Medical Food Review

Medical Food 4 legal tests + clinical evidence + channel audit

Medical Food Review

Medical Food must pass 4 legal tests: (1) oral/enteral tube feeding (2) physician supervision (3) specific disease (4) unique nutritional requirements. FDA issues 30+ Warning Letters yearly to 'health foods' disguised as medical foods. This flow tells you honestly whether you qualify.

Rigorous 4-test assessment (clear classification: true medical food vs DSHEA supplement)
Clinical nutrition evidence review + ICD-10 disease matching + literature citation verification
Label + channel audit (DTC sales = Warning Letter red flag)
If not qualified, recommend correct path (general food / supplement / OTC / NDA)

Product Information

Product name (Chinese) *

Product name (English)

Product form

Country of origin

Net weight

Unit

Clinical Use (4-test core)

Intended condition (Chinese) *

Intended condition (English)

Target population

Disease stage

Concurrent conditions / contraindications

Clinical evidence summary

Formula

Ingredients (Chinese) *

Nutrition profile per serving

Marketing claims

Channel / Physician Supervision Infrastructure

Primary sales channel

Consumer purchase requires physician prescription / HCP involvement

Has Medical Affairs team (in-house or outsourced)

Has HCP sample program (physician trial system)

Has AER (Adverse Event Reporting) SOP

HCPCS code (if any)

Has insurance coverage (Medicare / Medicaid / commercial)

Label

Label contains 'A Medical Food For the Dietary Management of [disease]' statement

Label contains 'Use under medical supervision'

Drug-like claims in label/ads (if any)

Structure/Function claims (if any)

Review mode

Thorough — 4 layers parallel + final-layer self-consistency (highest accuracy)