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CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements
September 2003; Updated August 2005, November 2005, and April 2007
Docket No. 2004Q-0201
11/08/2005 enforcement discretion letter,
enforcement discretion letter
Claim Statement for Tomatoes and/or Tomato Sauce and Prostate Cancer
Very limited and preliminary scientific research suggests that eating one-half to one cup of tomatoes and/or tomato sauce a week may reduce the risk of prostate cancer. FDA concludes that there is little scientific evidence supporting this claim.
Claim Statement for Tomato Sauce and Ovarian Cancer
One study suggests that consumption of tomato sauce two times per week may reduce the risk of ovarian cancer; while this same study shows that consumption of tomatoes or tomato juice had no effect on ovarian cancer risk. FDA concludes that it is highly uncertain that tomato sauce reduces the risk of ovarian cancer.
Claim Statement for Tomatoes and Gastric Cancer
Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer.
Claim Statement for Tomatoes and Pancreatic Cancer
One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer.
Eligible foods
Factors
The claim meets the general requirements for health claims in 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 (21 CFR 101.14(c)).
Claim Statement for Colon/Rectal Cancer
Some evidence suggests that calcium supplements may reduce the risk of colon/rectal cancer, however, FDA has determined that this evidence is limited and not conclusive.
Claim Statement for Recurrent Colon Polyps
Very limited and preliminary evidence suggests that calcium supplements may reduce the risk of colon/rectal polyps. FDA concludes that there is little scientific evidence to support this claim.
Eligible foods
Dietary supplements containing calcium
Factors
The claim meets the general requirements for health claims in 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 (21 CFR 101.14(c)).
The dietary supplement meet or exceed the requirement for a "high" level of calcium as defined in 21 CFR 101.54(b) (i.e., 200 mg or more calcium per reference amount customarily consumed)
The calcium content of the dietary supplement must be assimilable (i.e., bioavailable) (21 CFR 101.72(c)(ii)(B), and meet the United States Pharmacopeia (U.S.P.) standards for disintegration and dissolution applicable to their component calcium salts. For dietary supplements for which no U.S.P. standards exist, the dietary supplement must exhibit appropriate assimilability under the conditions of use stated on the product label (21 CFR 101.72(c)(ii)(C).
Docket No. 2004Q-0083
06/30/2005 enforcement discretion letter
Claim Statement(s)
Eligible Foods
Green tea and conventional foods and dietary supplements that contain green tea
Factors
Docket No. 02P-0457
02/21/2003 enforcement discretion letter
04/28/2003 letter
Claim Statement(s)
Eligible Foods
Dietary supplements containing selenium
Factors
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.
Docket No. 91N-0101
04/01/2003 enforcement discretion letter
Claim Statement(s)
Eligible Foods
Dietary supplements containing vitamin E and/or vitamin C
Factors
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.
Docket No. 02P-0505
07/14/2003 enforcement discretion letter
Claim Statement
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
Factors
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.
Docket No. 02P-0292
03/09/2004 enforcement discretion letter
Claim Statement
Eligible Foods
Whole or chopped walnuts
Factors
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.
Docket No. 2003Q-0401
09/08/2004 enforcement discretion letter,
enforcement discretion letter
Claim Statement
Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of the food] provides [ ] gram of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat, and cholesterol content.]
Note: Dietary supplements may declare the amount of EPA and DHA per serving in "Supplement Facts," instead of making the declaration in the claim.
Eligible Foods
Conventional foods and dietary supplements that contain EPA and DHA omega-3 fatty acids.
Factors
Dietary supplements should not recommend or suggest in their labeling a daily intake exceeding 2 grams of EPA and DHA
Total fat content
Dietary supplements that weigh 5 g or less per RACC (RACC for dietary supplement is labeled serving size) are exempted from the total fat disqualifying level, but if dietary supplements that weigh 5 g or less per RACC exceed the total fat disqualifying level (13.0 g per 50 g) the disclosure statement (i.e., "See nutrition information for total fat content") must be placed immediately adjacent to the health claim. Dietary supplements that weigh more than 5 g per RACC must not exceed the total fat disqualifying level (13.0 g per RACC and per 50 g if RACC is ≤ 30 g or ≤ 2 tbsp).
Fish (i.e., "products that are essentially all fish") may not exceed 16.0 g total fat per RACC. Fish with a total fat content greater than 13.0 g per RACC must include "See nutrition information for total fat content" with the health claim. The "products that are essentially all fish" include fish without any added ingredients and fish with a small amount of added fat or carbohydrate that meets the definition of an insignificant amount in 21 CFR 101.9(f)(1). Examples of these products are raw fish, boiled fish, and broiled fish.
