Supplements

Vitamins, herbal capsules, powders & tinctures

Verify Before You Sell

Nocottage-food exemption for supplements

DSHEAsets the federal framework

21 CFR 111manufacturing practice rules

0disease-treatment claims allowed

What's Covered / What Needs a Different Path

✓ Covered here

Dietary supplements manufactured under FDA Good Manufacturing Practice (21 CFR 111)
Products with a compliant Supplement Facts panel and structure/function claim disclaimer
Herbal capsules, powders, and tinctures sold as supplements, not as food or drugs

✗ Needs a different path

Selling supplements under either Home-Based or Homestead Vendor cottage law – dietary supplements fall outside both
Any disease-prevention or -treatment claim (“cures anxiety,” “treats arthritis”) without FDA drug approval
Skipping GMP recordkeeping because your operation is small – DSHEA applies regardless of scale

Three Steps to Compliance

Confirm you need the supplement pathway

If your product's purpose is health-related rather than nutritional/food, it's a supplement, not a cottage food, and needs its own compliance path.

Follow FDA GMP and labeling rules

Meet 21 CFR 111 manufacturing practices, include a proper Supplement Facts panel, and add the required “not evaluated by the FDA” disclaimer on any structure/function claim.

Check for state wholesale food registration

Since supplements aren't cottage-eligible, confirm whether an ISDH wholesale food establishment registration or a licensed co-packer is the right route for your production.

Quick Reference

Item	Rule	Regulator
Dietary supplement manufacturing	GMP under 21 CFR 111	FDA (federal, DSHEA)
Cottage food exemption	Does not apply to supplements	IC 16-42-5.3 / 5.4
Labeling	Supplement Facts panel + disclaimer	FDA (federal)
Production facility	ISDH wholesale food registration or co-packer	ISDH

Frequently Asked Questions

Can I make herbal capsules in my home kitchen under cottage law?

No – dietary supplements are excluded from both Indiana cottage food laws and follow the federal DSHEA framework instead.

What claims can I put on a supplement label?

General structure/function claims (“supports immune health”) with the required FDA disclaimer – never a disease-treatment or -cure claim.

Does DSHEA apply to a small home business?

Yes – there's no small-business or cottage carve-out for dietary supplement manufacturing practices.

Do I need a separate facility from my kitchen?

In most cases yes, or you'll need to work through a licensed contract manufacturer/co-packer, since ISDH wholesale food rules apply rather than the home-kitchen cottage exemption.

Printable Checklist

Confirm your product is a supplement, not a cottage food

Follow FDA 21 CFR 111 manufacturing practices

Use a compliant Supplement Facts panel

Avoid disease-treatment or -cure claims

Keep GMP records regardless of your production scale