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The Orange Pill Podcast

Author: KGK Science

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The Orange Pill Podcast 🎙️
Your go-to source for the latest in the dietary supplement and natural health product industry! Brought to you by KGK Science, a global leader in clinical research and regulatory consulting, this podcast delivers:
✔️ Breaking industry news and trends
✔️ Educational insights and practical takeaways
✔️ Discussions on cutting-edge research
✔️ Landmark cases and notable events shaping the field
Join us as we bridge the gap between science, regulation, and everyday impact.
90 Episodes
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Ultra-processed foods now make up over half of the average adult’s calories and nearly 60% of children’s diets. They look harmless. They’re marketed as “natural.” Some even carry health halos. But behind the packaging lies a system built on loopholes, engineered starches, and thousands of additives the FDA may never have formally reviewed. In Episode 90 of the Orange Pill Podcast, we unpack the growing bipartisan alarm around ultraprocessed foods - from the controversial GRAS loophole to the striking alliance between Robert F. Kennedy Jr. and former FDA Commissioner Dr. David Kessler under the “Make America Healthy Again” banner. This isn’t about fear. It’s about understanding how policy, processing, and profit reshaped the modern pantry. Because the real question isn’t just what are we eating? It’s who decided it was safe in the first place?
High heat built the modern food system. But it may also be limiting it. In Episode 89, we explore how Novel Food Processing (NFP) technologies are transforming protein at the molecular level, unlocking better texture, higher bioavailability, improved digestibility, and cleaner labels without sacrificing safety. From electricity-powered milk processing to ultra-high pressure seafood engineering, this episode breaks down how food science is moving beyond the burner and into the future. If you work in food innovation, functional ingredients, protein R&D, or regulatory strategy, this one changes how you think about what’s possible.
What if many of the ingredients in your food were never reviewed by the FDA? In Episode 88 of the Orange Pill Podcast, we break down the newly introduced GRAS Oversight and Transparency Act (February 3, 2026); a bill that aims to close one of the most controversial loopholes in U.S. food regulation. For decades, the “Generally Recognized as Safe” (GRAS) framework has allowed companies to self-determine ingredient safety without notifying the FDA, leaving regulators and consumers in the dark. This episode unpacks how that system works, why it matters, and how this new legislation could permanently reshape food ingredient oversight. From legacy ingredients approved decades ago, to a new interagency GRAS Review Board with real enforcement authority, we explore what this bill means for manufacturers, regulators, and the future of food transparency.
Erythritol has earned a near-perfect reputation in the clean-eating world. It’s natural, calorie-free, keto-friendly, and widely considered one of the safest sugar substitutes on the market. But new research from the University of Colorado suggests that this confidence may be dangerously misplaced. In Episode 87 of the Orange Pill Podcast, we unpack a startling new study from the DeSouza laboratory that shows how erythritol may quietly compromise the blood-brain barrier (BBB), the brain’s most critical line of defense against toxins, inflammation, and vascular injury. This episode breaks down: • How erythritol triggers a 75% surge in oxidative stress inside brain endothelial cells • Why the body’s antioxidant defenses can’t keep up • How nitric oxide suppression and endothelin-1 elevation promote dangerous vessel constriction • Why erythritol may disable the brain’s natural “clot-buster” response • And most critically, why these effects occur at blood concentrations reached after a single serving This isn’t a story about extreme overconsumption. It’s about everyday exposure hiding behind a “natural” label. If you consume sugar-free snacks, energy drinks, or keto products, this episode is essential listening.
Many wellness and nutraceutical companies believe that calling a product a dietary supplement creates a regulatory safe zone. FDA enforcement actions tell a very different story. In Episode 86 of the Orange Pill Podcast, we break down the FDA’s Bioresearch Monitoring (BIMO) Program and analyze recent FDA Warning Letters that caught sponsors, CROs, and IRBs completely off guard. This episode explains a hard regulatory truth: the FDA does not regulate labels - it regulates intent. We explore three critical lessons drawn directly from enforcement actions involving U.S.-based clinical trials: • Why study design, not product category, determines whether something is legally a drug • How enrolling diseased subjects instantly converts a “supplement study” into a drug trial • Why skipping an IND isn’t a paperwork error but a serious safety and data integrity failure • How validated clinical instruments can unintentionally trigger drug classification • The role CROs and IRBs play and where accountability ultimately falls If your clinical trial measures disease outcomes, targets pathology, or recruits diagnosed populations, the FDA will treat it as a drug study, regardless of what’s on the bottle. This episode is essential listening for sponsors, CROs, regulatory teams, and anyone designing human research in the supplement space.
