))
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.
…
continue reading
1
Episode 27: A Novel trial design by KGK Science on Unigen’s UP446 Ingredient to Demonstrate a Positive Immune Defense Response
17:21
17:21
Play later
Play later
Lists
Like
Liked
17:21
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…
…
continue reading
1
Episode 31: Determining Whether Human Research Studies Can Be Conducted Without an IND
19:04
19:04
Play later
Play later
Lists
Like
Liked
19:04
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…
…
continue reading
1
Episode 30: Review of the FDA Bioresearch Monitoring (BIMO) Program
34:42
34:42
Play later
Play later
Lists
Like
Liked
34:42
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…
…
continue reading
1
Episode 29: A GOOD IDEA for Better Blood Sugar
34:20
34:20
Play later
Play later
Lists
Like
Liked
34:20
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.…
…
continue reading
1
Episode 28: Natural Relief- The Science Behind Relieve-R and Its Role in Pain Management
53:27
53:27
Play later
Play later
Lists
Like
Liked
53:27
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…
…
continue reading
1
Episode 26- FDA Continues to Allow Companies to Use NDIs Submitted by Competitors - the Practice of Piggybacking
11:13
11:13
Play later
Play later
Lists
Like
Liked
11:13
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…
…
continue reading
1
Episode 25: MAHA Commission Report – Big Beautiful (FDA) Blueprint
16:07
16:07
Play later
Play later
Lists
Like
Liked
16:07
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.…
…
continue reading
1
Episode 24: Nestle Launches Salmon Oil Supplement with Hofseth's OmeGo
11:35
11:35
Play later
Play later
Lists
Like
Liked
11:35
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…
…
continue reading
1
Episode 23: Sustainability: The Future of the Dietary Supplement Industry
8:52
8:52
Play later
Play later
Lists
Like
Liked
8:52
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,…
…
continue reading
1
Episode 22: Pollen Extracts for Female Urinary incontinence
13:13
13:13
Play later
Play later
Lists
Like
Liked
13:13
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 flowe…
…
continue reading
1
Episode 21: The Sleep Secret Hidden in Corn Leaves
14:15
14:15
Play later
Play later
Lists
Like
Liked
14:15
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…
…
continue reading
1
Episode 20: History of the US Food Supply : Before and After FDA
13:04
13:04
Play later
Play later
Lists
Like
Liked
13:04
In this episode, we uncover the shocking state of America’s food supply before the FDA — from toxic milk to candy laced with arsenic — and explore how those chaotic beginnings shaped the future of food, supplements, and regulation.By KGK Science
…
continue reading
1
Episode 19: KGK Science and Nimble Science: Revolutionizing GI Health Research
10:47
10:47
Play later
Play later
Lists
Like
Liked
10:47
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.…
…
continue reading
1
Episode 18: RFK Jr.'s FDA Food Safety Agenda
10:17
10:17
Play later
Play later
Lists
Like
Liked
10:17
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…
…
continue reading
1
Episode 17: Yeast Postbiotic Effect On Cold And Flu In Children
16:11
16:11
Play later
Play later
Lists
Like
Liked
16:11
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…
…
continue reading
1
Episode 16: New Vitamin D Meta Analysis Study Shows no Benefit on Upper Respiratory Illness
14:02
14:02
Play later
Play later
Lists
Like
Liked
14:02
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…
…
continue reading
1
Episode 15: Upcoming Trends in 2025 for the Dietary Supplement Industry
11:18
11:18
Play later
Play later
Lists
Like
Liked
11:18
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…
…
continue reading
1
Episode 14: Disturbing New Trend in CRO Research- Use of Predicted Margins
13:53
13:53
Play later
Play later
Lists
Like
Liked
13:53
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…
…
continue reading
1
Episode 13: FDA's Final Rule for 'Healthy'
12:19
12:19
Play later
Play later
Lists
Like
Liked
12:19
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…
…
continue reading
1
Episode 12: Benefits of Fava Beans on Resistance Training
18:59
18:59
Play later
Play later
Lists
Like
Liked
18:59
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…
…
continue reading
1
Episode 11: Virtual Trials for Dietary Supplements and Conventional Foods
30:44
30:44
Play later
Play later
Lists
Like
Liked
30:44
In this episode of the Orange Pill Podcast, we explore the growing trend of virtual clinical trials in the dietary supplement and conventional food industries. Learn how these innovative trial designs are making research more accessible, efficient, and data-driven.By KGK Science
…
continue reading
1
Episode 10: Update of Kennedy Reform of FDA Operations
18:16
18:16
Play later
Play later
Lists
Like
Liked
18:16
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…
…
continue reading
1
Episode 9: The Science of Brain Supplements - Part 2
12:50
12:50
Play later
Play later
Lists
Like
Liked
12:50
In this episode of The Orange Pill Podcast, we continue our deep dive into cognitive health, exploring the science behind brain supplements and how they support memory, focus, and overall mental clarity. Tune in now for expert insights and practical takeaways!By KGK Science
…
continue reading
1
Episode 8: Supplements for Brain Health - Part 1
16:16
16:16
Play later
Play later
Lists
Like
Liked
16:16
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…
…
continue reading
1
Episode 7: Exploring The Science, Benefits, Challenges and Regulatory Implications of GLP-1 Agonists as Functional Food Ingredients
17:40
17:40
Play later
Play later
Lists
Like
Liked
17:40
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…
…
continue reading
1
Episode 6: Science of Plant-Based Protein (Pea Protein vs Whey)
20:11
20:11
Play later
Play later
Lists
Like
Liked
20:11
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…
…
continue reading
1
Episode 5: The Science of Collagen Supplements
19:54
19:54
Play later
Play later
Lists
Like
Liked
19:54
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…
…
continue reading
1
Episode 4: How Dietary Supplements Became Regulated - Part 3
25:03
25:03
Play later
Play later
Lists
Like
Liked
25:03
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…
…
continue reading
1
Episode 3: How Dietary Supplements Became Regulated - Part 2
11:20
11:20
Play later
Play later
Lists
Like
Liked
11:20
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…
…
continue reading
1
Episode 2: How Dietary Supplements Became Regulated - Part 1
19:00
19:00
Play later
Play later
Lists
Like
Liked
19:00
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.…
…
continue reading
1
Episode 1: The Trump Administration and the Future of the FDA
21:42
21:42
Play later
Play later
Lists
Like
Liked
21:42
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…
…
continue reading
