Sodium Ursolic Acetate topical spray

[bigdavid]

Did you know they can take a completely natural component of Red Yeast Rice (used for countless centuries), copy a compound contained in it, patent it, then force RYR off the market due to it being a "drug"?

when there is a will, there is an fda

 

[mattrag]

as with all the sprays we suggest you try to cover as much skin as you can once a day. 50 sprays usually is the average

we dont want to disclose how much of the active is in each mg right now, but its in the same ballpark as the amount of actives per mL in our other sprays

Thanks!

 

[mattrag]

Did you know they can take a completely natural component of Red Yeast Rice (used for countless centuries), copy a compound contained in it, patent it, then force RYR off the market due to it being a "drug"?

Yea... the FDA is a dirty bunch of angry fatties....

 

[Patrick Arnold]

did you know they can make a probiotic supplement (a naturally occuring bacteria) into a drug? Regulation like this may happen sooner than we think :/ but was said in jest, of course.

so?

 

[bigdavid]

so?

So, so what?

 

[Patrick Arnold]

Yea... the FDA is a dirty bunch of angry fatties....

i know u are making a joke but

i bet the FDA is full of all kinds of people with all kinds of opinions. I bet there are many there that would like to see supplement freedom. Certain policies become important for all sorts of reasons and then enforcement happens. At that point the personal opinions of the employees is irrelevant

Its so much more complicated than there just being an evil entity that is full of enemies. Sometimes people act like government employees are people from another planet

 

[Patrick Arnold]

So, so what?

i can see situations where a bacteria can become a drug. the technology has to be unobvious in the first place so that the drug company can file a patent.

At that point the company probably has two choices. Sell as a supplement or get it approved as a drug and sell as a drug. Being their patented invention its up to them. If I were them and could afford to get it approved as a drug that would make me hundreds of millions then you betcha i would go that route

So, I said so because I didnt think it was such an unusual thing. When you think about it......

 

[bigdavid]

i know u are making a joke but

i bet the FDA is full of all kinds of people with all kinds of opinions. I bet there are many there that would like to see supplement freedom. Certain policies become important for all sorts of reasons and then enforcement happens. At that point the personal opinions of the employees is irrelevant

Its so much more complicated than there just being an evil entity that is full of enemies. Sometimes people act like government employees are people from another planet

That is true of every company/organization. I am sure they are all filled with some great people with great intentions. But, do you agree with the policy that bans safe substances when used properly just because they were not derived from a natural source? Shouldn't the debate be over the compound itself, and not how it was derived?

 

[bigdavid]

i can see situations where a bacteria can become a drug. the technology has to be unobvious in the first place so that the drug company can file a patent.

At that point the company probably has two choices. Sell as a supplement or get it approved as a drug and sell as a drug. Being their patented invention its up to them. If I were them and could afford to get it approved as a drug that would make me hundreds of millions then you betcha i would go that route

So, I said so because I didnt think it was such an unusual thing. When you think about it......

I work in a lab that does a lot of research on probiotics. I am sure you come across some of the same obstacles we do. When writing grant proposals and wording our studies, we have to be very careful not to make it sound like we are treating an illness or curing a disease, even though some of these probiotics have the capacity to help a lot of GI disorders. If we were to word a study in a manner to treat something as simple as diarrhea, the fda would come down on us and make us do the study as if we were testing out a drug. Even though the probiotics are sold OTC and are readily available to potentially help a lot of people at a relatively cheap cost.

 

[Patrick Arnold]

That is true of every company/organization. I am sure they are all filled with some great people with great intentions. But, do you agree with the policy that bans safe substances when used properly just because they were not derived from a natural source? Shouldn't the debate be over the compound itself, and not how it was derived?

policy is made by lawmakers not agencies like the FDA. Also, priorities at an agency like the FDA are often influenced by outside forces like lobbyists, politicians, interest groups, private industry with big bux etc.

