardiovascular disease", "author": "Manson", "doi-asserted-by": "crossref", "first-page": "33", "journal-title": "N. Engl. J. Med.", "key": "ref_122", "volume": "380", "year": "2019" }, { "DOI": "10.1016/j.cct.2011.09.009", "article-title": "The VITamin D and OmegA-3 TriaL (VITAL): Rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease", "author": "Manson", "doi-asserted-by": "crossref", "first-page": "159", "journal-title": "Contemp. Clin. Trials", "key": "ref_123", "volume": "33", "year": "2012" }, { "DOI": "10.1016/S2213-8587(23)00063-3", "article-title": "The effect of monthly vitamin D supplementation on fractures: A tertiary outcome from the population-based, double-blind, randomised, placebo-controlled D-Health trial", "author": "Waterhouse", "doi-asserted-by": "crossref", "first-page": "324", "journal-title": "Lancet Diabetes Endocrinol.", "key": "ref_124", "volume": "11", "year": "2023" }, { "DOI": "10.1016/j.cct.2016.04.005", "article-title": "The D-Health Trial: A randomized trial of vitamin D for prevention of mortality and cancer", "author": "Neale", "doi-asserted-by": "crossref", "first-page": "83", "journal-title": "Contemp. Clin. Trials", "key": "ref_125", "volume": "48", "year": "2016" }, { "DOI": "10.1038/s41586-022-05543-x", "article-title": "Papers and patents are becoming less disruptive over time", "author": "Park", "doi-asserted-by": "crossref", "first-page": "138", "journal-title": "Nature", "key": "ref_126", "volume": "613", "year": "2023" }, { "key": "ref_127", "unstructured": "Carter, J. (2025, March 25). DIEing Academic Research Budgets. Available online: https://barsoom.substack.com/p/dieing-academic-research-budgets." }, { "key": "ref_128", "unstructured": "(2025, March 24). Visualizing Forty Years of Health Insurance Cost Inflation. Available online: https://politicalcalculations.blogspot.com/2024/10/visualizing-forty-years-of-health.html#google_vignette." }, { "DOI": "10.1016/j.amepre.2014.08.035", "article-title": "Receipt of diabetes preventive services differs by insurance status at visit", "author": "Bailey", "doi-asserted-by": "crossref", "first-page": "229", "journal-title": "Am. J. Prev. Med.", "key": "ref_129", "volume": "48", "year": "2015" }, { "DOI": "10.1111/1475-6773.12406", "article-title": "EHR adoption and hospital performance: Time-related effects", "author": "Everson", "doi-asserted-by": "crossref", "first-page": "1751", "journal-title": "Health Serv. Res.", "key": "ref_130", "volume": "50", "year": "2015" }, { "key": "ref_131", "unstructured": "Sloan, F., and Hsieh, C.-R. (2017). Health Economics, Mit Press. [2nd ed.]." }, { "DOI": "10.1377/hlthaff.2010.0048", "article-title": "Improved quality at Kaiser Permanente through e-mail between physicians and patients", "author": "Zhou", "doi-asserted-by": "crossref", "first-page": "1370", "journal-title": "Health Aff.", "key": "ref_132", "volume": "29", "year": "2010" }, { "DOI": "10.1370/afm.1713", "article-title": "From triple to quadruple aim: Care of the patient requires care of the provider", "author": "Bodenheimer", "doi-asserted-by": "crossref", "first-page": "573", "journal-title": "Ann. Fam. Med.", "key": "ref_133", "volume": "12", "year": "2014" }, { "key": "ref_134", "unstructured": "(2025, March 20). Alert and Special Legislative Update—Pharmacy Benefits Managers. Available online: https://aapsonline.org/alert-and-special-legislative-update-pharmacy-benefits-managers/." }, { "DOI": "10.3389/fnut.2024.1456089", "doi-asserted-by": "crossref", "key": "ref_135", "unstructured": "Saidu, S.F., and Danielson, R.A. (2024). Social determinants of health associated with increased prevalence of childhood malnutrition in Africa. Front. Nutr., 11." }, { "DOI": "10.1377/hlthaff.2014.0558", "article-title": "The impact of specialty pharmaceuticals as drivers of health care costs", "author": "Hirsch", "doi-asserted-by": "crossref", "first-page": "1714", "journal-title": "Health Aff.", "key": "ref_136", "volume": "33", "year": "2014" }, { "DOI": "10.1177/00333549241283586", "doi-asserted-by": "crossref", "key": "ref_137", "unstructured": "Mercado, C.I., Bullard, K.M., Bolduc, M.L.F., Andrews, C.A., Freggens, Z.R.F., Liggett, G., Banks, D., Johnson, S.B., Penman-Aguilar, A., and