Is a product really FDA-approved? Some facts about how to know.

by James Hubbard, M.D., M.P.H.

You’ve seen plenty of products that advertise they’re “FDA-approved.”  What does that really mean?

The U.S. Food and Drug Administration wants you to know that all advertising is not as it seems.  Many products that say “FDA-approved” aren’t. Some are not even in the jurisdiction of the FDA to approve.  They couldn’t approve them if they wanted to.  Others can be “approved” before the FDA really knows much about them.  What about food and drugs?  The words are in the title of the agency so the FDA must approve them.

Well, not really.

The U.S. Department of Agriculture regulates poultry and meat, except for game meats (such as venison, ostrich, snake, etc) which is regulated by the FDA (whew).  None is “approved”.   As I have posted in the past there is no FDA regulation (or approval) for dietary supplements.  They only get in trouble when they start claiming actual treatment of diseases with little evidence to back it up.

Here is the FDA mission statement.

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

That’s pretty broad.  Perhaps it’s better to say what the FDA cannot, therefore never, “approves”. You may be surprised.

FDA never approves:

  • health-care facilities, laboratories or manufacturers.
    • They do “inspect” them, and “certify” mammography facilities.
  • medical devices, unless they are “high risk,” like heart valves.
    • They “clear” devices like dialysis machines and catheters that are similar to those already in use.
  • cosmetics, except for color additives.
    • They “inspect” samples for safety and labeling and may “take action” against lawbreakers.
  • medical foods, which are foods that are “used for the dietary management of a disease or health condition.”
    • They gave an example of a food free of phenylalanine for people with the genetic disorder, phenylketonuria (PKU), who cannot process this protein.  It can be dangerous if it builds up in the body of these people.
    • Medical foods do not have to include nutrition information.
  • infant formula.
    • They “regulate” them after they are on the market.
  • dietary supplements.
    • They “evaluate” their safety and “monitor” adverse events.  The Federal Trade Commission polices false claims.
  • food labels, including nutrition facts.
    • They do require the nutrition facts label and demand that it is truthful, but don’t “approve” it before the foods are marketed.
  • claims on foods and supplements, such as, “calcium builds strong bones.”
    • They require that the firm “notify” the FDA within 30 days after advertising this claim.

So what does “FDA-approved” mean for the above?  Nothing.

The FDA does “approve” prescription and over-the-counter drugs, food additives and color additives.

They also “regulate”, “monitor”, “evaluate”, and “certify” a bunch of stuff.

What is the FDA’s definition of “approved”?  The known benefits outweigh the risks.

What are your thoughts? Any surprises or comments?

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7 Responses to “Is a product really FDA-approved? Some facts about how to know.”

  1. M Says:

    Very surprising and scary! Apparently there are thousands of drugs prior to the FDA’s involvement that have NOT been approved? Is there going to be retroactive approval? Wasn’t there an Act in 2002 that supposedly required food manufacturers to register with the F.D.A.? Thanks for the post!

  2. James Hubbard Says:

    Thanks Mark,
    I am not sure about the Act, but, remember, FDA approval and FDA registration are 2 different things when defined by the FDA. A lot of things are regulated (still another definition) by the FDA after they brought on the market.

  3. Judy Rodman Says:

    Very interesting indeed. One thing I wish the FDA would insist on- warnings for nutritional suppliments like “not for those with allergies to such and such”. Maybe this could come under the “regluation”. Strong nutritional suppliments, like drugs, can have adverse and sometimes disasterous consequences for certain people. I had a vocal student who took some tumeric powder, which for me has an anti-inflammatory effect, and nearly died because it caused what her doctors said was a “laryngeal edema” so serious she only had a pinhole left to breathe through. The doctor said if he had pushed the scoping tool he used a little farther, he would have had to trach her. Scary.

    I am glad that suppliments are legal to use, but do wish there was more regulation so protective information would be available to the public- which is, as you say, the role of the FDA.

  4. Judy Rodman Says:

    ps… I was NOT the one who suggested the tumeric powder to her :)

  5. James Hubbard Says:

    Thanks Judy,
    I agree. The FDA should regulate them. Nutritional drugs can have ingredients as strong as prescription drugs and with many side effects. They can also interact with your other drugs. No one gives the standard effective dose or even makes sure the dosage claimed is the dosage you get.

    According to the NIH Alternative Medicine Division, ,
    supplements can go on the market:
    1. Without proven safety
    2. Without proven effectiveness
    3. Without proven quality
    4 Without content analyzed

    The FDA can only take action, by removing a supplement from the market, if it finds the supplement to be unsafe after it is on the market.

    Supplements must meet the same requirements as food under FDA’s “Good Manufacturing Practices” for packaging, preparing and storing.

    “Standardized” on the bottle has not been defined under U.S. law so it means nothing.

    Is it any wonder that we, at JHMFD, emphasize publishing info from good, reliable scientific studies?

    There are good companies out there that consistently produce quality products. Stick with them.

  6. cathy Says:

    I am always amazed at the things that aren’t regulated. Thanks for this information!

  7. James Hubbard Says:

    Thanks Cathy, so am I.

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