Legal Guide to Health Claims on Food

Healthy, all-natural, organic, low-fat. These terms appear on food labels everywhere, but only some of them have strict definitions and regulations.

As nutrition guidelines change and more people are invested in how they nourish their bodies, digesting the information on food packaging becomes a tougher task. It’s hard to discern the difference between health claims with a legitimate backing and words that are grounded in marketing.

“I just don’t know that consumers actually know that … some claims are defined and some claims are not,” said Lauren Handel, principal attorney of New Jersey-based firm Handel Food Law.

The confusion even extends to alcohol.

“For beer, you have to have your governmental warning label and alcohol content on there, but outside of that, those are the only label requirements,” said University of Dayton adjunct professor of law Adam Armstrong.

Food labels can overwhelm and disorient consumers, but there are a few steps shoppers can take while browsing grocery aisles to make informed decisions that fit their dietary needs.

What Laws Regulate Food and Nutrition Labels?

There are several federal laws that govern food packaging: the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Nutrition Labeling and Education Act and the Fair Packaging and Labeling Act.

The FD&C Act, enacted in 1938, prohibits the misbranding of food, allows the Environmental Protection Agency to set limits on pesticide residue present on food, limits poisonous substances in foods and sets standards for uniform food labels, among other measures.

The Nutrition Labeling and Education Act, which amended the FD&C Act in 1990, requires most foods to be labeled with serving sizes and specific nutrition information, and it sets standards for food labels that make certain health claims.

The Fair Packaging and Labeling Act of 1966 spells out packaging requirements for food and other packaged goods. The act requires food manufacturers to identify the type of product on the label, disclose the name and place of business of the product’s maker, and list the quantity of the contents in weight or another measurement. The act also sets provisions to prevent consumers from being deceived.

“In general, we require food labeling to be truthful and not misleading and consider product labeling concerns on a case-by-case basis,” said FDA spokesman Nathan Arnold in an email. “Among other things, we consider the terms used within the context of the entire label when determining compliance with our requirements.”

Nutrition Label Updates

The FDA established new rules for nutrition facts labels that appear on packaged foods in May 2016. Changes to the panels include:

  • New information on the link between diet and chronic disease, such as heart disease and obesity, must appear on applicable labels.
  • Calories and serving size are listed in a larger, bolder font, with the number of servings per container also in a larger type size.
  • Serving sizes are based on the amount of food people actually eat rather than how much they should eat, requirements that were last published in 1993.
  • Packaged food that is between one and two servings will be required to be labeled as one serving, as people typically consume the whole package, but should indicate the amount of calories and nutrients per serving and per package in two columns.
  • A new footnote explains what percentage of the Daily Value (DV) means.
  • Labels must list the actual amount and DV for calcium, iron, potassium and vitamin D; vitamins A and C are no longer required.
  • Percentage of Daily Values for nutrients including sodium, fiber and vitamin D were updated.
  • “Added sugars” must be listed on labels in grams and percentage of Daily Value.
  • Labels still require manufacturers to list total fat, saturated fat and trans fat, but “calories from fat” is not required. 

Food manufacturers with at least $10 million in annual sales must have switched to the new label by January 1, 2020, while manufacturers that sell less than $10 million annually had until January 1, 2021, to bring their labels into compliance. Makers of certain flavored dried cranberries have until July 1, 2020, to comply, and single-ingredient sugar (such as honey or maple syrup) manufacturers must make the changes by July 1, 2021. 

Food Label Lawsuit Case Studies

Foods that have high sugar and fat content but call themselves “healthy” or those that claim to be “natural” but contain artificial ingredients have become hot areas for litigation. Neither “healthy” nor “natural” are regulated terms. Because the term “natural” is undefined and unregulated, foods that claim to be “all-natural” or contain “no artificial flavors” have become frequent targets of lawsuits.

Case Studies

High-sugar cereals labeled “healthy”: Kellogg’s agreed to pay $20 million to settle a class-action lawsuit over marketing some of its cereals as “healthy” when they also contained high amounts of sugar.

Artificial versus natural flavoring: Frito-Lay Inc. came under fire for allegedly falsely marketing its salt and vinegar-flavored chips as containing only natural ingredients when they contained malic acid. A California couple sued Frito-Lay, claiming its advertising was misleading, and a judge denied the snack company’s motion to dismiss a proposed class-action lawsuit. The judge said she could not determine whether malic acid was an artificial flavor.

High-fat oils labeled “healthy”: A lawsuit against Barlean’s Organic Oils alleged the company engaged in misleading marketing by callings its coconut oil “healthy” when it contained high levels of saturated fat.