Conventional foods other than fish may not exceed the total fat disqualifying levels. For individual foods, the total fat disqualifying level is 13.0 g per RACC and per 50 g if RACC is ≤ 30 g or ≤ 2 tbsp. The total fat disqualifying level is 26.0 g per label serving size for meal products and 19.5 g per label serving size for main dish products.
Saturated fat content
Dietary supplements must meet the criterion for low saturated fat with regard to the saturated fat content (≤ 1 g per RACC) but not with regard to the no more than 15 percent calories from saturated fat criterion.
Fish may not exceed the saturated fat disqualifying level of 4.0 g per RACC (or 4.0 g per 50 g if reference amount is ≤ 30 g or ≤ 2 tbsp).
Conventional foods other than fish must meet the criteria for low saturated fat (≤ 1 g per RACC and no more than 15 percent of calories from saturated fat for individual foods, ≤ 1 g per 100 g and less than 10 percent calories from saturated fat for meal products and main dish products). There is an error in the enforcement discretion letters in the section of "low saturated fat," stating that meal products and main dishes meet all criteria specified for the "low saturated fat" criteria (21 CFR 101.62(c)(2)). The CFR number should be (21 CFR 101.62(c)(3)).
Cholesterol content
Dietary supplements that weigh 5 g or less per RACC are exempt from the cholesterol disqualifying level (60 mg per 50 g), but those that exceed the cholesterol disqualifying level must include "See nutrition information for cholesterol content" with the health claim. Dietary supplements that weigh more than 5 g per RACC must meet the criterion for low cholesterol (≤ 20 mg per 50g).
Fish must meet the extra lean criterion with regard to cholesterol content (< 95 mg per RACC and per 100 g, whichever is greatest), but not with regard to saturated fat content. Fish with cholesterol content greater than 60 mg per RACC must include "See nutrition information for cholesterol content" with the health claim.
Conventional foods other than fish must meet the low cholesterol criterion (21 CFR 101.62(d)(2)). See 21 CFR 101.62(d)(2) for the low cholesterol criterion specific for individual foods, meal products, and main dish products.
Sodium
All conventional foods and dietary supplements must meet the sodium disqualifying level (≤ 480 mg per RACC and per 50 g if RACC is ≤ 30 g or ≤ 2 tbsp for individual foods, ≤ 960 mg per label serving size for meal products, ≤ 720 mg per label serving size for main dish products).
The 10 percent minimum nutrient requirement
All conventional foods must meet the 10 percent minimum nutrient requirement (Vitamin A 500 IU, Vitamin C 6 mg, Iron 1.8 mg, Calcium 100 mg, Protein 5 g, Fiber 2.5 g per RACC), prior to any nutrient addition.
The 10 percent minimum nutrient requirement does not apply to dietary supplements (21 CFR 101.14(e)(6)).
Docket No. 99P-3029
05/15/2002 clarification letter
11/28/2000 enforcement discretion letter
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
Factors
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.
Docket No. 2003Q-0559
11/01/2004 enforcement discretion letter
Claim Statement
Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of olive oil.
Note: The last sentence of the claim "One serving of this product contains [x] grams of olive oil." is optional when the claim is used on the label or in the labeling of olive oil.
Eligible foods
Factors
The claim meets the general requirements for health claims in 21 CFR 101.14, except for: (1) the requirement that the evidence for the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation (21 CFR 101.14(c)); (2) the requirement that the food comply with the total fat disqualifying level (21 CFR 101.14(e)(3)); (3) for olive oil, vegetable oil spreads, and shortenings the requirement that the food comply with the 50 gram-criterion of the saturated fat disqualifying level (21 CFR 101.14(e)(3)); and (4) for olive oil, dressings for salads, and shortenings, the requirement that the food contain a minimum of 10 percent of the Daily Value per RACC of at one of the following: vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per reference amount customarily consumed (21 CFR 101.14(e)(6)).
When the total fat disqualifying level is exceeded in vegetable oil spreads, dressings for salads, shortenings, or olive-oil containing foods the disclosure statement (i.e., See nutrition information for saturated fat content) must be placed immediately following the claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.
When the food does not meet the definition of low saturated fat (21 CFR 101.62(c)(2)) the disclosure statement (i.e., See nutrition information for saturated fat content) must be placed immediately following the claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.
If both of the above two conditions are met the disclosure statements for total fat and saturated fat can be combined (i.e., See nutrition information for total and saturated fat content)
*For the purposes of this qualified health claim:
Docket No. 2006Q-0091
10/06/2006 enforcement discretion letter
Claim Statement
Limited and not conclusive scientific evidence suggests that eating about 1 ½ tablespoons (19 grams) of canola oil daily may reduce the risk of coronary heart disease due to the unsaturated fat content in canola oil. To achieve this possible benefit, canola oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of canola oil.
