Archive for November 5th, 2008

Are Your Supplements “FDA Approved?”

November 5, 2008

You see supplements marketed as FDA Approved! Am not sure how the policy of the local FDA works but almost always, the same agencies operating elsewhere look at policies of the US FDA as their basis for regulating drugs.

Let us be clear what”FDA Approved” means.  The US FDA website has this to say:

FDA approves new drugs and biologics.

New drugs and biologics must be proven safe and effective to FDA’s satisfaction before companies can market them. FDA does not develop or test products; 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 risks for the intended use.

Meaning research should be done and presented to the body and then these studies should prove the products benefit outweigh the risks.  If however the risks outweigh the benefits then the marketing of the drug is not approved!

Now…How about the Dietary Supplements?  What about their claims for FDA Approval?

FDA does not approve dietary supplements.

Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. The notification must include the information that was the manufacturer or distributor’s basis for concluding that the dietary supplement will reasonably be expected to be safe.

After dietary supplements are on the market, FDA evaluates their safety through research and adverse event monitoring.

If you will note…the supplement will be in the market first and then if  adverse events occur then action will be taken by the FDA. review of side effects or untoward effects are made before releasing a supplement to the market. BUT how many patients will complain of side effects especially that supplements are marketed as having Zero side effects?  and where do they go to report when only the salesmen or networking friends advised or convinced  them of the safety of the supplements?

FDA does not approve structure-function claims on dietary supplements and other foods.

Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. 

Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been reviewed by FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease. Conventional foods are not required to carry such a disclaimer.

So Beware of the claims that these supplements are good for Diabetes, to boost ones Immunity or other medical benefits because NONE are based on studies and no proofs exist that they work!

In short DONT be FOOLED by claims that the product is FDA or BFAD APPROVED!!!