Dietary supplements may contain harmful or undesirable substances such as pesticides or heavy metals. Contaminants may be present before a substance is harvested for use as a dietary supplement or may be introduced during processing and packaging. For example, coral calcium, a dietary supplement said to contain remnants of living coral reefs, may contain significant [...]
Dietary supplements are natural substances that may contain variable amounts of active and inactive ingredients. These amounts depend on several factors, including the age and specific part of the plant, the composition of the soil in which it was grown, the time of year it was harvested, and how the substance was processed and stored. [...]
Dietary supplements may act differently in different people. As noted by Christine Lewis-Taylor, former director of the FDA’s Office of Nutritional Products, Labeling, and Dietary Supplements, “one man’s dose can be another man’s poison.” An individual’s genes and health status help to explain this difference. Nutritional genomics and metabalomics are growing areas of research that [...]
Dietary supplement safety should be of primary concern to consumers. Because they are assumed to be safe unless proven otherwise, dietary supplements present special safety challenges. In 2000 the FDA received 500 dietary supplement adverse event reports; that number rose to 553 in 2001 and to 1214 in 2002. Adverse events caused by dietary supplements [...]
Supplements are now being performed by the Office of Nutritional Products, Labeling, and Dietary Supplements’ Division of Dietary Supplement Programs, which comprises a regulations and review team, a compliance and enforcement team, and a clinical review team. Led by Dr. Susan Walker, the division creates policies, regulations, and guidance documents to ensure the safe manufacture [...]
The DSHEA gave the FDA the authority to establish special good manufacturing practices for dietary supplements. In March 2003 the FDA released its “Proposed Rule for Dietary Supplement Current Good Manufacturing Practices,” which addresses important components of dietary supplement manufacture, including design and construction of manufacturing facilities, quality-control procedures, testing of the final product(s) or [...]
Manufacturers of dietary supplements often seek to promote their product by providing supporting material such as a scientific study or the statement of a medical or nutrition professional. Under certain conditions, this additional material is not considered to be “labeling,” per se, and is therefore not regulated in the same fashion. If the manufacturer uses [...]
The use of health claims on food products is regulated by the Nutrition Labeling Education Act of 1990. Health claims describe the relationship between a specific nutrient and a disease or condition. In order to appear on the food or dietary supplement label, health claims must be evaluated and preapproved by the FDA based on [...]
According to the DSHEA, a dietary supplement is a product that • is intended to supplement the diet; • contains one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents; • is intended to be taken by mouth as a pill, capsule, tablet, or liquid; [...]
