Supplements send 23,000 American's to the Emergency Room
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Unfortunately the Interim Final Rule can EXEMPT a manufacturer from 100% testing. I believe they have product tested (and I think the manufacturer gives it to them rather than a random test) and if it passes and they have a minimum of complaints, they don't need to have continued monitoring of their product. All that means is that they could give a "pure" product for testing and not have the same manufacturing practices for the rest.
Whenever a manufacturer can be exempted, expect money to change hands.
A.C.E. Certified Personal and Group Fitness Trainer
IDEA Fitness member
Kickboxing Certified Instructor
Been in fitness for 30 years and have studied kinesiology and nutrition
Iterim Final Rule:
The manufacturer would have to provide data in its petition demonstrating that less than 100% identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient.
Also, the cGMP rules state that each batch of each product has to be tested, and there has to be a record of every single batch test. This is along with copious other records for each processing step.0 -
Derf_Smeggle wrote: »Unfortunately the Interim Final Rule can EXEMPT a manufacturer from 100% testing. I believe they have product tested (and I think the manufacturer gives it to them rather than a random test) and if it passes and they have a minimum of complaints, they don't need to have continued monitoring of their product. All that means is that they could give a "pure" product for testing and not have the same manufacturing practices for the rest.
Whenever a manufacturer can be exempted, expect money to change hands.
A.C.E. Certified Personal and Group Fitness Trainer
IDEA Fitness member
Kickboxing Certified Instructor
Been in fitness for 30 years and have studied kinesiology and nutrition
Iterim Final Rule:
The manufacturer would have to provide data in its petition demonstrating that less than 100% identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient.
Also, the cGMP rules state that each batch of each product has to be tested, and there has to be a record of every single batch test. This is along with copious other records for each processing step.
I'm going to look into this when I get home from work. Thank you for sharing.0 -
I feel like @CSARdiver needs to be in this discussion.0
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I'm going to look into this when I get home from work. Thank you for sharing.
Azexas, here is the link to the FDA's cGMP Guidelines. These are the guidelines that manufacturers follow if they want to be GMP certified.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm238182.htm
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My guess is that many of those people were taking weight loss drugs and not vitamin supplements.
It is a good idea for people to see their doctor every year and take only the supplements advised. I would not suggest limiting the use of supplements to those who are deficient. It is wise to prevent deficiency, but the doctor would be the best person to ask about that, too.
So many people are taking pills and powders that they just don't need and some of that can be dangerous.0 -
EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »
I never suggested that it be the primary treatment. Antibiotics and vitamin C can be used at the same time.EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »Not very well. And at those doses vitamin C has risks. It have been associated with multiple adverse effects such as blood clotting, death (heart-related), kidney stones, pro-oxidant effects, etc... so much for less side effects.
And still doesn't answer "by the general use of vitamin C" which is what this thread is about.
Why have you tried it? Most if not all the side effects are lies by the medical industry. Vitamin C causes kidney stones? wrong.
General use of vitamin C is for prevention not really a treatment as with most vitamins.
Lol. And a 1960 quack doctor reference for treating pneumonia?
Good luck with that.
I've yet to see a hospital guideline that would suggest primary treatment be vitamin C.
You know why? Because it would be criminal.
Oh please, your post was one or the other. To whit "Well at least vitamins have less side effects than most drugs and actually treat a disease or issue and not just the symptoms."
Vitamin C does not treat Pneumonia - it reduces duration - the proper treatment is, gasp, drugs.
Well when all antibiotics fail, I'll fall back on vitamin C. You can do what ever you want.
Well, good luck with that.
Assuming you are taking about bacterial pneumonia the therapy of choice and generally very high success rates will include antibiotics. If antibiotics are not working and the cause is viral, well, then it is anti-virals that should be used.
Not Vitamin C.
You see - despite that poor expression that "drugs don't treat disease just symptoms" the opposite is quite true.