Njai, R. (2024). A shift in approach to addressing public health Inequities and the effect of societal structural and systemic drivers on social determinants of health. Public. Health Rep., 333549241283586." }, { "key": "ref_138", "unstructured": "(2025, February 20). America’s Hospitals and Health Systems Continue to Face Escalating Operational Costs and Economic Pressures as they Care for Patients and Communities. Available online: https://www.aha.org/costsofcaring." }, { "key": "ref_139", "unstructured": "(2024, December 20). The Dangers of Polypharmacy and the Case for Deprescribing in Older Adults, Available online: https://www.nia.nih.gov/news/dangers-polypharmacy-and-case-deprescribing-older-adults." }, { "key": "ref_140", "unstructured": "Hobbs, L., and Holtz-Eakin, D. (2025, February 10). The Future of America’s Entitlements: What You Need to Know About the Medicare and Social Security Trustees Reports. Available online: https://www.americanactionforum.org/research/2024-medicare-social-security-report/#:~:text=At%20its%20current%20pace%2C%20Medicare%20Part%20A,disability%20benefits%20will%20become%20exhausted%20by%202035.&text=The%20report%20estimates%20that%20the%20combined%20(retirement,one%20year%20later%20than%20last%20year’s%20estimate." }, { "key": "ref_141", "unstructured": "Dodaro, G. (2025, March 03). Medicare and Medicaid: Additional Actions Needed to Enhance Program Integrity and Save Billions, Available online: https://www.gao.gov/assets/gao-24-107487.pdf." }, { "key": "ref_142", "unstructured": "(2025, March 22). Budget of the U.S. Government: Fiscal Year 2025, Available online: https://www.whitehouse.gov/wp-content/uploads/2024/03/budget_fy2025.pdf." }, { "key": "ref_143", "unstructured": "(2025, March 17). Fact Sheet: How Much Waste, Fraud, and Abuse Is There in Social Security?. Available online: https://www.crfb.org/press-releases/fact-sheet-how-much-waste-fraud-and-abuse-there-social-security." }, { "key": "ref_144", "unstructured": "Goss, J. (2025, March 20). How Much Fraud, Waste and Abuse Is There in the Social Security Administration. Available online: https://gossandfentress.com/how-much-fraud-waste-and-abuse-is-there-in-the-social-security-administration-part-two/." }, { "article-title": "The Promise and challenges of VA community care: Veterans’ issues in focus", "author": "Rasmussen", "first-page": "9", "journal-title": "Rand Health Q.", "key": "ref_145", "volume": "10", "year": "2023" }, { "key": "ref_146", "unstructured": "McCarthy, K. (2025, April 16). Health Chairwoman Dr. Miller-Meeks at Hearing on Mental Health Care, Substance Abuse, and Rehab Access: “VA Does Not Have a Resource Problem—It Has an Access and Process Problem”, Available online: https://veterans.house.gov/news/documentsingle.aspx?DocumentID=6674." }, { "DOI": "10.1177/0002716219882354", "article-title": "Identifying work capacity and promoting work: A strategy for modernizing the SSDI program", "author": "Maestas", "doi-asserted-by": "crossref", "first-page": "93", "journal-title": "Ann. Am. Acad. Pol. Soc. Sci.", "key": "ref_147", "volume": "686", "year": "2019" }, { "DOI": "10.1016/j.red.2022.11.001", "article-title": "Disability insurance and the effects of return-to-work policies", "doi-asserted-by": "crossref", "first-page": "351", "journal-title": "Rev. Economic Dynamics", "key": "ref_148", "volume": "49", "year": "2023" }, { "article-title": "Administrative waste in the US health care system in comparison to other nations", "author": "Himmelstein", "first-page": "89", "journal-title": "Health Aff.", "key": "ref_149", "volume": "40", "year": "2021" }, { "article-title": "Waste in the US health care system: Estimated costs and potential for savings", "author": "Resnick", "first-page": "872", "journal-title": "J. Urol.", "key": "ref_150", "volume": "203", "year": "2020" }, { "key": "ref_151", "unstructured": "Freed, M., Cubanski, J., and Neuman, T. (2025, April 02). Medicare Program Integrity and Efforts to