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Regulatory Challenges: A Category That Doesn’t Exist

Perhaps the most pressing issue facing edible biologics is
classification. They don’t fit neatly into current regulatory
buckets. They’re not just foods, even though they’re eaten.
They’re not quite traditional biologics, even though they
encode therapeutic proteins. They aren’t dietary
supplements or vaccines or gene therapies—though they
share features of all.

That ambiguity creates risk. Regulators need to evaluate
safety, efficacy, manufacturing consistency, and dosing
accuracy—but without established frameworks, review
becomes improvisational. Should plant-made drugs be
regulated as combination products? Should the FDA’s
Center for Biologics or Center for Food Safety take the
lead? How are GMP standards applied to living, leafy
systems?

None of these questions are rhetorical. They’re being
actively debated today in regulatory working groups and
biotech policy forums. Early companies navigating this
terrain are helping to establish precedent. But there’s still a
long way to go before edible biologics have a clear,
codified regulatory path.

Until then, progress may depend on creativity—finding
bridges between existing guidelines, or developing new
standards that embrace the unique nature of plant-based
therapeutics.

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