Vitamins are obtained naturally from many of the foods you eat like fruits, vegetables, dairy and grains. You can also get vitamins as individual supplements or in multivitamin compounds. The U.S. Food and Drug Administration regulates vitamins as a general food product in the category of dietary supplements. For vitamins, the FDA uses the term "regulate" to mean they are monitored after being introduced to the market, rather than controlled or approved before they are distributed. Before taking a vitamin supplement, consult your physician for recommendations.
Importance of Vitamins
Vitamins are essential to your diet, and each of the 13 vitamins has a specific function for daily functions. Without adequate intake of vitamins, you may develop deficiency diseases like scurvy, night blindness or cognitive disorders. A well-balanced diet typically provides your vitamin needs, but you may need supplements if you are pregnant, eat a vegetarian diet, have digestive problems limiting your ability to absorb nutrients or do not consume enough nutrients through diet. Before taking a new vitamin supplement, consult your physician.
FDA Label Requirements
The Dietary Supplement Health and Education Act of 1994 defines dietary supplements as products taken by mouth that contain "dietary ingredients" for the intent of supplementing the diet. The act deems vitamin supplements food items, not drugs, and they can take the form of tablets, capsules, liquids or powders. The FDA requires vitamin supplement labels to provide a descriptive name that indicates the item is a supplement, as well as a manufacturer, packer or distributor name and place of business, the ingredients list and net contents. A supplement facts panel must appear on the label, which identifies each ingredient contained in the product.
FDA Role in Product Safety
Manufacturers of vitamin supplements are responsible for product safety before marketing, since vitamins are categorized as a food product. The FDA does not have to approve, test or analyze the vitamin supplement before it is dispersed to the masses. However, if a vitamin product comes under scrutiny, the FDA has the responsibility of proving the item is unsafe before it can pull it from the market shelves. Once the manufacturer or distributor receives notice of adverse effects associated with a vitamin product, the manufacturer must send a report to the FDA within 15 days of the initial claim of questionable safety.
Disclaimers
Vitamin supplement products often have a disclaimer indicating certain statements on the label are not FDA evaluated. This means the FDA does not necessarily support manufacturers' health claims of what the supplement may do for your body. For instance, the label of a B-complex vitamin supplement may claim to improve your energy, help you think clearly and boost metabolism. Statements of this sort are claims made by the manufacturer, not tested and confirmed by the FDA.
Alerts
To report an adverse effect from an FDA-regulated vitamin supplement, contact your physician. Together, you and your physician can complete a formal report to the FDA MedWatch Program by phone, fax or online form. If you want to review any vitamin supplements under alert or advisement by the FDA, check the official website under "Consumer Updates."
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