Simplifying Food Regulation

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FDA Reader: Simplifying Food Regulation

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Food Labeling Errors That Can Cost You Your Business
 
3 Food Labeling Mistakes blog post image.png

Food Labeling Errors That Can Cost You Your Business*

*and how to avoid them

Designing a food label can be a daunting task for an entrepreneur bringing a new product to market. Even after you check the boxes for nutrition facts, product claims, and display requirements, you still have to make it work with your packaging design. But if you don’t have time to make sure your label is 100% compliant with every last regulation, then at least avoid the following mistakes — they could cost you your business.

1. Undisclosed Allergens

Many FDA food recalls are related to undeclared allergens. This typically is the result of two easily-avoidable mistakes: (1) the ingredients listing on the package doesn’t match the product in the packaging and (2) The allergens in the product are not displayed prominently to the consumer.

How to Avoid This Mistake: Make sure your ingredients list is complete and that you are identifying any of the Big 8 allergens using an Allergen statement, such as “contains peanuts”.

Who Cares? The FDA, the person you made sick. 

Likelihood of Discovery: High. Food allergies are common and undeclared allergens tend to get discovered when a consumer has an allergic reaction to the product, despite having checked the label first.

What it will cost you: Because of the potentially life threatening nature of an allergic reaction to food, food manufacturers typically conduct an immediate, voluntary recall of all effected products.


2. Unauthorized Health Claims

There are clearly defined rules when it comes to the types of claims you can make about a food product’s effect on the consumer’s health. The easiest way to guarantee the wrath of the FDA and a swift food recall is to make an-unauthorized health claim or drug claim. This means making a claim about how the product or one of its ingredients affects your body or provides some sort of therapeutic affect. It is unlawful to make this type of claim on the product label itself but also on marketing materials (e.g. the company website), even if you have scientific evidence to back it up.

While the FDA has approved a small number of Authorized health claims approved for use, there are only twelve of them, plus a handful of weakly phrased qualified health claims.

How to Avoid This Mistake: Do not make any unauthorized claim about your product’s effect on the body or treatment of any ailment. Make sure any claims related to nutrition or the benefits of specific ingredients align with the regulation

Who Cares? The FDA. Here’s why: let’s say you claim that the high levels of antioxidants in your popular snack bar has been shown to support immune health in cancer patients. If cancer patients forsake treatment measures in favor of your snack bar, this could have negative public health outcomes. Major retailers will also pull these products from their shelves if they don’t discover this error before they place their order.

Likelihood of Discovery: High. Claims are typically printed prominently to get the consumer’s attention. This also means getting the attention of regulators and savvy consumers.

What it will cost you: All of the products and materials containing the unauthorized claim, possibility of brand damage and the possibility of expensive lawsuits from customers who suffered damages due to this claim..

3. No Standard of Identity (or a misleading one)

FDA labeling requirements clearly require most packaged foods to declare what the product is. This is why a Tostito’s label must clarify that the product is Tortilla Chips and Nutella must describe itself as Hazelnut Spread. While there is a great deal of controversy and open questions surrounding naming conventions for milk-alternatives and meat-alternatives, this isn’t the case for most products.

How to Avoid This Mistake: Include the common name for your product on the front label.

Who Cares? Major retailers who don’t want to be held accountable for carrying a product which could be construed as misleading.

Likelihood of Discovery: Medium-High. It may not be discovered initially, but eventually someone will notice. Typically, a failure to disclose a product’s Standard of Identity doesn’t have negative health implications for the consumer, it’s just mildly confusing, an infraction which rates lower on the FDA’s list of priorities. It’s more likely that a wholesale purchaser or retailer will find issue with this labeling error than the FDA.

What it will cost you: Mainstream retailers may refuse to carry the product until this issue is remedied.

4. Undeclared Ingredients

Even when there’s no allergen implications, the discovery of an undeclared ingredient in a product can bring public outrage to a boil and even lead to a food scare. Quite simply, consumers don’t like finding out that they have been lied to, particularly about what’s in their food.

How to Avoid This Mistake: Work with trusty suppliers and conduct supplier verification activities so you can have confidence in the ingredients you purchase. Make sure that your food labels and ingredients reflect changes made to the product formula.

Who Cares? Your most loyal customers; Twitter.