Of course the possibility for personal bias within the FDA certainly exists, the possibility for positive bias also does. So my point was to just point to the FDA and saying "its all their fault!" is really missing the big picture

 

[Patrick Arnold]

I work in a lab that does a lot of research on probiotics. I am sure you come across some of the same obstacles we do. When writing grant proposals and wording our studies, we have to be very careful not to make it sound like we are treating an illness or curing a disease, even though some of these probiotics have the capacity to help a lot of GI disorders. If we were to word a study in a manner to treat something as simple as diarrhea, the fda would come down on us and make us do the study as if we were testing out a drug. Even though the probiotics are sold OTC and are readily available to potentially help a lot of people at a relatively cheap cost.

And the company that decides to go through the drug approval process for one of these probiotics can earn the right to sell it as a drug for one of those disease applications

If the technology of manufacturing the product is not novel though i think its a dumb move to do that though. Cuz others can still sell it as a supplement. Granted, only the drug company can market it for the particular disease application but people arent dumb. They will soon figure out that they can save a ton of money by just buying the stuff at the health food store

The FDA should not have the right to block sale of the probiotic natural supplement so long as none of the drug claims are being made by the manufacturer

correct me if i am wrong

 

[mattrag]

i know u are making a joke but

i bet the FDA is full of all kinds of people with all kinds of opinions. I bet there are many there that would like to see supplement freedom. Certain policies become important for all sorts of reasons and then enforcement happens. At that point the personal opinions of the employees is irrelevant

Its so much more complicated than there just being an evil entity that is full of enemies. Sometimes people act like government employees are people from another planet

Yea, I am sure that there are a lot of good, quality scientist in the FDA who generally want to help people. Just the government, liability, politics make it almost impossible. And even then look at the all the government agencies out there to help us like the heart association, diabetes association, hell all the health organizations out there supposedly to help us yet make claims that may not be in our best interest.

Sadly the world isn't black and white. And we as individuals just have to be either smart enough to know how to care for ourselves, or just go with what we are spoon fed and accept whatever consequences come with it.

 

[Patrick Arnold]

And even then look at the all the government agencies out there to help us like the heart association, diabetes association, hell all the health organizations out there supposedly to help us yet make claims that may not be in our best interest.
.

U sure those are government agencies?????

 

[bigdavid]

policy is made by lawmakers not agencies like the FDA. Also, priorities at an agency like the FDA are often influenced by outside forces like lobbyists, politicians, interest groups, private industry with big bux etc.

Of course the possibility for personal bias within the FDA certainly exists, the possibility for positive bias also does. So my point was to just point to the FDA and saying "its all their fault!" is really missing the big picture

I agree it is more complicated than just pointing the finger at one entity. It is just a shame that our government feels the need to ban relatively safe substances, like ephedrine, that have the ability to help a lot of people with obesity when used in moderate/safe doses. Yet, at the same time lobbyists succeed at keeping cigarettes legal, contributing not only to decreased quality of life, but also spiking up medical costs for the whole country for the medical treatments that result when cancer and other complications are diagnosed.

And the company that decides to go through the drug approval process for one of these probiotics can earn the right to sell it as a drug for one of those disease applications

If the technology of manufacturing the product is not novel though i think its a dumb move to do that though. Cuz others can still sell it as a supplement. Granted, only the drug company can market it for the particular disease application but people arent dumb. They will soon figure out that they can save a ton of money by just buying the stuff at the health food store

The FDA should not have the right to block sale of the probiotic natural supplement so long as none of the drug claims are being made by the manufacturer

correct me if i am wrong

Well you are looking at it from a companies point of view, which makes sense since that is your life. But, I work in a university research laboratory so our main goal isn't really profit or finding new ways to create a drug to patent. What I was getting at was that we can't actually do the studies that we want to, because if were to say "we would like to see if this probiotic has the potential to decrease diarrheal disease in infants" the fda would say "no, no, no, you can't do that. If you want to say that and test that you have to go through the drug testing process. This of course involves multiple clinical trials which will take ten + years and then has to be prescribed by a physician. We are in a nutritional science department so our goal is to test dietary components and how they affect immunity and GI disorders. We don't have the goal of testing a drug, just find dietary supplements that can help people. Thus, we have to beat around the bush in order to test what we want to test and say that we are doing it for another reason. We basically have to say "we aren't testing to see if this will improve outcomes for this disease, we are doing this to see how it affects sick days or this blood protein." And after we show that it could be used to treat this disorder/disease based on what we tested, we can't claim that about the supplement because that is something only a "drug" is capable of doing. So that is my rant about the fda's semantics.