Root out Improper Payments, Fraud, Waste and Abuse. Available online: https://www.kff.org/medicare/issue-brief/medicare-program-integrity-and-efforts-to-root-out-improper-payments-fraud-waste-and-abuse/#:~:text=The%20Trump%20administration%20recently%20cited,same%20as%20estimates%20of%20fraud." }, { "key": "ref_152", "unstructured": "(2025, March 20). Fiscal Year 2023 Improper Payments Fact Sheet, Available online: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2023-improper-payments-fact-sheet#:~:text=The%20Medicaid%20improper%20payment%20rate%20(comprised%20of,from%20the%202022%20reported%20rate%20of%2015.62%." }, { "key": "ref_153", "unstructured": "(2025, March 20). Fact Check: President Trump Will Always Protect Social Security, Medicare, Available online: https://www.whitehouse.gov/articles/2025/03/fact-check-president-trump-will-always-protect-social-security-medicare/." }, { "DOI": "10.1377/hlthaff.2013.1327", "article-title": "A comparison of hospital administrative costs in eight nations: US costs exceed all others by far", "author": "Himmelstein", "doi-asserted-by": "crossref", "first-page": "1586", "journal-title": "Health Aff.", "key": "ref_154", "volume": "33", "year": "2014" }, { "DOI": "10.1001/jama.2019.13978", "article-title": "Waste in the US health care system: Estimated costs and potential for savings", "author": "Shrank", "doi-asserted-by": "crossref", "first-page": "1501", "journal-title": "JAMA", "key": "ref_155", "volume": "322", "year": "2019" }, { "DOI": "10.1001/jama.2016.11237", "article-title": "The high cost of prescription drugs in the United States: Origins and prospects for reform", "author": "Kesselheim", "doi-asserted-by": "crossref", "first-page": "858", "journal-title": "JAMA", "key": "ref_156", "volume": "316", "year": "2016" }, { "DOI": "10.1093/biostatistics/kxx023", "article-title": "Discussion: The role, position, and function of the FDA-The past, present, and future", "author": "Fleming", "doi-asserted-by": "crossref", "first-page": "417", "journal-title": "Biostatistics", "key": "ref_157", "volume": "18", "year": "2017" }, { "key": "ref_158", "unstructured": "Lupkin, S. (2024, November 09). One-Third of New Drugs Had Safety Problems After FDA Approval. Available online: https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval." }, { "key": "ref_159", "unstructured": "Congress (2024, November 10). H. Rept. 112-495—Food and Drug Administration Reform Act of 2012, Available online: https://www.congress.gov/congressional-report/112th-congress/house-report/495#:~:text=Section%20602%2D%2DConflicts%20of%20interest%20The%20Food%20and,provision%20has%20discouraged%20the%20use%20of%20the." }, { "key": "ref_160", "unstructured": "Dunn, A.M., Florence, M.P., Turow, R., and Grimm, N.L. (2025, February 10). Gauging the Likelihood of Trump Administration FDA Reforms. Available online: https://www.skadden.com/insights/publications/2025/01/gauging-the-likelihood-of-trump-administration-fda-reforms." }, { "key": "ref_161", "unstructured": "Bottomiller, H. (2024, December 20). The FDA’s Food Failure. Available online: https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/." }, { "key": "ref_162", "unstructured": "Rapfogel, N. (2024, November 15). 5 Things to Know About Pharmacy Benefit Managers. Available online: https://www.americanprogress.org/article/5-things-to-know-about-pharmacy-benefit-managers/#:~:text=Requiring%20PBM%20transparency%20is%20not,that%20might%20better%20serve%20them." }, { "key": "ref_163", "unstructured": "Ginder-Vogel, K. (2025, January 10). The Evolution and Future of Pharmacy Benefits Managers. Available online: https://pharmacy.wisc.edu/2024/03/13/the-evolution-and-future-of-pharmacy-benefits-managers/#:~:text=By%20Katie%20Ginder%2DVogel,their%20discussion’s%20most%20salient%20points." }, { "key": "ref_164", "unstructured": "Conti, R.M., Frandsen, B., and Rebitzer, J.B. (2025, March 10). Pharmacy Benefit Managers and the U.S. Pharmaceutical Market. Available online: https://hmpi.org/2024/04/12/pharmacy-benefit-managers-and-the-us-pharmaceutical-market/." }, { "key": "ref_165", "unstructured": "Burns, J. (2025, March 