FDA clamps down on quack medicine #2

[MRC_Hans]

Here is a list of some of the quack actions that have been stiffled by the FDA within the last couple of months...

Quack medicine, potassium iodine claimed to cure practically everything:

http://www.fda.gov/foi/warning_letters/g4088d.htm

Misbranding medication in hopes of selling it to more people:

http://www.fda.gov/foi/warning_letters/g4093d.htm

Homeopathic cure against smallpox:

http://www.fda.gov/foi/warning_letters/g3971d.htm

Homeopathic ear-drops:

http://www.fda.gov/foi/warning_letters/g3998d.htm

Here is something that cures all viral infections, including SARS:

http://www.fda.gov/foi/warning_letters/g3975d.htm

More snake-oil:

http://www.fda.gov/foi/warning_letters/g3976d.htm

And a christian company peddling a SARS cure:

http://www.fda.gov/foi/warning_letters/g3979d.htm

Yet another cure for SARS (why the panic with all these cures around? ) :

http://www.fda.gov/foi/warning_letters/g3980d.htm

Or, how about this one, "Beta Glucan has been proven effective even against Anthrax, a deadly biological threat, and against cancer, so imagine what it might do for colds, flu, and other immune system problems?" :

http://www.fda.gov/foi/warning_letters/g3981d.htm

SARS again (and most everything else):

http://www.fda.gov/foi/warning_letters/g3982d.htm

OMG, another SARS cure...:

http://www.fda.gov/foi/warning_letters/g3978d.htm

For a refreshing change, here is something that cures eye disease, including age deterioration (had I only known about this earlier ) :

http://www.fda.gov/foi/warning_letters/g4054d.htm

And "…The ‘anti-radiation pill’ for the unthinkable emergency... " :

http://www.fda.gov/foi/warning_letters/g4069d.htm

What basically happens in all these cases is that some peddler advertizes some wonder drug, and the FDA steps in and essentially requires them to prove their claims.

I know the FDA is not overly popular "over there" (and they certainly make MY life more complicated, hehe), but if you think you would NOT be flooded with "snake oil" without the FDA or something equivalent, you are mighty naive.

Hans

 

[MRC_Hans]

Hey, the big ones do it too, sometimes:

http://www.fda.gov/foi/warning_letters/g4059d.htm

Hoffmann-La Roche, misinforming about efficiacy and side-effects, indeed!

Hans

 

[Dr. Imago]

Great job, Hans.

But, with the DSHEA laws, there's only so much the FDA can do with well-crafted claims against dietary supplements. Often, the enforcement of quack claims falls under the FTC's purview, and then only if they are so outrageous and/or fail to meet the letter of the DSHEA law.

And, legitimate Pharma companies often violate the post-marketing regulations, supposedly regulated by DDMAC , with regards to advertising. There was a report recently (I think I read it in the Sunday NY Times) about the FDA failing to strictly enforce the law. The report showed that the number of warning letters to big Pharma was down substantially over previous years, while actual violations weren't necessarily.

 

[MRC_Hans]

One reason the number of warning letters to big companies is down is that the FDA has had its ressources limited, while at the same time having to deal with many new companies and regulations. They have therefore adopted a strategy of "most likely targets", such that companies that have relatively few deviations are not visited as often as before. Also, big companies are no doubt better at keeping a deviation from resulting in a warning letter. This, however, does not neccessarily mean that they get off easy; it often just means that they fix the problem before they get the (much dreaded) public exposure in a warning letter.

Hans