Health Claims

The US Food and Drug Administration (FDA) allows conventional food and dietary supplement products sold in the US to include specific health claims on their labels. These health claims, which must be reviewed and allowed by the FDA prior to use, are either authorized or qualified:

Authorized health claims have significant scientific agreement among qualified experts that the claim is supported by the totality of publicly available scientific evidence.

Qualified health claims are supported by some scientific evidence but are not backed by significant scientific agreement among qualified experts. These claims are often required to include qualifying statements regarding the FDA’s determination on the level of available evidence.

The following is a list of authorized and qualified health claims that have been allowed by the FDA, organized by intended use. Natural Medicines’ effectiveness ratings are also provided. Due to the fact that some qualified health claims are based on poor or outdated evidence, Natural Medicines’ effectiveness ratings sometimes differ from the message provided in the health claim.

Condition

Ingredient

Authorized or Qualified Health Claim

Date

NM Effectiveness Rating

Atopic Disease Whey Protein [Qualified Health Claim] Very little scientific evidence suggests that, for healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula from birth up to 4 months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the 1st year of life and up to 3 years of age.   2011 Possibly Effective (atopic dermatitis prevention)
Bone Health  Calcium [Authorized Health Claim] Adequate calcium and vitamin D, as part of a well-balanced diet, along with physical activity, may reduce the risk of osteoporosis.  2008 Likely Effective (osteoporosis prevention)
Vitamin D [Authorized Health Claim] Adequate calcium and vitamin D, as part of a well-balanced diet, along with physical activity, may reduce the risk of osteoporosis. 2008 Likely Effective (osteoporosis prevention)
Cancer(s) Calcium [Qualified Health Claim] 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.  2005 Possibly Effective (colorectal cancer prevention)
[Qualified Health Claim] 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. 2005 Possibly Effective (colorectal cancer prevention)
Green tea [Qualified Health Claim] Drinking green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce that risk because there is very little scientific evidence for the claim. 2011 Insufficient Evidence (breast cancer prevention, prostate cancer prevention)
Selenium [Qualified Health Claim] 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.  2003 Insufficient Evidence (cancer prevention)
[Qualified Health Claim] One study suggests that selenium intake may reduce the risk of bladder cancer in women.  However, one smaller study showed no reduction in risk.  Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women.  2009 Possibly Ineffective (bladder cancer prevention)
[Qualified Health Claim] Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk.  Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.  2009 Possibly Ineffective (prostate cancer prevention)
[Qualified Health Claim] One weak, small study suggests that selenium intake may reduce the risk of thyroid cancer. Based on this study, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of thyroid cancer.  2009 Insufficient Evidence (thyroid cancer prevention)
Tomato [Qualified Health Claim] 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. 2005 Insufficient Evidence (prostate cancer prevention)
[Qualified Health Claim] 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. 2005 Insufficient Evidence (gastric cancer prevention)
[Qualified Health Claim] 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. 2005 Insufficient Evidence (ovarian cancer prevention)
[Qualified Health Claim] 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. 2005 Insufficient Evidence (pancreatic cancer prevention)
Vitamin C [Qualified Health Claim] One weak study and one study with inconsistent results suggest that vitamin C supplements may reduce the risk of gastric cancer. Based on these studies, FDA concludes that it is highly uncertain that vitamin C supplements reduce the risk of gastric cancer. 2009 Insufficient Evidence (gastric cancer prevention)
[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. 2003 Insufficient Evidence (cancer prevention)
Vitamin E [Qualified Health Claim] One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer. 2009 Insufficient Evidence (bladder cancer prevention)
[Qualified Health Claim] Two weak studies and one study with inconsistent results suggest that vitamin E supplements may reduce the risk of colorectal cancer. However, another limited study showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of colorectal cancer. 2009 Possibly Ineffective (colorectal cancer prevention)
[Qualified Health Claim] One weak and limited study suggests that vitamin E supplements may reduce the risk of renal cell cancer. FDA concludes that it is highly uncertain that vitamin E supplements reduce the risk of renal cell cancer. 2009 Insufficient Evidence (renal cell carcinoma prevention)
[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. 2003 Possibly Ineffective (cancer prevention)
Cardiovascular Disease                      Algal oil [Qualified Health Claim] Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-2016containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid). 2018 Insufficient Evidence (coronary heart disease prevention)
Barley [Authorized Health Claim] Diets low in saturated fat and cholesterol that include 750 mg of soluble fiber per day from barley or barley products may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber. 2016 Likely Effective (coronary heart disease prevention)
Beta-glucans [Authorized Health Claim] Diets low in saturated fat and cholesterol that include 750 mg of soluble beta-glucans fiber per day may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber. 2016 Likely Effective (coronary heart disease prevention)
Black psyllium [Authorized Health Claim] Diets low in saturated fat and cholesterol that include 1.7 grams of psyllium husk per day may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber. 2016 Possibly Effective (coronary heart disease prevention)
Black walnut [Qualified Health Claim] Supportive but not conclusive research shows that eating 1.5 ounces per day of black walnut, 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. 2004 Insufficient Evidence (coronary heart disease prevention)
Blond psyllium [Authorized Health Claim] Diets low in saturated fat and cholesterol that include 1.7 grams of psyllium husk per day may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber. 2016 Possibly Effective (coronary heart disease prevention)
Canola oil [Qualified Health Claim] Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid). 2018 Possibly Effective (coronary heart disease prevention)
[Qualified Health Claim] 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. 2006 Possibly Effective (coronary heart disease prevention)
English walnut [Qualified Health Claim] Supportive but not conclusive research shows that eating 1.5 ounces per day of English walnut, 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. 2004 Insufficient Evidence (coronary heart disease prevention)
Fish oil [Qualified Health Claim] 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.] 2019 Insufficient Evidence (cardiovascular disease prevention)
Folic acid [Qualified Health Claim] 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. 2001