 

[mattrag]

U sure those are government agencies?????

Heheh, I'm lying. I think

 

[Patrick Arnold]

I agree it is more complicated than just pointing the finger at one entity. It is just a shame that our government feels the need to ban relatively safe substances, like ephedrine, that have the ability to help a lot of people with obesity when used in moderate/safe doses. Yet, at the same time lobbyists succeed at keeping cigarettes legal, contributing not only to decreased quality of life, but also spiking up medical costs for the whole country for the medical treatments that result when cancer and other complications are diagnosed.




Well you are looking at it from a companies point of view, which makes sense since that is your life. But, I work in a university research laboratory so our main goal isn't really profit or finding new ways to create a drug to patent. What I was getting at was that we can't actually do the studies that we want to, because if were to say "we would like to see if this probiotic has the potential to decrease diarrheal disease in infants" the fda would say "no, no, no, you can't do that. If you want to say that and test that you have to go through the drug testing process. This of course involves multiple clinical trials which will take ten + years and then has to be prescribed by a physician. We are in a nutritional science department so our goal is to test dietary components and how they affect immunity and GI disorders. We don't have the goal of testing a drug, just find dietary supplements that can help people. Thus, we have to beat around the bush in order to test what we want to test and say that we are doing it for another reason. We basically have to say "we aren't testing to see if this will improve outcomes for this disease, we are doing this to see how it affects sick days or this blood protein." And after we show that it could be used to treat this disorder/disease based on what we tested, we can't claim that about the supplement because that is something only a "drug" is capable of doing. So that is my rant about the fda's semantics.

If you got private funding for one of these projects you wouldnt have that problem though right?

 

[EasyEJL]

That is true of every company/organization. I am sure they are all filled with some great people with great intentions. But, do you agree with the policy that bans safe substances when used properly just because they were not derived from a natural source? Shouldn't the debate be over the compound itself, and not how it was derived?

if they aren't natural, and haven't had safety tests, how exactly can you call them "safe substances when used properly" ? How can you say what "used properly" even is withot clinical data?

 

[Patrick Arnold]

if they aren't natural, and haven't had safety tests, how exactly can you call them "safe substances when used properly" ? How can you say what "used properly" even is withot clinical data?

i think he is referring to naturally occuring compounds that happened to be made by sythetic methods. The law considers the compounds legal if they come from the plant but if the identical compound was made by chemical means it suddenly is not legal.

this really is an issue above and beyond safety

 

[dsade]

if they aren't natural, and haven't had safety tests, how exactly can you call them "safe substances when used properly" ? How can you say what "used properly" even is withot clinical data?

Caveat Emptor.

 

[dsade]

i think he is referring to naturally occuring compounds that happened to be made by sythetic methods. The law considers the compounds legal if they come from the plant but if the identical compound was made by chemical means it suddenly is not legal.

this really is an issue above and beyond safety

So the Vitamin C tablets that I buy are actually extracted from Oranges? Or, perhaps, they make an arbitrary exception for no logical reason?

 

[mattrag]

So the Vitamin C tablets that I buy are actually extracted from Oranges? Or, perhaps, they make an arbitrary exception for no logical reason?

Orange Juice is not real either... well not the stuff in the stores anyway, anymore.....

 

[dsade]

Orange Juice is not real either... well not the stuff in the stores anyway, anymore.....

It goes nicely with some Pink Slime Sausage and vegan egg substitute.

 

[mattrag]

It goes nicely with some Pink Slime Sausage and vegan egg substitute.

indeed... the world we live in has definitely changed quite a bit.

 

[dsade]

indeed... the world we live in has definitely changed quite a bit.

