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!!!



14 Responses to “Are Your Supplements “FDA Approved?””

  1. Yu ching Liu Says:

    Super Lutein from Naturally Plus (Japan) sold in Taiwan claims with U.S. Special Permit No. 5382714
    Please kindly tell me whether it is the permit from FDA
    Thank you very much

  2. John Stewart Says:

    Extagen is a male enhancement website that I was looking to purchase their product because it specifically states the product is FDA approved.After reading your blog it made me kinda skeptical so to make a long story short If you no of any male enhancement product that is FDA approved,I would greatly appreciate it if you contact me via e-mail and let me know. Thank you for your time!!!

  3. Jen Says:

    Good Evening,
    What are the safest and effective joint supplements?

    Thank You,

  4. Michael Sosa Says:

    I’m working an at home business and I would like to know the differences positive and negative of the two companies Pharmanex and Usana Health Services. Both claim to be the leaders in Dietary supplements but I am unsure where to turn for my research or where to start to ask questions.

    Thank You

    • Stephanie Says:

      This is probably too late, and you probably already know the answer….Go to the Comparative Guide to Nutritional Supplements. You will find awesome information in their, and how products are rated. As to answer your question our right, by 3rd party studies, Usana is rated #1 in the market. Hope that helps.

  5. I usually don’t post in Blogs but your blog forced me to, amazing work..

  6. laura Says:

    for about 5 months I have been a vegetarian and I feel as though I am lacking vitamin B12. What vitamin B12 supplements are FDA approved & safe for my body?

  7. Elliot Says:

    I was doing some research to find out about FDA approval of supplements and came across your site. I think your article is somewhat disingenuous. Why? You imply that unless supplements are FDA approved they are dangerous. Show me that info. From what I’ve found there are usually 2 deaths per year via iron from infants and that’s it (poison control centers). Compare that with FDA Approved medications- over 100,000 deaths per year from properly prescribed medications (JAMA). So really what does FDA approval really mean? Common sense would tell me to avoid something that is FDA approved!

  8. Stephanie Says:

    I just stumbled on this wesite too….couple things Pharmanex Life Essentials are rated 3/5 stars in the Comparative Guide to Nutritional Supplements by Lyle MacWilliam, 4th Edition…Get it from Chapters. He rates over 1500 products for their completeness, absorbability potency and purity. Awesome resource for up to date products and what they rate. Usana Health Sciences rate 5/5 plus have a Gold Medal of Acheivement for their Essentials and Convenient Health Pak. They already adhere to the Pharmaceutical GMP’s, and just a couple weeks ago they ARE NOW AN FDA APPROVED FACILITY. Yes, they are a nutritional not a drug, and they can be trusted as Olympians trust them. To have optimum health, and to do our most to avoid the health care system, we are responsible for our own health. Take the best…it doesn’t hurt if they are FDA approved 🙂

  9. Wow that was unusual. I just wrote an really long
    comment but after I clicked submit my comment didn’t show up. Grrrr… well I’m not writing all that over again.
    Anyway, just wanted to say wonderful blog!

  10. Ahmed Says:

    t figure our way out of our consumerist addictions we will eventually have to go
    cold turkey. Support lifestyles that are
    more environmentally-friendly. Vegetables I sometimes grow in the Fall include beets, carrots, cabbage, brussel sprouts, lettuce, and broccoli.

  11. Olive Says:

    Bfad approved din po ba ang vita plus products?

  12. Nora Says:

    Ang health insight po ba ay bfad approved?

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