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6.2 – Regulatory Limbo

If edible biologics threaten the business model of Big
Pharma, then regulatory uncertainty is their first
battleground.

The current drug approval system was built around a clear
paradigm: drugs are chemically synthesized or grown in
cells, purified, and administered through controlled routes
like injection or infusion. Every element of the regulatory
pathway—from preclinical validation to cGMP standards to
clinical trial design—is calibrated around that central
dogma.

Edible biologics defy that model.

They introduce proteins orally, within unpurified plant
tissue. They blur the lines between food and
pharmaceutical, between biologic and supplement. And that
creates a kind of regulatory purgatory—where no one
knows exactly how to classify them, and therefore no one
knows exactly how to approve them.

Drug, Food, or Something Else?

Is an encapsulated lettuce leaf expressing a therapeutic
protein a drug? A food? A biologic? An advanced
therapeutic medicinal product? The answer is yes—and no.
And that’s the problem.

In the U.S., the FDA classifies biologics under the Public
Health Service Act, subject to rigorous CBER oversight.
But if a protein is expressed in a plant and not purified—if
it’s delivered in edible form—then it doesn’t fit neatly into
any existing category. It doesn’t behave like a traditional

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