Supplements

Vitamins, herbal capsules, powders and other dietary supplements

21 CFR 111cGMP for supplements

Supplement FactsRequired label panel

Nov 12, 2026IL Hemp Act (hemp cannabinoids)

Under 18Kratom sales barred

1What’s covered & what needs more

Covered under this path

Dietary supplements manufactured under FDA cGMP (21 CFR Part 111) with a Supplement Facts panel
Structure/function claims (with the required disclaimer) — FDA must be notified within 30 days
Herbal products marketed as food (not supplements/drugs) — e.g., plain dried herbs or tea blends (see those guides)

Needs a different path

Cottage food registration → does not cover supplements or health claims
Disease/treatment claims → unapproved drug
Hemp-derived cannabinoids (CBD/THC) → not authorized as food/supplement additives; Illinois Hemp Act adds licensing, testing and 0.4 mg THC/container limits from Nov 12, 2026
Kratom → Illinois bars sale to under-18s; several 2026 bills (21+) are pending — don’t list without legal review
Products imported, sold outside Illinois, or made in someone else’s facility → additional federal registration duties

2Three steps to compliant sales

Confirm it’s a supplement

A product with a Supplement Facts panel and structure/function language is a supplement; anything claiming to treat a disease is a drug. Keep marketing to permitted structure/function claims.

Build federal compliance

Supplement manufacturers, packagers and labelers follow FDA cGMP (21 CFR 111); label with identity, net quantity, Supplement Facts, ingredient list, and your name/address; report serious adverse events; notify FDA of structure/function claims within 30 days; register facilities as required.

Handle hemp & kratom carefully

IDPH treats THC/CBD as unapproved food additives. Illinois’ Hemp Act (signed June 12, 2026) takes effect Nov 12, 2026. Kratom is barred to minors. If you sell any of these, get legal advice first.

3Quick-reference table

Item	Rule	Regulator
cGMP	21 CFR Part 111 for anyone who manufactures, packages, labels or holds supplements.	FDA
Label	Statement of identity, net quantity, Supplement Facts, other ingredients, name/address, structure/function disclaimer.	FDA
Claims	Structure/function OK with disclaimer; disease claims prohibited; FDA notified within 30 days of first use.	FDA · FTC
Hemp / CBD	Not authorized food/supplement additives (IDPH); Illinois Hemp Act effective Nov 12, 2026.	IDPH · IDOA
Kratom	No sales to under-18s (720 ILCS 642); more restrictions proposed in 2026.	Illinois General Assembly

4Frequently asked

Can I sell herbal capsules under my cottage-food registration?

No. Cottage food doesn’t cover supplements or health claims — federal supplement rules apply.

Can I sell CBD gummies?

Not as food or supplements: THC and CBD are unapproved food additives under Illinois’ adoption of federal food rules. Illinois’ new Hemp Act adds further limits after Nov 12, 2026.

Do I have to test my products?

cGMP requires identity, purity, strength and composition controls — talk to a qualified consultant.

What about elderberry syrup?

If it’s marketed as food with no health claims it may be cottage-eligible; add immune-support claims and it becomes a supplement.

Printable checklist

Decide: food, supplement or drug — and remove drug claims
cGMP documentation (Part 111) in place
Label with Supplement Facts and required disclaimer
Adverse-event reporting process
FDA claim notification within 30 days
No hemp/CBD/THC or kratom without legal sign-off
Register with IDOR; verify tax classification
Product-liability insurance

Sales tax: Classification varies by product (food vs. qualifying drug vs. general merchandise). Confirm with IDOR before setting your tax rate.