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The Orange Pill Podcast

The Orange Pill Podcast

Written by: 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.Copyright ©2025 KGK Science. All rights reserved. Hygiene & Healthy Living
Episodes
  • Episode 88- How a New Bill Shuts the Door on Secret Food Safety Deals
    Feb 10 2026

    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.

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    31 mins
  • Episode 87- The Hidden Cost of “Safe” Sweets: How Erythritol May Be Quietly Compromising Your Brain’s Security
    Feb 5 2026

    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.

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    30 mins
  • Episode 86- When Supplements Become Drugs: What FDA’s BIMO Program Is Really Policing
    Feb 3 2026

    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.

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    52 mins
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