"This is not a world of men, Machine" ~ Ricky Roma

 

[EasyEJL]

i think he is referring to naturally occuring compounds that happened to be made by sythetic methods. The law considers the compounds legal if they come from the plant but if the identical compound was made by chemical means it suddenly is not legal.

this really is an issue above and beyond safety

sure, if thats what he meant, then I agree, his wording led me to think differently but it might just be me.

Even so though, taking (ugh) DMAA as an example. lets just say we agree it comes from geranium for the sake of the argument. How many pounds of geranium leaves would it take eating to get 40mg of DMAA? I'd have to guess its multiple pounds. So although it may be considered a "safe" supplement as its part of the food chain, the dosages are dosages that are probably physically impossible to get from the food chain, so safety is still a valid question.

 

[EasyEJL]

Caveat Emptor.

oh sure, you should have the right to eat what you want to or use what you want to, its actually your body. but our legal system isn't set up to be supportive of that.

 

[mattrag]

oh sure, you should have the right to eat what you want to or use what you want to, its actually your body. but our legal system isn't set up to be supportive of that.

sad but true....

 

[Patrick Arnold]

So the Vitamin C tablets that I buy are actually extracted from Oranges? Or, perhaps, they make an arbitrary exception for no logical reason?

they seem to be saying this applies to actives from botanicals (aka herbs). not to vitamins or amino acids etc

 

[dsade]

they seem to be saying this applies to actives from botanicals (aka herbs). not to vitamins or amino acids etc

That was my point about arbitrary exceptions with no logical reasons...

Now back to the product...what will this do to penile tissue? Do we have a new candidate for HUNG?

 

[Patrick Arnold]

That was my point about arbitrary exceptions with no logical reasons...

Now back to the product...what will this do to penile tissue? Do we have a new candidate for HUNG?

what is with your obsession with penis

 

[dsade]

what is with your obsession with penis

No need to be vulgar...this is a family board.

Perhaps I am just curious about the scientific data
Enough has been theorized to make this an interested experiment
Nevertheless, I appreciate the humor in your post, however
It is quite juvenile.
Someday, maybe you will grow up.

 

[Patrick Arnold]

No need to be vulgar...this is a family board.

Perhaps I am just curious about the scientific data
Enough has been theorized to make this an interested experiment
Nevertheless, I appreciate the humor in your post, however
It is quite juvenile.
Someday, maybe you will grow up.

there is data on ursolic acid and penis?

 

[bigdavid]

sure, if thats what he meant, then I agree, his wording led me to think differently but it might just be me.

Even so though, taking (ugh) DMAA as an example. lets just say we agree it comes from geranium for the sake of the argument. How many pounds of geranium leaves would it take eating to get 40mg of DMAA? I'd have to guess its multiple pounds. So although it may be considered a "safe" supplement as its part of the food chain, the dosages are dosages that are probably physically impossible to get from the food chain, so safety is still a valid question.

When I say safe, I am referring to substances that have gone through many studies showing their safety. DMAA is obviously an example. The fda says it would be ok if it came from a natural source, but since it is synthetically derived it is now going to be banned regardless of the countless amount of data showing it's safety when used at a moderate dose.

And as PA said, I made that post to discuss the issue of the compound itself. I think the issue should be the compound, and not if it was derived through natural means or synthetically. If it is a natural compound derived synthetically, it is the exact same compound, and that is not really about safety at that point.

 

[dsade]

there is data on ursolic acid and penis?

Plenty of data. Wait, you mean together?

 

[bigdavid]

If you got private funding for one of these projects you wouldnt have that problem though right?

We routinely get private funding from food companies hoping to either use these supplements in their food products or find new marketing points for their already existing products. This doesn't change the laws regarding food claims or claims made about supplements that we test. No matter what we cannot make those claims because a supplement cannot treat a disease, only a drug can. Obviously the companies that fund us privately do not want us to test drugs, because that gets rid of the point of us doing the study. If it becomes a drug they can't sell it anymore.

 

[EasyEJL]

When I say safe, I am referring to substances that have gone through many studies showing their safety. DMAA is obviously an example. The fda says it would be ok if it came from a natural source, but since it is synthetically derived it is now going to be banned regardless of the countless amount of data showing it's safety when used at a moderate dose.

