April 27, 2021

Can I Make That Label Claim?

Note: This article was originally published on April 27, 2021 and updated on April 19, 2025

Every day, consumers select food and beverage products off the shelf based on packaging claims such as “Fat-Free” or “Good Source of Protein”. A recent Gallup poll found that 33% of consumers in the US pay "a great deal" of attention to the nutritional information that is printed on food packaging, especially where Sugar, Added Sugar, Calories, Carbohydrates and Protein content is concerned.

Expecting that number to rise is a pretty safe bet, too: in just two years, the use of GLP-1 agonist weight loss drugs like semaglutide (Ozempic, Wegovy) and tirzepatide (Zepbound, Mounjaro) has more than doubled, and according to food industry trend forecaster Tastewise, interest in GLP-1 friendly foods has increased over 165% year-over-year.

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That means that a growing number of people will rely on a "High Protein" or "High in Fiber" label to make decisions about not just their food but overall health during the weekly "big shop". Because consumers need to be able to judge a carton of yogurt or box of granola bars by it's cover, so to speak, the packaging and labeling regulations are specific about how and when you can make a nutrient content claim.

Want to understand which content claims you're permitted to make on product labels? We'll zoom in on a few and explore common examples in this article.

What are Nutrient Content Claims?

Nutrient content claims are Food and Drug Administration (FDA)-regulated terms that characterize the level of a nutrient in a food, and their use on labels and packaging is permitted so long as companies adhere to the regulatory requirements laid out under 21 CFR § 101.13 and its related sections.

How the CFR Defines a Nutrient Content Claim:

"A nutrient content claim is a direct statement about the level (or range) of a nutrient in the food (e.g., 'low sodium' or 'contains 100 calories'), or an implied statement about the food's nutrient content (e.g., 'high in oat bran').

A Note on Reference Amounts Customarily Consumed (RACC) Values

You cannot qualify for a claim by shrinking your serving size to an unrealistic amount. You must use the FDA’s standard "eating occasion" amount to do your math. You can find the list of RACC values here. Genesis Foods uses the RACC value for your product to determine qualified claims.

Get the Cheat Sheet: FDA Serving Size Rounding Rules

What's the Difference Between Direct and Implied Claims?

A Direct Claim is an explicit, "black-and-white" statement about the level of a nutrient, such as "Low Sodium" or "Contains 100 calories." According to 21 CFR § 101.13(b)(1), these are strictly defined by the numerical data in your analysis and leave no room for interpretation.

An Implied Claim, however, is more nuanced. Under 21 CFR § 101.13(b)(2), these are statements that describe a food or ingredient in a way that suggests a nutrient is present or absent (e.g., "no oil"). They can also include ingredient highlights that draw attention to a component known for a specific nutrient.

The regulatory burden for these depends entirely on context and presentation. For example: "Made with real dairy" on its own can just be an ingredient statement. However, if that phrase is used in a context that implies a nutrient benefit (such as being positioned next to a "strong bones" graphic or a "High Protein" callout) it becomes an implied nutrient content claim.

Once that threshold is crossed, the product must legally meet the criteria for a "Good Source" or "High" claim for that specific nutrient (like Calcium or Protein) as defined in 21 CFR § 101.54.

"Free" Label Claim Requirements & Criteria

What the CFR Says About "Low" or "Free" Claims:

Because the use of a “free” or “low” claim before the name of a food implies that the food differs from other foods of the same type by virtue of its having a lower amount of the nutrient, only foods that have been specially processed, altered, formulated, or reformulated so as to lower the amount of the nutrient in the food, remove the nutrient from the food, or not include the nutrient in the food, may bear such a claim (e.g., “low sodium potato chips”).

The term "Free" (or "Zero," "No," and "Without") implies that the nutrient is present in a "dietarily insignificant" amount. It is important to note that "Free" rarely means an absolute zero. Per 21 CFR § 101.13, the common thresholds for "Free" claims include:

Fat-Free: Less than 0.5 g of fat per RACC
Calorie-Free: Less than 5 calories per RACC
Sugar-Free: Less than 0.5 g of sugars per RACC
Sodium-Free: Less than 5 mg of sodium per RACC

When Can I Use A "Sugar Free" Nutrient Content Claim on Food Labels?

“Sugar-Free” on a package can be used if:

There is less than 0.5 g of sugar per serving; and
The item contains no ingredient that is a sugar product or generally understood to contain sugars;
The package has a statement regarding the calorie content, such as “low calorie” or “not a reduced-calorie food.”

There’s one more consideration here, too. If you use one of the claims listed above, but your food had exceeded DV threshold levels for fat, cholesterol, saturated fat or sodium, you have to use the disclosure:

“See nutrition panel for [nutrient] content.”

The "Sugar-Free" vs. "No Added Sugar" Distinction:

A "Sugar-Free" claim is a nutrient content claim about the final state of the food. A "No Added Sugar" claim is a processing claim. You might have a product with "No Added Sugar" (like 100% grape juice) that still contains 30g of natural sugar, meaning it could never be labeled as "Sugar-Free."

What Are the Requirements for a "Low" Nutrient Content Claim?

