Summary of Qualified Health Claims Permitted

Required Claim Statement(s)

• (1) Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive. or,

• (2) Selenium may produce anticarcinogenic effects in the body. Some scientific evidence suggests that consumption of selenium may produce anticarcinogenic effects in the body. However, FDA has determined that this evidence is limited and not conclusive.

Eligible Foods
Dietary supplements containing selenium

Conditions
The disclaimer (i.e., Some scientific evidence suggests...) is placed immediately adjacent to and directly beneath the claim (i.e., Selenium may reduce the risk), with no intervening material, in the same size, typeface, and contrast as the claim itself

The supplement does not recommend or suggest in its labeling, or under ordinary conditions of use, a daily intake exceeding the Tolerable Upper Intake Level established by the National Academy of Sciences/Institute of Medicine for selenium (400 micrograms per day).

The claim meets all general health claim requirements of 21 CFR 101.14, except for the requirement that the evidence for the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation.

Paragraph 101.14(d)(2)(vii) requires that the dietary supplement bearing the claim meet the nutrient content claim definition for high (i.e., 20% or more of the daily value (DV) per RACC). 20% DV for selenium is 14 micrograms.

Required Claim Statement(s)

• (1) 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. or,

• (2) Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA does not endorse this claim because this evidence is limited and not conclusive. or,

• (3) FDA has determined that although some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer, this evidence is limited and not conclusive.

Eligible Foods
Dietary supplements containing vitamin E and/or vitamin C

Conditions
The disclaimer (i.e., ...evidence is limited and not conclusive) is placed immediately adjacent to and below the claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.

The supplement does not recommend or suggest in its labeling, or under ordinary conditions of use, a daily intake exceeding the Tolerable Upper Intake Levels established by the Institute of Medicine for vitamin C (2000 mg per day) or for vitamin E (1000 mg per day).

The claim meets all 21 CFR 101.14 general health claim requirements, except for the requirements that the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation.

Paragraph 101.14(d)(2)(vii) requires that the food bearing the claim meet the nutrient content claim definition for high (i.e., 20% or more of the daily value (DV) per RACC). 20% DV for vitamin C is 12 mg; 20% DV for vitamin E is 6 IU.

Required Claim Statement(s)
Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts [such as name of specific nut] as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. [See nutrition information for fat content.]

Notes: The bracketed phrase naming a specific nut is optional. The bracketed fat content disclosure statement is applicable to a claim made for whole or chopped nuts, but not a claim made for nut-containing products.

Eligible Foods

• (1) Whole or chopped nuts listed below that are raw, blanched, roasted, salted, and/or lightly coated and/or flavored; any fat or carbohydrate added in the coating or flavoring must meet the § 101.9(f)(1) definition of an insignificant amount.

• (2) Nut-containing products other than whole or chopped nuts that contain at least 11 g of one or more of the nuts listed below per RACC.

• (3) Types of nuts eligible for this claim are restricted to almonds, hazelnuts, peanuts, pecans, some pine nuts, pistachio nuts, and walnuts. Types of nuts on which the health claim may be based is restricted to those nuts that were specifically included in the health claim petition, but that do not exceed 4 g saturated fat per 50 g of nuts.

Conditions
Whole or chopped nuts
The claim meets all 21 CFR 101.14 general health claim requirements, except for: (1) the requirement that the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation; (2) the § 101.14(a)(4) requirement that the food comply with the total fat disqualifying level; and (3) for walnuts only, the § 101.14(e)(6) requirement that the food contain a minimum of 10 percent of the Daily Value per RACC of vitamin A, vitamin C, iron, calcium, protein, or dietary fiber.

Where the claim is used on whole or chopped nuts, the disclosure statement (see nutrition information...) must be placed immediately adjacent to and directly beneath the claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.

Nuts bearing the claim must comply with the § 101.14(a)(4) saturated fat disqualifying level (4 g saturated fat per 50 g nuts).

Nut-containing products
The claim meets all 21 CFR 101.14 general health claim requirements, except for the requirement that the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation

Nut-containing products bearing the claim must comply with all the § 101.14(a)(4) disqualifying levels which are 13 g total fat, 4 g saturated fat, 60 mg of cholesterol, and 480 mg of sodium per RACC.

The claim applies only to types of nuts that do not exceed the § 101.14(a)(4) disqualifying nutrient level for saturated fat (4 g saturated fat per 50 g nuts).

Nut-containing products bearing the claim must comply with the § 101.62(c)(2) definition of a low saturated fat food and the § 101.62(d)(2) definition of a low cholesterol food.

Nut-containing products bearing the claim must comply with the § 101.14(e)(6) requirement that the food contain a minimum of 10 percent of the Daily Value per RACC of vitamin A, vitamin C, iron, calcium, protein, or dietary fiber prior to any nutrient addition.

