FDA clamps down on Quack medicine producer.

[MRC_Hans]

The FDA has issued a warning letter to a producer of quack medicine after finding unsubstantiated claims on labelling.


Full text of waning letter here: http://www.fda.gov/foi/warning_letters/g3819d.htm

Promotional material accompanying your products is labeling, as defined in Section 201(m) of the Act, and includes the Ultimate Health booklet and the MPDirect catalog.

These materials include the following, and other, therapeutic claims:

1. "Ultimate Health", Copvrinht 2001 Media Power, Inc.

CalMax sections of the booklet:

"What Results Can I Expect with CalMax?. . . . People suffering from symptoms associated with chronic illnesses such as arthritis, fibromyalgia, low back pain, insomnia or fatigue, have reported noticeable results within the first 3-4 weeks of using CalMax consistently . . . ."
The booklet also suggests that CalMax is useful in treating or preventing migraines, anxiety, depression, chronic fatigue syndrome, hypertension, hypoglycemia, and obesity.

*snip*

These claims cause your CalMax, Bl-Bomber and Nu-Zymes products to be drugs as defined in Section 201(g)(1)(B) of the Act. Because we are unaware of any evidence that these products are generally recognized as safe and effective when used as labeled, they are also new drugs as defined under Section 201(p) of the Act. Under Section 505 of the Act, a new drug may not be legally marketed in the United States without an approved New Drug Application.

These products are further misbranded under Section 502(f)(1) of the Act in that they fail to bear adequate directions for use.



Way to go :D

Hans

It's about time! It would be cool if you posted this in banter as well!

[Plutarck]

Well, I guess the FDA is good for something...I guess ;)

[shanek]

Originally posted by Plutarck
Well, I guess the FDA is good for something...I guess ;)

Sure; protecting people against fraud is one of the legitimate functions of government. As long as they follow due process, I don't have a problem.

[Plutarck]

Originally posted by shanek


Sure; protecting people against fraud is one of the legitimate functions of government. As long as they follow due process, I don't have a problem.

True; I was a bit hesitant in the fact that such actions can instill false confidence. If they don't do this sort of thing reliably and thoroughly then they can end up making people even more susceptible to fraud. It's a paradox, really.

Just wanted to still haultingly give credit when they at least seem to be doing something right :)

[shanek]

Originally posted by Plutarck
True; I was a bit hesitant in the fact that such actions can instill false confidence. If they don't do this sort of thing reliably and thoroughly then they can end up making people even more susceptible to fraud.

That's a good point. They should do this as a matter of course. In fact, it's probably one of the few legitimate functions of the FDA.

[MRC_Hans]

Mmm, another version of this thread is running in Banter. I thought I might repeat my latest post there:

I am aware that the FDA is not so popular, "over there", but I really don't think you give them enough credit. I have worked in the medical industry for more than a decade, and I can tell you that the FDA is highly instrumental in securing the quality of medical and consumable products, not just in the USA, but indirectly all over the world.

It might be desirable if they went into the quack branch more, and I'm sure they would, if they were given the ressources.

Hans

Originally posted by MRC_Hans

It might be desirable if they went into the quack branch more, and I'm sure they would, if they were given the ressources.

Hans

They are prevented from doing so by two regulations: 1) The entire homeopathic pharmacopoeia was "grandfathered" long ago due to the influence of a senator who was a homeopath.* 2) DSHEA was passed some years ago that permits almost anything to be palmed off as a "dietary supplement" rather than a "drug." So long as they fly under the radar by wording their claims so that they don't look like claims, they escape FDA scrutiny.

Cheers,



*if I had said "homeopathic senator" people might have thought I meant he was diluted rather than deluded.**

** boy, I crack myself up.

[shanek]

Originally posted by MRC_Hans
It might be desirable if they went into the quack branch more, and I'm sure they would, if they were given the ressources.

This goes back to what I was saying in the other FDA thread last year (which no one seemed to get): Since they're a political organization, and they have to do as Congress instructs, they spend most of their time restricting legitimate pharmaceutical companies and driving up the cost of legitimate pharmaceuticals and very little time actually protecting us from quack medicines and claims. This track record would never be tolerated in the free market.

[MRC_Hans]

Since they're a political organization, and they have to do as Congress instructs, they spend most of their time restricting legitimate pharmaceutical companies and driving up the cost of legitimate pharmaceuticals and very little time actually protecting us from quack medicines and claims. This track record would never be tolerated in the free market.

No, and this shows that a free market is not the best solution for pharmaceuticals (I'm not hereby implying that the present solution is the best, only that it is better).

