Page 352 - Binder2

The Power of the Undefined

In the absence of clear regulatory frameworks, everything
remains negotiable:

● How clinical trials should be structured.
● What endpoints are required.
● Whether plant-derived proteins must meet the same
sterility standards as injected ones.
● Whether a dried lettuce capsule qualifies as a
biologic, a drug, a supplement, or some new hybrid.

This lack of clarity creates a chilling effect on capital
investment and internal prioritization. Even if a company
sees the potential, it can justify deprioritizing edible
biologics simply because the rules don’t yet exist.

But once the rules are written—once the FDA approves a
plant-made oral biologic with clear guidance—the clock
starts ticking. Then, large players will no longer be able to
hide behind ambiguity. They’ll need to compete.

And they know it.

Strategic Inertia Disguised as Regulatory
Prudence

In this way, regulatory ambiguity becomes strategic
inertia—not just tolerated by incumbents, but quietly
welcomed. It allows companies to:

● Appear supportive of innovation without actually
advancing it.

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