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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.
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Can magnesium slow brain aging? New research says yes. This episode breaks down emerging evidence on magnesium’s role in preserving brain volume, protecting against white matter lesions, and lowering dementia risk. We explore why post-menopausal women see the strongest benefits, how magnesium regulates neuroinflammation, and what you can do to incr…
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How do tariffs shape your supplements? In this episode, we break down the economic and regulatory impact of the 2025 Reciprocal Tariff System and Executive Order 14257 on the dietary supplement industry. Learn how key ingredients like CoQ10 and Vitamin B Complex secured tariff exemptions—saving the industry over $200 million in just over two months…
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In this episode of the orange pill podcast, we spotlight a groundbreaking clinical trial that could redefine how omega-3s are delivered to the brain and eyes. Aker BioMarine has partnered with KGK Science to launch the first-ever human clinical trial on Lysoveta, a next-gen omega-3 ingredient that uses lyso-phosphatidylcholine (LPC) to deliver EPA …
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In this episode of the Orange Pill Podcast, we unpack the FDA’s newly released 2025 Human Foods Programme guidance agenda and the persistent challenges stalling finalization of the long-awaited New Dietary Ingredient (NDI) guidance. From the implications of regulatory orders that demand a "10-for-1" rule, to open questions around bioidentical molec…
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In this episode of the Orange Pill Podcast, we unpack the federal class action lawsuit alleging deceptive labeling practices on dietary supplements sold through one of the world’s largest online retailers. Plaintiffs claim the company systematically omits mandatory disclaimers and promotes unapproved health claims—leaving consumers under the false …
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A new FDA study reveals that many melatonin supplements—especially those marketed for children—contain wildly inaccurate doses, ranging from 0% to over 600% of what is listed on the label. In this episode, we unpack the science and regulatory implications of this inconsistency. Why is a powerful hormone treated like a harmless vitamin? What does th…
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Episode 34 takes a closer look at paraxanthine (Px) — the main metabolite of caffeine — and why it might be the next big thing in clean, functional energy. With claims of fewer jitters, smoother focus, and a safer toxicity profile, Px is drawing attention from both scientists and the beverage industry. This episode explores: How paraxanthine compar…
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Psyllium husk is taking the wellness world by storm, but is it just hype, or a true hero in your supplement stack? In this episode, we break down what makes psyllium more than just a fiber. From its rising nickname “Nature’s Ozempic” to its documented benefits in digestion, heart health, and even colorectal cancer prevention, we look at where the s…
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In this episode, we explore the findings of a newly published clinical trial investigating the impact of an 84-day probiotic regimen on gut and mental health in older adults aged 50–85 who experience occasional constipation. The probiotic blend—Lactiplantibacillus plantarum strains KABP031 and KABP032 (marketed as INNERIM™)—was tested in a randomiz…
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The FDA’s guidelines on when human research studies require an Investigational New Drug (IND) application can be a maze for researchers and sponsors. In this episode, we break it all down for you: from the broad definition of "drugs" under the FD&C Act to exemptions in clinical investigations. We discuss the core criteria that help you determine if…
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The FDA’s Bioresearch Monitoring (BIMO) program is more than just inspections—it's a regulatory safeguard for the rights and welfare of clinical trial participants and the integrity of data used to support FDA submissions. In this episode, we break down the scope and function of the BIMO program, explore common findings during inspections, and disc…
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In today's episode, we explore a clinically studied nutritional supplement drink made with five amino acids and chromium — shown to reduce post-meal blood sugar levels by up to 25%. We break down the research, the claims, and what it could mean for metabolic health, diabetes prevention, and the supplement industry as a whole.…
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In this episode, we unpack a fascinating clinical trial conducted by KGK Science for LifeSeasons Inc., evaluating the natural health product Relieve-R (formerly Pain Bloc-R) as an alternative for occasional pain relief and inflammation. Published in the journal Nutrients, this randomized, double-blind, placebo-controlled crossover study compared Re…
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In this episode, we explore an innovative clinical trial by KGK Science evaluating Unigen’s UP446, a natural health ingredient composed of Acacia catechu and Scutellaria baicalensis. Designed as a randomized, triple-blind, placebo-controlled study, this trial used a human vaccine model to assess immune response following influenza vaccination. We d…
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In this episode on the Orange Pill Podcast, we tackle a long-standing regulatory loophole: piggybacking on NDI submissions. While companies like Natural Alternatives International (NAI) invest in proper safety and regulatory filings, like their recent successful NDI notification for CarnoSyn® beta-alanine, authored by the regulatory team at KGK Sci…
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The MAHA Commission Report is expected to be released today—and it’s already making waves. In this special pre-release episode, we explore what to expect from the report, and how it could reshape conversations around policy, governance, and the future. As the noise ramps up, we give you the context and clarity you’ll need to navigate the headlines.…
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In this episode, we explore Nestlé’s U.S. debut of a salmon oil supplement under the Garden of Life brand, featuring OmeGo — a unique whole fish extract by Hofseth Biocare. We break down what makes this omega-3 product stand out in a crowded market, the role of sustainability and full-spectrum benefits, and how KGK Science supported Hofseth in obta…
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As consumer demand grows for clean, conscious products, the supplement industry is being called to evolve. In this episode, we explore the many ways companies can engage in sustainable sourcing and production—from eco-friendly packaging and ethical ingredient procurement to promoting responsible consumer practices. Learn how reducing plastic waste,…
