Docket: 2006D-0480; It's about time the FDA acted....

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Glocksman
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Docket: 2006D-0480; It's about time the FDA acted....

Post by Glocksman »

....against the purveyors of 'alternative' medicines and quack remedies such as Scalarwave and Penta water.

A friend of mine at work sent me this:
The natural food industry is hated by the drug companies and, by extension, their official support organization, the Food and Drug Administration, and now the FDA is attempting a "stealth" attack on the supplements industry in an effort to stamp out the drug companies competition once and for all.
A new FDA "guidance" document, published on the FDA's website, reveals plans to reclassify virtually all vitamins, supplements, herbs and even vegetable juices as FDA-regulated drugs. Massage oils and massage rocks will be classified as "medical devices" and require FDA approval. The document is called Docket No. 2006D-0480. Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. http://www.fda.gov/
It is essential that the public make its wishes known regarding this. The FDA is obligated by law to respect public comment, so the more people who sign on in opposition to this outrageous attack on our freedom, the more effect public reaction will have.
The FDA is open to public comment on this until April 30.
You can comment on the FDA's official site here.

From the limited research I did, it seemed to me that all of the claims about banning vitamins and fruit juices are so much bullshit put out by the quacks to frighten others into opposing the FDA's efforts to regulate them.
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Scottish Ninja
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Post by Scottish Ninja »

The only thing that can scare the quacks is the FDA, and so they put a lot of time and effort into trying to spook people about it. I'm in the situation where my own parents have been brainwashed into believing all this crap. It's gotten to the point where logic and facts have absolutely no effect on them; they just decry everything I say that's contrary to what their idol "Dr" Mercola says as drug company propaganda.

Interestingly, because I tend to disbelieve the claims put out by the "natural health" industry, as well as those made by rabid conspiracy theorists (I'm pretty sure my dad took every claim made in "Loose Change" at face value), my dad seems to now think that I'm the Bush fan in the house, while my parents seem to match the descriptions of religious right-wing fundies in everything but exact details of beliefs.
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Post by TheLemur »

The only thing that can scare the quacks is the FDA,
Why even bother with the FDA- why not just send in ordinary federal prosecutors on charges of libel and false advertising? It's not like it's hard to find blatant lies in many of these "natural medicines" ads. A simple chemical check shows that a lot of these quack products do not even contain the quack remedies they claim to contain.
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Post by Scottish Ninja »

I think that's the FDA's job. The quack response was to describe unverifiable and unquantifiable effects that their products have. It's easy to shrug off accusations of false advertising when there is no actual definition or quantifiable effects of "detoxification", as is often promoted.
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Post by Darth Wong »

Just glancing at this proposal, it looks like a purveyor of chicken noodle soup could be charged if he suggests that it's good for the common cold, unless he can meet the FDA's regulatory standards for pharmaceutical drug testing in order to make this claim.
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Post by TheLemur »

Just glancing at this proposal, it looks like a purveyor of chicken noodle soup could be charged if he suggests that it's good for the common cold, unless he can meet the FDA's regulatory standards for pharmaceutical drug testing in order to make this claim.
Notice if you change "chicken noodle soup" to "snake oil/Hoodia/megavitamins/"natural remedies"/homeopathy/insert-quack-medicine-here", this sounds entirely reasonable.
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Post by Darth Wong »

TheLemur wrote:
Just glancing at this proposal, it looks like a purveyor of chicken noodle soup could be charged if he suggests that it's good for the common cold, unless he can meet the FDA's regulatory standards for pharmaceutical drug testing in order to make this claim.
Notice if you change "chicken noodle soup" to "snake oil/Hoodia/megavitamins/"natural remedies"/homeopathy/insert-quack-medicine-here", this sounds entirely reasonable.
I was not aware that the wisdom of a law was decided by ignoring examples that make it look foolish.
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Nova Andromeda
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Post by Nova Andromeda »

Darth Wong wrote:Just glancing at this proposal, it looks like a purveyor of chicken noodle soup could be charged if he suggests that it's good for the common cold, unless he can meet the FDA's regulatory standards for pharmaceutical drug testing in order to make this claim.
-Why is that so unreasonable? Chicken noodle soup is only good for the common cold in so far as you need to eat. If they want to say that "chicken noodle soup" is "part of a healthy diet" which is good for the common cold that would be fine. However, suggesting soup is a cure for the common cold just reinforces social myths.
-However, the OP reads like they want to treat common items (like regular vitamins) just like drugs and medical devices and presumably require strigent testing even if those things make no real medically significant claims at all. In the case of supplements, herbs, etc. I'd love to see them restricted from saying they're good for x, y, or z disease, condition, etc. unless they actually do the scientific studies.
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Post by Molyneux »

