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LG Sciences said:
I have filed I believe 15-20 NDIs in the past 4 years or so. The FDA objections are absurd. There doesn't even seem to be a provision to allow them to do that.

Once I finish law school I will most certainly file suit inquiring about the legality of their objections however that will be a few years yet.
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We don't have to wait for you to finish law school lol, I'm sure plenty of companies have lawyers that do the same...
 
LG Sciences said:
I have filed I believe 15-20 NDIs in the past 4 years or so. The FDA objections are absurd. There doesn't even seem to be a provision to allow them to do that.

Once I finish law school I will most certainly file suit inquiring about the legality of their objections however that will be a few years yet.
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You may want to read your post 219 in this thread….

Why would you sue a fair process. Its only for the dumb that don't follow it….
 
USPlabsRep said:
You may want to read your post 219 in this thread….

Why would you sue a fair process. Its only for the dumb that don't follow it….
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I think that post was being sarcastic....not to many people call anything a wonder law...and mean it.
 
No, I was being serious. The law is very favorable. The FDA's interpretation of the law is absurd in my eyes.

No, it's not clear that they have the right to "object" since that is not at all addressed in the statute. There is no provision in the statute for an FDA "objection" not that their objection means anything. To me the objection circumvents congressional intent.
 
It isn't the "law" that would be challenged it is the objection. Congress was clear when they wrote DSHEA and the FDA is simply using an administrative power to usurp Congress. This can be addressed in the courts by a review process.
 
LG Sciences said:
No, I was being serious. The law is very favorable. The FDA's interpretation of the law is absurd in my eyes.

No, it's not clear that they have the right to "object" since that is not at all addressed in the statute. There is no provision in the statute for an FDA "objection" not that their objection means anything. To me the objection circumvents congressional intent.
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You have to submit an NDI that meets all of their requirements to their satisfaction.

If you fail to meet one or more of their requirements, they have the right to say 'hey, you didn't meet the requirements, try again later'

The fact that you'll try and claim some sort of loophole like 'the law doesn't explicitly say they can reject an NDI, even if my NDI is deficient it should therefore pass through' is just the sort of thing one would expect in the supplement industry.
 
Lots of lol's
 

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Let me explain the difference.

A notification "Mom, I am going to my friend's house"

an approval "Mom, can I go to my friends house?"

Of course what does the guy who had been in the industry 12 years and sued the FDA and is in law school know... lol
 
LG Sciences said:
Let me explain the difference.

A notification "Mom, I am going to my friend's house"

an approval "Mom, can I go to my friends house?"

Of course what does the guy who had been in the industry 12 years and sued the FDA and is in law school know... lol
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Not much apparently.

If mom tells you that you have to say which friend's house your going to, and when you're getting back, and you cry when you get in trouble for not providing the required information, that's your own fault not mom's.
 
They have not even issued NDI guidance yet thus it appears unreasonable to object arbitrarily. As I said the law is favorable and well drafted to do what it was intended to do, grow an industry and make the US the world leader in alternative health (aside from maybe Germany).
 
De__eB said:
Not much apparently.

If mom tells you that you have to say which friend's house your going to, and when you're getting back, and you cry when you get in trouble for not providing the required information, that's your own fault not mom's.
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To be fair, it would be mom's fault if mom failed to ask for those additional details in a relatively timely manner :P
 
LG Sciences said:
Please show me the required information?

The statute is clear it must be reasonably expected to be safe.
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(a) At least 75 days before introducing or delivering for introduction into interstate commerce a dietary supplement that contains a new dietary ingredient that has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered, the manufacturer or distributor of that supplement, or of the new dietary ingredient, shall submit to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, information including any citation to published articles that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. An original and two copies of this notification shall be submitted.

(b) The notification required by paragraph (a) of this section shall include:

(1) The name and complete address of the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient, or of the new dietary ingredient;

(2) The name of the new dietary ingredient that is the subject of the premarket notification, including the Latin binomial name (including the author) of any herb or other botanical;

(3) A description of the dietary supplement or dietary supplements that contain the new dietary ingredient including:

(i) The level of the new dietary ingredient in the dietary supplement; and

(ii) The conditions of use recommended or suggested in the labeling of the dietary supplement, or if no conditions of use are recommended or suggested in the labeling of the dietary supplement, the ordinary conditions of use of the supplement;

(4) The history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe, including any citation to published articles or other evidence that is the basis on which the distributor or manufacturer of the dietary supplement that contains the new dietary ingredient has concluded that the new dietary supplement will reasonably be expected to be safe. Any reference to published information offered in support of the notification shall be accompanied by reprints or photostatic copies of such references. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation; and

(5) The signature of the person designated by the manufacturer or distributor of the dietary supplement that contains a new dietary ingredient.
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People can pretend that history of consumption of whole plants is somehow evidence of safety of some constituent of that plant being consumed at thousands of times the dose that anyone has ever consumed naturally all they want, but that is just a blissfully ignorant attempt to avoid the obvious intent of the law.

Also, all of this only even applies if the product is actually a dietary supplement, most NDIs get rejected based on the fact that they do not even meet the definition of dietary supplement as set forth by the FDA.
 