12). Pharmacy Benefit Managers Raised Prices by over 1,000% on Specialty Drugs. Available online: https://healthjournalism.org/blog/2025/02/pharmacy-benefit-managers-raised-prices-by-over-1000-on-specialty-drugs/." }, { "article-title": "If pharmacy benefit managers raise drug prices, Then why are they needed?", "author": "Gale", "first-page": "243", "journal-title": "Mo. Med.", "key": "ref_166", "volume": "120", "year": "2023" }, { "key": "ref_167", "unstructured": "Cox, C., Ortaliza, J., Wagner, E., and Amin, K. (2025, March 20). Health Care Costs and Affordability: How has U.S. Health Care Spending Changed Over Time?. Available online: https://www.kff.org/health-policy-101-health-care-costs-and-affordability?entry=table-of-contents-how-has-u-s-health-care-spending-changed-over-time." }, { "key": "ref_168", "unstructured": "(2025, March 03). Food Safety: Status of Foodborne Illness in the US, Available online: https://www.gao.gov/assets/gao-25-107606.pdf." }, { "key": "ref_169", "unstructured": "Firm, K.L. (2024, November 11). FDA Chiefs’ Ties to Big Pharma Raise Conflict of Interest Concerns. Available online: https://www.linkedin.com/pulse/fda-chiefs-ties-big-pharma-raise-conflict-interest-concerns-eg2se/." }, { "article-title": "Slowing down accelerated approval: Examining the role of industry influence, patient advocacy organizations, and political pressure on FDA drug approval", "author": "Diu", "first-page": "2303", "journal-title": "Foedham Law. Review", "key": "ref_170", "volume": "90", "year": "2022" }, { "DOI": "10.1001/jamainternmed.2022.6444", "article-title": "US Food and Drug Administration approval of drugs not meeting pivotal trial Primary end points, 2018–2021", "author": "Johnston", "doi-asserted-by": "crossref", "first-page": "376", "journal-title": "JAMA Intern. Med.", "key": "ref_171", "volume": "183", "year": "2023" }, { "key": "ref_172", "unstructured": "Karas, L. (2024, November 12). FDA’s Revolving Door: Reckoning and Reform. Available online: https://law.stanford.edu/publications/fdas-revolving-door-reckoning-and-reform/." }, { "DOI": "10.1038/s41591-020-01200-w", "article-title": "The limits of acceptable political influence over the FDA", "author": "Joffe", "doi-asserted-by": "crossref", "first-page": "188", "journal-title": "Nat. Med.", "key": "ref_173", "volume": "27", "year": "2021" }, { "key": "ref_174", "unstructured": "CDC (2024, November 11). Clinical Data Summary Pilot Program, Available online: https://www.fda.gov/drugs/development-approval-process-drugs/clinical-data-summary-pilot-program#:~:text=The%20Center%20for%20Drug%20Evaluation,medical%20researchers%2C%20and%20the%20public." }, { "key": "ref_175", "unstructured": "FDA (2024, November 10). Information for Consumers on Using Dietary Supplements, Available online: https://www.fda.gov/food/dietary-supplements/information-consumers-using-dietary-supplements#:~:text=Under%20DSHEA%2C%20FDA%20is%20not,your%20family%20about%20dietary%20supplements." }, { "key": "ref_176", "unstructured": "Baell, J., Jennings, M., and Parker, M. (2024, November 15). Ivermectin Shows Us How Hard It Is to Use Old Drugs for COVID. Here’s How to Do Better Next Time. Available online: https://theconversation.com/ivermectin-shows-us-how-hard-it-is-to-use-old-drugs-for-covid-heres-how-to-do-better-next-time-168192." }, { "key": "ref_177", "unstructured": "(2024, March 25). Group-C19.com. Vitamin D for COVID-19: Real-Time Analysis of All 300 Studies, Available online: https://c19early.org/d." }, { "DOI": "10.2105/AJPH.2021.306273", "article-title": "Emergency Use Authorizations (EUAs) versus FDA approval: Implications for COVID-19 and public health", "author": "Zuckerman", "doi-asserted-by": "crossref", "first-page": "1065", "journal-title": "Am. J. Public Health", "key": "ref_178", "volume": "111", "year": "2021" }, { "key": "ref_179", "unstructured": "Surgeon General, F. (2025, January 10). Updated Guidance for COVID-19 Boosters for the Fall and Winter 2024–2025 Season, Available online: https://www.floridahealth.gov/newsroom/2024/09/20210912-UpdatedGuidanceCOVID-19.html." }, { "DOI": "10.3390/biology13100831", "doi-asserted-by": "crossref", "key": "ref_180", "unstructured": "Wimalawansa, S.J. (2024). Unveiling the interplay-vitamin D and ACE-2 molecular interactions in mitigating complications and deaths from SARS-CoV-2. Biology, 13." }, { "key": "ref_181", "unstructured": "HRSA (2025, January 05). 