Inspections, Compliance, Enforcement, and Criminal Investigations

NUTRITION LABELING AND EDUCATION ACT (NLEA) REQUIREMENTS- ATTACHMENT 4

ATTACHMENT 4

HEALTH CLAIMS CHART

Approved Claims Food Requirements Claim Requirements Model Claim Statements
Calcium and Osteoporosis 101.72 High in calcium, Assimilable Bioavailable, Supplement must disintegrate and dissolve, and Phosphorus content cannot exceed calcium content.

Indicated disease depends on many factors by listing risk factors for the disease.

Gender - Female

Race - Caucasian and Asian

Age - Growing older

Primary target population

Females Caucasian and Asian races

Teens and young adults in their bone forming years Additional factors necessary to reduce risk

Eating healthful meals

Regular exercise

Mechanism relating calcium to osteoporosis Optimizes peek bone @@@

Foods or supplement containing more than 400 mg calcium

Must state that total intakes of greater than 2,000 mg calcium provide no added benefit to bone health

Regular exercise and a healthy diet with enough calcium helps teens and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life.
Sodium and Hypertension 101.74 low sodium

Required terms

"Sodium"

"High blood pressure"

Includes physician statement (Individuals with high blood pressure should consult their physicians) If claim defines high or normal blood pressure

Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.
Dietary fat and Cancer 101.73 Low fat Fish & game meats: "Extra lean"

Required terms

"Total fat" or "Fat" "Some types of cancers" or "Some cancers"

Does not specify types of fats or fatty acids that may be related to risk of cancer

Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.
Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease 101.75 Low saturated fat, Low cholesterol, and Low fat Fish & game meats: "Extra lean"

Required terms:

"Saturated fat and cholesterol"

"Coronary heart disease" or "Heart disease" Includes physician statement (Individuals with elevated blood total - or LDL - cholesterol should consult their physician) If claim defines high or normal blood total and LDL-cholesterol

White many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.
Fiber-Containing Grain Products, Fruits, and Vegetables and Cancer 101.76 A grain product, fruit, or vegetable that contains dietary fiber, Low fat, and Good source of dietary fiber (without fortification)

Required terms:

"Fiber", "Dietary fiber", or "Total dietary fiber"

"Some types of cancer" or "Some cancers" Does not specify types of dietary fiber that may be related to risk of cancer.

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.

ATTACHMENT 4

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HEALTH CLAIMS CHART

Approved Claims Food Requirements Claim Requirements Model Claim Statements
Fruits, Vegetables, and Grain Products That Contain Fiber, Particularly Soluble Fiber, and Risk of Coronary Heart Disease 101.77 A Fruit, vegetable, or grain product that contains fiber, Low saturated fat, Low cholesterol, Low fat, At least 0.6 grams of soluble fiber At least 0.6 grams of soluble fiber per RA (without fortification), and Soluble fiber constant provided on label

Required terms:

"Fiber",

"Dietary fiber", "Some types of dietary fiber",

"Some dietary fibers", or "Some fibers" "Saturated fat" and "Cholesterol"

"Heart disease" or "Coronary heart disease" Includes physician statement (individuals with elevated blood Total - or LDL - cholesterol should consult their physicians) if claim defines high or normal blood total - and LDL - cholesterol

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
Fruits and Vegetables and Cancer 101.78 A fruit or vegetable, Low fat, end Good source {without fortification} of at least one of the following: Vitamin A, Vitamin C, or dietary fiber

Required terms:

"Fiber",

"Dietary fiber", or "Total dietary fiber" "Total fat" or "Fat"

"Some types of cancer" or "Some cancers" Characterizes fruits and vegetables as "Foods that are low in fat and may contain Vitamin A, Vitamin C, and dietary fiber" Characterizes specific food as a "Good source" of one or more of the following: Dietary fiber, Vitamin A, or Vitamin C

Does not specify types of fats or Fatty acids or types of dietary fibers that may be related to risk of cancer.

