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The creation of uniform production and testing standards for dietary supplements is an ongoing process. While several trade organizations have been active in defining and implementing standards, no national organization or authority currently oversees a general standard. Numerous economic and technical issues must be resolved before a general standard can be set. Supplements, unlike pharmaceuticals, are often largely natural in origin and thus are not subject to patent protection. Without economic incentive, clinical testing is left to academic research, rather than the well-funded corporate trials associated with pharmaceuticals.

The Dietary Supplement Quality Initiative actively supports the development of high quality standards. See our mission statement for more information.

The manufacture and sale of dietary supplements is regulated in the United States by federal and state laws and regulatory agencies. On the federal level, the Food and Drug Administration (FDA) regulates product labeling and other safety and quality-related practices. The Federal Trade Commission (FTC) regulates advertising. Other federal agencies such as the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), U.S. Department of Agriculture (USDA), and the National Academy of Sciences (NAS) impact regulations. In addition, a growing number of state laws affect dietary supplements.

Before the Dietary Supplements Health and Education Act (DSHEA) was passed in 1994, dietary supplements fell under the same regulations as food. DSHEA changed things considerably by establishing specific authority for the FDA to oversee product labeling, package inserts, product literature, manufacturing practices, and product safety. This served to free manufacturers to make health claims that previously had been banned.

Certain restrictions on health claims established by the Nutrition Labeling and Education Act (NLEA) passed in 1990 and other laws still govern product labeling as well.

DSHEA authorizes the FDA to regulate Good Manufacturing Practices (GMPs) which they have not as yet taken beyond the point of a proposal. The FDA was also granted authority to ban products that are proven to be unsafe--which they have exercised very little since DSHEA's passage.

The FDA has concentrated its efforts on regulation of product labeling. For a breakdown of current labeling requirements, see new labeling requirements.

Government regulations are constantly impacted by new legislation, new FDA and FTC regulations, and court rulings. A controversy came to light surrounding the FDA's rejection of several health claims that a manufacturer wished to make. A January 1999 court ruling found the FDA's refusal was an infringement of the manufacturer's First Amendment rights of free speech (read details). As another example, new FDA product labeling requirements went into effect in March of 1999.

To find out more about standards and regulation issues, click on a section title below or page through the entire article with the "next page" buttons.

Industry Standards

Creating a quality model for dietary supplements
Different types of standards
Pros and cons of standards
Competing standards
Testing products for quality
Dosage recommendations
Good manufacturing practices (GMPs)
Self-regulatory quality standards

  Goverment Regulations

FDA safety monitoring
Federal Trade Commission (FTC)
State laws
Health benefit claims
RDA, DV, and other recommended intake values
Funding of research at the National Institutes of Health (NIH)
Possible future FDA regulations
Possible future Codex regulations

 

 

   
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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.