The definition of "reasonable" is very open ended and debatable.

I think nitrates seem reasonably safe since we eat them all the time. I didn't look at the Thermolife filing however.
 
LG Sciences said:
The definition of "reasonable" is very open ended and debatable.

I think nitrates seem reasonably safe since we eat them all the time. I didn't look at the Thermolife filing however.
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"when used under the conditions recommended or suggested in the labeling of the dietary supplement"

Something being a dietary constituent of a meal is literally irrelevant to consuming something before exercise, or in higher doses, or in whatever context the label of your supplement recommends.
 
LG Sciences said:
The definition of "reasonable" is very open ended and debatable.

I think nitrates seem reasonably safe since we eat them all the time. I didn't look at the Thermolife filing however.
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What specific compounds have you submitted an NDI for that was rejected?

Keep in mind, I'm not telling you I think the law is perfect as is, I'm just telling you that regardless of your attempts to weasel your away around the law as is, that doesn't change the law.

The law defines a dietary supplement.
The law defines when a dietary supplement would be a new dietary ingredient.
The law defines what information you need to provide in order to market your new dietary ingredient.

To say the law isn't clear, or has been unfairly enforced is just bizarre, when all they've done is go by the enforcable statue they have in front of them.
 
I do tend to agree but in the case of something like nitrates I have to assume there are safety studies showing the effects of high levels of nitrates. I didn't look at the filing.

The reality is most everything is reasonably safe that we ingest. The statute was clear to not say risk/benefit or anything of that sort.

So, is smoking reasonably safe? Yes, people smoke for 40 years.

I happen to be a libertarian thus I believe that fully aware people should be able to take what they wish as long as it doesn't hurt others.
 
Any reason you are using words like "weasel" and others?

There is really no reason to turn a discussion like this into that kind of exchange.
 
I disagree with your position. That's not "all" that they do. They misuse the statute all the time and ignore valid data. It's absurd.
 
LG Sciences said:
I disagree with your position. That's not "all" that they do. They misuse the statute all the time and ignore valid data. It's absurd.
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Example? On an NDI that you submitted preferably.

Their standards certainly have room to change, but I don't think they ignore data so much as cast an overly narrow scope on contextual relevance of data in terms of demonstrating safety of an ingredient in the exact context of its use.
 
The acute oral LD50 for sodium nitrate is about 9.5g in humans. Now creatine is a lot bigger than sodium thus you'd probably need 12-15g to be dangerous at all.
 
That actually is a little close of you ask me. I don't know what the average dose for CN is though. Still clearly it is reasonably safe since no one is dropping dead (putting the cart before the horse I know)
 
LG Sciences said:
The acute oral LD50 for sodium nitrate is about 9.5g in humans. Now creatine is a lot bigger than sodium thus you'd probably need 12-15g to be dangerous at all.
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Being well below an LD50 doesn't mean that an acute dose is necessarily safe.

FWIW, I agree with you that nitrates are safe, I've used them personally for years.

Some people are susceptible to them though, Some people don't tolerate them well. In some rare cases, some people could have pretty major side effects technically.

Whether those people are responsible for what they put in their body or not is besides the point, most users are naive.

When a few dozen people get hepatitis, and a lot of them used a product with Aegeline, people blame the FDA as much as they blame the company regardless of the merits of who's to blame, or even if the supplement had anything to do with it.
 
LG Sciences said:
I do tend to agree but in the case of something like nitrates I have to assume there are safety studies showing the effects of high levels of nitrates. I didn't look at the filing.

The reality is most everything is reasonably safe that we ingest. The statute was clear to not say risk/benefit or anything of that sort.

So, is smoking reasonably safe? Yes, people smoke for 40 years.

I happen to be a libertarian thus I believe that fully aware people should be able to take what they wish as long as it doesn't hurt others.
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I wouldnt say smoking is reasonably safe; just because it can take a while to develop adverse effects doesnt make it any less toxic.

But anyway lol
 
No it doesn't mean it's necessarily safe at all. What it means is "reasonable" and that definition legally is a pretty low standard. It doesn't mean safe for everyone or unequivocally safe. It is reasonable to assume in the target audience that the product will be safe.

Thus the debate. However the FDA IMHO takes this standard out of context and asks for data that is unreasonable and often ignores data that is valid to establish safety.
 
LG Sciences said:
No it doesn't mean it's necessarily safe at all. What it means is "reasonable" and that definition legally is a pretty low standard. It doesn't mean safe for everyone or unequivocally safe. It is reasonable to assume in the target audience that the product will be safe.

Thus the debate. However the FDA IMHO takes this standard out of context and asks for data that is unreasonable and often ignores data that is valid to establish safety.
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This is true indeed, even coffee for some can be unsafe real quicly while others such as myself get sleepy from it. Where as synthetic caffeine which wakes me up, it all comes down to people responding differently according to all the factors surrounding. The FDA either way could care less if there is evidence of safety and efficiency, if it works good enough pharma will pick it up, other than that it aint "natural" so it has no place in supplements to their eyes.
 
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