Quack Miranda Warning

“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

This “Quack Miranda Warning” is on every just about every woo-meister’s website. I see dozens of patients every day, and I never Mirandize them, so whats the deal?

There are three ways to look at this: the truthful way, the sinister way, and the bat-shit insane way.

  • Truth: Anyone who wants to sell you something that’s a load of crap must use this statement to cover themselves legally.
  • Sinister: Variation of above–someone wants to sell you something that you are supposed to believe is medically useful, but at the same time they tell you in fine print that it is not medically useful. When it doesn’t work, they don’t get sued. I wonder why anyone would buy something with that disclaimer attatched to it? When I treat someone for a medical problem, I pretty much say that I intend to diagnose, treat, cure, or prevent a disease. Why would I say otherwise? It would be a lie. Also, who would go to see a doctor that told you that they didn’t intend to diagnose or treat disease. The whole thing is bizarre.
  • Bat-shit insane: The FDA and Big Pharma are in cahoots with the AMA to keep you from learning all the simple ways to treat diseases. They want your money, and they’ll do anything they can to get it from you, including suppressing the knowledge that anyone can learn to heal cancer.
  • I can’t really help the people who believe #3, but people who are willing to suspend their paranoia should read #’s 1 and 2 a few times. Unless you’re being arrested, no one should be reading you your rights. The Quack Miranda Statement is the red flag that should send you running.

    Comments

    1. #1 blf
      March 24, 2008

      It’s there a fourth option, something like:

      Reality: This is crap. And we can sell it because the FDA et al. is too underfunded/whatevered to do anything about it. This notice is just to prevent us from being successfully sued by those who are dissatisfied with our finest crap.

    2. #2 qetzal
      March 24, 2008

      Actually, blf, I’d put it more like this:

      Reality: This is crap. But we can sell it because Congress passed a law saying FDA can’t touch us as long as we include this disclaimer. Plus some other legal mumbo-jumbo, but don’t you worry about that – just buy it already.

    3. #3 blf
      March 24, 2008

      s/It’s/Isn’t/

      qetzal: Ah, Ok. Thanks for the improvement! I don’t live in the USA and so am not too sure of the reason(s?) for the FDA not going after these bozos. Even so, it is my understanding the FDA is very short of inspectors (or something like that, I admit I cannot quite recall right now).

    4. #4 PalMD
      March 24, 2008

      It’s not a funding thing as much as a political thing (just as qetzal says). I’m not sure of the entire history, but the FDA basically sold out it’s right to regulate any “nutritional” substances or supplements, as long as they contain the standard disclaimer.

      http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-32102.htm

    5. #5 genewitch
      March 25, 2008

      resident pedant checking in in #3 last sentence, “than” should be “that”

      post moar, IMO

    6. #6 Will K.
      March 25, 2008

      It’s Lord/Liar/Lunatic of the supplementals, I guess.

    7. #7 Abel Pharmboy
      April 7, 2008

      PalMD, I’ll actually defend the FDA on this count because they can only uphold laws they are charged with enforcing – in this case, it was Congress that caved in and passed the 1994 Dietary Supplement Health and Education Act (DSHEA). This watered-down piece of legislation was sponsored by Orrin Hatch and passed in the wee hours of the last session of the 103rd Congress. As written by a supplement industry representative in Nutrition Business Journal:

      The Gingrich New Deal Republicans were about to sweep out the old line House Democrats who were holding up DSHEA, which caused the Democrats to unload the DSHEA issue at the very last minute to save their jobs. In the Senate, Senator Orrin Hatch (R-UT) was able to hold off a last minute attempt to derail DSHEA as it was coming up for unanimous consent vote in the closing minutes of the 1994 Senate session. Literally, DSHEA was a political “Hail Mary” of unprecedented proportions. Frantic last-minute deal making resulted in the addition of the structure/function claim disclaimer, among other things.

      Hence, listing the disclaimer statement allows manufacturers to sell these products as long as they do not make direct disease treatment claims (there was no lower limit on the font size, however.). The law also put the burden of proof on the FDA to demonstrate that a product is unsafe (rather than how a drug company must submit reams of safety data) and to be honest, FDA can only remove products from the market if they contain unapproved drugs or are adulterated with Rx drugs. The FTC has greater authority to step intervene if these products are marketed fraudulently.

      Regarding DSHEA, I love this quote from the same NBJ article above:

      A powerful congressional veteran, John Dingell (D-MI), is quoted as saying, “I would like to repeal the whole sorry mess” [DSHEA].

      This single issue is perhaps the primary driving force behind my starting Terra Sigillata.

    8. #8 PalMD
      April 7, 2008

      Thanks, Abel!

    9. #9 BeBe
      June 13, 2008

      “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

      If you will allow me, I would like to add an evidently alternative stance on the above statement. The truth as I see it, is that business (whether it be medicine, pharmacy or whatever) will not invest money in something they cannot get a decent return on. Therefore, little money is invested in products, substances etc which are natural, because you cannot patent anything God created. This however, does not mean that these products are not useful and or valuable, they are just not “patentable.” Since the AMA along with pharmacy wants to be the only one with the ability to diagnose/treat/cure(??) disease and are not willing to invest in a product that will not guarentee a huge return, this statement still extends to them their “supposed” or implied superioty but at the same time allows the end user to attempt to help themselves, if they cannot afford expensive pharmaceutical based medicine or lack faith in its ability to heal them.

