A food may say "gluten-free" on its label only if it meets FDA's definition: it contains no wheat, rye or barley (or a cross of them), no ingredient made from them unless the gluten has been removed, and any gluten that's unavoidably there is below 20 parts per million. "No gluten", "free of gluten" and "without gluten" are held to the same rule. A food made with wheat starch processed to remove gluten can still qualify, if the food tests under 20 ppm and the label carries FDA's wheat statement. In the example below, a taro business labels its kūlolo and poi mochi gluten-free, can't label its taro bread, and tests both gluten-free products by lot because all three are made in the same kitchen. Below are the rules, the example, testing, and a free checklist.
The short version
- "Gluten-free" means no gluten grain, no ingredient from one unless processed to remove gluten, and under 20 ppm gluten.
- "No gluten", "free of gluten" and "without gluten" follow the same rule.
- Gluten-containing grains are wheat, rye and barley, and crosses such as triticale.
- Foods that are naturally gluten-free can carry the claim too, if they're under 20 ppm.
- Wheat starch processed to remove gluten is allowed, with an asterisk and FDA's wheat statement.
- The rule doesn't say how often to test; FDA checks by testing the food, so test by lot if you share a kitchen with wheat.
- TaroStack keeps each lot's test result on the lot, and each batch records the lots it used. More below.
The rules
The definitions are in 21 CFR 101.91(a):
| A food can say gluten-free if | It can't if |
|---|---|
| It has no ingredient that's a gluten-containing grain | It contains spelt, rye, barley or any wheat |
| Ingredients from those grains have had the gluten removed, and the food is under 20 ppm | It contains wheat flour, barley malt or another ingredient with the gluten still in it |
| It inherently contains no gluten | Unavoidable gluten from cross-contact is 20 ppm or more |
Twenty parts per million is 20 milligrams of gluten in a kilogram of food. If a gluten-free food lists wheat, as wheat starch for example, or carries a "Contains wheat" statement, the word "wheat" needs an asterisk pointing to this statement near the ingredient list: "The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods." When FDA checks a food, it uses a test that can find 20 ppm gluten in raw, cooked and baked foods; for fermented or hydrolyzed foods, where tests don't work, the maker keeps records instead (21 CFR 101.91(c)). This is general information, not legal advice.
An example: three taro products from one kitchen
Windward Roots, the made-up taro business on Oʻahu I use in these examples, makes three products in one kitchen:
| Product | Ingredients | Gluten-free claim? |
|---|---|---|
| Kūlolo | Taro, coconut milk, brown sugar | Yes, if under 20 ppm |
| Poi mochi | Poi, mochiko (sweet rice flour), sugar, coconut oil | Yes, if under 20 ppm |
| Taro bread | Enriched wheat flour, taro, yeast, sugar, butter, salt | No: wheat flour |
Mochiko is made from glutinous rice, which is sticky, not gluten: "glutinous" describes the texture. The kūlolo and poi mochi have nothing from a gluten grain in them, but the taro bread's flour is in the same kitchen, so the risk is flour in the air and on the tables. Windward Roots makes the gluten-free products first thing in the morning, after the kitchen has been cleaned and before the bread dough comes out, and sends a sample from one lot of each to a lab every quarter:
| Sent | Product | Lot | Result | Under 20 ppm? |
|---|---|---|---|---|
| July 6 | Kūlolo | KUL-0706-1 | Below 5 ppm | Yes |
| July 6 | Poi mochi | PM-0706-1 | Below 5 ppm | Yes |
| October 5 | Kūlolo | KUL-1005-2 | Below 5 ppm | Yes |
| October 5 | Poi mochi | PM-1005-1 | 12 ppm | Yes, but rising |
October's poi mochi still passes, and it's a warning: that lot was made in the afternoon of a bread day, after a schedule change. Windward Roots moved the poi mochi back to the morning and tests the next lot. What the extra steps add to a gluten-free product's cost is in how to price gluten-free baked goods.
Certification
FDA doesn't certify gluten-free foods; the label is the maker's own claim, and the maker is responsible for it. Private certification programs add audits, their own logos and their own limits, some stricter than FDA's, which some buyers ask for. A wheat allergy is a separate matter: wheat is a major food allergen and is declared on the label whether or not the food is gluten-free; how is in food allergen labeling requirements, and the rest of a label in food labeling requirements for small business.
Get the checklist
Download the gluten-free labeling checklist. Two sheets: products, one line for each ingredient with its gluten status, where whether the product can carry the claim fills in; and a test log, each sample with its product, lot, lab and result, where under 20 ppm passes and a fail turns red. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
A test log says how one lot tested. It doesn't say which lot of mochiko went into that lot, which bags of poi mochi from the 12 ppm lot are still in stores, or which lots were made on bread days. If a test ever comes back over 20 ppm, the question is which bags to pull, and a sheet of results can't answer it.
How TaroStack does it
TaroStack keeps each lot's test result on the lot, and each batch records the lots it used.
Test results on the lot. Fields of your own on each lot, such as the lab's result in ppm and the report number, keep the test with the lot it tested, and on the batch record, a tick box for "made after clean-down, before bread".
Batches with their lots. Each batch of poi mochi records which lots of mochiko and poi it consumed, automatically, and gets a lot of its own.
Who got which lot. Each order records the lots each customer got as it ships, so if a lot tests over 20 ppm, one recall report shows which stores have it and what's still on your shelves.
| The job | Test log | In TaroStack |
|---|---|---|
| A lot's test result | A row in a sheet | A field on the lot |
| Made after clean-down | Remembered | A tick box on the batch record |
| Which mochiko went into a lot | Not recorded | Recorded automatically |
| Which stores have a lot | Search the invoices | One recall report |
Lots, batches, batch records with fields of your own, and recalls are on every plan, from $49 a month. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.