The FDA is considering regulating how the term “natural” is used on food packaging. The federal agency received three petitions to look at the term “natural,” to determine if the term should be defined and to decide whether it should be allowed on food labels. The FDA requested comments on use of the term “natural” on food labeling beginning in November 2015. The comment period closed May 10, 2016; no other action has been taken since then, Arnold said.

“The agency has reviewed the comments and is determining the next steps, which are contingent upon our resources and other priorities,” he said.

Four Tips for Buying Groceries

It can be difficult for grocery shoppers to discern what certain terms on food packages mean, particularly if consumers lack a basic understanding of nutrition principles.

“I think the only real way for consumers to know if a product is good for them or fits within their dietary needs is to look at the nutrition label and the ingredients list,” Handel said. “And they have to know something about nutrition, which might be asking a lot, but I don’t think you can rely strictly on the labeled claims or marketing claims to make that determination.”

The lines become further blurred when food marketers use terms that are not defined or regulated or that mimic competitor foods with a healthier nutrition profile.

“There are plenty of products out there that are truthfully marketing themselves as healthy or nutritious. And they do that not only with claims but [also] the whole way they position the product and the look and feel of it,” Handel said. “But they are also products that probably aren’t so healthy and that are trying to capitalize on the same messaging and look and feel.”

There are a few guidelines shoppers can follow to make educated decisions that fit their diets and to avoid terms that are more geared toward marketing than nutritional content.

1

Read the ingredients list.

Ingredients listed on labels are ordered from those with the highest content to the lowest.

“Lists are very regulated,” Handel said. “That doesn’t mean they’re always a hundred percent accurate. And then companies can make mistakes or might not be in compliance, but there is a better chance that information is mostly accurate, and that is the best way to assess what you’re getting.”

2

Look for claims that target specific ingredients.

Specific claims are more reliable than vague adjectives used to describe a product, Handel said. Products that claim to be “high in protein” or “low in fat,” for example, are subject to regulations.

“If it’s more fuzzy — if it’s an adjective and not an objective statement of facts — then it’s more likely to be subjective and open to interpretation,” Handel said.

3

Use the nutrition facts panel.

When you read a nutrition label, the FDA suggests assessing these factors in order: serving size, calories, nutrients to limit, nutrients to get enough of and the footnote. The agency provides a guide to interpreting and using nutrition labels, though the nutrition label requirements have since been updated.

4

Understand that no alcoholic beverages are healthy.

Alcoholic beverage manufacturers are not allowed to make health claims on their packaging.

“From the alcohol industry, you’re prohibited from making any claim that it’s going to give you any health,” Professor Armstrong said.

However, alcohol can be certified organic if it follows the same guidelines as organic food.

Glossary of Food Label Terms

The FDA and USDA define and regulate hundreds of terms that appear on food packaging. But some words that appear on labels are not regulated and skew more toward marketing than the reliable information about a food’s composition. The list below provides an overview and definition (if applicable) of some of the more popular terms on food labels and indicates whether they are regulated.

A number of these definitions refer to the Reference Amount Customarily Consumed (RACC), which is the amount of a food that a person usually eats. The RACC does not necessarily correspond to the serving size listed on a label.

The FDA’s full food labeling guide is available here (PDF, 8.9 MB).

Calories

Table Description
Word/Phrase on Label
Is it Regulated?
How is it defined?
Calorie-free, zero-calorie Yes Fewer than 5 calories per Reference Amounts Customarily Consumed (RACC) and per serving.
Light/lite in calories Yes If at least half the calories in a food are from fat, then fat must be reduced by at least 50% per RACC. If less than half the calories are from fat, then fat must be reduced at least 50% or calories reduced at least one-third per RACC. A “light” or “lite” meal or main dish meets the definition for a “low-calorie” or “low-fat” meal and is labeled to indicate which definition it meets.
Low-calorie Yes Has 40 calories or fewer per RACC (or per 50 grams if the RACC is small). For meals and main dishes, 120 calories or fewer per 100 grams.
Reduced/ fewer calories Yes At least 25% fewer calories per RACC than a reference food. For meals and main dishes, at least 25% fewer calories per 100 grams.

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Cholesterol

Table Description
Word/Phrase on Label
Is it Regulated?
How is it defined?
Cholesterol-free, no cholesterol Yes Contains fewer than 2 milligrams of cholesterol per RACC and per labeled serving. No ingredients in the food contain cholesterol unless a trivial amount is indicated in a footnote on the nutrition facts panel.
Low-cholesterol Yes Has 20 milligrams or fewer per RACC (or per 50 grams if the RACC is small). For meals and main dishes, 20 milligrams or fewer per 100 grams.
Reduced/less cholesterol Yes At least 25% fewer cholesterol per RACC than a reference food. For meals and main dishes, at least 25% less cholesterol per 100 grams.