From AIDS to river blindness to, yes, various infectious diseases like pneumonia - these are all treated and possibly cured with drugs. Current therapies to treat and cure cancer may involve drugs - not just targeted chemotherapy but cancer necrosis factors, etc... Insulin and replacement hormones don't treat symptoms but are actual functional cures. Vaccines.
Vitamins are important - but heck, who would treat AIDS or hemorrhagic fever successfully with vitamins?
Again I never said "drugs don't treat disease just symptoms." I said "most drugs don't." I probably shouldn't say vague things like this.
Drugs are essential when one gets ill but they are not nutrients like vitamins and they should compliment each other. Most of the propaganda against high doses of vitamins is untrue.0 -
It is too easy to overdose on minerals. I can pull spec sheets if you don't believe me. This includes iron, calcium, zinc, and lithium.
There's a reason therapeutic iron is kept behind the counter.0 -
TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »
I never suggested that it be the primary treatment. Antibiotics and vitamin C can be used at the same time.EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »Not very well. And at those doses vitamin C has risks. It have been associated with multiple adverse effects such as blood clotting, death (heart-related), kidney stones, pro-oxidant effects, etc... so much for less side effects.
And still doesn't answer "by the general use of vitamin C" which is what this thread is about.
Why have you tried it? Most if not all the side effects are lies by the medical industry. Vitamin C causes kidney stones? wrong.
General use of vitamin C is for prevention not really a treatment as with most vitamins.
Lol. And a 1960 quack doctor reference for treating pneumonia?
Good luck with that.
I've yet to see a hospital guideline that would suggest primary treatment be vitamin C.
You know why? Because it would be criminal.
Oh please, your post was one or the other. To whit "Well at least vitamins have less side effects than most drugs and actually treat a disease or issue and not just the symptoms."
Vitamin C does not treat Pneumonia - it reduces duration - the proper treatment is, gasp, drugs.
Well when all antibiotics fail, I'll fall back on vitamin C. You can do what ever you want.
Well, good luck with that.
Assuming you are taking about bacterial pneumonia the therapy of choice and generally very high success rates will include antibiotics. If antibiotics are not working and the cause is viral, well, then it is anti-virals that should be used.
Not Vitamin C.
You see - despite that poor expression that "drugs don't treat disease just symptoms" the opposite is quite true.
From AIDS to river blindness to, yes, various infectious diseases like pneumonia - these are all treated and possibly cured with drugs. Current therapies to treat and cure cancer may involve drugs - not just targeted chemotherapy but cancer necrosis factors, etc... Insulin and replacement hormones don't treat symptoms but are actual functional cures. Vaccines.
Vitamins are important - but heck, who would treat AIDS or hemorrhagic fever successfully with vitamins?
Again I never said "drugs don't treat disease just symptoms." I said "most drugs don't." I probably shouldn't say vague things like this.
Drugs are essential when one gets ill but they are not nutrients like vitamins and they should compliment each other. Most of the propaganda against high doses of vitamins is untrue.
My patients that come in with toxic levels of vitamins would disagree with your last statement.0 -
TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »
I never suggested that it be the primary treatment. Antibiotics and vitamin C can be used at the same time.EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »Not very well. And at those doses vitamin C has risks. It have been associated with multiple adverse effects such as blood clotting, death (heart-related), kidney stones, pro-oxidant effects, etc... so much for less side effects.
And still doesn't answer "by the general use of vitamin C" which is what this thread is about.
Why have you tried it? Most if not all the side effects are lies by the medical industry. Vitamin C causes kidney stones? wrong.
General use of vitamin C is for prevention not really a treatment as with most vitamins.
Lol. And a 1960 quack doctor reference for treating pneumonia?
Good luck with that.
I've yet to see a hospital guideline that would suggest primary treatment be vitamin C.
You know why? Because it would be criminal.
Oh please, your post was one or the other. To whit "Well at least vitamins have less side effects than most drugs and actually treat a disease or issue and not just the symptoms."
Vitamin C does not treat Pneumonia - it reduces duration - the proper treatment is, gasp, drugs.
