Laws on vitamins benefit consumers and manufacturers. The U.S. Food and Drug Administration administers laws on vitamins and considers them as dietary supplements. The quality and safety of vitamins are not as regulated as you might think. The law allows manufacturers to market vitamins without following the pre-market approval process required for prescription medication.
DSHEA
Laws on vitamins come from the Dietary Supplement Health and Education Act of 1994, or DSHEA. An amended version of the Federal Food, Drug, and Cosmetic Act of 1938, the DSHEA changed the laws regarding the regulation and labeling of vitamins, and other dietary supplements. The act defines "dietary supplement," lists the types of claims permitted on the label and provides requirements for nutrition labeling. It also defines the term "new dietary ingredient," and it established the Office of Dietary Supplements as a department within the National Institutes of Health.
Dietary Supplement
A dietary supplement, as defined by DSHEA, is one that people orally ingest that contains one or more dietary ingredients to supplement the diet. Dietary supplements come in tablets, capsules, softgels, gelcaps, liquids and powders. The law considers vitamins, minerals and botanical ingredients sold in the U.S. before October 15, 1994, dietary ingredients. Products containing dietary ingredients do not require a pre-market safety review.
Safety and Quality
Manufacturers and the FDA share the responsibility of regulating vitamin safety. Before marketing, the FDA holds the manufacturer responsible for the safety and quality of the product. After marketing, the FDA must prove the supplement unsafe before banning or pulling it off the shelves. Manufacturers must provide any reports of adverse events related to their product to the FDA -- if reported to them directly. These reports help the FDA determine the safety and quality of the product.
Label
The DSHEA requires specific information on all over-the-counter vitamin labels. The name of the product, quantity in the package and directions must appear on the label along with the manufacturer's name and place of business. The dosage size, list of ingredients and any established percentage of daily nutrient value of the listed ingredients must appear on the supplement facts panel, along with the names of any botanical ingredients. The FDA established the daily value for known nutrients.
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