Regulations Related to Functional Foods

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Functional foods are regulated by the United States Food and Drug Administration (FDA) under the authority of two laws. The Federal Food, Drug, and Cosmetic Act (FD&C) of 1938 provides for the regulation of all foods and food additives. The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the FD&C Act to cover dietary supplements and ingredients of dietary supplements. Functional foods may be categorized as whole foods, enriched foods, fortified foods, or enhanced foods. Labeling claims that are used on functional foods are of two types: (1) Structure and function claims, which describe effects on normal functioning of the body, but not claims that the food can treat, diagnose, prevent, or cure a disease phytochemical: chemical produced by plants fatty acids: molecules rich in carbon and hydrogen; a component of fats fortified: altered by addition of vitamins or minerals herbal: related to plants psyllium: bulk-forming laxative derived from the Plantago psyllium seeds food additive: substance added to foods to improve nutrition, taste, appearance, or shelf-life cardiovascular: related to the heart and circulatory system immune system: the set of organs and cells, including white blood cells, that protect the body from infection

(claims such as "promotes regularity," "helps maintain cardiovascular health," and "supports the immune system" fit into this category); and (2) Disease-risk reduction claims, which imply a relationship between dietary components and a disease or health condition.

Structure and function claims do not require preapproval by the FDA, and they require much less stringent scientific consensus than disease-risk reduction claims. Under the FD&C Act, structure and function claims cannot be false or misleading. However, the law does not define the nature or extent of evidence necessary to support these claims. To complicate matters, the evidence available to support structure and function claims varies widely


Functional food

Potential health benefit

Labeling claim

Whole foods


Reduces cholesterol and constipation,

May reduce the risk of heart disease

reduces risk of heart disease


Reduces cholesterol, reduces risk of

May reduce the risk of heart disease

osteoporosis, certain cancers, and heart disease

Fruits and vegetables

Reduces risk of certain cancers and heart

May reduce the risk of some cancers;

disease; reduces hypertension

May reduce the risk of heart disease


Reduces cholesterol and triglycerides



Reduces risk of heart disease and certain


cancers, reduces cholesterol

Grapes/grape juice

Reduces risk of heart disease

Structure/function claim


Reduces risk of heart disease and certain


cancers; reduces triglycerides; increases

blood-glucose control


Reduces risk of heart disease


Enriched foods


Reduces risk of certain cancers, heart

May reduce the risk of some cancers;

disease, and nutrient deficiencies

May reduce the risk of heart disease

Fortified foods

Juices with calcium

Reduces risk of osteoporosis, reduces

Helps maintain healthy bones and


may reduce risk of osteoporosis

Grains with folic acid

Reduces risk of heart disease and neural

May reduce risk of brain and spinal cord

tube birth defects

birth defects

Infant formulas with iron

Reduces risk of iron deficiency


Grains with added fiber

Reduces risk of certain cancers and heart

May reduce the risk of some cancers;

disease; reduces cholesterol and

May reduce the risk of heart disease

constipation; increases blood-glucose control

Milk with vitamin D

Reduces risk of osteomalacia and

Helps maintain healthy bones and may


reduce risk of osteoporosis

Juices with added fiber

Reduces risk of certain cancers and heart

May reduce risk of some cancers

disease; reduces cholesterol,

hypertension, and constipation

Enhanced foods

Dairy products with probiotics

Reduces risk of colon cancer and candidal vaginitis;

Structure/function claim

controls inflammation; treatment of respiratory

allergies, diarrheal disorders, and eczema

Beverages and salad dressings with

May support overall health

Structure/function claim


Foods and beverages containing herbal

Varies with ingredients

Structure/function claim


Sports bars

Varies with ingredients

Structure/function claim

Spreads with stanol esters

Reduces cholesterol

Structure/function claim

Foods containing sugar alcohols in

Reduces risk of tooth decay

May reduce risk of tooth decay

place of sugar

Eggs with omega-3 fatty acids

Reduces risk of heart disease

Structure/function claim

because some ingredients have been studied extensively, some have not been studied very much, and some ingredients are backed by mixed results.

Disease-risk reduction claims, typically called health claims, do require FDA approval before they can be used on products and must reflect scientific consensus. For example, the health claim for soy protein and its relation to cardiovascular disease reads: "Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease.

One serving of (name of food) provides_grams of soy protein." This claim may appear only on soy products that provide at least 6.25 grams of soy protein per serving. Other FDA-approved health claims include those related to fruits and vegetables and a reduced risk of cancer; saturated fat and an increased risk of heart disease; sodium and increased risk for hypertension, and folic acid-fortified foods and reduced risk of neural tube defects.

Many developed functional foods seem to have benefits for human health. For example, calcium-fortified orange juice provides approximately the same amount of calcium as milk. With more than half of all children under the age of five and nearly 85 percent of females age twelve to nineteen not meeting the Dietary Reference Intake (DRI) for calcium, calcium-fortified orange juice may contribute significantly to calcium intake. On the other hand, a positive impact on health is more difficult to establish for other developed functional foods. These include prepared foods spiked with herbal preparations, which may contain little of the herbal ingredients listed on the label, or insufficient quantities of these ingredients to produce the claimed effect. Additionally, some herbal ingredients can be harmful, such as kava, which has been associated with liver damage, and belladonna, which is toxic.

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