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Category 23 of 25 · Hawaii

Supplements

Capsules, Powders & Herbal Extracts

Federal (FDA) Framework — No HI Cottage Path
Does not apply
HI cottage exemption
DSHEA / FDA
Federal rule
FDA / DCCA
Agency
4.5%
GET

What's Covered / What Needs More

✓ What's Covered

  • Dietary supplements (capsules, powders, tinctures, gummies) manufactured following FDA's dietary supplement Good Manufacturing Practice (GMP) rules
  • Products labeled with a Supplement Facts panel, ingredient list, and the required FDA disclaimer for structure/function claims
  • Selling direct, online, and wholesale once properly labeled and (if applicable) manufactured at a GMP-compliant facility
  • Registering the business for a GET license and following standard interstate commerce rules if selling beyond Hawaii

✕ Needs More

  • Assuming Hawaii's cottage food exemption (HAR 11-50) covers supplements — it does not; capsules, powders, and extracts fall under FDA's separate dietary supplement framework, not state cottage food law
  • Making disease-treatment claims ('cures arthritis,' 'treats diabetes') — this turns the product into an unapproved drug under federal law
  • Skipping the required FDA disclaimer: 'This statement has not been evaluated by the FDA...' on any structure/function claim
  • Manufacturing without following dietary supplement GMP requirements (21 CFR Part 111), especially for encapsulated or extracted products

How to Get Compliant

A

Confirm you're outside the cottage exemption

Supplements are federally regulated dietary products, not a home-kitchen cottage food category — plan for FDA compliance from the start.

B

Manufacture and label per FDA rules

Follow dietary supplement GMP practices, build a compliant Supplement Facts panel, and include the mandatory FDA disclaimer on any health-related claim.

C

Register the business

Get a GET license from the Dept. of Taxation; consider FDA facility registration if you manufacture (not just resell) supplement products.

Quick Reference

Sales ChannelRequirementNotes
Capsule/powder supplement, direct saleFDA labeling + GMP practicesNo Hawaii cottage exemption applies
Herbal tincture/extractFDA labeling + GMP practicesSame federal framework regardless of scale
Wholesale to a storeGET license + FDA-compliant labelRetailer may request GMP documentation
Any disease-treatment claimNot permitted without drug approvalReclassifies product as an unapproved drug

Frequently Asked Questions

Can I sell my herbal capsules under my cottage food permit?
No — Hawaii's cottage food law covers home-kitchen foods, not dietary supplements, which are governed by a separate federal (FDA) framework regardless of state cottage rules.
What's a Supplement Facts panel?
The FDA-required label format for dietary supplements, distinct from the Nutrition Facts panel used on conventional foods.
Can I say my supplement 'supports immune health'?
Structure/function claims like that are allowed if paired with the required FDA disclaimer, but disease-treatment claims are not allowed without drug approval.
Do I need a Hawaii-specific supplement license?
No state-specific supplement manufacturing license exists in Hawaii; compliance runs primarily through federal FDA dietary supplement rules plus a standard GET license.

Printable Checklist