For years, protein dominated the wellness conversation. Shakes, bars, and macro tracking became the gold standard of “healthy.” But a new movement is rapidly reshaping nutrition culture  and it isn’t coming from gyms or supplement brands. It’s coming from the gut. In Episode 85 of the Orange Pill Podcast, we unpack the science behind #Fibermaxxing - the viral trend shifting attention from protein obsession to microbiome-driven health. This episode explores why fiber has suddenly become the internet’s most powerful nutrient and how it connects directly to the decade’s most talked-about pharmaceutical target: GLP-1. We break down: • How fiber naturally stimulates GLP-1 -  the hormone behind fullness, glucose control, and metabolic regulation • Why the U.S. is facing a hidden fiber deficiency crisis • The biological risks of jumping from low fiber to extreme fiber overnight • The overlooked science of soluble vs. insoluble fiber and fermentation • How ultra-processed “fiber-added” foods differ from whole-food fiber sources • And a practical, microbiome-safe way to increase intake without digestive fallout Fibermaxxing isn’t a hack. It’s a return to biological fundamentals.
For decades, America’s food system operated in a gray zone where chemicals could quietly enter the supply chain, nutrition guidance lagged behind chronic disease, and safety was often reactive rather than preventive. That era is ending. In Episode 84 of the Orange Pill Podcast, we unpack the FDA’s newly solidified Human Foods Program (HFP) and its sweeping 2026 agenda, a regulatory blueprint that signals one of the most aggressive transformations in food policy in modern history. This episode explores how the FDA is shifting from a watchdog to an architect of national health, built around three core pillars: Food Chemical Safety, Nutrition, and Microbiological Food Safety. We dive into what’s actually coming in 2026, including: • The dismantling of the GRAS loophole and the rise of mandatory pre-market chemical transparency • The targeted review of controversial additives like phthalates, BHA, BHT, and parabens • The phase-out of petroleum-based food dyes in favor of plant-derived colors • New front-of-package nutrition labeling designed to influence real-time consumer behavior • FDA’s expansion into microplastics, heavy metals, and PFAS oversight • The modernization of infant formula standards under Operation Stork Speed • And the federal effort to formally define “ultra-processed foods” This is not incremental regulation. It is a structural reset of the relationship between government, industry, and the grocery shelf.  
For nearly a century, U.S. cosmetic regulation remained largely unchanged. That era officially ended with the passage of the Modernization of Cosmetics Regulation Act (MoCRA), and now, the FDA is racing to catch up. In Episode 83 of the Orange Pill Podcast, we unpack five major regulatory developments that signal a fundamental shift in how cosmetics are tested, labeled, and enforced in the United States. Drawing from recent FDA actions and the Fall 2024 Unified Agenda, this episode explores: • The FDA’s long-awaited move to mandate asbestos testing in talc products • Why the agency is using a broader mineral definition to future-proof safety • How fragrance “trade secrets” are ending with allergen disclosure rules • The delayed but historic push toward a formaldehyde ban in hair products • How the 2025 administrative transition has triggered a widespread regulatory freeze impacting MoCRA timelines We discuss what these shifts mean for brands, manufacturers, regulatory teams, and consumers, and why companies should already be preparing their quality systems, documentation, and compliance strategies. This episode isn’t just about beauty. It’s about accountability, transparency, and the future of consumer protection.  
The world is facing a neurological emergency. Dementia cases are projected to nearly triple by 2050, and despite decades of pharmaceutical research, effective, scalable solutions remain limited. This has pushed scientists to look beyond single-target drugs and toward food-based, systems-level interventions. In Episode 82 of the Orange Pill Podcast, we explore why red beetroot is emerging as a serious scientific contender in the fight against what many researchers now call “Type 3 Diabetes” , the metabolic and insulin-resistant decline of the aging brain. This episode unpacks groundbreaking research showing that beetroot’s benefits are not just nutritional, but neurological, vascular, and microbiome-dependent. It also reframes brain health as a mouth-to-microbe-to-mitochondria conversation, and positions beetroot as a powerful example of how whole foods may influence neurodegeneration. 🎧 Listen to Episode 82 to discover why the future of cognitive resilience may begin not in the pharmacy, but in the produce aisle.