Well when all antibiotics fail, I'll fall back on vitamin C. You can do what ever you want.
Well, good luck with that.
Assuming you are taking about bacterial pneumonia the therapy of choice and generally very high success rates will include antibiotics. If antibiotics are not working and the cause is viral, well, then it is anti-virals that should be used.
Not Vitamin C.
You see - despite that poor expression that "drugs don't treat disease just symptoms" the opposite is quite true.
From AIDS to river blindness to, yes, various infectious diseases like pneumonia - these are all treated and possibly cured with drugs. Current therapies to treat and cure cancer may involve drugs - not just targeted chemotherapy but cancer necrosis factors, etc... Insulin and replacement hormones don't treat symptoms but are actual functional cures. Vaccines.
Vitamins are important - but heck, who would treat AIDS or hemorrhagic fever successfully with vitamins?
Again I never said "drugs don't treat disease just symptoms." I said "most drugs don't." I probably shouldn't say vague things like this.
Drugs are essential when one gets ill but they are not nutrients like vitamins and they should compliment each other. Most of the propaganda against high doses of vitamins is untrue.
My patients that come in with toxic levels of vitamins would disagree with your last statement.
My roommate from college would also agree after overdosing on vitamin a.0 -
Derf_Smeggle wrote: »I'm going to look into this when I get home from work. Thank you for sharing.
Azexas, here is the link to the FDA's cGMP Guidelines. These are the guidelines that manufacturers follow if they want to be GMP certified.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm238182.htm
Thank you for the link0 -
TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »
I never suggested that it be the primary treatment. Antibiotics and vitamin C can be used at the same time.EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »Not very well. And at those doses vitamin C has risks. It have been associated with multiple adverse effects such as blood clotting, death (heart-related), kidney stones, pro-oxidant effects, etc... so much for less side effects.
And still doesn't answer "by the general use of vitamin C" which is what this thread is about.
Why have you tried it? Most if not all the side effects are lies by the medical industry. Vitamin C causes kidney stones? wrong.
General use of vitamin C is for prevention not really a treatment as with most vitamins.
Lol. And a 1960 quack doctor reference for treating pneumonia?
Good luck with that.
I've yet to see a hospital guideline that would suggest primary treatment be vitamin C.
You know why? Because it would be criminal.
Oh please, your post was one or the other. To whit "Well at least vitamins have less side effects than most drugs and actually treat a disease or issue and not just the symptoms."
Vitamin C does not treat Pneumonia - it reduces duration - the proper treatment is, gasp, drugs.
Well when all antibiotics fail, I'll fall back on vitamin C. You can do what ever you want.
Well, good luck with that.
Assuming you are taking about bacterial pneumonia the therapy of choice and generally very high success rates will include antibiotics. If antibiotics are not working and the cause is viral, well, then it is anti-virals that should be used.
Not Vitamin C.
You see - despite that poor expression that "drugs don't treat disease just symptoms" the opposite is quite true.
From AIDS to river blindness to, yes, various infectious diseases like pneumonia - these are all treated and possibly cured with drugs. Current therapies to treat and cure cancer may involve drugs - not just targeted chemotherapy but cancer necrosis factors, etc... Insulin and replacement hormones don't treat symptoms but are actual functional cures. Vaccines.
Vitamins are important - but heck, who would treat AIDS or hemorrhagic fever successfully with vitamins?
Again I never said "drugs don't treat disease just symptoms." I said "most drugs don't." I probably shouldn't say vague things like this.
Drugs are essential when one gets ill but they are not nutrients like vitamins and they should compliment each other. Most of the propaganda against high doses of vitamins is untrue.
My patients that come in with toxic levels of vitamins would disagree with your last statement.
That's probably because they don't read any books before taking them. There are a couple you should stay away from like vitamin A, time released niacin, and synthetic vitamin E.
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It is too easy to overdose on minerals. I can pull spec sheets if you don't believe me. This includes iron, calcium, zinc, and lithium.
There's a reason therapeutic iron is kept behind the counter.