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Fat

Table Description
Word/Phrase on Label
Is it Regulated?
How is it defined?
Fat-free Yes For total fat: less than 0.5 gram of fat per RACC and per labeled serving. For meals and main dishes, less than 0.5 gram per labeled serving. No ingredients in the food are fat or contain fat, unless the ingredient list refers to a footnote (e.g., “*adds a trivial amount of fat”).

For saturated fat: less than 0.5 gram of saturated fat and less than 0.5 gram of trans fatty acids per RACC. In main dishes, less than 0.5 gram of saturated fat and less than 0.5 gram of trans fatty acids per labeled serving. This food contains no ingredient that is or that contains saturated fat, unless the ingredient list refers to a footnote (e.g., “*adds a trivial amount of fat”).
Low-fat Yes For total fat: 3 grams of fat or fewer per RACC (or per 50 grams if RACC is small). For meals and main dishes, 3 grams or fewer of fat per 100 grams and not more than 30% of calories from fat.

For saturated fat: no more than 1 gram of saturated fat per RACC and 15% or less of calories from saturated fat. For meals and main dishes, 1 gram or less of saturated fat per 100 grams and less than 10% of calories from saturated fat.
Reduced/less fat Yes For total fat and saturated fat: at least 25% less fat per RACC than a reference food. For meals and main dishes, at least 25% less fat per 100 grams.

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Nutrient Amounts

Table Description
Word/Phrase on Label
Is it Regulated?
How is it defined?
% Daily Value Yes “How much a nutrient in a serving of food contributes to a daily diet; 2,000 calories a day is used for general nutrition advice,” according to the updated nutrition facts panels.
Free, low Yes In products that have been altered to lower the amount of a particular nutrient — such as fat or sodium — in the food, the nutrient is removed from or not included in the food. Foods that are naturally low in or free of a nutrient may only make a statement that indicates the food is naturally low in or free of that nutrient.
Good source of, contains, provides Yes Each RACC of a food contains 10 to 19% of the Daily Value of a nutrient.
High, rich in, excellent source of Yes The food contains at least 20% of the Daily Value of a nutrient per RACC.
Light/lite Yes Light/lite has different definitions for different ingredients/nutrients.

When compared to an appropriate reference food, a “light” food should be one the consumer would recognize as a food that is improved in its nutrient value compared to other average products of its type.

“Light” may also be used to describe a physical attribute of a food, such as “light in color,” “light in texture” or “light and fluffy.”
More, fortified, enriched, added, extra, plus Yes When compared with a reference food, contains 10% or more of the Daily Value of a vitamin, mineral, protein, dietary fiber or potassium per RACC.

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Organic/ Natural

Table Description
Word/Phrase on Label
Is it Regulated?
How is it defined?
Certified organic (PDF, 1.5MB) Yes There are four levels of organic certification: 100% organic, organic, made with organic [ingredient] and specific organic ingredients. Organic products are grown without methods such as genetic engineering, ionizing radiation or sewage sludge, and they comply with the National List of Allowed and Prohibited Substances, which dictates synthetic substances that may be used and natural substances that may not be used to produce organic crops and livestock. Certified organic foods are overseen by a USDA National Organic Program-authorized certifying agent.
100% organic Yes All ingredients and processing aids in 100% organic foods are certified organic. These products may include the USDA organic seal or a “100% organic” claim on their labels. (See “certified organic.”)
Organic Yes All agricultural ingredients in the product are certified organic, except where specified on the National List of Allowed and Prohibited Substances. Up to 5% of ingredients (excluding salt and water) can be non-organic if they comply with the National List. The product may include the USDA organic seal or organic claim on the label. (See “certified organic.”)
Made with organic [ingredient] Yes Can list up to three ingredients on the label. Contains at least 70% certified organic ingredients (excluding salt and water). Remaining ingredients are not required to be organically produced but must be produced without excluded methods, such as genetic engineering, ionizing radiation or sewage sludge. Non-agricultural ingredients must be explicitly allowed on the National List. All ingredients, including the up-to-30% non-organic contents, must be produced without GMOs. (See “certified organic” and “GMO.”)
Natural, all-natural No The word “natural” is not defined or regulated by the FDA, but the agency is considering defining how “natural” can be used on food labels.