Likelihood of Discovery: Low-Medium. Using the final few rolls of old food labels after a slight change in product formulation will likely go unnoticed. The deliberate, ongoing failure to accurately convey ingredient composition is more common than we know. Large-scale food fraud can go undetected for years before being uncovered and technology is sometimes altogether incapable of detecting when ingredients are replaced with a cheaper alternative.

What it will cost you: The ongoing failure to accurately declare ingredient composition could result in lawsuits, fines, and total destruction of your brand.


 
Qualified Health Claims

To learn about nutrition and health claims generally, see Introduction to Food Product Claims

What You Need to Know:

A Qualified Health Claim is a statement approved by the FDA for use on food labels that has strict wording requirements. 

When there is emerging evidence between a food and the reduced risk of a disease or health condition, but not enough for the FDA to issue an Authorized Health Claim, the FDA may approve a "Qualified Health Claim"

Example of a Qualified Health Claim:

"Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive."

What Qualified Health Claims Can I Use?


Qualified Health Claims 2000-2013

The attached PDF contains a list of qualified health claims released by the FDA in their 2013 Food Labeling Guide. This represents Qualified Health Claims Through 2013.

Qualified Health Claims 2013-2018

A number of Qualified Health Claims have been released since the FDA Food Labeling Guidance Document. The links below are the FDA's response, known as a "Letter of Enforcement Discretion". This includes the qualified health claim that the FDA will allow (usually in the conclusion) and the specific requirements associated with using that qualified health claim.

Cardiovascular Disease

Diabetes

Peanut Allergy


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Authorized Health Claims

To learn about nutrition and health claims generally, see Introduction to Food Product Claims

What is an Authorized Health Claim?

An Authorized Health Claim describes a health claim that has been reviewed by the FDA and approved for use.

This means you can make an authorized health claim on your product or label without having for the FDA to approve it.

There must be a "significant scientific agreement" in order for the FDA to issue an Authorized Health Claim. This means that the science supporting that health claim is unlikely to change.


What are the Approved Health Claims?

You can get a full list of authorized health claims in our article Approved Health Claims You Can Use on Your Label


How Do I Submit a Health Claim for Approval?

Anyone may submit a petition to the FDA to issue a qualified health claim or an authorized health claim (note that only 12 authorized health claims were issued between 1990-2018). 

The petition may include clinical laboratory studies, non-clinical laboratory studies and findings released by the FDA.

You can learn more about where to submit a health claim for approval on the FDA website and you can learn more about the requirements in the Code of Federal Regulations

Health claims will be reviewed based on the criteria defined in this FDA Guidance Document


References

Requirements for petitioning a Authorized Health Claim

Requirements for petitioning a Authorized Health Claim

Health claims will be reviewed based on the criteria defined in this FDA Guidance Document

Health claims will be reviewed based on the criteria defined in this FDA Guidance Document

 
 
Authorized Health Claims You Can Use On Your Label

Below is a list of the twelve Authorized Health Claims that can be used on your product label. 

You may author your own health claim as it relates to the food-disease relationships listed. However, any health claim you write is subject to the regulations in §101.70 Subpart E Requirements for Health Claims, so it may be easier to pick one of the pre-approved ones below.

Cancer Related Claims

Dietary Lipids and Cancer

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers."

"Eating a healthful diet low in fat may help reduce the risk of some types of cancers. Development of cancer is associated with many factors, including a family history of the disease, cigarette smoking, and what you eat."

Requirements for Using These Claims:

If you wish to write your own claim on Dietary Lipids and Cancer, see Subpart E -- 101.73


Fiber-Containing Grain products, Fruits, Vegetables and Cancer

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Low fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors."

"Development of cancer depends on many factors. Eating a diet low in fat and high in grain products, fruits, and vegetables that contain dietary fiber may reduce your risk of some cancers."

Requirements for Using These Claims:

  • The food must be OR contain a fruit, grain, or vegetable

  • The food must meet the requirements for a "low fat food"

  • The food must meet the requirements for a "good source of fiber" without fortification

If you wish to write your own claim on Fiber-Containing Grain products, Fruits, Vegetables and Cancer, see Subpart E -- 101.7


Fruits, Vegetables, and Cancer

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, and vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber."

