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PODCAST

The Orange Pill Podcast

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.

health & fitness nutrition

All Episodes

22:02

Episode 41: The "Ensuring Safe and Toxic-Free Foods...

The Orange Pill Podcast ·

2025/07/22

In this episode, we unpack the newly introduced Ensuring Safe and Toxic-Free Foods Act of 2025, spearheaded by Senators Markey and Booker. This legislation aims to reform the FDA’s GRAS (Generally Recognized as Safe) system, which has long allowed food companies to self-approve potentially harmful additives without FDA oversight. We explore how this act seeks to phase out self-GRAS determinations, prohibit toxic substances, and demand full transparency in food safety evaluations. Tune in for a deep

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15:57

Episode 40: The Impact of Magnesium on Brain Health...

The Orange Pill Podcast ·

2025/07/17

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 increase intake through food and supplements. Find out why magnesium is becoming a key focus in brain health, cognitive longevity, and healthy aging.

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28:23

Episode 39: Tariff policies are reshaping the dietary...

The Orange Pill Podcast ·

2025/07/15

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—and why supplement leaders are pushing back against pharmaceutical-level scrutiny. We also unpack the latest US-China trade truce and what it means for

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29:32

Episode 38: Crossing Barriers: The Omega-3...

The Orange Pill Podcast ·

2025/07/10

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 and DHA across the blood-brain and blood-retina barriers. Why does that matter? Because targeted delivery to the brain and eyes has long been the holy

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35:59

FDA's Human Foods Program and New Dietary Ingredient...

The Orange Pill Podcast ·

2025/07/08

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 molecules and the fate of the self-affirmed GRAS pathway, we explore what’s at stake for dietary supplement stakeholders.We also dive into how industry can

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20:00

Episode 36: Class Action Lawsuit Against Amazon...

The Orange Pill Podcast ·

2025/07/01

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 impression that the products are FDA-approved.With the court denying a motion to dismiss, discovery will now proceed into not only the purchased

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33:57

Episode 35: Unreliable Melatonin Supplement Doses and...

The Orange Pill Podcast ·

2025/06/26

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 this mean for consumer safety, especially among children? We explore the risks, expert recommendations, and what regulators and manufacturers need to do

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21:56

OPP EP 34: Paraxanthine as a Caffeine Alternative

The Orange Pill Podcast ·

2025/06/24

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 compares to caffeine in terms of safety and effectiveness Its nootropic and physical performance benefits Why new coffee products are being formulated

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33:55

Episode 33: Psyllium Husk – "Nature’s Ozempic" and...

The Orange Pill Podcast ·

2025/06/19

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 science stands today. We also touch on dosage safety, clinical findings, and what formulators and regulators need to keep in mind as psyllium’s popularity

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30:18

Episode 32: Efficacy of Probiotic Supplementation for...

The Orange Pill Podcast ·

2025/06/17

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 randomized, double-blind, placebo-controlled study to evaluate its efficacy and safety.The results are significant: - Participants taking the probiotic showed

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19:04

Episode 31: Determining Whether Human Research...

The Orange Pill Podcast ·

2025/06/12

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 your research falls under the IND requirements and how to avoid common pitfalls.Whether you’re working with new compounds, marketed drugs, or even

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34:42

Episode 30: Review of the FDA Bioresearch Monitoring...

The Orange Pill Podcast ·

2025/06/10

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 discuss practical strategies for maintaining continuous inspection readiness.Learn how sponsors, CROs, investigators, IRBs, and testing labs can stay ahead

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34:20

Episode 29: A GOOD IDEA for Better Blood Sugar

The Orange Pill Podcast ·

2025/06/05

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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53:27

Episode 28: Natural Relief- The Science Behind...

The Orange Pill Podcast ·

2025/06/03

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 Relieve-R to acetaminophen and placebo across three 7-day supplementation periods. The results? Relieve-R significantly reduced pain severity

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17:21

Episode 27: A Novel trial design by KGK Science on...

The Orange Pill Podcast ·

2025/05/29

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 discuss the implications of this design, the significance of the findings, and how UP446 may play a vital role in supporting respiratory

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11:13

Episode 26- FDA Continues to Allow Companies to Use...

The Orange Pill Podcast ·

2025/05/27

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 Science, others sidestep the process entirely.The FDA’s lack of enforcement has allowed un-notified, and in many cases counterfeit or imported ingredients,

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16:07

Episode 25: MAHA Commission Report – Big Beautiful...

The Orange Pill Podcast ·

2025/05/22

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. From structural insights to potential implications, we break it all down before the official release lands. Get ahead of the narrative. Tune in now.

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11:35

Episode 24: Nestle Launches Salmon Oil Supplement...

The Orange Pill Podcast ·

2025/05/20

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 obtaining the crucial NDI status that paved the way for this launch. Tune in for an inside look at the intersection of innovation, regulatory success, and

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08:52

Episode 23: Sustainability: The Future of the Dietary...

The Orange Pill Podcast ·

2025/05/15

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, sourcing local or organic ingredients, and embracing circularity can help your brand lead the change—and why it’s no longer optional.

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13:13

Episode 22: Pollen Extracts for Female Urinary...

The Orange Pill Podcast ·

2025/05/13

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 flower pollen extracts may support urinary health Key findings from the clinical trial What this means for the future of women’s health and

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