The USDA defines “natural” as a product that does not contain artificial ingredients or added color and that has not been fundamentally altered. A “natural” food’s label must include a statement explaining the meaning of the term “natural” (e.g., “no artificial ingredients; minimally processed”).
Natural flavor Yes An essential oil, essence, distillate or other product of roasting, heating or enzyme catalyst whose primary function is flavoring rather than nutrition. The flavor is derived from a spice, fruit, fruit juice, vegetable, vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy or fermentation products thereof.

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Sodium

Table Description
Word/Phrase on Label
Is it Regulated?
How is it defined?
Low-sodium, low in sodium Yes No more than 140 milligrams of sodium per RACC (or per 50 grams if RACC is small). For meals and main dishes, 140 milligrams of sodium or fewer per 100 grams.

“Very low sodium” means 35 milligrams of sodium or fewer per RACC (or per 50 grams if the RACC is small). For meals and main dishes, 35 milligrams of sodium or fewer per 100 grams.
Light in sodium, light in salt Yes The food is “low-calorie” and “low-fat,” and its sodium is reduced by at least 50% per RACC. For meals and main dishes, “light in sodium” meets the definition for “low in sodium.” “Lightly salted” indicates a product has 50% less sodium than is normally added to a reference food; the nutrition information panel indicates if the food is not also “low-sodium.”
Reduced/less sodium Yes At least 25% less sodium per RACC than a reference food. For meals and main dishes, at least 25% less sodium per 100 grams.
Sodium-free, salt-free Yes Fewer than 5 milligrams of sodium per RACC and per labeled serving. For meals and main dishes, fewer than 5 milligrams of sodium per labeled serving. Includes no ingredient that is sodium chloride or contains sodium chloride, except trivial amounts noted on the information panel.

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Sugar

Table Description
Word/Phrase on Label
Is it Regulated?
How is it defined?
Low-sugar No Not defined. May not be used on food labels.
No added sugars, without added sugars Yes No sugar or sugar-containing ingredient is added to the food during processing. If the food is not a “low” or “reduced-calorie” food, it’s indicated on the label.
Reduced/less sugar Yes At least 25% less sugar per RACC than a reference food. For meals and main dishes, at least 25% less sugar per 100 grams.
Sugar-free Yes Less than 0.5 gram sugars per RACC and per labeled serving. For meals and main dishes, less than 0.5 gram sugars per labeled serving. Includes no ingredient that is a sugar or contains sugar, except trivial amounts noted in the ingredients list.
Unsweetened, no added sweeteners Yes Factual statements.

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Other

Table Description
Artificial flavor Yes Any substance used to create flavor that is not derived from a spice, fruit, fruit juice, vegetable, vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy or fermentation of such ingredients.
Free-range, free-roaming Yes Poultry has been allowed to access the outside.
Fresh Yes The food is raw and has not been frozen or subjected to any thermal processing or preservation. “Fresh” products may still be coated in approved waxes or coatings, treated with post-harvest-approved pesticides, washed with mild acid or mild chlorine, or treated with less than 1 kilogray of ionizing radiation.
Gluten-free, without gluten, free of gluten, no gluten Yes Foods that do not contain wheat, rye, barley or crossbreeds of those grains.

Food that has been processed to remove gluten and contains gluten levels lower than 20 parts per million — the lowest level that can be consistently and scientifically detected.

Foods that are naturally gluten-free can be labeled as such if they never came into contact with gluten during production.
GMO (or non-GMO) No GMO stands for “genetically modified organism” and indicates it has been bioengineered. The FDA prefers terms like “not genetically modified,” “not bioengineered” or “not genetically modified through the use of modern biotechnology,” but labeling is voluntary and the FDA will not take action against manufacturers that use the “GMO” acronym on products.
Healthy No The FDA provides guidance on using the word “healthy” on food labels, but it is not strictly defined. The agency is working to redefine how the word is used on labels.
Imitation Yes A new food that resembles and is a substitute for a traditional food but contains less protein, essential vitamins or minerals than the original.
No antibiotics added Yes Meat or poultry that was not raised with antibiotics.
No hormones Yes “No hormones administered” can be used on beef labels if the producer can prove to the USDA that no hormones were used in raising the animals.

Hormones are not allowed in raising hogs or poultry, so the term “no hormones added” may not be used on pork/poultry labels unless they also indicate, “Federal regulations prohibit the use of hormones.”
Sustainable No Not defined.
Trace amounts No The FDA does not define “trace amounts,” but it requires food manufacturers to declare some ingredients present in incidental amounts, including major food allergens. Sulfites added to any food or food ingredient must also be declared if they are present at more than 10 parts per million.

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Citation for this content: University of Dayton’s online JD degree.