Eligible foods
Factors
The claim meets the general requirements for health claims in 21 CFR 101.14, except for: (1) the requirement that the evidence for the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation (21 CFR 101.14(c)); (2) the requirement that the food comply with the total fat disqualifying level (21 CFR 101.14(e)(3)); (3) for canola oil, dressings for salads, and shortenings, the requirement that the food contain a minimum of 10 percent of the Daily Value per RACC of at one of the following: vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per reference amount customarily consumed (21 CFR 101.14(e)(6)).
When the total fat disqualifying level is exceeded in vegetable oil spreads, dressings for salads, shortenings, or canola-oil containing foods, the disclosure statement (i.e., See nutrition information for total fat content) must be placed immediately following the claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.
*For the purposes of this qualified health claim:
Docket No. 2006P-0243
3/26/2007 enforcement discretion letter
Claim Statement
Very limited and preliminary scientific evidence suggests that eating about 1 tablespoon (16 grams) of corn oil daily may reduce the risk of heart disease due to the unsaturated fat content in corn oil. FDA concludes that there is little scientific evidence supporting this claim. To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of corn oil.
Eligible foods (see * for definitions)
Factors
The claim meets the general requirements for health claims in 21 CFR 101.14, except for: (1) the requirement that the evidence for the claim meet the significant scientific agreement standard and be made in accordance with an authorizing regulation (21 CFR 101.14(c)); (2) the requirement that the food comply with the total fat disqualifying level (21 CFR 101.14(e)(3)); 3) for corn oil, vegetable oil blends, vegetable oil spreads, and shortenings the requirement that the food comply with the 50 gram-criterion of the saturated fat disqualifying level (21 CFR 101.14(e)(3)); (4) for corn oil, vegetable oil blends, dressings for salads, and shortenings, the requirement that the food contain a minimum of 10 percent of the Daily Value per RACC of at one of the following: vitamin A, vitamin C, iron, calcium, protein, or dietary fiber per reference amount customarily consumed (21 CFR 101.14(e)(6)).
When the total fat disqualifying level is exceeded in vegetable oil spreads, dressings for salads, shortenings, or corn-oil containing foods, the disclosure statement (i.e., See nutrition information for total fat content) must be placed immediately following the claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.
When the food does not meet the definition of low saturated fat (21 CFR 101.62(c)(2)), the disclosure statement (i.e., See nutrition information for saturated fat content) must be placed immediately following the claim, with no intervening material, in the same size, typeface, and contrast as the claim itself.
If both of the above two conditions are met, the disclosure statements for total fat and saturated fat can be combined (i.e., See nutrition information for total and saturated fat content)
*For the purposes of this qualified health claim:
Docket No. 02P-0413
02/24/2003 enforcement discretion letter
05/13/2003 letter
11/24/2004 updated letter
Claim Statement
Eligible Foods
Dietary supplements containing soy-derived phosphatidylserine
Factors
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.
Docket No. 2004Q-0144
08/25/2005 enforcement discretion letter
Claim Statement
One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain.
Eligible Foods
Dietary supplements
Factors
Dietary supplement containing chromium should meet or exceed the requirement for a "high" level of chromium as defined in 21 CFR 101.54(b) (i.e., 24 mg or more per reference amount customarily consumed under the current regulation) for FDA to exercise enforcement discretion.
The claim meets all applicable statutory and regulatory requirements under the Federal Food, Drug, and Cosmetic Act, with the exception of the requirement that a health claim meet the significant scientific agreement standard and the requirement that the claim be made in accordance with an authorizing regulation.
Docket No. 2004Q-0098
10/12/2005 enforcement discretion letter
Claim Statement(s)
Eligible Foods
Dietary supplements containing calcium
Factors
The claim meets the general requirements for health claims in 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 (21 CFR 101.14(c)).
The dietary supplement meet or exceed the requirement for a "high" level of calcium as defined in 21 CFR 101.54(b) (i.e., 200 mg or more calcium per reference amount customarily consumed)
The calcium content of the dietary supplement must be assimilable (i.e., bioavailable) (21 CFR 101.72(c)(ii)(B), and meet the United States Pharmacopeia (U.S.P.) standards for disintegration and dissolution applicable to their component calcium salts. For dietary supplements for which no U.S.P. standards exist, the dietary supplement must exhibit appropriate assimilability under the conditions of use stated on the product label (21 CFR 101.72(c)(ii)(C).
Docket No. 91N-100H
04/03/2001 clarification letter
10/10/2000 enforcement discretion letter
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
Factors
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).
Abbreviations:
RACC - reference amount customarily consumed per eating occasion, as defined in 21 CFR 101.12