The Orange Pill Podcast

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 dem...

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 fo...

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. W...

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? Beca...

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 d...

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 dis...

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 ...

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 physica...

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 form...

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 r...

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 pitfall...

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 s...

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 ...

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 UP...

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...

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 ...

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 insi...

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...