340B Drug Pricing Program, Available online: https://www.hrsa.gov/opa#:~:text=The%20340B%20Program%20enables%20covered,entities%20at%20significantly%20reduced%20prices." }, { "DOI": "10.4103/jomfp.JOMFP_34_20", "article-title": "Extracellular matrix degradation by host matrix metalloproteinases in restorative dentistry and endodontics: An overview", "author": "Anshida", "doi-asserted-by": "crossref", "first-page": "352", "journal-title": "J. Oral. Maxillofac. Pathol.", "key": "ref_182", "volume": "24", "year": "2020" }, { "key": "ref_183", "unstructured": "Aboy, M., Crespo, C., and Stern, A. (2024, November 10). Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway. Available online: https://www.nature.com/articles/s41746-024-01021-y#:~:text=Accordingly%2C%20the%20510(k),of%20future%20device%20safety6." }, { "key": "ref_184", "unstructured": "FDA (2024, November 10). FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program—Program Updates, Available online: https://www.fda.gov/medical-devices/510k-clearances/fda-continues-take-steps-strengthen-premarket-notification-510k-program-program-updates#:~:text=The%20510(k)%20Program%20accounts,changes%20to%20the%20device%20marketplace." }, { "DOI": "10.1038/s41587-022-01294-2", "article-title": "The clinical progress of mRNA vaccines and immunotherapies", "author": "Barbier", "doi-asserted-by": "crossref", "first-page": "840", "journal-title": "Nat. Biotechnol.", "key": "ref_185", "volume": "40", "year": "2022" }, { "key": "ref_186", "unstructured": "Jones, J.L. (2025, February 15). One Culprit in Rising College Costs: Administrative Expenses. Available online: https://www.usnews.com/education/articles/one-culprit-in-rising-college-costs." }, { "key": "ref_187", "unstructured": "Hultman, J. (2025, February 10). The High Cost of Waste in Healthcare. Available online: https://www.podiatrym.com/pdf/2019/8/HultmanFeature819web.pdf." }, { "key": "ref_188", "unstructured": "Mulhern, C., Spies, R.R., and Wu, D.D. (2025, March 17). The Effects of Rising Student Costs in Higher Education. Available online: https://sr.ithaka.org/publications/the-effects-of-rising-student-costs-in-higher-education/." }, { "key": "ref_189", "unstructured": "Cooper, P. (2025, April 02). How Many Administrators Do Colleges Have?. Available online: https://www.aei.org/education/how-many-administrators-do-colleges-have/." }, { "key": "ref_190", "unstructured": "Green, J. (2025, March 10). Administrative Bloat at Universities RAISES Costs Without Helping Students. Available online: https://www.heritage.org/education/commentary/administrative-bloat-universities-raises-costs-without-helping-students." }, { "key": "ref_191", "unstructured": "Ellen, N. (2024, December 20). Are Rising Education Costs a Necessary Evolution or Excessive Expenditure?. Available online: https://academichelp.net/blog/higher-education-news/are-rising-education-costs-a-necessary-evolution-or-excessive-expenditure.html." }, { "key": "ref_192", "unstructured": "Picchi, A. (2025, February 15). One-Third of Graduate Schools Leave THEIR Alums Drowning in Debt. Available online: https://www.cbsnews.com/news/student-loan-graduate-school-drowning-in-debt/." }, { "key": "ref_193", "unstructured": "Twomey, J. (2025, February 10). Recent Grads High in Student LOAN Debt, Low in Financial Literacy. Available online: https://www.earnest.com/blog/student-debt-research/." }, { "key": "ref_194", "unstructured": "Aboulenein, A.U.S. (2025, January 20). Healthcare Spending Rises to $4.8 Trillion in 2023, Outpacing GDP. Available online: https://www.reuters.com/business/healthcare-pharmaceuticals/us-healthcare-spending-rises-48-trillion-2023-outpacing-gdp-2024-06-12/." }, { "key": "ref_195", "unstructured": "Release, P. (2025, June 