An Executive Summary

This article summarizes and comments on a groundbreaking policy paper by Dr. Sunil J. Wimalawansa, Professor of Medicine, Endocrinology, and Human Nutrition, a world-renowned endocrinologist and nutrition and vitamin D researcher. Dr. Wimalawansa has long championed the role of micronutrients—especially vitamin D—in holistic medicine, focusing on disease prevention and public health.

He had highlighted its central role in immune health, chronic disease prevention, especially related to cardiovascular diseases, prevention of complications and deaths from SARS-CoV-2 (COVID-19) outcomes. His most recent scientific work discussed here reflects the same urgency and scientific integrity highlighting the urgent needs and importance of regulatory reforms and health policy changes.

The original article, “Reforming Food, Drug, and Nutraceutical Regulations to Improve Public Health and Reduce Healthcare Costs,” was published in Foods in June 2025.³ https://www.mdpi.com/2304-8158/14/13/2328

Executive Summary

• Non-communicable diseases (NCDs)—such as cardiovascular disease, type 2 diabetes, obesity, and cancer—account for over 60% of global deaths and 80% of healthcare costs.
• The US healthcare system remains predominantly reactive, focusing on pharmaceutical management rather than disease prevention and lifestyle-based solutions.
• The FDA’s centralized oversight of food, drugs, and supplements has led to both overreach and neglect—allowing harmful food additives while delaying or obstructing access to safe, evidence-based nutraceuticals.
• Prof. Wimalawansa proposes and rationalizes the need for splitting the FDA into two separate agencies:

– A Drug and Device Agency (DDA), focused solely on pharmaceuticals and medical technologies, including devices.

– A new Food and Nutraceutical Agency (FNA), dedicated to food safety, micronutrient regulation, nutraceuticals, and public health promotion through lifestyles and nutrition. This is crucial at this point.

The Problem: Systemic Neglect of Nutrition

Current regulations have failed to protect the public from chronic exposure to food contaminants and toxic additives. The article lists substances that remain legal in US food but are banned in the European Union, due to strong evidence of harm, including:

• Titanium dioxide (linked to genotoxicity)
• Red Dye No. 3 (banned in cosmetics and food)
• Potassium bromate (a known carcinogen)
• Parabens and PFAS (“forever chemicals”)
• Bleached flour and excessive added sugars

In parallel, essential micronutrients like vitamin D, magnesium, omega-3s, and vitamin K2 are not only underutilized but actively marginalized by outdated clinical guidelines and limited public access.

The Solution for the USA – An Agency for Prevention

The proposed Food and Nutraceutical Agency (FNA) would:

• Regulate food additives with a public safety-first approach
• Mandate transparency in food and supplement labeling
• Fund research on long-ignored contaminants (e.g., glyphosate, BPA, microplastics)
• Establish and publish safe and optimal intake guidelines for essential nutrients
• Encourage the use of evidence-based nutraceuticals to prevent or manage chronic diseases
• The use of community-based, prospective clinical studies, instead of randomized controlled trials, for the evaluation of food and nutraceuticals.

This shift would not only promote health but could save up to US$ 1 trillion in healthcare costs within four years.

Importance of Root-Cause-Based Solutions and Revolution

As with holistic medicine and integrative orthomolecular medicine, Dr. Wimalawansa’s paper (in Foods journal) is a critical step toward root-cause, prevention-based public health policy. As with the above, it advocates:

• Micronutrient insufficiency (especially vitamin D, C, magnesium, zinc, omega-3, and K2)
• Toxin overload from diet, environment, and medications
• Hormonal and metabolic imbalances
• Gut and mitochondrial dysfunction

The cost of healthcare continues to rise each year, largely due to the flawed reliance on symptom-based pharmaceutical treatments rather than preventive strategies. This ineffective approach fails to address the root causes of poor health—particularly lifestyle-related diseases that now affect two-thirds of Americans—and cannot curb the escalating expenses. As outlined in Dr. Wimalawansa’s paper on nutrition and health, a novel, practical, and effective approach must be implemented, including:

• Prioritizing lifestyle changes
• Low-carb and anti-inflammatory nutrition
• Diets without toxins with micronutrient sufficiency
• Avoid adding high fructose (corn syrup) to bakery foods
• Minimize and eliminate highly processed food
• Restoration of metabolic and hormonal rhythm

A dedicated FNA would give regulatory legitimacy and scientific attention to these solutions.

