Herbal capsules, tinctures, and dietary supplement products sold direct to Iowa customers
Iowa's cottage food statute even says compliance with the state exemption doesn't represent compliance with federal law — dietary supplements are regulated by FDA under the Dietary Supplement Health and Education Act (DSHEA), which generally requires food facility registration and adherence to dietary supplement manufacturing practices (21 CFR 111) regardless of your Iowa cottage food status.
Use a proper Supplement Facts panel (not a Nutrition Facts panel), list every ingredient, and if you make a structure/function claim ("supports immune health"), include the required FDA disclaimer that the statement hasn't been evaluated by FDA and the product isn't intended to diagnose, treat, cure, or prevent disease.
If your formulation includes a dietary ingredient not marketed in the U.S. before October 1994, you generally need to submit a New Dietary Ingredient (NDI) notification to FDA before selling it — check your ingredient list against this rule early, since it can take real lead time.
| Item | Rule | Regulator |
|---|---|---|
| FDA food facility registration | Required for most supplement manufacturers; renew biennially | FDA |
| Supplement Facts labeling | Required panel format, differs from food Nutrition Facts | 21 CFR 101.36 |
| Structure/function claims | Allowed with required FDA disclaimer language | FDA / DSHEA |
| New Dietary Ingredient notification | Required before selling a post-1994 novel ingredient | FDA / DSHEA |
| Iowa cottage food exemption | Does not substitute for federal supplement compliance | Iowa Code 137F.20(1) |
Shelf stability might satisfy the state's non-TCS test, but Iowa's own statute explicitly notes that cottage food compliance does not equal federal law compliance — dietary supplements still answer to FDA's DSHEA framework on top of anything Iowa requires.
That kind of structure/function claim is allowed if it's truthful and carries the required FDA disclaimer, but you can't say it "prevents colds" or "treats the flu" without crossing into unapproved drug-claim territory.
Not required by law, but you do need to be able to substantiate any claim you make and ensure your ingredients and manufacturing meet applicable dietary supplement GMP standards.
Iowa does not run a distinct state supplement license separate from general food establishment rules; your main compliance burden here is federal (FDA/DSHEA), not a state license.