A structure/function claim describes how a nutrient affects the body's normal structure or function: FDA's own example is "calcium builds strong bones", and "fiber maintains bowel regularity" is another. On a conventional food, the claim has to come from the food's nutritive value, the protein, fiber, vitamins or minerals actually in it, and it must be truthful and not misleading. FDA doesn't pre-approve these claims, and a food maker doesn't notify FDA or print a disclaimer; those are rules for dietary supplements, which notify within 30 days and print that FDA hasn't evaluated the claim. The line not to cross is a disease claim: anything saying the food treats, cures, prevents or eases a disease or its symptoms makes it a drug. Claims tying a nutrient to reducing the risk of a disease are health claims, a separate category FDA authorizes one by one. In the example below, a Utah granola maker sorts its new bag copy.
The short version
- Structure/function: a nutrient's role in the body's normal structure or function.
- On food, the claim must come from nutritive value.
- No FDA notice or disclaimer for conventional foods.
- Supplements notify FDA within 30 days and print a disclaimer.
- Disease claims make a food a drug: don't make them.
- Risk-reduction claims are health claims, authorized by FDA.
- TaroStack keeps each recipe by weight, so what's in the bag is on record. More below.
Three kinds of claim
| Kind | Example | On a food |
|---|---|---|
| Structure/function | "Protein helps build muscle"; "fiber supports regularity" | Allowed if it comes from nutritive value and is true; no notice or disclaimer |
| Health claim | "Diets with enough calcium may reduce the risk of osteoporosis" | Only as FDA has authorized, with its conditions |
| Disease claim | "Lowers blood pressure"; "fights colds" | Not allowed: it makes the food a drug |
Authorized health claims are in health claims on food labels, and the "healthy" claim in healthy claim fda.
The rules
| Rule | Where |
|---|---|
| What it is | A nutrient's role in the normal structure or function of the body; on conventional foods, from nutritive value; no notification or disclaimer for conventional foods (FDA, Structure/Function Claims) |
| Supplements | Notify FDA within 30 days of marketing; the disclaimer that FDA hasn't evaluated the statement and the product isn't intended to diagnose, treat, cure or prevent any disease (21 CFR 101.93) |
| Disease claims | A statement that the product affects a specific disease or its characteristic signs or symptoms (101.93(g)) |
| Health claims | A substance's relationship to a disease or health-related condition; only as FDA authorizes (21 CFR 101.14) |
This is general information, not legal advice.
An example: new bag copy
Cache Valley Granola Co., the made-up granola maker in Logan, Utah, I use in these examples, drafted copy for a new protein granola with 12 grams of protein and 5 grams of fiber in a serving, and checked each line:
| Draft line | Kind | Kept? |
|---|---|---|
| "Protein to help build and repair muscle" | Structure/function, from the 12 g of protein | Kept |
| "Fiber for digestive regularity" | Structure/function, from the 5 g of fiber | Kept |
| "Iron helps carry oxygen in the blood" | Structure/function, but the iron is low | Cut: too little iron to be truthful |
| "Lowers cholesterol" | Disease claim | Cut |
| "Boosts immunity through cold and flu season" | Disease claim, by naming colds and flu | Cut |
| "May reduce the risk of heart disease" | Health claim | Cut unless it meets an authorized claim's conditions |
The iron line was true of iron in general but not of this granola, which has too little to claim anything about it, in good source of iron. The heart line would need one of FDA's authorized health claims, with its wording and conditions, so it came off the draft. No disclaimer went on the bag: it's a food, not a supplement.
Get the checker
Download the structure/function claim checker. One sheet: each draft claim, whether it names a disease or its symptoms, whether the effect comes from a nutrient in the food, whether it's about reducing disease risk, and whether the product is a supplement; what kind of claim it is and what to do fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The checker sorts the words. Whether the bag really has 12 grams of protein depends on the recipe the batch followed, and a recipe change can make a true claim false.
How TaroStack does it
TaroStack keeps each recipe by weight, so the ingredients behind a protein claim are on record for every batch.
Recipes by weight. The protein granola is a recipe by weight: oats, protein crisps, almonds, honey.
Batches from the recipe. Each batch records the recipe it followed and the ingredient lots it used.
Recalls. If a batch went out with the wrong label, one report shows every customer who got it.
| The job | Notebook | In TaroStack |
|---|---|---|
| Which recipe a batch followed | Remembered | Each batch from its recipe |
| The protein crisps in a batch | Not recorded | Batches by lot |
| Who got a mislabeled batch | Invoices | One recall report |
Recipes, batches 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.