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biologic. And it doesn’t behave like a dietary supplement
either.

This ambiguity creates regulatory paralysis:

● If classified as a food, it must meet safety and
nutritional standards—but efficacy data is optional.
● If classified as a biologic, it must adhere to sterility,
purification, and injection-based protocols that
edible platforms inherently bypass.
● If classified as a drug-device combination (as some
encapsulated forms might be), a whole new layer of
rules applies.

The lack of clarity keeps these therapies in bureaucratic
limbo—not because they lack merit, but because the
system lacks language to define them.

Oral Delivery: An Anomaly in the Eyes of the FDA

The oral delivery of proteins is still considered an anomaly
by most regulators. Proteins are supposed to be injected,
not swallowed. That’s the dogma.

So when a company proposes to deliver an antibody via
dried lettuce capsule or a vaccine via engineered rice grain,
regulators are caught off guard. How do you prove
bioavailability? How do you standardize dosing? How do
you validate pharmacokinetics when the “formulation” is
part of the delivery matrix?

Edible biologics require a new framework—one that treats
the GI tract not as a hostile barrier, but as a legitimate route
for immune modulation and protein absorption. That
framework doesn’t fully exist yet.

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