"Development of cancer depends on many factors. Eating a diet low in fat and high in fruits and vegetables, foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber, may reduce your risk of some cancers. Oranges, a food low in fat, are a good source of fiber and vitamin C."

Requirements for Using These Claims:

  • The food must be OR contain a fruit or a vegetable.

  • The food must meet the requirements for a "low fat" food.

If you wish to write your own claim on Fruits, Vegetables and Cancer, see Subpart E -- 101.78


Risk of Heart Disease Claims

Dietary Saturated Fat, Cholesterol and the Risk of Coronary Heart Disease

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease"

"Development of heart disease depends upon many factors, but its risk may be reduced by diets low in saturated fat and cholesterol and healthy lifestyles"

"Development of heart disease depends upon many factors, including a family history of the disease, high blood LDL-cholesterol, diabetes, high blood pressure, being overweight, cigarette smoking, lack of exercise, and the type of dietary pattern. A healthful diet low in saturated fat, total fat, and cholesterol, as part of a healthy lifestyle, may lower blood cholesterol levels and may reduce the risk of heart disease"

"Many factors, such as a family history of the disease, increased blood- and LDL-cholesterol levels, high blood pressure, cigarette smoking, diabetes, and being overweight, contribute to developing heart disease. A diet low in saturated fat, cholesterol, and total fat may help reduce the risk of heart disease"

"Diets low in saturated fat, cholesterol, and total fat may reduce the risk of heart disease. Heart disease is dependent upon many factors, including diet, a family history of the disease, elevated blood LDL-cholesterol levels, and physical inactivity."

Requirements for Using These Claims:

If you wish to write your own claim on Saturated Fat, Cholesterol and Coronary Heart Disease Subpart E -- 101.75


Fruits, Vegetables, and Grain Products that Contain Fiber, and the Risk of Coronary Heart Disease

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.


 "Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors."

"Development of heart disease depends on many factors. Eating a diet low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber may lower blood cholesterol levels and reduce your risk of heart disease."

Requirements for Using These Claims:

  • The food must be OR contain a fruit, grain, or vegetable

  • The food must meet the requirements for a "low saturated fat" food, "low cholesterol" food, or a "low fat" food

  • The food must contain 0.6g of soluble fiber per serving (without fortification).

  • The soluble fiber content must de displayed in the nutrition panel.

If you wish to write your own claim on Fruits, Vegetables, and Grain Products that Contain Fiber, and the Risk of Coronary Heart Disease, see Subpart E -- 101.77


Soluble Fiber and the Risk of Coronary Heart Disease 

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Soluble fiber from foods such as [*Insert name of applicable soluble fiber]) of this section and, if desired, the name of food product], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies ____ grams of the [grams of soluble fiber applicable soluble fiber specified] soluble fiber from [*Insert name of applicable soluble fiber] necessary per day to have this effect."

"Diets low in saturated fat and cholesterol that include ____ grams of soluble fiber per day from [*Insert name of applicable soluble fiber] may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber."

*Applicable Soluble Fibers: oat bran, rolled oats, whole wheat flour, oatrim, whole grain barley, dry milled barley, barley betafiber, psyllium husk,

Requirements for Using These Claims:

  • The food product must include at least 0.75g (per amount of the food typically consumed) of one of the following:

    • Oat Bran

    • Rolled oats

    • Whole wheat flour

    • Whole grain barley and dry milled barley

  • The food containing oatrim must contain ≥0.75g of beta-glucan soluble fiber per amount of the food typically consumed.

  • The food containing psyllium husk must contain ≥01.7g of soluble fiber per amount of the food typically consumed.

  • The amount of soluble fiber must be claimed in the nutrition information label.

  • The food must meet the requirement for a "low saturated fat" The only acceptable exception is if the food exceeds the requirement for "low fat" food due to fat derived from the whole oat sources.

  • The food must meet the requirement for a "low cholesterol food".

If you wish to write your own claim on Soluble Fiber and the Risk of Coronary Heart Disease, see Subpart E -- 101.81


Soy Protein and the Risk of Coronary Heart Disease


Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein."

"Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein."

Requirements for Using These Claims:

  • The food must meet the nutrient requirements for a "low fat" food unless it comes from soybeans and contains no additional fat than the fat inherent in those soybeans.

