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And the ones that played it safe?
They’ll be licensing the future at a premium—if they can
get it at all.

3. Regulatory Ambiguity is Convenient

Regulatory uncertainty is often cited as one of the main
barriers to innovation in edible biologics—and on the
surface, that’s true. The FDA and other global regulatory
bodies have yet to provide clear, standardized pathways for
approving biologics expressed in edible plants and
delivered orally. These products don’t fit neatly into
existing categories:

● They are biologics, but not injected or purified.
● They are drugs, but embedded in plant tissue.
● They are foods, but designed to modulate immune
or enzymatic function.
● They are vaccines, but taken by mouth, sometimes
without adjuvants or refrigeration.

This liminal status leads to hesitation, additional meetings,
uncertain trial design requirements, and long back-and-
forths about classification. For smaller biotech companies,
this is a genuine challenge. They must blaze a new path
through a regulatory wilderness without precedent or
protection.

But for large pharmaceutical companies, this ambiguity
isn’t a threat.
It’s a gift.

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