Audit every marketing claim on your label, know which agency defines it, and either meet the definition or drop the word — before a technically-fine claim misbrands a technically-fine product.
Do these first
Real help from real food people
Chef Diego runs a real food plant. If this page didn't get you there, tell us — a person reads every message.
By the end of this lesson you can go down your label one claim at a time — "healthy," "natural," "made with real butter," "organic," "gluten-free," "Made in USA" — and for each one either point to the federal definition you meet or take the word off. The required elements are the law telling you what you must say; a claim is you choosing to say more, and every word you add is a promise a regulator can hold you to. The reassuring part: almost every claim trap is avoidable, because the rule for each one is written down.
The elements in the last lesson were mandatory. Claims are optional — but the moment one goes on the package, it is regulated, and a claim you can't back up makes the product . That's the same section of the Federal Food, Drug, and Cosmetic Act the whole label rides on: labeling that is false or misleading in any particular is misbranding under section 403(a), 21 U.S.C. 343(a) (verified July 2026). So the safe default is simple — if you can't prove a claim, don't print it.
The second thing to learn before any single claim is which desk it sits on, because three different agencies police label claims and they don't share a rulebook:
For every claim on your label, the job is the same: find the desk it belongs to, find the definition, and meet it or drop it.
FDA splits the claims about what's in the food into two families, and they sit at very different heights.
A is any word that describes how much of a nutrient the food carries. The general rules live at 21 CFR 101.13, and each specific term has its own numeric definition in Subpart D of Part 101. Two you'll meet constantly: "good source" (also "contains," "provides") means the food has 10 to 19 percent of the Daily Value of that nutrient per serving, and "high" (also "rich in," "excellent source") means 20 percent or more (21 CFR 101.54, verified July 2026). "Low fat," "reduced sodium," and the rest each have their own threshold.
The rule to internalize: you either hit the number or you don't use the word. "Almost low-fat" is not a category. The Daily Values and per-serving basis are the same ones you set in the Nutrition Facts and the rounding that misbrands a correct number lesson, so a nutrient-content claim has to agree with the panel it sits next to. One placement note from 101.13: a nutrient-content claim can't be printed in type more than twice the size of the statement of identity — you can't let the claim shout down the name of the food.
A is a different and much higher bar. You cannot invent one. A health claim has to be one FDA has already authorized by regulation (21 CFR 101.14 and the authorized claims in Subpart E, verified July 2026), and the food has to clear a floor to carry it: contain at least 10 percent of the Daily Value of a beneficial nutrient before any fortification — the "jelly bean rule," so a candy can't buy its way in — and stay under the disqualifying levels of fat, saturated fat, cholesterol, and sodium set in 101.14.
One line never to cross: a claim that a food "treats," "cures," or "prevents" a disease is a drug claim, not a food claim, and it turns your product into an unapproved drug in FDA's eyes — a far worse problem than a misbranded label. For most small makers the practical rule is short: don't make a health claim unless it's on FDA's authorized list and you clearly meet it.
"Healthy" reads like a soft marketing word, but FDA treats it as an implied nutrient-content claim with a hard definition at 21 CFR 101.65 — and that definition was rewritten recently, which makes it the single most common way a label built on an old template is now wrong.
In a final rule published December 27, 2024 (89 FR 106064, verified July 2026), FDA replaced the old approach. The former limits on total fat and cholesterol are gone. In their place a food has to pass two new tests to call itself "healthy": it must contain a minimum amount of food from at least one of the groups the Dietary Guidelines are built on — fruit, vegetables, whole grains, dairy, or protein foods — and it must stay under set limits for saturated fat, sodium, and added sugars.
Two dates to write down for 'healthy'
The new rule is effective February 25, 2025, and manufacturers may use the new standard now. The compliance date is February 25, 2028 — after that, any food labeled "healthy" must meet the new definition. A product that earned the word under the old rule may not qualify under the new one. Don't carry "healthy" forward on faith: re-check it against the current 21 CFR 101.65 and the 2024 final rule, and put the 2028 date on your calendar.