Required Claim Statement(s)

• (1) Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.

  • Note: The bracketed phrase "and calorie" is optional in that FDA does not intend for the presence or absence of such phrase to be a factor in whether it considers enforcement discretion for the use of the qualified health claim. FDA considered this additional information might be beneficial to consumers to heighten their awareness of the caloric contribution from walnuts and encourages companies to include it in product labeling.

Eligible Foods
Whole or chopped walnuts

Conditions
The claim meets the general requirements for health claims in 21 CFR 101.14, except for the requirement that: (1) the evidence for the claim meet the significant scientific agreement standard; (2) the claim be made in accordance with an authorizing regulation; (3) the food not exceed the disqualifying level for total fat; and (4) the food provide at least 10 percent of the Daily Value of vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per reference amount customarily consumed.

The disclosure statement about total fat content (i.e., See nutrition information for fat content) is placed immediately following the claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.

Required Claim Statement(s)
Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease. FDA evaluated the data and determined that, although there is scientific evidence supporting the claim, the evidence is not conclusive.

Eligible Foods
Dietary supplements containing the omega-3 long chain polyunsaturated fatty acids eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA)

Conditions
The claim does not recommend or suggest in its labeling, or under ordinary conditions of use, a daily intake exceeding 2 grams per day of EPA and DHA. FDA encourages manufacturers to limit the products that bear the qualified claim to a daily intake of 1 gram of omega-3 fatty acids or below.

Dietary supplements exceeding the § 101.14(a)(4) total fat disqualifying level must have a disclosure statement (i.e., "see nutrition information for fat content") immediately adjacent to the claim.

The claim meets all 21 CFR 101.14 general health claim requirements, except for: (1) the requirements that the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation, and (2) the claim specify the daily dietary intake necessary to achieve the claimed effect. The claim may not suggest a level of omega-3 fatty acids as being useful in achieving the claimed effect.

Required Claim Statement
As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular disease. FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.

Eligible Foods
Dietary supplements containing vitamin B6, B12, and/or folic acid

Conditions
The disclaimer (i.e., FDA evaluated the above claim...) must be immediately adjacent to and directly beneath the first claim (i.e., As part of a well-balanced diet... ) with no intervening material that separates the claim from the disclaimer, and the second sentence must be in the same size, type face and contrast as the first sentence.

Products that contain more than 100 percent of the Daily Value (DV) of folic acid (400 micrograms), when labeled for use by adults and children 4 or more years of age, must identify the safe upper limit of daily intake with respect to the DV. The folic acid safe upper limit of daily intake value of 1,000 micrograms (1 mg) may be included in parentheses.

The claim meets all 21 CFR 101.14 general health claim requirements, except for: (1) the requirement that the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation, and (2) the requirement that the claim specify the daily dietary intake necessary to achieve the claimed effect. The claim may not suggest a level of vitamins B6, B12, and/or folic acid as being useful in achieving the claimed effect.

Dietary supplements containing folic acid must meet the United States Pharmacopeia (USP) standards for disintegration and dissolution, except that if there are no applicable USP standards, the folate in the dietary supplement shall be shown to be bioavailable under the conditions of use stated on the product label.

Required Claim Statement

• (1) Consumption of phosphatidylserine may reduce the risk of dementia in the elderly. Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of dementia in the elderly. FDA concludes that there is little scientific evidence supporting this claim. or,

• (2) Consumption of phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly. Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of cognitive dysfunction in the elderly. FDA concludes that there is little scientific evidence supporting this claim.

Eligible Foods
Dietary supplements containing soy-derived phosphatidylserine

Conditions
The disclaimer (i.e., Very limited and preliminary scientific research...) is placed immediately adjacent to and directly beneath the claim (i.e., Phosphatidylserine may reduce...), with no intervening material, in the same size, typeface, and contrast as the claim itself.

The claim meets all 21 CFR 101.14 general health claim requirements, except for: (1) the requirement that the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation, and (2) the claim specify the daily dietary intake necessary to achieve the claimed effect. The claim may not suggest a level of phosphatidylserine as being useful in achieving the claimed effect.

The soy-derived phosphatidylserine used is of very high purity.

Required Claim Statement
0.8 mg folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form. FDA does not endorse this claim. Public health authorities recommend that women consume 0.4 mg folic acid daily from fortified foods or dietary supplements or both to reduce the risk of neural tube defects.

Eligible Foods
Dietary supplements containing folic acid

Conditions
The disclaimer (i.e., FDA does not endorse this claim...) is placed immediately adjacent to and directly beneath the claim (i.e., 0.8 mg folic acid ...), with no intervening material, in the same size, typeface, and contrast as the claim.

The claim meets all 21 CFR 101.14 general health claim requirements, except for the requirements that the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation.

Note: there also is a folic acid/neural tube defect health claim authorized by regulation (see 21 CFR 101.79).