Low fat diets rich in fruits and vegetables {foods that are low in fat and may contain dietary fiber, Vitamin A, or 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 is a good source of dietary fiber.
Folate and Neural Tube Defects 101.79 {responds to the Dietary Supplement Act of 1992}

Dietary supplements, or Foods in conventional food form that are naturally good sources of folate (i.e., only non-fortified food in conventional food form)

The claim shall not be made on products that contain more than 100 percent of the RDI for vitamin A as retinol or preformed vitamin A or Vitamin D Dietary supplements shall meet USP standards for disintegration and dissolution or otherwise bioavailable

Required terms:

Terms that specify the relationship - {e.g., woman who are capable of becoming pregnant and who consume adequate amounts of folate}

"Folate", "folic acid", "folacin", "folate", "folate a B vitamin", "folio acid, a B vitamin", or "folacin, a B vitamin"

"Neural tube defect", "birth defects, spinal bifida, or anencephaly", "birth defects of the brain or spinal cord anencephaly or spinal bifida", "spinal bifida or

Must also include Information on the multifactorial nature and prevalence of neural tube defects, dietary sources of folate, and the safe upper limit of daily intake

Woman who consume adequate amounts of folate daily throughout their childbearing years may reduce their risk of having a child with a neural tube birth defects. Such birth defects, while not widespread, are very serious. They can have many causes. Adequate amounts of folate, a B vitamin, can be obtained from diets rich in fruits, dark green leafy vegetables and legumes, enriched grain products, fortified cereals, or a supplement. Woman who have had a child with a spinal cord birth defect should consult a physician before becoming pregnant. Folate consumption should be limited to 1,000 ug per day front all sources.

General criteria all claims must meet: See following page.

ATTACHMENT 4

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HEALTH CLAIMS CHART

General Criteria All Claims Must Meet:

  • Only information on the value that intake or reduced intake, as part of a total dietary pattern, may have on a disease or health-related condition
  • Enables public to understand information provided and significance of information in the context of a total daily diet
  • Complete, truthful, and not misleading
  • Food contains, without fortification, 10 percent or more of the Daily Value of one of six nutrients (Dietary supplements excepted)
 
Vitamin A
500IU
Calcium
100mg
Vitamin C
6mg
Protein
5g
Iron
1.8mg
Fiber
2.5g
  • All information in one place without intervening material {Reference statement permitted)
  • Not represented for infants or toddlers less than 2 years of age
  • Uses "may" or "might" to express relationship between substance and diseases
  • Does not quantify any degree of risk reduction
  • Indicates disease depends on many factors
  • Food contain less than the specified levels of four disqualifying nutrients
Disqualifying Nutrient Foods Main Dishes Meal Products
Fat 13g 19.5g 26
Saturated Fat 4g 6g 5g
Cholesterol 60mg 90mg 120mg
Sodium 480mg 720mg 960mg

 

 

Low Fat

< or = 3g per RA (And per 50 g If RA is small)

Meats and main dishes: < 3g per 100 g inf not more than 30% of calories from fat

Low Sodium

< or = 140mg per RA (and per 50g if RA is small)

Meals and main dishes: < or = 140mg per 100g

Good source of Vitamin A

food 500 to 950 IU per RA

Meals and main dishes: Contains food that is a good source of Vitamin A and identifies food

Low saturated fat

< or = 1g per RA and < or = 15% of calories from saturated fat

Meals and main dishes: < or = 1g per 100g and

< 10% of calories from saturated fat

"Extra Lean"

< 5g total fat and < 2g saturated and

< 95 mg cholesterol per RA and per 100g

Meals and main dishes: <5g total fat and

< 2g saturated fat and < 95 mg cholesterol per 100 g and per SS

Good source of Vitamin C

6 to 11.4 mg per RA

Meals and main dishes: Contains food that is a good source of Vitamin C and identifies food

Low cholesterol

< or = 20mg per RA (and per 50g if RA is small)

Meals and main dishes: < or = 20mg per 100g

High in calcium

> or = 200 mg per RA

Meals and main dishes: Contains food that is high in calcium and identifies the food

Good source of dietary fiber

2.5 to 4.75 per RA

Meals and main dishes: Contains food that is a good source of dietary fiber and identifies food

Abbreviations: RA = Reference Amount; SS = Serving Size; IU = International Units

 

ATTACHMENT 4

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Page Last Updated: 11/25/2014
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