      As with anything in life, you have to take the good with the bad. Just as in allopathic medicine you must take the benefits of acute care and emergency situations along with the determent / adverse effects that can occur with many of its patented drugs. In this situation the good is that no one can control natural substances. That is good because it allows of the freedom to think for ourselves, and not be mandated or dictated to by a monopolized system. Nor do we have to go pay for expensive office visit repeatedly, which one may not be able to afford, to get a perscription of Vitamin C, CoQ 10 etc. Also, it keeps incredibly inflated prices for products at a reasonable cost. It is good because some believe that what God created is superior to man’s creation, with usually much less adverse effect. It is good because since less money is involved and the inability to “control”, weeds out profit hungry entities.

      The bad side is that you have to do your own homework and find the reputable companies who can base their assertions on either science based, sometimes historical based or testimoninal based content. Also, finding those companies that do their own quality control and base their reputation on the quality of their products. Just because something is not approved by the FDA or AMA does not discredit it necessarily in my opinion. Its just saying that no one has been interested in researching it in its entirely because to do so is not necessary cost effective for them.

      Another bad side is that anyone can cut their own grass and put it in pill form and call it herb XYZ, this is where the importance of finding the reputable companies comes in. Reputable companies do exist. It is unfortuate that on both sides of the fence there are those who put profits before people. These days it seems to find the truth of something, you must do your own legwork or homework. That takes time along with the ability to comprehend what you read and find, and sometimes you must be able to put concepts together to achieve an understanding.

      Even with the bad side of the statement, it has enough good to it that I believe that Congress actually did a very good thing by passing this issuance of statement. I don’t discredit everything based on this statement that natural product producers are forced to use for protection against those who want all the power and control. I’m not sure that’s paranoia but rather the reality of this present day.

      As with all things, buyer beware, whether the FDA or the AMA approves or not. Their track record alone is not very impressive and does not automatically presume truth and accuracy.

      Just an alternate insight,

      Belinda

    10. #10 Simon
      July 6, 2008

      It seems we all need to make disclaimers, dont we. -”The information in my posts is intended for discussion purposes only and not as recommendations on how to diagnose or treat illnesses…”

    11. #11 Marshall
      July 11, 2008

      The sad thing is that all three are true. The proliferation of lawsuits make this type of labels a necessity. They are even on Vitamins which can be beneficial. Have you ever read product warnings on just about everything you buy? It is a sad day when a woman sues because she spilled coffee in her lap and it was hot . . .well duh

    12. #12 Theo
      September 19, 2008

      why is it called “Miranda”? does it mean anything special? (my english is very average), tks.

    13. #13 PalMD
      September 19, 2008

      Miranda was a supreme court case in the US which led to cops having to read people their rights. It has become a verb as well, as in “the cops mirandized the robber”.

    14. #14 LanceR
      September 19, 2008

      Theo,

      In America we have the “Miranda Warning” named after a Supreme Court case about self-incrimination. “You have the right to remain silent…” and all that. This is a reference to that warning.

    15. #15 Kathy
      March 9, 2009

      Some consumers know it’s BS but are after hope – or maybe a placebo effect. I heard one fellow say “I have no insurance and can’t afford to go to a doctor. At least I can afford this and maybe it will help.”

    16. #16 Don
      March 17, 2009

      You are an arrogant, ignorant fool. First of all, the companies HAVE to put that disclaimer per the rules set forth by the (corrupt) FDA that will not allow any medical claim to be made about anything that hasn’t undergone a multi-million dollar test…so basically only pharmaceutical drugs (most of which are formulated and patented from natural components found in supplements anyway) treat disease in the fantasy-land of Western medicine. Ever heard of DSHEA? If the companies who produce natural supplements don’t put this label on EVERYTHING that even hints at assisting your body in maintaining health or curing disease, then the FDA can come in with a SWAT team and confiscate all the product and shut the company down for selling an “unapproved drug”. Yes, they have done this. And you of all people, based on your “education” should understand the role of nutrients in maintaining bodily health…but somehow I think you have disengaged that portion of your brain based on your asinine drivel pasted all over this worthless site.

      It is about time you do a little more research you diluted, presumptuous cretin. It is people like you that perfectly illustrate the irrationality of “educated” egomaniacs in peddling their pseudo-science, acting as self-appointed royalty in all things “scientific”. One day you will be reduced to your proper place from the perceived throne of superiority in which you have seated yourself. Pride comes before the fall.

      I accidentally came across this pathetic site while doing some research and you can be sure I will never return.

    17. #17 Another Anonymous Poster
      March 17, 2009

      And Don picks door #3! Tell him what he’s won!

    18. #18 LanceR, JSG
      March 17, 2009

      And Don picks door #3! Tell him what he’s won!