10). CMS Office of the Actuary Releases 2021–2030 Projections of National Health Expenditures, Available online: https://www.cms.gov/newsroom/press-releases/cms-office-actuary-releases-2021-2030-projections-national-health-expenditures." }, { "DOI": "10.1186/s12913-022-08194-w", "doi-asserted-by": "crossref", "key": "ref_196", "unstructured": "Kakemam, E., Arab-Zozani, M., Raeissi, P., and Albelbeisi, A.H. (2022). The occurrence, types, reasons, and mitigation strategies of defensive medicine among physicians: A scoping review. BMC Health Serv. Res., 22." }, { "key": "ref_197", "unstructured": "Long, J. (2025, January 20). Congress Boosts Funding for FDA Dietary Supplement Office. Available online: https://www.naturalproductsinsider.com/regulatory/congress-boosts-funding-fda-dietary-supplement-office." }, { "key": "ref_198", "unstructured": "Rudolph, L., Caplan, J., Mitchell, C., Ben-Moshe, K., and Dillon, L. (2024, November 21). Health in All Policies: Improving Health Through Intersectoral Collaboration. Available online: https://nam.edu/perspectives-2013-health-in-all-policies-improving-health-through-intersectoral-collaboration/." }, { "DOI": "10.3390/nu14214637", "doi-asserted-by": "crossref", "key": "ref_199", "unstructured": "Puri, V., Nagpal, M., Singh, I., Singh, M., Dhingra, G.A., Huanbutta, K., Dheer, D., Sharma, A., and Sangnim, T. (2022). A comprehensive review on nutraceuticals: Therapy support and formulation challenges. Nutrients, 14." }, { "DOI": "10.3390/molecules26092540", "doi-asserted-by": "crossref", "key": "ref_200", "unstructured": "AlAli, M., Alqubaisy, M., Aljaafari, M.N., AlAli, A.O., Baqais, L., Molouki, A., Abushelaibi, A., Lai, K.S., and Lim, S.E. (2021). Nutraceuticals: Transformation of Conventional Foods into Health Promoters/Disease Preventers and Safety Considerations. Molecules, 26." }, { "DOI": "10.1016/j.focha.2024.100749", "article-title": "A review on the influence of nutraceuticals and functional foods on health", "author": "Vignesh", "doi-asserted-by": "crossref", "first-page": "100749", "journal-title": "Funct. Chem. Adv.", "key": "ref_201", "volume": "5", "year": "2024" }, { "key": "ref_202", "unstructured": "(2025, March 15). Foods: Some Foods Contain Chemicals on the Proposition 65 List (Fact Sheets), Available online: https://www.p65warnings.ca.gov/fact-sheets/foods#:~:text=BPA%20can%20leach%20into%20food,beverages%20from%20plastic%20food%20packaging." }, { "DOI": "10.1016/j.scitotenv.2022.159834", "article-title": "Microplastics in human food chains: Food becoming a threat to health safety", "author": "Mamun", "doi-asserted-by": "crossref", "first-page": "159834", "journal-title": "Sci. Total Environ.", "key": "ref_203", "volume": "858", "year": "2023" }, { "key": "ref_204", "unstructured": "Hovav, K. (2025, March 20). Which Types of Cookware Should You Avoid? The Best and Worst Pots and Pans for Your Health. Available online: https://www.goodrx.com/health-topic/environmental/dangerous-cookware-to-avoid." }, { "DOI": "10.1001/jama.2017.0410", "article-title": "Benefit-risk assessments at the US food and drug administration: Finding the balance", "author": "Califf", "doi-asserted-by": "crossref", "first-page": "693", "journal-title": "JAMA", "key": "ref_205", "volume": "317", "year": "2017" }, { "key": "ref_206", "unstructured": "Deubberly, H. (2025, March 25). How Cybernetics Connects Computing, Counterculture, and Design. Available online: https://www.dubberly.com/articles/cybernetics-and-counterculture.html." }, { "DOI": "10.1007/978-3-030-18557-2", "doi-asserted-by": "crossref", "key": "ref_207", "unstructured": "Ficher, T., and Herr, C. (2019). Design Cybernetics: Navigating the New, Springer Nature. Design Research Foundations." } ], "reference-count": 207, "references-count": 207, "relation": {}, "resource": { "primary": { "URL": "https://www.mdpi.com/2304-8158/14/13/2328" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "title": "Reforming Food, Drug, and Nutraceutical Regulations to Improve Public Health and Reduce Healthcare Costs", "type": "journal-article", "volume": "14" }