Nutrient Content and Health Claims: What May Be Said
Every statement on a package about a nutrient or a disease falls into a category, and the category decides what evidence is needed before the words may appear. Two of the three require government action first; the third requires a disclaimer and a notification.
The rule in short
A nutrient content claim characterizes the level of a nutrient and may be used only where the food meets the definition established by regulation for that term. A health claim describes a relationship between a substance and a disease and requires either an authorizing regulation, an authoritative statement notification, or enforcement discretion for a qualified claim with disclosing language. A structure or function claim requires no preapproval but may not mention a disease.
Claims on a food package are sorted into three categories, and the category is determined by what the claim says rather than by how it is worded. A statement about the level of a nutrient is a nutrient content claim. A statement linking a substance to a disease is a health claim. A statement about how a nutrient affects the normal structure or function of the body is a structure or function claim. Each carries a different evidentiary route.
Defined terms and the amounts behind them
A nutrient content claim characterizes the level of a nutrient in the food. The terms are defined by regulation, and a food may use a term only if it meets the definition. Free means an amount that is nutritionally trivial and defined numerically for each nutrient. Low means an amount that allows frequent consumption without exceeding dietary guidance, again defined per nutrient. Reduced and less require at least a twenty-five percent reduction compared with an appropriate reference food, and the comparison must be stated on the label.
The source claims run on percentages of the daily value per reference amount customarily consumed. Twenty percent or more supports high, rich in or excellent source. Ten to nineteen percent supports good source, contains or provides. At least ten percent more of the daily value than the reference food supports more, fortified, enriched or added, with the comparison disclosed.
Two structural points recur. Claims are evaluated per reference amount rather than per serving as the manufacturer defines it, which prevents a claim being manufactured by shrinking the serving. And where a food bearing a claim exceeds a threshold for total fat, saturated fat, cholesterol or sodium, a disclosure statement referring the consumer to the nutrition information is required alongside it.
The three routes to a health claim
A health claim expressly or by implication characterizes the relationship of a substance to a disease or health-related condition. There are three ways one may lawfully appear.
The first is an authorizing regulation. The agency reviews the evidence and, where there is significant scientific agreement among qualified experts, issues a regulation permitting the claim, prescribing model wording and stating the conditions the food must meet. Any food meeting those conditions may use the claim.
The second is a notification based on an authoritative statement from a designated scientific body of the federal government. The notifier submits the statement and the proposed claim, and the claim may be used after the notification period unless the agency acts.
The third is a qualified health claim. Where the evidence is credible but falls short of significant scientific agreement, a petitioner may obtain a letter setting out the circumstances in which the agency intends to exercise enforcement discretion, including the qualifying language that must accompany the claim. That language is often longer than the claim itself, and it is not optional.
A food may not bear a health claim if it contains a nutrient at a level exceeding the disqualifying amount per reference amount, per labeled serving, or per fifty grams for foods with small reference amounts. The disqualifying nutrients are total fat, saturated fat, cholesterol and sodium. Separately, the food must contain, before any nutrient addition, at least ten percent of the daily value for one of six specified nutrients. A product can therefore satisfy every element of an authorized claim and still be barred by its own composition.
The three categories side by side
| Category | What it says | What is required first | Mandatory accompanying language |
|---|---|---|---|
| Nutrient content claim | Characterizes the level of a nutrient | The food meets the regulatory definition of the term used | Referral disclosure where a disqualifying nutrient exceeds the threshold |
| Authorized health claim | Links a substance to a disease or condition | An authorizing regulation based on significant scientific agreement | The claim's prescribed elements and conditions |
| Authoritative statement claim | Same subject matter as an authorized claim | Notification supported by a federal scientific body's statement | Wording consistent with the statement relied on |
| Qualified health claim | Links a substance to a disease on weaker evidence | A petition and a letter of enforcement discretion | The qualifying language specified in the letter |
| Structure or function claim | Describes an effect on normal structure or function | No preapproval; substantiation must exist | For supplements, the disclaimer that the agency has not evaluated the statement |
The last row is the one most often misused. A structure or function claim may not mention a disease, expressly or by implication. Claiming support for normal joint comfort is a structure or function claim; claiming relief of joint inflammation implicates a disease and converts the statement into an unauthorized health claim.