A "Low" claim is an absolute claim, meaning the food must meet a specific numerical threshold regardless of how it compares to other products. According to 21 CFR § 101.60-62, these claims are reserved for foods that have been specifically formulated or processed to reduce a nutrient, or are naturally low in that nutrient. To qualify for a "Low" claim, the food must meet the following criteria per RACC (Reference Amount Customarily Consumed):

Low Calorie: 40 calories or less
Low Fat: 3 g or less
Low Saturated Fat: 1 g or less and no more than 15% of calories from saturated fat
Low Cholesterol: 20 mg or less and 2 g or less of saturated fat
Low Sodium: 140 mg or less
Very Low Sodium: 35 mg or less

Crucial Exception: If a food is inherently low in a nutrient (like plain broccoli being low in sodium), you cannot label it "Low-Sodium Broccoli." The FDA views this as misleading because it implies your brand is unique. Instead, the label must state: "Broccoli, a low-sodium food."

When Can I Make a "Low Sodium" Label Claim?

To use the claim “Low Sodium” on your packaging, your food item must:

Contain 140 mg or less of sodium per individual serving or per 100 g for meals and main dishes; and
Have been formulated to lower the amount of sodium relative to foods of the same type; or
Be a food that is inherently low in sodium; in which case, your claim must be phrased in terms that all foods of that type are low-sodium foods

EXAMPLE: POTATO CHIPS

The RACC for one serving of potato chips is 30 g.
Your analysis shows that there is 98 mg of sodium per serving of your potato chips, which meets the <140 mg qualifier.
On average, potato chips have about 150-215 mg of sodium per serving, so your potato chips differ from other foods of the same type.

Your chips, therefore, qualify for a “low sodium” claim: “Low-sodium potato chips.”

potato chips

white rice

EXAMPLE: PLAIN WHITE RICE

The RACC for one serving of prepared white rice is 140 g.
There is 15 mg of sodium per serving in your rice.
Rice is an inherently low-sodium food, so the allowable claim/text is different.

Your rice can use the claim “Rice, a low-sodium food.”

"High" Claims: What's the Difference Between a "Good Source" of Nutrients and an "Excellent" One?

What the CFR Says About "High" Claims:

The terms "high," "rich in," or "excellent source of" may be used on the label or in labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that the food contains 20 percent or more of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) per reference amount customarily consumed.

Unlike "Low" claims, which focus on absolute numbers, "High" claims are relative to the Daily Value (DV). These are officially known as "Relative Level" claims under 21 CFR § 101.54. These claims are primary drivers for products targeting consumers who are strictly monitoring their protein, fiber, or vitamin intake. The requirements are:

"High," "Rich In," or "Excellent Source of": The food must contain 20% or more of the DV per RACC
"Good Source," "Contains," or "Provides": The food must contain 10% to 19% of the DV per RACC
"More," "Fortified," or "Enriched": The food must contain at least 10% more of the DV than a comparable "reference" food.

The Disclosure Requirement: If you make a "High Protein" claim but your product is also high in a "negative" nutrient (like having more than 13g of fat or 480mg of sodium), you must include a disclosure statement immediately adjacent to the claim, such as: "See nutrition panel for sodium content."

When Can I Make a "High in Vitamin C" Label Claim?

Make Label Claims with Confidence in Genesis Foods

If this all sounds complex and potentially extremely time consuming that's because it is, and it can be. Fortunately, Genesis Foods incorporates regulatory citations and threshold amounts to automatically calculate and display which claims can be used on your product's label. With the click of a button, you can know if your recipe is “Low in Sodium”, “a Good Source of Vitamin D,” "Sugar Free," and so on.

Instant Regulatory Accuracy

By integrating your ingredient data with established FDA and Health Canada regulations, thesoftware eliminates the guesswork. Whether you are aiming for a "High Protein" claim (which requires a specific PDCAAS value entry) or a "Sugar-Free" label, Genesis Foods scans your analysis and flags available claims with a green checkmark. It even handles complex Comparative Claims, such as "Reduced Sugar", by allowing you to search and link to an "Approved Food" for an instant side-by-side compliance check.

Global Compliance & Risk Mitigation

For brands operating in North America, Genesis Foods simplifies the transition between FDA and Health Canada guidelines. It automatically accounts for varying Reference Amounts and specific phrasing requirements (like "Excellent source" vs. "High in"). By surfacing mandatory disclosures and requiring explicit agreement for sensitive claims (like "No added sodium"), the platform ensures that every claim on your Packaging Assets report is legally defensible and scientifically accurate.

Visit the Genesis Foods Help Center to Learn More About:
Adding Nutrient Content Claims in Genesis Foods	Adjusting Reference Amounts in Genesis Foods	Canadian Nutrient Content Claims in Genesis Foods

Note: Although Genesis Foods makes it easy to quickly identify what claims your food qualifies for, it is a best practice to double-check with the CFR and consider all of the required conditions for making claims on your product packaging.

Ready to simplify labeling compliance?

Learn more about how Genesis can help with our on-demand webinar, Top 5 Strategies for Compliance-Driven Innovation with Genesis Foods, a conversation with leading QSR brands like Wendy's and Uncle Crumbles on how they use our gold-star solution to innovate product development and accelerate time-to-market while balancing regulatory compliance. Then get in touch with one of our experts for a personalized demo of Genesis Foods.

Tag(s): Food Labeling , Trustwell Software

Theresa Rex

Theresa Rex is Trustwell's Digital Marketing Manager. She has over two decades' experience researching, writing, creating, and marketing content for curious readers and leaders online. A former food and lifestyle writer, Theresa joined Trustwell in 2024.