Some claims have no numeric definition, which makes them feel safer than they are. They aren't — they just fail in a different way.
FDA has never defined "natural" through rulemaking. It has only a longstanding, informal policy: it hasn't objected to "natural" on a food when nothing artificial or synthetic — including added color — has been included that wouldn't normally be expected to be there (FDA, Use of the Term "Natural", verified July 2026). That policy is narrow: it says nothing about how the food was grown or processed — pesticides, high-fructose corn syrup, pasteurization all sit outside it — and nothing about whether the food is nutritious. Because there is no bright line, "natural" is one of the most-litigated claims in food, and the pressure comes less from FDA than from consumers in court. Use it only when it is plainly true that nothing artificial was added, and know it shields you less than a defined term would.
"Made with real butter," "made with whole grain," "made with real fruit" — these sit under the basic misbranding rule (truthful and not misleading, 21 U.S.C. 343(a)) plus the common-or-usual-name rule at 21 CFR 102.5 (verified July 2026). When the amount of an ingredient you highlight has a material bearing on the product's price or on whether a shopper buys it — or when the label or the picture would otherwise leave a false impression — you have to declare that ingredient's percentage right in the name ("made with 10% real fruit"). "Made with real fruit" splashed across a product that is 2 percent fruit is exactly the impression 102.5 exists to catch.
Two of the most valuable words on a shelf are also two of the most exacting, and they're strict in opposite ways.
"Organic" is not an FDA term at all — it belongs to USDA's National Organic Program under 7 CFR Part 205. To label a product "organic" or "made with organic [ingredients]," you generally have to be first. There is one carve-out: an operation with 5,000 dollars or less a year in gross organic sales is exempt from certification (7 CFR 205.101, verified July 2026) — but even then it must follow the organic production and labeling rules, and it may not use the USDA Organic seal or represent itself as "certified organic." The moment you expect to cross that 5,000-dollar line, start certification before you print, because it takes time to earn.
"Gluten-free" is FDA's, defined at 21 CFR 101.91. Using it is voluntary, but once the words are on the label the food actually has to be : less than 20 ppm of gluten (FDA gluten-free Q&A, verified July 2026). People with celiac disease rely on that number, so it is the entire promise. Fermented and hydrolyzed foods carry an added recordkeeping rule on top of it. Confirm the current requirement against FDA's page before you print the claim.
"Made in USA" isn't an FDA claim at all — it's the Federal Trade Commission's. Under the FTC's Made in USA Labeling Rule (16 CFR Part 323, in effect since August 13, 2021), an unqualified "Made in USA" label requires the product to be "all or virtually all" made and sourced in the United States, and the FTC can impose civil penalties for getting it wrong (FTC, Complying with the Made in USA Standard, verified July 2026). If your ingredients aren't all domestic, the honest move is a that tells the truth about what came from where.
One neighbor worth knowing so you don't confuse it: USDA's Country of Origin Labeling (COOL) requires origin information on certain raw commodities — fresh and frozen produce, fish and shellfish, some nuts, and certain meats — but it lands on the retailer, not the manufacturer, and excludes processed foods, so it usually won't touch a sauce or baked-good maker's own package. The habit is the one from every section here: match the claim to the right desk.
Work claims the way you worked the elements — in order, one at a time. Write down every claim on the package; for each, name the agency that owns it, find the definition, and either confirm you meet it or take the word off. Then re-check the ones that move — "healthy" just changed, and "natural" could get a definition someday — and read the live rule rather than copying a claim off a competitor's box, because that box may be running out its own compliance clock.
With the elements right, the allergens declared, and the claims honest, the label is legal — and a legal, truthful label is most of what keeps a good product out of trouble. The last thing this course does is prepare for the day something goes wrong anyway: the product-liability and recall coverage first-timers skip, and why retail buyers ask for proof of it before they'll stock you.
Do this in your operation