Possibly Effective (stroke prevention)

Insufficient Evidence (cardiovascular disease prevention)

Hazelnut [Qualified Health Claim] Supportive but not conclusive research shows that eating 1.5 ounces per day of hazelnut, 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. 2004 Insufficient Evidence (coronary heart disease prevention)
Macadamia [Qualified Health Claim] Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content. 2017 Insufficient Evidence (coronary heart disease prevention)
Oats [Authorized Health Claim] Diets low in saturated fat and cholesterol that include 750 mg of soluble fiber per day from oats or oat products may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of this soluble fiber. 2016 Likely Effective (coronary heart disease prevention)
Oleic acid [Qualified Health Claim] Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid). 2018 Possibly Effective (coronary heart disease prevention)
Olive [Qualified Health Claim] 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. 2004 Possibly Effective (coronary heart disease prevention)
[Qualified Health Claim] Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid). 2018 Possibly Effective (coronary heart disease prevention)
Plant sterols [Authorized Health Claim] Foods containing at least 0.65 grams of vegetable oil sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, 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 vegetable oil sterol esters. 2010 Possibly Effective (coronary heart disease prevention)
Safflower [Qualified Health Claim] Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid). 2018 Insufficient Evidence (coronary heart disease prevention)
Soybean oil [Qualified Health Claim] Supportive but not conclusive scientific evidence suggests that eating about 1 ½ tablespoons (20.5 grams) daily of soybean oil, which contains unsaturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, soybean oil is to replace saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] grams of soybean oil. 2017 Insufficient Evidence (coronary heart disease prevention)
Sunflower oil [Qualified Health Claim] Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. To achieve this possible benefit, oleic acid-containing oils should not increase the total number of calories you eat in a day. One serving of [x] oil provides [x] grams of oleic acid (which is [x] grams of monounsaturated fatty acid). 2018 Possibly Effective (coronary heart disease prevention)
Sweet almond [Qualified Health Claim] Supportive but not conclusive research shows that eating 1.5 ounces per day of almonds, 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. 2004 Insufficient Evidence (coronary heart disease prevention)
Vitamin B6 [Qualified Health Claim] 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. 2001

Insufficient Evidence (cardiovascular disease prevention)

Insufficient Evidence (stroke prevention)

Vitamin B12  [Qualified Health Claim] 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. 2001 Possibly Effective (stroke prevention)
Dental Caries Xylitol [Authorized Health Claim] Frequent eating of foods high in sugars and starches as between-meal snacks can promote tooth decay. The sugar alcohol, xylitol, used to sweeten this food may reduce the risk of dental caries. – OR – 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. 2008 Likely Effective (dental caries prevention)
Diabetes   Black psyllium [Qualified Health Claim] Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim. 2014 Insufficient Evidence (diabetes prevention)
Blond psyllium [Qualified Health Claim] Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim. 2014

Possibly Effective (diabetes prevention)

Insufficient Evidence (diabetes prevention)

Chromium [Qualified Health Claim] 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. 2005

Possibly Effective (diabetes treatment)

Insufficient Evidence (diabetes prevention)

Hypertension  Calcium [Qualified Health Claim] Some scientific evidence suggests that calcium supplements may reduce the risk of hypertension. However, FDA has determined that the evidence is inconsistent and not conclusive. 2005 Possibly Effective (hypertension prevention)
[Qualified Health Claim] Four studies, including a large clinical trial, do not show that calcium supplements reduce the risk of pregnancy-induced hypertension during pregnancy. However, three other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of pregnancy-induced hypertension. Three studies, including a large clinical trial, do not show that calcium supplements reduce the risk of preeclampsia during pregnancy. However, two other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of preeclampsia. 2005 Possibly Effective (pre-eclampsia prevention)
Fish oil [Qualified Health Claim] Consuming EPA and DHA combined may help lower blood pressure in the general population and reduce the risk of hypertension. However, FDA has concluded that the evidence is inconsistent and inconclusive. One serving of [name of the food or dietary supplement] provides [  ] gram(s) of EPA and DHA. 2019 Possibly Effective (hypertension prevention)
Neurologic Disorders   Folic acid [Authorized Health Claim] Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord defect. – OR – 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. Folate intake should not exceed 250% of the DV (1,000 mcg). 2008 Likely Effective (neural tube defect prevention)
Phosphatidylserine  [Qualified Health Claim] 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. 2003  Insufficient Evidence (dementia prevention)
[Qualified Health Claim] 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. 2003 Possibly Effective (age-related cognitive decline prevention)
Urinary Tract Infections  Cranberry  [Qualified Health Claim] Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent. 2020 Possibly Effective (urinary tract infection prevention)
[Qualified Health Claim] Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim. 2020 Possibly Effective (urinary tract infection prevention)