      The coveted golden *headdesk*! This prized award is plated in 100% fake gold, just like his “argument”!

      He’s also won a copy of our home game! Back to you, PalMD!

    19. #19 LanceR, JSG
      March 17, 2009

      Sorry about the double post… I dunno why. Half the time it tells me I’ve “posted too many comments in a short time” or something… this time it doubled.

    20. #20 Kim C
      April 27, 2009

      I’ll stick with #3. I ‘ve lived in Asia and I totally believe in the efficacy of Chinese herbals. I’ve seen them work.

    21. #21 Kim C
      April 27, 2009

      Whoops! Forgot to say I am bat shit insane!

    22. #22 Skemono
      April 27, 2009

      I’ve seen them work.

      Your anecdotal evidence that people took items labeled “herbals” and then got better does not constitute evidence that alternative medicines do any better than placebo.

    23. #23 Lisa
      May 14, 2009

      I am a little late on adding to this post, but I am pretty sure that I saw Don in my office the other day. I wished him well with his red yeast rice to lower his cholesterol now that he had his 3rd heart attack. He could not reconcile why he would NOT give his money to the “evil Pharm” when he was perfectly content to pay the Malboro man. Darwin continues to disappoint me. :-)

    24. #24 Bruce Kahn
      June 6, 2009

      Take a look at Don’s post above, then Belinda’s further up. What’s interesting is that they’re both saying very similar things, but Belinda’s is reasoned, polite, and issue oriented. Don’s is a ranting, paranoid personal attack. It’s unfortunate when people can’t or won’t realize how to communicate in a way which actually encourages others to take them seriously. For the record, I agree with Belinda. Don- get a clue.

    25. #25 Al
      June 19, 2009

      It’s easier to disregard anything if you are skeptic but believe it or not some herbal remedies eally work. If the user think that they are getting something out of a product even if it is just placebo who are we to deny them that right.
      http://www.hghhelp.info

    26. #26 Chris
      October 21, 2009

      Go, Belinda! Well written. The value of FDA approval is certainly of limited value. Yes, it assists us in determining which substances have been tested properly. But it regularly releases substances for use that substitute a small print disclosure in place of the unregulated disclaimer. Very few people realize the extent to which approved pharmaceuticals are often very dangerous substances that assault the body with a measured amount of toxin to produce an array of effects, one or two of which are useful, the rest small printed down to a lengthy and rarely read “side effects” disclosure statement. The disclaimers on unregulated supplements are mandated by the feds to alert folks to an untested and not yet approved substance. I’d like to see alternative/unregulated supplements and medicines carry a warning that said:

      “This substance is intended to (fill in the blank). Many people report that it is effective in (fill in the blank). This substance has not been scientifically tested, and there is no guarantee of results. Reported side effects are (fill in the blank). There may be other side effects that are not known or fully understood. There may be unpredictable interactions with other regulated or unregulated substances or medications. Let your physician know that you are or intend to use this product.”

      Why not let people know what the intended result or use is? Why not share the reported responses and reactions to a substance that may have been in documented use for centuries? I strongly support sound research, and hope to see it done more often on known, and believed by many to be useful substances that now fall under the category of unregulated supplements,that while un-patentable, may be very useful, rather than a total dependance on this dollar driven frenzy to re-invent wheels that have lost thier patents. If we had as many resources devoted to a “let’s look into this” mentality as are devoted to the “lets invent something totally new, and make billions” approach, (And note I said “as many resources”, not all resources, nor am I suggesting we suspend all new research.) we could move through a lot of these things and regulate dosages and production standards and increase the useable, reliable pharmacopeia, as well as increasing our access to inexpensive, non-patented alternatives.

      Having not yet been exposed to empirical rigors does not discount the possibility of quantifiable usefulness, nor is it fair to assign, wholesale, the label of “quackery”.

    27. #27 Nahan Batalion
      December 24, 2009

      Good spouting of allopathic dogma disguised as being objective

    28. #28 rick
      February 29, 2012

      Are you people here just to criticize or get a solution to this problem. Because I tried to post two times on this blog with information that I feel that is important that should be investigated. The fact is AIDS is not a virus. AIDS is a condition that develops in those person who have used cocaine. The solvents in cocaine is the problem. This epidemic started when the cocaine cartels flooded the United States with cheap cocaine. Cocaine that is processed with solvents that are not intended for human consumption. In the first AIDS deaths in the United States they have a connection to those same solvents. Those deaths occurred in 1959. Those deaths have a commission to solvents. And the time that the cocaine cartels flooded his country would this illicit drugs have a connection to the AIDS epidemic. I only hope that you instead of trying to be right about the AIDS denialisumn, would look into this matter and see if you draw the same conclusion that I have drawn. Google(history of cocaine use in the United States), (illicit cocaine production) where you will find that they use these solvents,(and first AIDS deaths) you will find the connection.
      Rick

    29. #29 NJ
      February 29, 2012

      Posting bullshit 10 times on a 2+ year moribund thread won’t make it true…

      It just shows you’re a moron.