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High Functioning Podcast · June 16 · 58 min

They Said Lab-Made 🥦 Was Fake. The FDA Disagrees | James Winokur, CitraChem

Everyone hears "synthetic" and thinks fake. James Winokur, CEO of CitraChem, explains why 99.9% of FDA-approved drugs are synthetic, and why a plant-inspired molecule has a 45% shot at approval while a fully novel one sits at 10%. We get into what Schedule III actually changes for operators, why lab-made doesn't mean fake, the FDA botanical route almost nobody clears, and where hemp beverages, the November repeal, and Big Pharma all collide. James spent 12 years in cannabis as the former CEO of Berkshire Roots and a product leader at Mary Med. Now he's building a life sciences platform that synthesizes botanically identical cannabinoids for pharmaceutical research. (00:00) Cold Open (01:35) Synthetic Doesn't Mean Fake (07:54) Schedule III and What CitraChem Does (13:37) The FDA Math: 45% vs 10% (15:23) Why Lab-Made Doesn't Mean Fake (18:31) What You're Actually Inhaling (21:05) The R&D Platform Play (23:34) Building the Molecule Library (30:00) Hemp Beverages and the November Repeal (36:48) Microdosing and the Education Gap (39:55) The Repeal Fight and Race to the Bottom Host: Jason Reposa Guest: James Winokur, CEO of CitraChem New episodes drop Tuesdays at 10 AM ET.

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show notes

Everyone hears "synthetic" and thinks fake. James Winokur, CEO of CitraChem, explains why 99.9% of FDA-approved drugs are synthetic, and why a plant-inspired molecule has a 45% shot at approval while a fully novel one sits at 10%.


We get into what Schedule III actually changes for operators, why lab-made doesn't mean fake, the FDA botanical route almost nobody clears, and where hemp beverages, the November repeal, and Big Pharma all collide.


James spent 12 years in cannabis as the former CEO of Berkshire Roots and a product leader at Mary Med. Now he's building a life sciences platform that synthesizes botanically identical cannabinoids for pharmaceutical research.


(00:00) Cold Open

(01:35) Synthetic Doesn't Mean Fake

(07:54) Schedule III and What CitraChem Does

(13:37) The FDA Math: 45% vs 10%

(15:23) Why Lab-Made Doesn't Mean Fake

(18:31) What You're Actually Inhaling

(21:05) The R&D Platform Play

(23:34) Building the Molecule Library

(30:00) Hemp Beverages and the November Repeal

(36:48) Microdosing and the Education Gap

(39:55) The Repeal Fight and Race to the Bottom


Host: Jason Reposa

Guest: James Winokur, CEO of CitraChem


New episodes drop Tuesdays at 10 AM ET.