Health Claims, Qualified Health Claims, and Nutrient Content Claims
In a previous Quality Matters column, I introduced the complex topic of label claims—particularly structure–function claims—for dietary supplements. These claims are regulated by the U.S. Food and Drug Administration (FDA) in cooperation with the Federal Trade Commission. The FDA recognizes three main types of label claims: 1) structure-function claims, which are most commonly used by supplement companies; 2) fully authorized health claims, with a subset of qualified health claims; and 3) nutrient content claims. This post will explore health claims, qualified health claims, and nutrient content claims in greater detail.
What Is a Health Claim?
A health claim describes a nutrient’s or dietary ingredient’s potential to reduce the risk of a disease or health condition. Unlike structure–function claims, which cannot imply a direct link to disease prevention, health claims can make what the FDA calls “disease claims.” However, the FDA typically requires precise language when applying health claims to dietary supplement or food labels.
Health claims must receive FDA approval before they can be used on dietary supplement or food labels, unlike structure–function claims, which often lack robust scientific evidence. For a health claim to be approved, evidence backing its merit must first be submitted to the FDA. Double-blind trials incorporate scientific methods that generate more reliable information. The FDA conducts an extensive review of the relevant scientific literature, consulting reputable scientific bodies as needed to strengthen the evaluation. At this point, the FDA either authorizes the health claim, rejects it with explanation, or proposes modifications based on its interpretations of available evidence backing the dietary component.
Authorized health claims must be supported by significant scientific agreement (SSA). In its industry guidance, the FDA emphasizes that assessments of health benefits are based on a high standard of scientific evidence agreed on by qualified experts, including reputable health organizations. The FDA has shown a willingness to be flexible regarding SSA and the exact language allowed for authorized health claims. Fully authorized FDA health claims include the following:
For hypertension or abnormally high blood pressure
- Diets low in sodium may reduce the risk of high blood pressure.
- Diets low in sodium and high in potassium may reduce hypertension and stroke risk.
For lowering cancer risk
- Diets low in total fat may reduce the risk of some cancers.
- Low-fat diets high in fiber-containing grains and rich in fruits and vegetables (especially broccoli) may reduce the risk for some cancers.
- Whole-grain foods, when included in a diet low in total fat, saturated fat, and cholesterol, may help reduce cancer risk.
For lowering risks of heart or circulatory diseases
- Whole-grain foods, as part of a diet low in total and saturated fat and cholesterol
- Diets as low as possible in trans fats
- Soluble fibers from certain foods, as part of a diet low in fat and cholesterol
- Diets low in fat and cholesterol and rich in grains, fruits, and vegetables that contain some types of dietary fiber, particularly soluble fiber
- Foods low in fat and cholesterol that contain 51 percent or more whole-grain ingredients
- Diets low in fat and cholesterol that include 25 grams of soy protein per day
- Plant sterol/stanol esters, with a daily total intake of at least 1.3 grams, as part of a diet low in fat and cholesterol
Other authorized health claims
- A healthy diet with adequate folate may lower the risk of a child being born with brain or spinal cord defects.
- Frequent consumption of sugar and starch between meals contributes to tooth decay. Food labels must include the following statement: “The sugar alcohols in [food] do not promote tooth decay.”
- Adequate calcium and vitamin D intake throughout life, as part of a healthy diet, may reduce the risk of osteoporosis.
What Is a Qualified Health Claim?
The FDA defines a Qualified Health Claim (QHC) as “supported by less scientific evidence than an authorized health claim.” A QHC must be accompanied by a disclaimer explaining the level of proof suggested by the scientific evidence. Since QHCs fall short of significant scientific agreement, the FDA commits only to “exercise enforcement discretion” by not going after products that adhere to the allowed language of the QHC and carry the required disclaimer.