Colostrum, often called “liquid gold”, has taken over longevity circles, biohacking podcasts, and premium supplement shelves. Marketed for everything from gut health to immune resilience and anti-aging, its popularity has surged faster than human clinical research. In Episode 81 of the Orange Pill Podcast, we break down a newly published randomized, double-blind, placebo-controlled clinical trial from the Journal of Functional Foods that finally puts colostrum to the test in adults aged 55–70. This episode explores what the data actually shows: • Colostrum’s antibodies survive digestion and remain bioactive in the gut • IGF-1 levels increased while age-related decline continued in the placebo group • Participants saw reduced leg fat accumulation, suggesting metabolic preservation • Markers pointed toward immune priming, not just passive immunity • No short-term changes in bone density or cognition - a reality check on timelines • A strong safety profile, with mostly mild, short-term digestive effects Rather than a miracle cure, this study positions colostrum as a biologically active, patience-requiring intervention for immune and metabolic resilience in aging populations.
Neuropathic pain affects up to 18% of the global population and remains one of the most difficult chronic conditions to manage. Existing therapies often come with serious trade-offs such as sedation, dependency, and limited long-term relief, highlighting the urgent need for safer, more effective solutions. In Episode 80 of the Orange Pill Podcast, we explore fascinating new preclinical research on geraniin, a naturally occurring compound found in plants like the peel of the rambutan fruit. The study suggests this compound doesn’t just blunt pain signals, it may actually help damaged nerves function better. Rather than acting as a single-target “painkiller,” geraniin demonstrated a multi-pathway approach, addressing several biological drivers of nerve damage at once. This research highlights the growing potential of complex natural compounds in tackling equally complex chronic conditions.
When you scan a food or supplement label, you might assume you’re seeing the most credible health information available. But what if some of the most authoritative, government-backed science is being kept off labels altogether? In this episode of the Orange Pill Podcast, we unpack a new legal battle that’s putting the FDA’s regulatory authority, free speech, and consumer rights under the spotlight. At the center of the case is a surprising contradiction: claims drawn directly from research published by the NIH, CDC, and other federal health agencies are being blocked by the FDA from appearing on product labels. We explore: • Why the FDA is preventing companies from sharing government-authored health findings • How a 1997 law was designed to allow these claims and why critics say the FDA overrode Congress • Why this case is being framed as a First Amendment issue, not just a regulatory one • How a recent Supreme Court ruling could dramatically shift the balance of power • What this fight means for scientific transparency and informed consumer choice This episode isn’t just about supplements. It’s about who gets to decide what health information reaches the public and whether consumers are being protected or restricted.
More than one in four adults struggle to fall or stay asleep and while prescription sleep aids can help, they often come with side effects like grogginess, confusion, and memory impairment. That’s why researchers are increasingly searching for safer, evidence-based alternatives. In this episode of the Orange Pill Podcast, we dive into a fascinating new triple-blind, placebo-controlled clinical trial published in Food Science & Nutrition that explored a standardized Corn Leaf Extract (CLE) as a natural sleep aid. The results were striking. We also explore one of the most intriguing findings of all: while objective brain data showed clear improvements over placebo, both groups felt their sleep had improved - highlighting the powerful difference between perception and measurable physiology. This episode unpacks what this means for the future of natural sleep solutions and why objective clinical tools matter more than ever.
As dementia rates climb worldwide, projected to reach nearly 153 million cases by 2050, diet has emerged as one of the most important modifiable risk factors. But the science behind “brain food” is far more complex than simply avoiding certain foods or adding others. In this final episode of the year, the Orange Pill Podcast takes a deep dive into three surprising scientific findings that are reshaping how we think about diet and long-term cognitive health. In Episode 77, we explore: • Why the inflammatory potential of your overall diet matters more than individual foods • How a massive 25-year study found high-fat cheese and cream were associated with lower dementia risk • Why “healthy eating” isn’t one-size-fits-all  and how race, genetics, and vascular health change outcomes Drawing from large population studies including the Framingham Heart Study, Malmö Diet and Cancer cohort, and the Chicago Health and Aging Project, this episode challenges simplistic narratives and points toward a more personalized, inflammation-aware approach to brain health. As we wrap up the year, this episode invites a more thoughtful question: What does a truly brain-healthy diet look like for you?
Dietary supplements promise strength, focus, resilience, and disease prevention, but how well do we truly understand their benefits and risks? In Episode 76 of the Orange Pill Podcast, we take a deep dive into one of the most comprehensive investigations of supplement use ever conducted: a Department of Defense–commissioned report by the Institute of Medicine examining dietary supplement use among U.S. military personnel- one of the world’s most physically and mentally stressed populations. This episode unpacks the most important and surprising findings, including: • Why supplements are regulated as foods, not drugs, and what that really means for safety • Why “sold on base” does not mean “military-approved” • The proven benefits and real limitations of caffeine as a performance aid • The striking gap between supplement use and disclosure to healthcare providers • Why more clinical research is urgently needed in high-stress populations like the military We also address common misconceptions about FDA oversight, dietary supplement GMPs, and adverse event reporting, revealing a regulatory framework that is often misunderstood by the public. This episode offers critical insights not just for service members, but for consumers, healthcare providers, regulators, and supplement brands alike.