If there were no govt bodies like the FDA, you would have no guarantee when you bought a drug: Any claims of efficiacy or contents would be worth only the paper they were printed on. Anybody could market a drug and claim it contained any substance and was efficient against any disease. But sure, prices might be lower :rolleyes:

Hans

[shanek]

Originally posted by MRC_Hans
If there were no govt bodies like the FDA, you would have no guarantee when you bought a drug: Any claims of efficiacy or contents would be worth only the paper they were printed on. Anybody could market a drug and claim it contained any substance and was efficient against any disease. But sure, prices might be lower :rolleyes:

Let's reword this slightly:

If there were no govt bodies like the Underwriters Laboratories (UL), you would have no guarantee when you bought a home appliance: Any claims of safety would be worth only the paper they were printed on. Anybody could market an electrical device and claim it was perfectly safe. But sure, prices might be lower :rolleyes:

Only one hitch: The UL is not a government body. It's completely private. And yet, almost every piece of electronic equipment in your home bears the UL label. Go ahead and check. There's no mandate, no regulation forcing them to do this. The manufacturers want to be sure they're marketing a safe product. And the UL has every incentive to verify the safety of the appliances they test and approve, since they're underwriting the device. It's a system that has worked for over 100 years.

Your claim is nothing more than bald assertion, with no real facts to back it up.

[MRC_Hans]

Why do you think it maked a fundamental differnece whether if a certifing body is owned by the government or privately? If there was no governmet FDA, there might (hopefully) be a private one, like UL. How big would the difference be? The FDA is there to do a job that needs done. We can discuss how well they do the job, but nevertheless, the job needs to be done.


Hans

[shanek]

Originally posted by MRC_Hans
Why do you think it maked a fundamental differnece whether if a certifing body is owned by the government or privately? If there was no governmet FDA, there might (hopefully) be a private one, like UL.

I would support the formation of one as a replacement for the FDA, or privatizing the FDA. I'd also support leaving portions of the FDA, like the one that started this thread—the prodecution of those who make fraudulent claims or actually cause damage to others— as part of the justice system.

How big would the difference be?

Well, if there's not a big difference, then we'd be no worse off than we are now. But judging by how the private sector deals with similar issues, it's clear to me that we wouldn't have anywhere near the level of politics that has resulted in honest, responsible pharmaceutical companies spending billions of dollars every year complying with government regulations while the frauds and quacks basically get a free ride.

The FDA is there to do a job that needs done. We can discuss how well they do the job, but nevertheless, the job needs to be done.

I agree with that; I just don't see why it has to be done by the government.

[MRC_Hans]

Originally posted by shanek
*snip*

But judging by how the private sector deals with similar issues, it's clear to me that we wouldn't have anywhere near the level of politics that has resulted in honest, responsible pharmaceutical companies spending billions of dollars every year complying with government regulations while the frauds and quacks basically get a free ride.

Which of the regulations for the pharmaceutical industry do you find unreasonable? What makes you think a private body could do with less regulation (and get similar results)? Isnt the problem with the quacks that they are not held to those regulations?

I agree with that; I just don't see why it has to be done by the government.

Basically because a government institution can be made reasonably indepentent. Would you like the Supreme Court privatized? If no, then why not?

Hans

[shanek]

Originally posted by MRC_Hans
Which of the regulations for the pharmaceutical industry do you find unreasonable?

It's not so much that the regulations themselves are unreasonable, it's that the government has no incentive to make the system as efficient as possible, so the pharmaceutical companies have to spend millions if not billions more dollars getting their products to market, over a longer period of time. That hurts both the pharmaceutical companies and us. Robert Goldberg of Brandeis University has concluded that over 200,000 people have died waiting for the FDA to approve medicine that most likely would have saved their lives. This is far more lives than they can claim to have saved.

What makes you think a private body could do with less regulation (and get similar results)?

By examining the track record of private bodies in other areas responsible for safety and efficacy testing.

Isnt the problem with the quacks that they are not held to those regulations?

The problem is that, since it's in the hands of government, the regulation is arbitrary. I don't know of one single area of government regulation where that isn't the case.

Basically because a government institution can be made reasonably indepentent.

I'm fighting the urge to roll on the floor laughing. Name one government body that is in any way "independent." (It sure as heck isn't the FDA!)

Would you like the Supreme Court privatized? If no, then why not?

No, because their job is to examine and rule on laws passed by Congress. They're a vital part of the checks and balances. You're comparing apples and Studebakers.

[Houngan]

I have emailed Gail Costello, author of the warning (gcostell@ora.fda.gov) the following. You may or may not choose to do the same.

[b]Ms. Costello,

I would like to thank you for your recent action of declaring Media Power's product "CalMax" a drug subject to regulation due to their claims. (Warning Letter NWE-09-03W) As a concerned citizen and someone who closely follows false or questionable healthcare claims, it is refreshing to see this type of dangerous fraud being handled by the proper authorities. You can be sure that you have the support of many others in this action, and I hope that the FDA will zealously pursue a critical examination of homeopathic and naturopathic "medicines" that glut the market and deceive American consumers.

Sincerely,

Matt Griffin