Regulating Food Supplements
Chester J. Zelasko, Ph.D. | March 5, 2002

If you read the typical magazine or newspaper article about food supplements, you would read that food supplements (also known as dietary supplements) are not regulated by the U. S. Food and Drug Administration (FDA). Therefore, the article usually continues, you never know what you're buying, whether the supplement is safe, or whether it actually contains what the label reports. Since the purpose of the Newsletters are to clarify health news, let's get the facts straight on this issue.

The FDA is responsible for the regulation of dietary supplements. The scope of that regulation is different from that of pharmaceuticals and over-the-counter medications, but they are under FDA jurisdiction nevertheless. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which created a category that is in-between medications and foods. The primary difference between medications and food supplements is that the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed, while the FDA makes that determination for pharmaceuticals. Further, the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Manufacturers don't have a free pass to sell anything they want in pill form. The fact that the FDA doesn't require pre-market testing does not reduce the liability of the manufacturer if a product is not safe.

The FDA also regulates what a dietary supplement manufacturer may say on its labels. The manufacturer must make sure product label information is truthful and not misleading. While there are differing categories of statements that can be placed on food labels, the bottom line is that a food supplement cannot state that it will cure a disease or condition. That would make it a medication. You can get more information about the regulations for dietary supplements at the link on the bottom of this page.

Think about it logically: would the executives of a company that wants to remain in business offer to sell a product that they know is not safe and might harm someone? Not in today's litigious society. But because there are unscrupulous manufacturers who make wild health claims and sell products that may not contain the ingredients on the label, the entire dietary supplement industry is often suspect.

Your health is primarily in your hands, and Better Life Unlimited recommends that you be a savvy consumer. Eat your fruits and vegetables. Exercise regularly. Get regular medical check-ups. And if you choose to supplement your diet with food supplements, buy them from a quality manufacturer. Make sure you purchase your supplements only from a manufacturer who uses the Good Manufacturing Practices industry standards, who has a proven record of standing behind the products, and who doesn't make exaggerated claims about the benefits of using the products.

For further information, check out www.cfsan.fda.gov/~dms/supplmnt.html.
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