OmniRayn · Foundry Classroom · Regulatory literacy

What you may
and may not say

Claim-language literacy.

Students Employers
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OmniRayn/Claim-Language Literacy
StudentsEmployers
The three lanes

Three lanes, three rulebooks.

DSHEA

Dietary supplement

Structure-function claims only — "supports." Never "treats."

505(b)(2)

Repurposed drug

A known molecule, new medical use. "Treats" — but you must earn it.

Composition-of-matter

Novel molecule

Brand-new chemistry. The highest bar — and the biggest prize.

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OmniRayn/Claim-Language Literacy
StudentsEmployers
The same molecule, two legal worlds

One molecule. The sentence is what changes.

As a supplement · DSHEA

"Supports cellular health."

Legal — a structure-function claim.

As a drug · 505(b)(2)

"Treats Parkinson's."

Requires trials + FDA review. Not interchangeable.

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OmniRayn/Claim-Language Literacy
StudentsEmployers
Orphan designation

Aim at a rare disease and the path changes again.

The example

Point the candidate at a rare indication — ALS — and orphan rules apply.

What shifts

Different exclusivity, different IP, a different route to market. The indication is a strategic choice.

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OmniRayn/Claim-Language Literacy
StudentsEmployers
Reading a real listing's regulatory block

"Intelligence,
not an asset."

  • Names the honest lane — supplement, repurposed, or novel.
  • Says plainly what it is not — a finished product.
  • The job skill: a compliant claim vs. a warning letter.
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OmniRayn/Claim-Language Literacy
Non-commercial
The license

"Computational predictions, pending wet-lab; structure-function framing only; not experimental evidence and not a disease, treatment, or efficacy claim."

Holding the line on claim language — even about a result you love — is the discipline this module teaches.

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