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Biologically Based Practices: An Overview

Article Provided by National Center for Complementary and Alternative Medicine (NCCAM)

Introduction [Introduction}

The CAM domain of biologically based practices includes, but is not limited to, botanicals, animal-derived extracts, vitamins, minerals, fatty acids, amino acids, proteins, prebiotics and probiotics, whole diets, and functional foods.

Dietary supplements are a subset of this CAM domain. In the Dietary Supplement Health and Education Act (DSHEA) of 1994, Congress defined a dietary supplement as a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and they can occur in many forms, such as tablets, capsules, softgels, gelcaps, liquids, or powders.¹

The Food and Drug Administration (FDA) regulates dietary supplements differently than drug products (either prescription or over-the-counter). First, drugs are required to follow defined good manufacturing practices (GMPs). The FDA is developing GMPs for dietary supplements. However, until they are issued, companies must follow existing manufacturing requirements for foods. Second, drug products must be approved by the FDA as safe and efficacious prior to marketing. In contrast, manufacturers of dietary supplements are responsible for ensuring that their products are safe. While the FDA monitors adverse effects after dietary supplement products are on the market, newly marketed dietary supplements are not subject to premarket approval or a specific postmarket surveillance period. Third, while DSHEA requires companies to substantiate claims of benefit, citation of existing literature is considered sufficient to validate such claims. Manufacturers are not required, as they are for drugs, to submit such substantiation data to the FDA; instead, it is the Federal Trade Commission that has primary responsibility for monitoring dietary supplements for truth in advertising. A 2004 Institute of Medicine (IOM) report on the safety of dietary supplements recommends a framework for cost-effective and science-based evaluation by the FDA.²

Dietary supplements reflect some of humankind's first attempts to improve the human condition. The personal effects of the mummified prehistoric "Ice Man" found in the Italian Alps in 1991 included medicinal herbs. By the Middle Ages, thousands of botanical products had been inventoried for their medicinal effects. Many of these, including digitalis and quinine, form the basis of modern drugs.³