  • The food must meet the requirements for a "low saturated fat" food and a "low cholesterol" food.

If you wish to write your own claim on Soy Protein and the Risk of Coronary Heart Disease, see Subpart E -- 101.82


Plant Sterol/Stanol Esters and the Risk of Coronary Heart Disease

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

For Plant Sterol Esters:

"Foods containing at least 0.65 g per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil sterol esters."

"Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 1.3 g of vegetable oil sterol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil sterol esters."


For Plant Stanol Esters:

"Foods containing at least 1.7 g per serving of plant stanol esters, eaten twice a day with meals for a total daily intake of at least 3.4 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of plant stanol esters."

"Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 g of vegetable oil stanol esters in two meals may reduce the risk of heart disease. A serving of [name of the food] supplies ___grams of vegetable oil stanol esters."

Requirements for Using These Claims:

  • The food must contain ≥ 0.65g of applicable plant sterol* esters per amount typically consumed.

  • The food must contain ≥ 1.7g of plant stanol esters per amount typically consumed. Note that only certain food products are eligible to make this claim, including spreads, salad dressings, snack bars, and dietary supplements.

  • The food must meet the nutrient requirements for a "low saturated fat" food and a "low cholesterol" food.

  • The food must meet the limit for total fat per 50g -- except for spreads and salad dressings, which can exceed this limit if they have a disclosure statement such as, "see nutrition information for fat content"

  • Except for salad dressing, the food must meet the minimum nutrient requirement (see §101.14(e)(6)).

*Applicable Plant Sterols: prepared by esterifying a mixture of plant sterols from edible oils with food-grade fatty acids. The plant sterol mixture shall contain at least 80%  beta-sitosterol, campesterol, and stigmasterol (combined weight).

*Applicable Plant Stanol Esters: Plant stanol esters prepared by esterifying a mixture of plant stanols derived from edible oils or byproducts of the kraft paper pulping process with food-grade fatty acids. The plant stanol mixture shall contain at least 80 percent sitostanol and campestanol (combined weight).

If you wish to write your own claim on Plant Sterol/Stanol Esters and the Risk of Coronary Heart Disease, see Subpart E -- 101.83

Other Health Claims

Sodium and Hypertension

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."

"Development of hypertension or high blood pressure depends on many factors. [This product] can be part of a low sodium, low salt diet that might reduce the risk of hypertension or high blood pressure."

Requirements for Using These Claims:

If you wish to write your own claim on Sodium and Hypertension, see Subpart E -- 101.74


Calcium, Vitamin D and Osteoporosis

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."

"Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life."

"Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."

"Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life."

Requirements for Using These Claims:

  • If the claim references Vitamin D, then the food must exceed the requirements for a "high" level of vitamin D (see here)

  • The calcium in the food must be absorbable as a nutrient.

  • There may not be more phosphorus than calcium in the food (by weight.)

If you wish to write your own claim on Calcium, Vitamin D, and Osteoperosis, see Subpart E -- 101.72


Folate and Neural Tube Defects

Pre-Approved Health Claims

Neural tube defects are a birth defect of the brain or spinal cord that can lead to disability or infant mortality.

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Model health claim appropriate for foods containing 100 percent or less of the DV for folate per serving or per unit. The example contains all required elements plus optional information: Women who consume healthful diets with adequate folate throughout their childbearing years may reduce their risk of having a child with a birth defect of the brain or spinal cord. Sources of folate include fruits, vegetables, whole grain products, fortified cereals, and dietary supplements."

"Model health claim appropriate for foods intended for use by the general population and containing more than 100 percent of the DV of folate per serving or per unit: Women who consume healthful diets with adequate folate may reduce their risk of having a child with birth defects of the brain or spinal cord. Folate intake should not exceed 250% of the DV (1,000 mcg)."

The following health claims may be used if the food contains 100% or less of the daily value for the serving per-unit.

" Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect."

"Adequate folate in healthful diets may reduce a woman's risk of having a child with a brain or spinal cord birth defect."

Requirements for Using These Claims:

  • The food must meet the minimum requirements for a "good source of folate"

  • The foods must not contain more than 100% of the daily recommended intake for vitamin A as retinol per serving.

