denialism blog

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.

Posted by: blf | March 24, 2008 4:34 PM

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).

Posted by: blf | March 24, 2008 5:34 PM

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

post moar, IMO

Posted by: genewitch | March 25, 2008 3:36 PM

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.

Posted by: Abel Pharmboy | April 7, 2008 8:08 PM

"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

Posted by: BeBe | June 13, 2008 11:35 AM

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

Posted by: Marshall | July 11, 2008 12:09 PM