Role U.S. FDA in Regulating Dietary Supplements

What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them? In October 1994, the Dietary Supplement Health and Education Act (DSHEA) was signed into law by President Clinton. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. This new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.

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Basic Points to Consider of Dietary Supplements

Do I need to think about my total diet?

Yes. Dietary supplements are intended to supplement the diets of some people, but not to replace the balance of the variety of foods important to a healthy diet. While you need enough nutrients, too much of some nutrients can cause problems. You can find information on the functions and potential benefits of vitamins and minerals, as well as upper safe limits for nutrients at the National Academy of Sciences Web site.

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U.S. FDA Tips on Searching the Web for Information on Dietary Supplements

When searching on the Web, ask yourself the following questions:

Who operates the site?

Is the site run by the government, a university, or a reputable medical or health-related association (e.g., American Medical Association, American Diabetes Association, American Heart Association, National Institutes of Health, National Academies of Science, or U.S. Food and Drug Administration)? Is the information written or reviewed by qualified health professionals, experts in the field, academia, government or the medical community?

Read more: FDA Tips on Searching the Web for Information on Dietary Supplements

"PDR for Herbal Medicines" - Worldwide Expert for Herbal Medicines and Natural Dietary Supplements

Use this book to make sure that the active ingredients are presented in the interesting product in the required quantities

"Herbal medicines are preparations derived from naturally occurring plants with medicinal or preventive properties. The World Health Organization (WHO) estimates that 4 billion people, amounting to 80% of the world's population, use herbal medicines for some aspect of primary health care. Herbal medicine is a major component in all indigenous peoples' traditional medicine and a common element in Ayurvedic, homeopathic, naturopathic, traditional oriental, and Native American medicine. The foods early humans ate contained a million different phytochemicals and through modern science we are also recognizing some of these as functional foods (e.g. green tea catechins and pomegranate ellagitannins).

Many spices such as cayenne and curcumin have medicinal properties in addition to their roles in flavoring foods. Today, we are rediscovering the utility of herbal medicines as botanical dietary supplements with potentially important preventive and medicinal effects. However, when patients talk about using herbal medicines, primary care physicians often lack the knowledge to provide informed advice on their use or misuse."

David Heber, MD, PhD, FACP,FACN, Professor of Medicine

Manufacturers are required to substantiate the identity, purity, quality, strength, and composition of dietary supplements

In the United States, herbal products are marketed under the provisions of the Dietary Supplement. Health and Education Act of 1994, which prohibits their sale for the diagnosis, treatment, cure, or prevention of disease. In 2007, the U.S. Food and Drug Administration (FDA) took further action toward protecting consumers' health when it issued a final rule establishing current good manufacturing practice requirements (CGMP) for dietary supplements. Under the final rule, manufacturers are required to substantiate the identity, purity, quality, strength, and composition of dietary supplements, and, further, to report all serious dietary supplement adverse events to the FDA.

Source: PDR for Herbal Medicines, Fourth Edition 

Worldwide Bestseller for Herbal Medicines