A health claim on a food label links the food, or something in it, to a disease or health condition: "diets low in saturated fat and cholesterol that include soluble fiber from whole oats may reduce the risk of heart disease". FDA allows only the claims it has authorized, each in its own section of 21 CFR part 101, subpart E, with its own wording and conditions, plus qualified health claims FDA has reviewed with specific wording. Every health claim also fails if the food carries too much of four things per reference amount: 13 g of fat, 4 g of saturated fat, 60 mg of cholesterol or 480 mg of sodium, the disqualifying levels. The authorized claims then add their own tests, and those are where small makers trip: the oat soluble fiber claim, for one, needs at least 0.75 g of soluble fiber from whole oats per reference amount and a food that's low fat, low saturated fat and low cholesterol, which rules out most granola. Different from health claims are structure and function statements, like "calcium builds strong bones", which don't name a disease, and nutrient content claims, like "good source of fiber". In the example below, a granola maker checks whether its oats can carry the heart claim. Below are the rules, the oat claim worked out, the example, and a free checker.
The short version
- A health claim links a food or nutrient to a disease or health condition.
- Only claims FDA has authorized, with their exact conditions, or qualified claims FDA has reviewed.
- Disqualifying levels per reference amount: 13 g fat, 4 g saturated fat, 60 mg cholesterol, 480 mg sodium.
- The oat heart claim needs 0.75 g soluble fiber from whole oats per reference amount.
- It also needs a low fat, low saturated fat and low cholesterol food.
- The claim says "may" or "might", and the daily oat fiber amount.
- Structure and function statements don't name a disease; nutrient claims like "good source" have their own rules.
- TaroStack keeps the recipe a claim rests on, with its versions. More below.
The rules
| Rule | 21 CFR part 101 |
|---|---|
| Allowed claims | Only those provided for in subpart E, meeting the general and specific provisions (101.14) |
| Disqualifying levels | 13 g fat, 4 g saturated fat, 60 mg cholesterol or 480 mg sodium per reference amount and per serving (101.14) |
| Low fat | 3 g or less per reference amount, for foods over 30 g (101.62) |
| Low saturated fat | 1 g or less per reference amount, and no more than 15% of calories (101.62) |
The oat claim worked out
| Condition | 21 CFR 101.81 |
|---|---|
| Wording | Diets low in saturated fat and cholesterol that include soluble fiber from the named oat source "may" or "might" reduce the risk of heart disease (101.81) |
| Daily amount | The claim states 3 g or more a day of beta-glucan soluble fiber from whole oats or barley, and what one serving gives |
| Per serving | At least 0.75 g of soluble fiber from whole oats per reference amount |
| On the label | Soluble fiber declared in the Nutrition Facts |
| The food | Low saturated fat, low cholesterol, and low fat unless the fat comes from the oats themselves |
How the label adds up is in food labeling requirements for small business, and a nutrient claim worked out in high protein claim requirements. This is general information, not legal advice.
An example: a Logan granola maker
Cache Valley Granola Co., the made-up granola maker in Logan, Utah, I use in these examples, wanted the oat heart claim on its new bags, and checked three products per reference amount:
| Product | Fat | Sat fat | Oat soluble fiber | Disqualifying level? | Low fat and low sat fat? | Claim allowed? |
|---|---|---|---|---|---|---|
| Honey almond granola | 9.0 g | 2.5 g | 1.0 g | No | No | No |
| Maple pecan granola | 11.5 g | 3.0 g | 0.9 g | No | No | No |
| Toasted oat clusters, no nuts | 2.5 g | 0.5 g | 1.1 g | No | Yes | Yes, if low cholesterol too |
The granolas have plenty of oat fiber, but the almonds, pecans and oil take them past low fat, and that fat doesn't come from the oats. Only the plain oat clusters can carry the claim, with the exact wording and the daily 3 g on the bag. The nutrition values here are made up for the example; a lab or analysis is what a claim rests on. The recipe and bake are in how to make granola in bulk.
Get the checker
Download the oat health claim checker. One sheet: each product's fat, saturated fat, cholesterol, sodium and oat soluble fiber per reference amount, checked against the disqualifying levels, the low fat and low saturated fat tests and the soluble fiber minimum, with "No" in red. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
A claim rests on a recipe: add more pecans, swap the oil, and a claim that held on last year's bag doesn't hold on this year's. A checker knows the numbers you typed, not the recipe you're making now.
How TaroStack does it
TaroStack keeps the recipe a claim rests on, with its versions.
Recipes with versions. Each product is a recipe by weight, and recipes keep their versions, so the formula behind a claim, and when it changed, is on record.
Batches record what went in. Each batch records the ingredient lots it used, so the oats and oil in a given run are on record.
Packaging on hand. Printed bags are items with stock, so you know how many claims are still in the warehouse before a recipe change.
| The job | Notebook | In TaroStack |
|---|---|---|
| The formula behind a claim | A file somewhere | The recipe's version |
| What went into a run | Not recorded | Lots on each batch |
| Printed bags left | Count the boxes | Stock of the bag item |
Recipes with versions, batches, lots and counts 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.