What is an supplement?
Supplements are intended to supplement an overall healthy nutritional intake that may be lacking in a few key areas
In defining a supplement, it is also important to understand how the supplement industry is regulated. Since the passing of the DSHEA ( Dietary Supplement Health & Education Act)
In 1994, the FDA regulates dietary supplements under a different sets of regulations from those covering “conventional” foods and drugs (prescription & over the counter)
Under the DSHEA, the supplement manufacturer, not the FDA, must ensure that a dietary supplement is safe before it’s marketed.
According to the FDA:
Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for the FDA to approve dietary supplements for safety or effectiveness before they reach the consumer.
Under DSHEA, once the products is marketed, the FDA has the responsibility for showing that a dietary supplement is UNSAFE, before it can take action to restrict the products use or removal from the marketplace.
The important thing to remember is that the FDA
DOES NOT GET INVOLVED UNTIL AFTER THE PRODUCT HAS BEEN ON THE MARKET.
The FDA does Post marketing surveillance of supplements, but doesn’t ensure their safety or effectiveness. The agency may restrict a substance only if it poses a ” significant and unreasonable risk” after it is being sold and used.
So What is FDA Approved?
FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.