Phosphatidylserine (PS), a nutrient naturally present in all our cells and highly concentrated in the brain, was granted two QHCs: one for cognitive decline (which includes memory decline) and another for dementia. So far, PS is the only ingredient with QHCs related to memory and other higher brain functions.
Other ingredients with QHCs, by health category, include the following:
Hypertension
- Adequate calcium intake for hypertension, pregnancy-induced hypertension, and preeclampsia
- Omega–3 EPA and DHA for risk reduction in the general population
Cancer (most associations are very weak)
- Antioxidant vitamins (vitamins C and E) for certain cancers
- Calcium for colon/rectal cancer or polyps
- Selenium for certain cancers
- Green tea for breast and prostate cancer
- Tomatoes for certain cancers
Heart or circulatory disease
- B vitamins (folate, B6, B12)
- Omega–3 fatty acids
- Oleic acid (an omega–9 monounsaturated fatty acid) for coronary heart disease
- Monounsaturated fatty acids from olive oil for heart disease (mainly oleic acid)
- Oils high in unsaturated fatty acids (especially soybean oil, corn oil, and canola oil) may lower heart disease risk when substituted for saturated fats in the overall diet.
- Nuts (macadamia, walnuts) may reduce the risk of heart disease.
Diabetes
- Chromium picolinate and reduced risk of insulin resistance, type 2 diabetes
- Psyllium husk and reduced risk of diabetes
- Whole grains and reduced risk of diabetes
Other QHCs
- Folic acid to lower risk of neural tube defects in newborns
- Partially hydrolyzed whey protein in infant formula linked to reduced risk of atopic dermatitis
What Is a Nutrient Content Claim?
A nutrient content claim indicates the level of a particular nutrient in a dietary supplement or food product. For the claim to be made, the nutrient must be present at a required minimum level. Strict guidelines dictate how the claim is presented on the product label. Food and dietary supplement manufacturers generally aren’t allowed to invent nutrient content claims.
Allowed nutrient content claims include healthy, high, good source, more, high potency, antioxidant, light or lite, calorie or sugar, sodium or salt, and fat, fatty acid, and cholesterol.
For example, a claim of high can be made when the product provides more than 20 percent of the nutrient’s Daily Value (DV). A level of 10–19 percent of the DV qualifies for the good source claim. High potency describes individual vitamins or minerals present at 100 percent or more of the DV.
Nutrient content claims are intricate. For example, to make an antioxidant claim, the product must provide a high or good source level of one or more nutrients with measurable antioxidant activity.
Dietary Supplement Label Claims Can Empower Consumers
Authorized health claims, nutrient content claims, and qualified health claims on dietary supplement or food labels enhance consumer understanding and confidence in the health benefits of a dietary substance. These claims are grounded in nutrition knowledge and are likely more reliable than structure–function claims, which may rest on limited scientific evidence. FDA maintains consumer-accessible nutrition information and dietary guidance on its website, with extensive details for dietary supplement and food label claims.1A Food Labeling Guide: Guidance for Industry. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Published September 1994. Revised January 2013. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-labeling-guide
Unlike the often misleading claims made by many manufacturers, label claims supported by solid clinical evidence empower consumers and practitioners to make informed decisions about reducing disease risk through dietary supplements—especially when combined with a healthy diet.
Featured image depicts brain energy scans of a woman with Alzheimer’s disease before (top row) and after (bottom row) taking PS. Her brain energy markedly increased.2Klinkhammer P., Szelies B., Heiss W.D. Effect of phosphatidylserine on cerebral glucose metabolism in Alzheimer’s disease. Dement Geriatr Cogn Disord. 1990;1(4)197–201.
Footnotes
- 1A Food Labeling Guide: Guidance for Industry. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Published September 1994. Revised January 2013. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-labeling-guide
- 2Klinkhammer P., Szelies B., Heiss W.D. Effect of phosphatidylserine on cerebral glucose metabolism in Alzheimer’s disease. Dement Geriatr Cogn Disord. 1990;1(4)197–201.