  • The foods must not contain more than 100% of the daily recommended intake of preformed vitamin A or D per serving.

  • The nutrition information label must include information about folate.

*Note there are additional requirements for dietary supplements

If you wish to write your own claim on Folate and Neural Tube Defects, see Subpart E -- 101.72


Dietary Sweeteners and Dental Tooth Decay

The title of this section in the legislation is "Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries"

Pre-Approved Health Claims

The following authorized health claims are pre-approved for use, subject to the requirements below.

"Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. The sugar alcohol [name, optional] used to sweeten this food may reduce the risk of dental caries."

"Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay."

"Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. [*insert the applicable sweetener from the list below], the sugar used to sweeten this food, unlike other sugars, may reduce the risk of dental caries."

"Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. [*insert the applicable sweetener from the list below], the sugar in [name of food], unlike other sugars, does not promote tooth decay."

"Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. Sucralose, the sweetening ingredient used to sweeten this food, unlike sugars, does not promote tooth decay."

Shortened Claims for Use on Small Packages:

"Does not promote tooth decay."

"May reduce the risk of tooth decay."

"[*insert the applicable sweetener from the list below] sugar does not promote tooth decay."

"[*insert the applicable sweetener from the list below] sugar may reduce the risk of tooth decay."

*Applicable Sweeteners:  xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, D-tagatose, isomaltulose, sucralose."

Requirements for Using These Claims:

If you wish to write your own claim on Dietary Sweeteners and Dental Tooth Decay, see Subpart E -- 101.80 Dietary Non-Cariogenic Carbohydrate Sweeteners and Dental Caries

 
Introduction to Food Product Claims
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What You Need to Know

There are 4 major types of product claims. Each one has specific requirements.

Health Claim: Describes a relationship between a food and a reduced risk of a disease or a health-related condition.

Authorized Health Claims:A health claim that the FDA has authorized for use based on "significant scientific agreement" on the subject. 

Qualified Health Claims: A health claim is one that is supported by scientific evidence but does not achieve the "significant scientific agreement" standard. The FDA authorizes Qualified Health Claims for use only when specific wording is applied.

Nutrient Content Claims describe the level of a nutrient in a food.

Structure/Function Claims: describe the role of a nutrient or ingredient on the structure or function of the human body.


Health Claims

A health claim describes a relationship between a food and a reduced risk of a disease or a health-related condition. This can be made in words, images (i.e. a heart), or a reference to a 3rd party certification.

Example of a Health Claim: "Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors."

Not a Health Claim: "fruits and vegetables contribute to good dietary health" This is not a health claim because no assertion is made about the reduced risk of a disease or health condition. Instead, this statement would simply be called 'dietary guidance'.)

Types of Health Claims

There are two types of health claims that appear on food labels and marketing. They are:

Requirements for a Health Claim

  • Health claims cannot be made about the diagnosis, cure, mitigation or treatment of diseases (this is a drug claim)

  • They must be complete, truthful and not misleading.

  • Certain foods may be disqualified from health claims based on nutrient levels that are deemed unhealthy. See §101.14 (4)

  • Health claims must be associated with a risk or health related condition for which the US population or a subgroup (i.e. the elderly) is at risk.

  • The substance that is the subject of the health claim must have a taste, aroma or nutrient value when consumed at the levels used to justify the claim.


Authorized Health Claims

See main article Authorized Health Claims

Health-Claim-Example-1.png

What is an Authorized Health Claim?

An Authorized Health Claim describes a health claim that has been reviewed by the FDA and approved for use.

There must be a strong scientific case in order for the FDA to issue an Authorized Health Claim. 

When there is emerging evidence between a food and a reduced risk of disease or health condition the FDA will allow the use of a "Qualified Health Claim" in food labeling.

What Health Claims Can I Use On My Product Label?

See full article Authorized Health Claims You Can Use On Your Label 

Example of a Qualified Health Claim

Example of a Qualified Health Claim

You may use an Authorized Health Claim or Qualified Health Claim that has already been approved by the FDA. For examples, see the 2013 FDA Labeling Guide. The wording requirements for Authorized Health Claims offer some flexibility in how that claim is stated.