And as PA said, I made that post to discuss the issue of the compound itself. I think the issue should be the compound, and not if it was derived through natural means or synthetically. If it is a natural compound derived synthetically, it is the exact same compound, and that is not really about safety at that point.

I agree on the latter part for sure. But again, where is this "countless amount of data showing its safety" ? there are 2 or 3 studies sponsored by USP without a statistically significant number of people in the studies, and the metrics tested are very minimal. I have not seen any significant human in vivo safety studies on DMAA. I could have just missed them, but I don't particularly think there is a lot out there. Most botanicals are considered safe because they are part of normal food chain items even if the dosing is higher, but then again there is a safe dose of hemlock too.

 

[bigdavid]

I agree on the latter part for sure. But again, where is this "countless amount of data showing its safety" ? there are 2 or 3 studies sponsored by USP without a statistically significant number of people in the studies, and the metrics tested are very minimal. I have not seen any significant human in vivo safety studies on DMAA. I could have just missed them, but I don't particularly think there is a lot out there. Most botanicals are considered safe because they are part of normal food chain items even if the dosing is higher, but then again there is a safe dose of hemlock too.

The problem is a natural product does not make it necessarily safer than synthetic. We could feed you a synthetically derived chemical that has no natural origin that will have no ill effects on you and we can feed you a naturally occurring poison and you will die. THe idea that natural is safer than synthetic is rather ridiculous. Of course, we can reverse that example as well. What I am getting at is the safety of a compound (doesn't have to be DMAA, can be anything really), does not depend on the way it was derived, it depends on the compound itself. If anything I would say a synthetically derived version of a compound is safer than its natural counterpart, because we are guaranteed a more pure product.


And that is why DMAA is being banned, not because of safety, but because of how it is derived.

 

[Patrick Arnold]

We routinely get private funding from food companies hoping to either use these supplements in their food products or find new marketing points for their already existing products. This doesn't change the laws regarding food claims or claims made about supplements that we test. No matter what we cannot make those claims because a supplement cannot treat a disease, only a drug can. Obviously the companies that fund us privately do not want us to test drugs, because that gets rid of the point of us doing the study. If it becomes a drug they can't sell it anymore.

why would you be making claims? u are simply a university researcher. why cant you test a supplement for anything you want? there are a million studies out there on natural ingredients and disease. the problem comes when you market the product, not the research part

you were telling me that the FDA says you cannot even research a nutraceutical for a disease application? thats baloney

i am missing something here

 

[Patrick Arnold]

I agree on the latter part for sure. But again, where is this "countless amount of data showing its safety" ? there are 2 or 3 studies sponsored by USP without a statistically significant number of people in the studies, and the metrics tested are very minimal. I have not seen any significant human in vivo safety studies on DMAA. I could have just missed them, but I don't particularly think there is a lot out there. Most botanicals are considered safe because they are part of normal food chain items even if the dosing is higher, but then again there is a safe dose of hemlock too.

remember that in DSHEA it states that the FDA needs to show a reasonable cause for safety concern to remove a supplement from the market (for the specific reason that they believe it is unsafe). The FDA has zero clinical studies showing the stuff is unsafe. The USP studies may not be perfect but its greater than zero

What the FDA is basing their belief of safety concerns upon would be ridiculous to an objective scientist

 

[bigdavid]

why would you be making claims? u are simply a university researcher. why cant you test a supplement for anything you want? there are a million studies out there on natural ingredients and disease. the problem comes when you market the product, not the research part

you were telling me that the FDA says you cannot even research a nutraceutical for a disease application? thats baloney

i am missing something here

If we were to tell the IRB review board that has to approve our study that we are seeing if x can treat y disease they would be up our ass and make us use the probiotic (which, remember, is what we test in a lot of our studies and what I am specifically referring to in these examples) and test it as a drug, since only drugs can treat disease outcomes. We have to instead say that we are testing how it does something else, like "reduces sick days" not how it "can possibly be used to help this specific disease". We literally cannot say that it can help a specific disease, that would not be allowed. There ARE ways to beat around the bush and still study what we want, we just can't make the appropriate health claims when it is all over because of the health claim regulations they have in place.