Nova Andromeda wrote:
Darth Wong wrote:Just glancing at this proposal, it looks like a purveyor of chicken noodle soup could be charged if he suggests that it's good for the common cold, unless he can meet the FDA's regulatory standards for pharmaceutical drug testing in order to make this claim.
-Why is that so unreasonable? Chicken noodle soup is only good for the common cold in so far as you need to eat. If they want to say that "chicken noodle soup" is "part of a healthy diet" which is good for the common cold that would be fine. However, suggesting soup is a cure for the common cold just reinforces social myths.
-However, the OP reads like they want to treat common items (like regular vitamins) just like drugs and medical devices and presumably require strigent testing even if those things make no real medically significant claims at all. In the case of supplements, herbs, etc. I'd love to see them restricted from saying they're good for x, y, or z disease, condition, etc. unless they actually do the scientific studies.
Chicken soup is served hot and steaming. Steam is good for the nose, which directly helps alleviate the symptoms of the common cold.
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Post by Stile »

Nova Andromeda wrote:
Darth Wong wrote:Just glancing at this proposal, it looks like a purveyor of chicken noodle soup could be charged if he suggests that it's good for the common cold, unless he can meet the FDA's regulatory standards for pharmaceutical drug testing in order to make this claim.
-Why is that so unreasonable? Chicken noodle soup is only good for the common cold in so far as you need to eat. If they want to say that "chicken noodle soup" is "part of a healthy diet" which is good for the common cold that would be fine. However, suggesting soup is a cure for the common cold just reinforces social myths.
-However, the OP reads like they want to treat common items (like regular vitamins) just like drugs and medical devices and presumably require strigent testing even if those things make no real medically significant claims at all. In the case of supplements, herbs, etc. I'd love to see them restricted from saying they're good for x, y, or z disease, condition, etc. unless they actually do the scientific studies.
Chicken Soup Inhibits Neutrophil Chemotaxis In Vitro
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Post by Vendetta »

Darth Wong wrote:Just glancing at this proposal, it looks like a purveyor of chicken noodle soup could be charged if he suggests that it's good for the common cold, unless he can meet the FDA's regulatory standards for pharmaceutical drug testing in order to make this claim.
It should be pointed out that some scientific studies have shown that soup really is quite good for colds, beyond the fact that it's warm, easily digested, and quite nutritious (depending on ingredients). All things your body tends to need when you are unwell.
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Post by Nova Andromeda »

Stile wrote:
Nova Andromeda wrote:
Darth Wong wrote:Just glancing at this proposal, it looks like a purveyor of chicken noodle soup could be charged if he suggests that it's good for the common cold, unless he can meet the FDA's regulatory standards for pharmaceutical drug testing in order to make this claim.
-Why is that so unreasonable? Chicken noodle soup is only good for the common cold in so far as you need to eat. If they want to say that "chicken noodle soup" is "part of a healthy diet" which is good for the common cold that would be fine. However, suggesting soup is a cure for the common cold just reinforces social myths.
-However, the OP reads like they want to treat common items (like regular vitamins) just like drugs and medical devices and presumably require strigent testing even if those things make no real medically significant claims at all. In the case of supplements, herbs, etc. I'd love to see them restricted from saying they're good for x, y, or z disease, condition, etc. unless they actually do the scientific studies.
Chicken Soup Inhibits Neutrophil Chemotaxis In Vitro
-I didn't know that. However, a curosry read of abstract suggests that these effects are by not unique to chicken soup. "All of the vegetables present in the soup and the chicken individually had inhibitory activity, although only the chicken lacked cytotoxic activity." In addition, this sort of study is what we'd like to see before you make the claim that chicken soup is good for the common cold.
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Post by Darth Wong »

I don't think you understand. First, the existence of therapeutic benefit is in no way altered by the fact that those chemicals are not unique to chicken noodle soup. Second, a scientific study is not, despite what you may think, sufficient to placate the FDA. They require certain types of studies done in a certain way, along with shitloads of paperwork. The cost runs into the millions of dollars, and who's going to do that for something you can't patent?
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Post by Nova Andromeda »

Darth Wong wrote:I don't think you understand. First, the existence of therapeutic benefit is in no way altered by the fact that those chemicals are not unique to chicken noodle soup. Second, a scientific study is not, despite what you may think, sufficient to placate the FDA. They require certain types of studies done in a certain way, along with shitloads of paperwork. The cost runs into the millions of dollars, and who's going to do that for something you can't patent?
-On your second point, I already suggested that any plans by the FDA to treat common items like food and recommended vitamins the same way they treat the latest pharma drug would be over the top (although it isn't entirely clear that is the plan). Nevertheless, the FDA shouldn't ignore them or the claims made about them (especially the latest fad supplements and herbs). It is the Food and Drug Adm. after all. Which brings me to your first point, soup appears to have a therapeutic benefit that is obtained simply by eating a healthy diet and suggesting otherwise should not be allowed. Just to be clear, I don't think soup providers shouldn't point out the benefits of soup. Misleading advertising was just something minor I was thinking of at the time.
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