Additionally, anyone may submit a notification to the FDA of a health claim based on scientific studies conducted by certain branches of the US government. This is called a Health Claim Based on an Authoritative Statement by a Scientific Body

The FDA may approve the health claim, reject it, or issue a Qualified Health Claim with specific guidelines about how the claim can be used.


Qualified Health Claims

What is a Qualified Health Claim?

A Qualified Health Claim is a statement approved by the FDA for use on food labels that has strict wording requirements. 

When there is emerging evidence between a food and the reduced risk of a disease or health condition, but not enough for the FDA to issue an Authorized Health Claim, the FDA may approve a "Qualified Health Claim". 


Nutrient Content Claims

Nutrient Content Claims

Main Article: Nutrient Content Claims

Examples of Nutrient Content Claims

What is a Nutrient Content Claim?

Nutrient Content Claim is a claim that characterizes the level of a nutrient in the food. 

This is different than information listed in the Nutrition Information Panel. Any claims made about nutrition outside of the Nutrition Information Panel would be considered Nutrient Content Claims.


Structure/Function Claims

What is a Structure/Function Claim?

A Structure/Function Claim describe the role of a nutrient or ingredient on the structure or function of the human body. These may appear on the labels of foods, dietary supplements or drugs.

Examples of a Structure/Function Claim:

  • "Calcium builds strong bones"

  • "Fiber maintains bowel regularity"

  • "Antioxidants maintain cell integrity"

Conventional food producers do not need to notify the FDA about structure/function claims or make disclaimers associated with these claims on their product labels. Producers of Dietary Supplements may face additional requirements.

Categories of Structure/Function Claims:

These claims are only associated with producers of Dietary Supplements.

Claims of General Well-Being: These describe general well-being from consumption of a nutrient or ingredient. 

Nutrient-Deficiency Disease Claims: These describe a benefit related to a nutrient deficiency disease (such as vitamin C and scurvey).

  • These claims are only allowed if the claim also states how prevalent the disease is in the US.

  • A business making a nutrient-deficiency disease claim must submit a notification that includes the text of the claim to the FDA no later than 30 days after marketing the dietary supplement that contains the claim.

 
Nutrient Content Claims

What You Need to Know:

A Nutrient Content Claim is a claim that characterizes the level of a nutrient in the food. 

This is different than information listed in the Nutrition Information Panel. Any claims made about nutrition outside of the Nutrition Information Panel would be considered Nutrient Content Claims. Some basic requirements:

  • You can't make claims that could be misleading in any way.

  • Terms like "low-fat" or "sugar-free" have specific nutritional thresholds.

  • Most terms related to nutrition content claims are regulated (and the guidelines are below). If a nutrient content claim is not regulated then it does not mean you are allowed to make that claim.


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What You Need to Do:

  • Comply with the guidelines below.

  • Make sure your label is aligned with formatting guidelines in §101.13. (I have not listed these in detail)

  • Keep records to verify any nutrient content claims that you make (including test results)


Types of Nutrient Content Claims:

Implied Nutrient Claim

Describes the food or ingredient in a manner that suggests that a nutrient is present or absent in a certain amount. An implied nutrient claim may also suggest that the food may be useful in maintaining a healthy diet.

  • "high in oat bran"

Expressed Nutrient Claim

An expressed nutrient claim is a direct statement about the level of nutrients in a food.

  • "low sodium"

  • "high protein"

  • "contains 100 calories"

High Content Disclosures

Foods that contain an extremely high amount of one or more nutrients per serving must disclose this on the product label if they wish to also make a nutrient content claim.

The rationale is that, if you want to advertise the nutritional benefits of your product, then you must also disclose other nutritional characteristics that may be less desirable.

For example, if a product which is high in calories advertises itself as “low sugar” then it must also disclose that it is not a low calorie food.

The threshold required for making this type of disclosure is:

  • >13g fat per serving

  • 4.0g of saturated fat

  • 60mg of cholesterol

  • 480mg of sodium

If the reference size for a product is 30g, then you should consider the thresholds above per 50g of that product. This prevents companies from avoiding high-content disclosures by simply using a small reference amount.

These products must have the following statement: "See nutrition information for ___ content" (insert the applicable ingredient). This must be displayed clearly in bold type and no smaller than the "Net Quantity of Contents claim" on the packaging.