 

[Patrick Arnold]

And that is why DMAA is being banned, not because of safety, but because of how it is derived.

please read the letter that was sent out again

 

[bigdavid]

please read the letter that was sent out again

Is this incorrect? Oh are you referring to it "increasing someone's heart rate"?

 

[Patrick Arnold]

If we were to tell the IRB review board that has to approve our study that we are seeing if x can treat y disease they would be up our ass and make us use the probiotic (which, remember, is what we test in a lot of our studies and what I am specifically referring to in these examples) and test it as a drug, since only drugs can treat disease outcomes. We have to instead say that we are testing how it does something else, like "reduces sick days" not how it "can possibly be used to help this specific disease". We literally cannot say that it can help a specific disease, that would not be allowed. There ARE ways to beat around the bush and still study what we want, we just can't make the appropriate health claims when it is all over because of the health claim regulations they have in place.

Clarify something for me. Are you talking about testing specific supplement products or individual ingredients? That would make a big difference

 

[Patrick Arnold]

Is this incorrect? Oh are you referring to it "increasing someone's heart rate"?

they talk about much more than just it being synthetically derived. thats just a part of what they talk about

 

[EasyEJL]

remember that in DSHEA it states that the FDA needs to show a reasonable cause for safety concern to remove a supplement from the market (for the specific reason that they believe it is unsafe). The FDA has zero clinical studies showing the stuff is unsafe. The USP studies may not be perfect but its greater than zero

What the FDA is basing their belief of safety concerns upon would be ridiculous to an objective scientist

Oh I know, more just that bigdavid mentioned safety data, and I haven't seen much on it. Not that it should need it according to the DSHEA if it is a constituent of geraniums. but that if is a big one too. Damn FDA anyhow.

 

[bigdavid]

Clarify something for me. Are you talking about testing specific supplement products or individual ingredients? That would make a big difference

Well the studies we do are generally done both ways. Either as a product with many ingredients (like a grain with multiple health components/phytochemicals) or specific pure product (like a specific oligosaccharide or a pure probiotic). Either way health claims and testing to treat a disease is the same.

 

[bigdavid]

they talk about much more than just it being synthetically derived. thats just a part of what they talk about

I was more referring to if DMAA was produced from a natural source, this would not even be an issue right now. If it was derived from a natural source, wouldn't it still be allowed to be used in supplements?

 

[EasyEJL]

I was more referring to if DMAA was produced from a natural source, this would not even be an issue right now. If it was derived from a natural source, wouldn't it still be allowed to be used in supplements?

There wasn't an NDI filed, that is really the largest issue currently, but the FDA is reserving the right to do more

The Federal Food, Drug, and Cosmetic Act (the act) requires that
manufacturers and distributors who wish to market dietary supplements that
contain "new dietary ingredients" notify the Food and Drug Administration about
these ingredients. (See Section 413b of the act (21 U.S.C. 350b).) Generally,
the notification must include information that is the basis on which
manufacturers/distributors have concluded that a dietary supplement containing a
new dietary ingredient will reasonably be expected to be safe under the
conditions of use recommended or suggested in the labeling.

Overall the FDA is hoping that everyone will just drop using it so they don't have to figure the rest out.

 

[bigdavid]

There wasn't an NDI filed, that is really the largest issue currently, but the FDA is reserving the right to do more



Overall the FDA is hoping that everyone will just drop using it so they don't have to figure the rest out.

And the issue here circulates around the quote "new dietary ingredient". If it is present in our food supply how is it something new that requires their notification?

 

[EasyEJL]

And the issue here circulates around the quote "new dietary ingredient". If it is present in our food supply how is it something new that requires their notification?

When to Notify FDA and What is a New Dietary Ingredient
What is a "new
dietary ingredient?"
The term "new dietary ingredient" means a dietary ingredient that was not
marketed in the United States in a dietary supplement before October 15, 1994.

there was a lot of debate over this rule when it was created