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Kentucky · Direct-to-Consumer Compliance

Supplements

No cottage exemption; federal manufacturing and labeling rules apply

Federal Rules Apply
DSHEAFederal supplement framework
cGMP21 CFR 111 manufacturing practices
TaxableDietary supplements are taxable in Kentucky
NoneNo home-based processor path

What's Covered / Needs a Different Path

What's Covered

  • Supplements made under cGMP with compliant Supplement Facts labels
  • Structure-function claims with the required disclaimer

Needs a Different Path

  • Home-kitchen capsules and tinctures
  • Claims to treat or cure disease
  • Products with unsafe ingredients

Compliance Steps

A

Confirm status

Decide if the product is a supplement.

B

Follow cGMP

Manufacture in a compliant facility.

C

Label and notify

Supplement Facts panel; notify FDA of claims where required.

Quick Reference

ItemRuleRegulator
ManufacturingcGMP (21 CFR 111)FDA
LabelSupplement FactsFDA
ClaimsStructure-function onlyFDA / FTC
Sales taxTaxableKY Dept. of Revenue

Frequently Asked Questions

Can I sell tinctures at a market?

Only if compliant with federal supplement rules.

Is herbal tea a supplement?

Depends on claims.

Do I pay tax?

Yes.

Printable Checklist