  • This requirement does not apply to the following types of foods:

    • infant foods or foods for children under 2 yrs

    • meal products (defined in §101.13 (l))

    • main dish products (defined in §101.13 (m))

See Subpart A 101.13 (h)


Nutrient Level Statements

You may make a statement about the amount or percentage of a nutrient in a serving. For example "less than 3g of fat per serving". Some conditions apply:

  • If the statement characterizes the level of the nutrient as low, but the amount is not actually low, then this must be clarified. For example, if you wanted to say "only 10g of fat per serving" then you would have to additionally state "not a low fat food". This is because 10g of fat is not a low amount of fat for a single serving.

  • Similar to above, if a statement characterizes the level of an ingredient as high but the amount is not actually high, then this must be clarified. For example, You wanted to say, "Contains at least 25mg of protein per serving", then you would have to additionally state "not a significant source of protein" because 25mg is not a significant amount of protein.

  • If the quantity is not characterized in any way (by using a word like "only", then you may simply state the quantity of the nutrient in the food without any disclaimer. For example, "150 calories" or "4g of fat"

Source Subpart A 101.13 (i)


Relative Claims

Relative claims are claims that compare the nutrient level to another reference food. These claims are allowed to use terms such as "light" "reduced" "fewer" "less" and "more". Some considerations when making relative claims:

  • For claims making "less" "fewer" or "more" claims, you may compare the product to the same product (i.e. potato chips to potato chips) or to different product that is part of the same category (i.e. orange juice as a reference for vitamin C tablets).

  • You can also compare to a similar product produced by another brand. If you are comparing to another brand, that brand must be widely available.

  • For claims using the words "light" "added" "reduced" "extra" "plus" "fortified" or "enriched", you must compare similar food products (i.e. your orange juice to another orange juice product)

  • For claims using the word "light" or any other claims, the referenced food must represent the general category of products in that claim. In other words, if you are comparing to a specific brand of lemonade, the brand you are comparing to should be nutritionally representative of lemonades overall.

  • The claim include a comparison of the nutrient amounts in both products in quantitative, clear and concise language.

  • You cannot make a relative claim for lower levels of a nutrient in your product if the referenced product itself meets the requirement for a "low" claim (i.e. 3g of fat or less per serving).


Vitamin and Mineral Claims

You may make claims about vitamin or mineral contents that reference the reference daily intake (RDI) without any special disclaimers. For example "Contains 100% Vitamin C " is allowed.

If you wish to make a claim for a vitamin or mineral content for which there is no reference daily intake (i.e. recommended daily value), you may do so. 


Formatting:

  • Nutrient content claims must be less than 2x the size of the statement of identity (common name of the product) and must be in a prominent and clear type.


Specific Nutrient Content Claim Requirements

Calorie Content Claims (i.e. "Calorie-free" "low calorie")

You may make nutrient content claims about the calorie contents of food.

"Calorie Free" Claims

 For terms such as "calorie free", no calories" "zero calories",

  • The foods must contain less than 5 calories per typical serving amount.

  • If the food naturally meets this condition without any special processing, then this must be described. For example "cider vinegar, a calorie-free-food"

"Low Calorie" Claims

For the terms "low calorie" "few calories" or "low source of calories",

  • The food must have a serving size of >30grams and has fewer than 40 calories per serving. The reasoning here is that you can't make the portion size very small and then claim the product has "low calories per serving".

  • If the food naturally meets this condition without any special processing, then this must be described. For example "celery, a low-calorie-food"

"Reduced Calorie" Claims

For the terms "reduced calorie" or "fewer calories" or "lower calories",

  • The food must contains at least 25% fewer calories than the reference food (this is a relative claim)

  • This claim cannot be made if the referenced product meets the definition for "low calorie"

Sugar Content Claims

Use of the terms "sugar free" "no sugar" "zero sugar" is allowed if:

  • The product contains less than 0.5g of sugar per serving

  • The product contains no ingredient that is a sugar or contains sugars, unless this is explained in the ingredients section

  • It either is labeled as "low calorie"/"reduced calorie" or "not a reduced calorie food"/"not for weight control". The rationale here is that consumers expect sugar-free foods to be low calorie, so this must be specified.

"No Added Sugar" Claims

"No Added Sugar" claims are allowed if:

  • No sugars have been added in processing or production.