Weight-loss science is having a renaissance. While today’s blockbuster drugs curb appetite by acting on the brain, a groundbreaking new discovery points to an entirely different frontier - one inside the gut. In Episode 75 of the Orange Pill Podcast, we explore a remarkable molecule produced not by our bodies, but by our gut bacteria. It’s called Desaminotyrosine (DAT), and new research suggests it could help the body burn fat faster, cleaner, and without ever decreasing appetite. This discovery points toward a future where weight management isn't about eating less,  but about helping your gut bacteria work smarter. Listen to Episode 75 to learn how your microbiome could become one of the most powerful tools in metabolic health.
In a world where stress is constant and focus feels fleeting, many people turn to L-theanine, the calming amino acid found in green tea. But new clinical research on a purified form, AlphaWave® L-Theanine, reveals a story far more sophisticated than the usual “relaxation without drowsiness” claim. In Episode 74 of the Orange Pill Podcast, we unpack four surprising scientific discoveries that challenge long-held assumptions about L-theanine and how it affects the brain: 1️⃣ It creates a measurable state of “relaxed wakefulness.” A single dose significantly boosts alpha brainwaves - the same patterns seen in meditation. 2️⃣ It sharpens attention, not just calm. In a 28-day clinical trial, participants taking AlphaWave® improved their cognitive reaction speed faster and more consistently than placebo. 3️⃣ It may improve sleep efficiency, not sleep duration. Surprisingly, participants slept less but maintained strong next-day cognitive performance - suggesting more restorative sleep cycles. 4️⃣ Your mindset matters too. The study also showed that placebo participants reported lower stress, highlighting the powerful interplay between biology and belief. This episode paints a new picture of L-theanine as a cognitive state modulator, not just a calming agent - one that helps the brain filter out stress “noise” while elevating focus, clarity, and restorative rest. 🎧 Tune in to Episode 74 to explore the science behind stress, focus, and the future of nootropics.
The global protein crisis is here and science may have just delivered an unexpected solution: a gene-edited fungus that uses 44% less sugar, grows 88% faster, produces clean, complete protein, and still tastes remarkably like meat. In this episode of the Orange Pill Podcast, we dive into groundbreaking new research on Fusarium venenatum, the same fungus behind mycoprotein, and explore how a precise, “scarless” CRISPR edit is reshaping the sustainability, nutrition, and future potential of alternative proteins. From environmental impact to regulatory acceptance to consumer perception, this episode explores how fungi, and gene-edited foods more broadly, may redefine the future of protein on a warming planet.
The supplement aisle is packed with promises - better sleep, stronger immunity, improved focus - but how much of it is truly backed by science? In this episode of the Orange Pill Podcast, we go beyond the marketing noise to explore five surprising truths decades of research have revealed about dietary supplements. From the downfall of once-hyped herbal remedies to the rise of personalized nutrition and the untapped influence of the gut microbiome, this episode challenges the outdated “one nutrient, one solution” mindset. We uncover: • Why some of the biggest studies on popular herbs failed • Why “one-size-fits-all” nutrition simply doesn’t work • How your gut microbes change how supplements behave • The real story behind industry-funded research • How nutrition science has evolved from deficiency prevention to health optimization This is a must-listen for anyone who wants to make smarter, science-driven choices about their health and understand what’s truly shaping the future of supplements.
Most of us trust that the foods we buy are safe and clearly labeled,  but a new bill in Washington may quietly change the rules. In this episode, we break down the “Better Food Disclosure Act of 2025”, a bill introduced by Senator Roger Marshall that promises to strengthen transparency in the food system. At first glance, it looks like progress. But beneath the surface are four major structural issues that critics warn could actually weaken food safety regulation, not strengthen it. We explore: • How new food chemicals could be approved by default if the FDA runs out of time • Why removing unsafe ingredients may become harder than ever • The massive, unfunded workload the bill hands to an already overextended FDA • How “disclosure” doesn’t necessarily mean public transparency With insights from the Center for Science in the Public Interest (CSPI), we uncover why some experts are calling this bill a legislative “lobster trap”- easy for chemicals to enter the food supply, nearly impossible to remove them once inside. Join us for Episode 71 as we unpack the fine print and help you understand what this bill could mean for public health and the future of food safety in the U.S.
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