Herbs and Dietary Supplements

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CHAPTER 7 Herbs and Dietary Supplements

II. Formulation and Regulation of Dietary Supplements

A. A dietary supplement may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, and metabolites taken in addition to a normal dietary intake. Supplements are available in many dosage forms including extracts, concentrates, tablets, capsules, gel caps, liquids, teas, and powders. Herbs used for medicinal purposes are sold in many different forms, including capsules, tablets, tinctures, teas, powders, whole herbs, and creams.

B. Regulation of health claims is largely monitored by the Dietary Supplement Health and Education Act (DSHEA), although the Food and Drug Administration (FDA) and other health alliances play minor roles.

1. The Dietary Supplement Health and Education Act (DSHEA) was passed by the US Congress in October 1994. Topics discussed in DSHEA include product labeling and content, structure and function, and health claims. Health claims describe a relationship between food, food component, or dietary supplement ingredient, or health-related condition, and are not about treating, mitigating, or curing diseases (Table 7-1).

Table 7-1 Health Claims Approved by the FDA

Supplement Health Claim
Calcium Reduced risk of Osteoporosis
Dietary sugar alcohol (polyols) Does not promote tooth decay
Dietary fats Increased risk of Cancer
Dietary saturated fat and cholesterol Increased risk of coronary heart disease
Fiber-containing grain products, fruits, and vegetables Reduced risk of coronary heart disease
Folate Prevention of Neural tube defects (in pregnancy)
Fruits and vegetables Reduced risk of Cancer
Plant sterol/stanol esters Reduced risk of coronary heart disease
Potassium Reduced risk of high blood pressure and stroke
Sodium Increases Hypertension
Soy protein Reduced risk of coronary heart disease
Vitamin B3 Treatment of Pellagra
Vitamin C Treatment of Scurvy
Whole grain foods Reduced risk of heart disease and certain cancers