  • No ingredients contains added sugars (such as jam or fruit juice)

  • The food it resembles and which it is substituting as a "no added sugar alternative" typically contains added sugars.

  • The product bears a statement that the food is not "low calorie" or calorie reduced" unless the product meets that requirements. Again, the rationale here is that consumers expect added-sugar-free foods to be low calorie, so this must be clarified if it is not true.

"Reduced Sugar" "Lower Sugar" Claims

  • The food must contains at least 25% less sugar than the reference food (this is a relative claim)

Fiber Content Claims

If you make a fiber claim, then you must also disclose the level of fat in a serving, unless the product meets the definition of a low fat food (see below)

See Subpart A -- 101.54 (d) for more details

Specific Wording Requirements

"Low" or "Free" Claims:

  • You may only use the terms "low" or "free" (i.e. "fat free" or "low sodium") when you have specifically processed the food to lower the amount of that nutrient or you not included that nutrient in the formulation of the food

    • A claim of "low sodium potato chips" may be achieved by not adding salt to the chips, since potato chips typically contain salt

    • A claim of "Fat-free peanut butter" may be achieved by a process that removes fat from the peanut butter.

    • If the product inherently lacks a nutrient and it has not been specifically processed to remove that nutrient, then you must clarify that the claim refers to all foods of that type and not simply to your particular product.

See Subpart A 101.13 (e)

"High" or "Rich in" Claims:

You may use these terms if the food contains 20% or more of the Daily-Recommended-Value (DRV) in the amount that is typically consumed.

If the product is a "meal product" containing multiple foods, then you must identify which food is the subject of this claim (i.e. the serving of cauliflower in this product is high in vitamin C)

See Subpart A -- 101.54 (b) for more details

"Good Source" or "Contains"or "Provides" Claims

You may use the terms "good source" "contains" or "provides" if the food contains 10-19% of the Daily-Recommended-Value (DRV) in the amount that is typically consumed.

If the product is a "meal product" containing multiple foods, then you must identify which food is the subject of this claim (i.e. the serving of yams in this product is a 'good source' of fiber)

See Subpart A -- 101.54 (c) for more details

"More" or "Added" or "Extra" Claims

Relative Claims that contain the words "more", "fortified", "enriched", "added", "extra", and "plus" may be used to describe the following:

  • protein content

  • vitamins or mineral content

  • dietary fiber content

  • potassium

The product of the claim must have >10% more of the recommended intake than the referenced product in the claim. All other requirements for relative claims apply (see above).

See Subpart A -- 101.54 (e)

"High Potency" Claims

When Used to Describe Vitamins & Minerals:This claim may be used to describe vitamins and minerals where the product contains 100% or more of the recommended daily intake for that vitamin or mineral.

 For example "Contains botanical X with high-potency vitamin C")

When Used to Describe a Product: "High Potency" claims may be used to describe a product if it contains 100% or more of the daily intake for 2/3 of the vitamins and minerals listed in the RDI which are present at 2% or more in the product.

See Subpart A -- 101.54 (f)

"Light" or "Lite" Claims

These claims may be made if one of the following criteria are met:

The food gets 50% or more of its calories from fat and its fat content is reduced by 50% or more as compared to a similarly reference food (see relative claims).

OR

The food derives less than 50% of its calories from fat and the number of calories is reduced by 1/3 when compared to a reference food (see relative claims).

OR 

The food's fat content is reduced by 50% or more when compared to a referenced food (see relative claims).

See Subpart A -- 101.56

"Antioxidant" Claims

You may make a claim about the antioxidant nutrients present in a food insofar as:

  • A recommended daily intake (RDI) has been established for each of the nutrients that are the basis for the claim.

  • The nutrients subject to the claim have recognized, scientific antioxidant activity.

  • The level of each nutrient in the claim must be high enough to qualify for either a "more" "good source of" or "high" claim.

  • The specific nutrients which are the basis for the antioxidant claim must be referenced where the claim is made and again where that specific nutrient is listed.

See Subpart A -- 101.54 (g)


Exceptions:

Your product may be subject to additional regulations if you produce one of the following foods.

  • dietary supplements

  • infant foods

  • imitation foods

  • Medical foods

  • "meal products"

  • "main dish products"