What is covered and what needs another path
Covered
- Supplements made under cGMP
- Labels with a Supplement Facts panel
- Structure-function claims with notice
Needs a different path
- Disease treatment claims
- Unsafe ingredients
- Home-kitchen manufacturing
Three compliance steps
A
Meet cGMP
Manufacturing must follow federal cGMP rules.
B
Label correctly
Supplement Facts, ingredient list, net quantity and the required disclaimer.
C
Notify FDA
Structure-function claims require notice within 30 days.
Quick reference
| Item | Rule | Regulator |
|---|---|---|
| Manufacturing | cGMP compliance | FDA |
| Label | Supplement Facts panel | FDA |
| Claims | Structure-function only | FDA / FTC |
| State | Confirm LDH food and drug rules | LDH |
FAQ
Is cottage law enough?
No.
Do I need FDA approval?
Not pre-approval, but you must follow the rules.
Checklist
- cGMP plan
- Label compliant
- Claims reviewed
- FDA notice filed
- LDH confirmation
- Tax checked