Dietary supplements and the notification duty
Supplements may bear structure or function claims without preapproval, but three conditions attach. The manufacturer must have substantiation that the statement is truthful and not misleading. The label must carry the disclaimer stating that the statement has not been evaluated by the agency and that the product is not intended to diagnose, treat, cure or prevent any disease. And the manufacturer must notify the agency of the statement no later than thirty days after first marketing it.
For conventional foods, a structure or function claim must derive from the nutritive value of the food. A claim resting on a non-nutritive effect is outside the category and is evaluated as a drug claim.
Working through a proposed claim
The practical sequence is short. Identify which category the proposed wording falls into, reading it as a consumer would rather than as the drafter intends. If it is a nutrient content claim, confirm the food meets the defined level per reference amount and check whether a disclosure statement is triggered. If it is a health claim, identify the specific authorization or letter relied on and reproduce its required elements. If it is a structure or function claim, confirm no disease is implicated and assemble the substantiation before the package prints.
Claims sit on top of the mandatory elements rather than replacing them, so a package carrying a claim still must satisfy everything in the mandatory label element rules, and adding a claim removes the small business nutrition labeling exemption. Because label accuracy is also a control in a written food safety plan, a claim change should route through the review described in the preventive controls and plan requirements.
Two further constraints apply to particular products. The word organic on a package is governed by the organic certification and labeling categories rather than by these rules, and using it without certification is a separate violation with its own penalties. Generic promotion funded through the checkoff programs is advertising, and the same claim standards apply to it.
Points to carry away
- Nutrient content claims may be used only where the food meets the regulatory definition of the term.
- An excellent source claim requires twenty percent or more of the daily value per reference amount.
- A good source claim requires ten to nineteen percent of the daily value per reference amount.
- A health claim describes a relationship between a substance and a disease or health-related condition.
- A food exceeding a disqualifying nutrient level may not bear a health claim without disclosure.
- A structure or function claim on a supplement requires a disclaimer and notification to the agency after first marketing.
Questions readers ask
What is an implied nutrient content claim?
A statement that describes the food or an ingredient in a way suggesting a nutrient is absent or present in a certain amount, or that suggests the food may be useful in maintaining healthy dietary practices and is made alongside an explicit claim. Statements about an ingredient rather than a nutrient — that a product contains no tropical oils, for example — can be implied claims about saturated fat. Because implied claims are regulated on the same terms as express ones, the food must meet the underlying definition.
How does a qualified health claim differ from an authorized one?
An authorized health claim rests on significant scientific agreement among qualified experts and is established by regulation, so any food meeting the conditions may use the claim's stated wording. A qualified health claim rests on credible evidence falling short of that standard, and the agency responds to a petition with a letter stating the circumstances in which it intends to exercise enforcement discretion, including the qualifying language. The qualifying language is part of the claim, and dropping it removes the basis for the discretion.
Do these rules apply to advertising as well as labels?
Labeling and advertising are regulated by different agencies under different standards, though the substantive expectations converge. A claim that could not appear on a label because the food fails the definition is also likely to be challenged as deceptive in advertising, since the underlying representation is the same. Firms that clear label claims through one review and advertising claims through another frequently end up with a package and a campaign that do not match, which is itself evidence in a challenge.
Sources
- Cornell Legal Information Institute — 21 U.S.C. 343, Misbranded FoodThe statutory basis for nutrient content claims, health claims and supplement statements.
- eCFR — 21 CFR Part 101, Subpart D, Specific Requirements for Nutrient Content ClaimsThe defined terms and the levels a food must meet to use each of them.
- eCFR — 21 CFR Part 101, Subpart E, Specific Requirements for Health ClaimsThe authorized claims, their required wording and the conditions attached to each.
- eCFR — 21 CFR 101.14, Health Claims: General RequirementsThe disqualifying nutrient levels and the minimum nutrient contribution requirement.
- Food and Drug Administration — Label Claims for Conventional Foods and Dietary SupplementsThe agency's description of the three claim categories and their approval routes.
- Food and Drug Administration — Food Labeling and NutritionCurrent claim guidance, petitions and the letters issued on qualified claims.
Lawwise is a publication, not a law firm. This article states general rules and cites its sources; it is not advice about any particular case, and the law differs by state and changes over time.
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