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In this episode, we explore how flower pollen extracts are being studied as a potential solution for urinary incontinence in women. We break down the latest clinical evidence from a newly published trial in Current Urology, conducted by KGK Science and sponsored by Graminex®. We’ll discuss: The impact of urinary incontinence on daily life How flowe…
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We are back with a deep dive into the world of sleep — and why melatonin may not be the long-term solution we’ve all been promised. In this episode we cover: Why melatonin is widely used in hospitals, yet many still struggle to sleep What makes sleep so critical to overall health The growing global demand for new, effective sleep supplements A look…
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In this episode of the Orange Pill Podcast, we talk about the exciting new partnership between KGK Science and Nimble Science. Learn how this collaboration is set to redefine gastrointestinal (GI) health research through the integration of SIMBA™, a novel ingestible capsule that collects high-quality gut samples—without invasive procedures.…
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In this episode, we dive into U.S. presidential candidate Robert F. Kennedy Jr.’s provocative vision for the future of food regulation. RFK Jr. is calling for nothing short of a revolution—taking aim at food chemicals, plastics, and the FDA’s current approach to food safety. We unpack his stance on rethinking Generally Recognized as Safe (GRAS) det…
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In this episode, we unpack a compelling clinical study conducted by KGK Science for Cargill on the impact of EpiCor® postbiotic supplementation in children. Learn how a daily gummy dose of this yeast-derived ingredient significantly reduced cold and flu symptoms, limited the need for medication, and offered a safe, science-backed immune support opt…
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In this episode, we dive into a recent Lancet meta-analysis that questions vitamin D’s effectiveness in preventing acute respiratory infections. What does the data actually say, and how should consumers respond? We also explore promising new findings from Pediatric Research on EpiCor, a postbiotic that may reduce cold and flu symptom severity in ch…
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In this forward-looking episode, we explore the major shifts on the horizon for the dietary supplement and nutraceuticals sector in 2025. Expect a transformation driven by sustainability, science, and personalization. We cover: The rise of plant-based and functional ingredients Personalized nutrition through genomics and AI Regulatory updates on GR…
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In this episode, we explore a growing issue in nutraceutical clinical research: the misuse of predicted margins to gloss over incomplete data in virtual trials. When predictive models are used in place of raw results—without validation or transparency—scientific rigor is compromised. We break down what predicted margins are, when they should (and s…
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In this episode, we explore the FDA’s newly finalized definition of “healthy” for food labeling — a major regulatory update released in December 2024. The goal? To bring food labels in line with today’s nutrition science and help consumers make better choices. We unpack what’s changed, why it matters, and how these new rules will impact how compani…
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In this episode, we discuss a new clinical trial conducted by KGK Science and published in the British Medical Journal of Nutrition, Prevention and Health. This randomised, double-blind, placebo-controlled study evaluated how supplementation with a fava bean protein supplement impacts human strength and endurance when combined with resistance train…
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In this episode of the Orange Pill Podcast, we explore the evolving landscape of federal health agencies under the leadership of Secretary Robert Kennedy Jr. We’ll take a closer look at the potential reforms he aims to implement at the FDA and how these changes could impact the industry. From Kennedy's well-documented policy positions to recent ini…
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In this episode, we dive into groundbreaking research on cognitive health, exploring a clinical study conducted at KGK Science on Neuriva, a leading brain health supplement. Learn how it impacts cognitive performance in healthy adults with self-perceived memory concerns—delivering insights you won’t want to miss! Tune in for the science, and what i…
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In this episode, we unravel the fascinating world of GLP-1 agonists—widely known for their role in diabetes and weight management—and their potential as functional food ingredients. From scientific breakthroughs to real-world applications and regulatory hurdles, this discussion offers a comprehensive look at what the future may hold for these power…
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Could plant-based protein be just as effective as whey for muscle growth? In this episode, we break down a clinical trial conducted by KGK Science for Roquette, comparing pea protein and whey protein head-to-head. We discuss the findings, what they mean for athletes and fitness enthusiasts, and whether plant-based proteins are ready to take over th…
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In Episode 5, we explore the science behind collagen supplements, including a KGK Science clinical trial on marine collagen from Vinh Wellness, published in the Journal of Cosmetic Dermatology. Tune in to discover what the research says about collagen’s impact on skin hydration, elasticity, and wrinkle reduction—and whether your supplement is reall…
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In this episode, we continue our deep dive into the evolution of dietary supplement regulations. From the passage of DSHEA in 1994 to the introduction of cGMPs, health claim requirements, and the enforcement actions that shaped the industry, we explore how FDA oversight has developed over the years. We also discuss pivotal legal cases, the impact o…
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In Part 2 of "How Supplements Became Regulated in the US" on the Orange Pill Podcast, the focus is on the Dietary Supplement Health and Education Act (DSHEA) of 1994, led by Senators Orrin Hatch and Tom Harkin. This legislation established the framework for dietary supplements, defining ingredients and directing the FDA to create NDI Guidance and G…
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Many believe dietary supplements aren't regulated, but they are. This podcast's Part I explores the history of their regulation in the US, from the 1960s Vitamin and Mineral Regulations to the NLEA of 1990 for labeling and the 1994 Dietary Supplement Health and Education Act. Stay tuned for future episodes detailing this fascinating journey.…
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In this episode, we explore Robert F. Kennedy Jr.'s nomination as U.S. Secretary of Health and Human Services (HHS) and Elon Musk's leadership of the new Department of Government Efficiency (DOGE). We discuss potential budget cuts, workforce reductions, and regulatory changes within HHS and the FDA, particularly the Center for Food Safety and Appli…
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