From Fragmented Care to Functional Systems

By separating food and drug oversight, the US could begin to:

• Acknowledge the profound role of nutrition in disease prevention
• Use the concept “Food as Medicine” for better health
• Introduction of formal education on nutrition should be in schools and universities
• Adding a mandated course on food and nutrients in medical schools’ and nursing curricula
• Remove conflicts of interest between pharmaceutical and food safety regulators, as well as other health agencies like the CDC
• Accelerate public access to affordable, life-saving micronutrient therapies.
• Non-infringement by the state boards of medical examiners on physicians’ freedom to practice medicine
• Restore public trust in regulatory institutions.

This reform isn’t just administrative—it’s visionary. It reflects a needed return to common sense, biochemistry, cellular health and nutrition, rather than blind allegiance to pharmaceutical paradigms and prescriptions. Without addressing most of the concerns and concepts discussed by Professor Wimalawansa, there is no possibility of making America healthy.

Final Thoughts

Dr. Wimalawansa’s proposal is bold, timely, and deeply aligned with what America needs now:

We stand at a crossroads:

• Continue down the path of chronic disease, healthcare inflation, and overmedication, leading to escalating premature deaths

or

• Embrace a future of prevention-based and transparency-driven nutrient-powered health via highly economical, holistic programs that cost significantly less and markedly improve the health of the nations.

The choice is clear. The creation of an independent food and nutraceutical agency could mark the beginning of a new era—one where science, not industry interests, shapes the health of nations.

References (Prof Wimalawansa, Peer-Reviewed Publications 2023-25):

1. Wimalawansa, SJ. Prophylactic use of vitamin D to maintain a robust immune system against infections like SARS-CoV-2. Glob J Endocrinol Metab 3(5). GJEM. 000571. 2023. DOI: 10.31031/GJEM.2023.03.000571. https://doi.org/10.31031/GJEM.2023.03.000571

2. Wimalawansa, SJ. Physiological basis for using vitamin D to improve health. Biomedicines 11, 1542. 2023. https://doi.org/10.3390/biomedicines11061542, https://www.mdpi.com/2227-9059/11/6/1542

3. Wimalawansa, SJ. Vitamin D: Cost-effectively overcome infections and chronic diseases. https://encyclopedia.pub/entry/48753, 2023, DOI: 10.3390/nu15163623

4. Sthanadar, IA, Zahid, M, Siraj, S, Malik, O, Wimalawansa, S.J. Impact of Type-2 diabetes (T2DM) on cardiovascular disease in diabetic patients with COVID-19, positive family history of diabetes and consanguinity: A 12-Month cohort study in Khyber Pakhtunkhwa, Pakistan. J Xi’an Shiyou University (Natural Sci Ed.), 19: 4, 558-572, 2023. https://www.xisdxjxsu.asia/viewarticle.php?aid=2145

5. Wimalawansa, SJ, Dissanayake CB. Nanocrystal-induced chronic tubular nephropathy in tropical countries: diagnosis, mitigation, and eradication. European Journal of Medical Research, 28, 221 (2023) DOI: 10.1186/s40001-023-01162-y. https://doi.org/10.1186/s40001-023-01162-y or PDF; https://link.springer.com/content/pdf/10.1186/s40001-023-01162-y.pdf

6. Wimalawansa, SJ. Controlling Chronic Diseases and acute infections with vitamin D sufficiency. Nutrients 2023, 15, 3623. https://doi.org/10.3390/nu15163623; https://www.mdpi.com/2072-6643/15/16/3623

7. Polonovita, AK and Wimalawansa, SJ. Molecular quantum and logic process of consciousness—Vitamin D big-data in covid-19—a case for incorporating machine learning in medicine. EJPBS, 10(12), 24-43, 2023. DOI: 10.5281/zenodo.10435649; https://storage.googleapis.com/journal-uploads/ejbps/article_issue/volume_10_december_issue_12/1702368786.pdf.

