Why does NOT the FDA evaluate natural health remedies?

I take a natural product that eliminates the Pain that I get from osteoarthritis. It has not been evaluated by the FDA? It works better than FDA approved RX medicines. Saw Palmetto has none of the side effects of RX drugs but it works better and is cheaper. There are dozens of examples bu the FDA does not approve them. Why? It would make medical procedures less expensive and save everyone money.It appears to be a no brainer.
WOW! This surely brought the weirdo’s out. It just shows how brainwashing does it’s job. education is great if you have the correct information and teachers. Pharmaceutical manufacturers run the medical universities. They teach Cholesterol is bad and Statins are good. That’s a lie.

6 comments

  • Micheala3-#1 Fan of WDPLM?3

    They WANT to keep people doped up and in bondage, dependent on the gvt.

    Plus, big pharmaceuticals and govt corruption, bribes, and payoffs.

    Bladderwrack is great for thyroid hormone balance.

  • evirustheslaye

    because the supplements industry were made exempt from FDA regulations unless they make specific health claims like "cures cancer". for instance supplements aren’t required to list any side effects, as opposed to real medicine which the FDA requires the listing of all possible side effects.

    the simple fact is that supplements have only a vary narrow range of uses, much less than what is claimed by the supplement industry. unless your problem arise from malnutrition supplements aren’t going to help you.

  • they don’t want people to use alternatives. the first, and easiest way to keep people away is to not mention them. if that doesn’t work, you bring out your own "experts" to publicly discredit them. then you sic the law on them, claiming they are practicing medicine without a license. then you make them illegal so no one can get them. (where they’re headed about now).

  • Gary Y

    Your natural product eliminates osteoarthritis pain? Really? What natural product is this then? How do you know it works for everybody?

    Saw Palmetto has none of the side effects of RX drugs? Really? Are you talking about ALL RX drugs? Or just one? What is you evidence please?

    Saw Palmetto works better? Really? Works better than what and for what? And what is you evidence please?

    It’s cheaper? Not where I live.

    FDA evaluation depends on the claim.
    http://www.fda.gov/RegulatoryInformation/Guidances/ucm144657.htm#iii

    For info:
    "Saw palmetto side effects:
    Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using saw palmetto and call your doctor at once if you have any of these serious side effects:

    weakness or fainting;
    black, bloody, or tarry stools;
    coughing up blood or vomit that looks like coffee grounds;
    pain or swelling in your breasts or testicles;
    chest pain;
    fast, slow, or uneven heart rate;
    easy bruising or bleeding; or
    nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

    Less serious side effects may include:

    nausea, vomiting, stomach pain;
    diarrhea or constipation;
    bad breath;
    headache;
    dizziness;
    sleep problems (insomnia);
    muscle pain;
    depressed mood; or
    increased or decreased interest in sex;

    This is not a complete list of side effects and others may occur. Tell your doctor, pharmacist, herbalist or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088."
    http://www.drugs.com/mtm/saw-palmetto.html

  • Mathieu

    It is complicated, controversial, and to some extent just bizarre.

    Firstly there is federal law that does not allow FDA oversight unless a serious problem occurs, only them may the intervene. A member of US congress used some natural remedies, got better, and went on a crusade to make supplements legal, easily available, and intentionally unrestricted due to fears the FDA would require too much testing and oversight, reducing the availability of products. Also certain natural substances can not be patented. For example people knew about Lithium for a few hundred years but drug companies would not spend the money because it is natural.

    However we are not talking about "natural health remedies." Many pharmaceuticals are naturally occurring substances, I always use morphine as an example because some people claim that natural is good and synthetic is bad yet most people don’t recommend morphine for a stubbed toe ad morphine has great dangers, yet it is natural. So it is not a matter of natural vs. synthetic. In fact many synthetic substances, often only available by prescription outside of The US, are supplements with no oversight.

    Here is the other thing that is critical for people to understand. In order for a drug to gain FDA approval is must under go extensive testing, the testing must be high quality (typically some A and B level quality), it must be shown to have a genuine effect, if studies show it to work it must work BETTER than placebo. Anecdotal and individual beliefs and experiences are not enough.

    So lets take your example, Saw Palmetto. I believe it did help you but (forgetting studies for a moment) just because it helped YOU and because prescription drugs did not does not indicate anything. If some one wanted to sell you a car and said "I did a test drive myself, no one else has, and there are no safety studies on the car." Even if the care looks great would you buy it? Of course not, because aside from one person saying "it is good" there is no evidence it is actually good.

    Yes there have been studies on Saw Palmetto but here is the problem, the number of studies is small, the quality of the studies indicating it is beneficial are low and unimpressive, and the number of people involved are small so they are not considered to be proof. Studies like that are good because they might show something that another person will do a better quality test for but alone those studies on Saw Palmetto are not enough. The couple of better studies with controls, and blinds, where more negative and saw no difference between placebo and Saw Palmetto. Even they are not enough to say it does not work but they have more credit.

    There are possible side effects to Saw Palmetto, like I said just because you had none does not really indicate anything. Nothing is risk free, even supplements have risks, in some cases serious risks.

    Even a huge scale, high quality study with many participants is not enough. If you read some of the best studies they often say "more testing should be done" or "this alone should not change prescribing practices." So it takes a lot of time, research, and money to do everything.

    There was a recent study saying that giving morphine to a person injured during a traumatic event (the study was US military in Iraq) had a 40% less chance of developing PTSD. Basically everything about the study was fairly good in terms of quality yet that is not enough to cause doctors to routinely give morphine to people just to help prevent PTSD.

    A large meta-analysis (a study of a large group of studies) found that about 96% of all drugs needed more testing. And if that study would have applied to supplements it would probably be 100%.

    Based on its evidence I can’t imagine Saw Palmetto would be approved. Also as bad as drug companies can be the supplement companies also have lobbyist and almost everything drug companies have except oversight. So when you buy Saw Palmetto the maker has no required standards or testing and there is a great variation of the quality and amount of substance found in various makers product.

    Just always remember just because it "works" for you does not mean it works for everyone or that it even works. There are likely people of prescription drugs, proven to work, that don’t help the person taking it but the placebo effect does. Yet most people take the drug and it chemically works. No one person can prove a drug works or not and the people who say "it worked for me so it clearly works" have a huge flaw in their logic, much like the logic of "I have a rock and there are no lions around me, thus the rock keeps lions away."

  • Flizbap

    Because they made THEMSELVES exempt from the FDA approval process in the mid 70s IIRC.

    EDIT: Cholesterol is good? Sweet now I can go back to chugging clarified butter.

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