8. Wimalawansa, S.J. Infections and Autoimmunity—The immune system and vitamin D: A systematic review. Nutrients 2023, 15, 1-33. 3842. https://doi.org/10.3390/nu15173842; https://www.mdpi.com/2072-6643/15/17/3842#B115-nutrients-15-03842

9. Polonowita, AK and Wimalawansa, SJ. The impact of withholding cost-effective early treatments, such as vitamin D, on COVID-19: An analysis using an innovative logical paradigm. World J. Adv. Pharma. Life Sci., 05(2); 13–34, 2023. doi.org/10.53346/wjapls.2023.5.2.0080. https://zealjournals.com/wjapls/content/impact-withholding-cost-effective-early-treatments-such-vitamin-d-covid-19-analysis-using

10. Wimalawansa, SJ. Decoding the paradox: Understanding elevated hospitalization and reduced mortality in SARS-CoV-2 variants. Int J Frontiers in Sci and Technol Res., 6(2): 1-20, 2024. DOI: 10.53294/ijfstr.2024.6.2.0031. https://frontiersrj.com/journals/ijfstr/sites/default/files/IJFSTR-2024-0031.pdf

11. Wimalawansa, SJ. Unveiling the interplay—Vitamin D and ACE-2 molecular interactions in mitigating complications and deaths from SARS-CoV-2. Biology, 13(10), 831, 2024. https://www.mdpi.com/2079-7737/13/10/831

12. Wimalawansa, SJ. Physiology of vitamin D—Focusing on disease prevention. Nutrients 2024, 16(11), 1666. https://doi.org/10.3390/nu16111666; https://www.mdpi.com/2072-6643/16/11/1666.

13. Wimalawansa, SJ. Unlocking insights: Navigating COVID-19 challenges and emulating future pandemic Resilience strategies with strengthening natural immunity. Heliyon, 10 (15), 2024L e34691. DOI: 10.1016/j.heliyon.2024.e34691

14. Wimalawansa, SJ. Weiss ST, Hollis, BW. DOI: 10.3390/nu16223969: Nutrients, 16(22), 3969, 2024. Integrating Endocrine, Genomic, and Extra-Skeletal Benefits of Vitamin D into National and Regional Clinical Guidelines. https://www.mdpi.com/2072-6643/16/22/3969

15. Wimalawansa, SJ. Vitamin D deficiency meets Hill’s criteria for causation in SARS- CoV-2 susceptibility, complications, and mortality: A systematic review, Nutrients, 17(3), 2024. https://www.mdpi.com/2072-6643/17/3/599 , DOI: 10.3390/nu17030599

16. Ambagaspitiya, SS, Appuhamillage, GA, Wimalawansa, SJ. Impact of vitamin D on skin aging and age-related dermatological conditions. Front. Biosci. (Landmark Ed.) 2025; 30(1): 25463; https://doi.org/10.31083/FBL25463; https://www.imrpress.com/journal/FBL/30/1/10.31083/FBL25463/htm

17. Grant WB, Wimalawansa, SJ, Pludowski P, Cheng RZ. Vitamin D: Evidence-Based Health Benefits and Recommendations for Population Guidelines. Nutrients, 17(2), 277; 2025. DOI: 10.3390/nu17020277; https://www.mdpi.com/2072-6643/17/2/277

18. Razzaque M, Wimallawansa, SJ. Minerals and human health: From deficiency to toxicity. Nutrients,17(3), 454, 2025. https://doi.org/10.3390/nu17030454; https://www.mdpi.com/2072-6643/17/3/454

19. Wimalawansa, SJ., Enhancing the design of nutrient clinical trials for disease prevention —A focus on vitamin D: A Systematic review. Nutrition Reviews (nuae164), 2025. https://doi.org/10.1093/nutrit/nuae164|

20. Wimalawansa, SJ., Reforming food, drug, and nutraceutical regulations to improve public health and reduce healthcare costs. Foods, 14(13), 2328 2025, DOI:10.3390/foods14132328. https://www.mdpi.com/2304-8158/14/13/2328

21. Wimalawansa, SJ., A Reduction of Cancer Incidence and Mortality: A Systematic Review. https://www.mdpi.com/2072-6643/17/14/2333