I agree that iron and lithium you can overdose quite easily. calcium and zinc you'd have to take a lot and high doses of zinc will make you throw up.0 -
Not for supplements that I know of. Please highlight the line in the cGMP that states that every batch has to be tested.Derf_Smeggle wrote: »Unfortunately the Interim Final Rule can EXEMPT a manufacturer from 100% testing. I believe they have product tested (and I think the manufacturer gives it to them rather than a random test) and if it passes and they have a minimum of complaints, they don't need to have continued monitoring of their product. All that means is that they could give a "pure" product for testing and not have the same manufacturing practices for the rest.
Whenever a manufacturer can be exempted, expect money to change hands.
A.C.E. Certified Personal and Group Fitness Trainer
IDEA Fitness member
Kickboxing Certified Instructor
Been in fitness for 30 years and have studied kinesiology and nutrition
Iterim Final Rule:
The manufacturer would have to provide data in its petition demonstrating that less than 100% identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient.
Also, the cGMP rules state that each batch of each product has to be tested, and there has to be a record of every single batch test. This is along with copious other records for each processing step.
The interim final rule allows manufacturers to petition FDA for an exemption from the requirement of 100 percent identity testing of one or more dietary ingredients used in manufacturing the dietary supplement. The manufacturer would provide data to demonstrate that its proposed reduced frequency of identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient. Each petition will be considered on a case by case basis.
Interim Final Rule:
The interim final rule (IFR) establishes a petition process for a manufacturer to apply for exemption from the 100 percent identity testing requirements for dietary ingredients used in manufacturing dietary supplements.
If a manufacturer is granted an exemption, the manufacturer would still be responsible for ensuring the quality of the final dietary supplement product.
The manufacturer would have to provide data in its petition demonstrating that less than 100% identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient.
The IFR is effective in June 2008 when the CGMP final rule becomes effective. However, there is a 90-day comment period. Based on the comments received, the IFR may be revised.
http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm
A.C.E. Certified Personal and Group Fitness Trainer
IDEA Fitness member
Kickboxing Certified Instructor
Been in fitness for 30 years and have studied kinesiology and nutrition
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Most vitamins have a limit that our bodies can handle. If you are considering to take a vitamin that has a limit you should definitely confirm with a dr. I always check with a dr before taking a vitamin supplement. Sometimes I am told it is pointless and no benefit from taking a certain vitamin but they let me know if it is safe if I do wish to take it anyway.0
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janejellyroll wrote: »Considering how many people take supplements, that's a relatively low number. Half the U.S. population takes supplements, so 23,000 out of 250,000,000 isn't all that much.
it may be a "low" number to some, but I see it as a number that can lowered if people chose only to supplement when they actually needed to.
Okay, what's your proposed solution?
Only take supplements when someone is actually deficient in something ( I mentioned this in the OP), education for people looking for quick fixes, and possible get some sort of regulatory body involved to ensure that that is listed as ingredients is actually in the supplement.The authorities said they had conducted tests on top-selling store brands of herbal supplements at four national retailers — GNC, Target, Walgreens and Walmart — and found that four out of five of the products did not contain any of the herbs on their labels. The tests showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies.
http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/
I take supplements so I WON'T be deficient. Waiting until I have a deficiency of B12 (something I supplement) would be way too late -- the effects of B12 deficiency can be permanent and serious.
If thats your plan then fine, but lets say hypothetically, someone is taking Vit D which is a fat soluble vitamin, and they are overdosing themselves because they don't need to take it. They can cause a buildup of calcium in your blood (hypercalcemia), which can cause poor appetite, nausea and vomiting. Weakness, frequent urination and kidney problems also may occur.
Now we have a situation where someone can cause kidney problems due to supplementing when they didn't have to.
Vitamin d has a limit that we can handle, anything over the limit would cause those problems you listed. Which is why vit d should only be taken if advised by your dr after a blood test and with a time limit. Some people need d indefinitely but that needs to be determined by a dr.
However b12 has a high limit or maybe no limit at all. Ive read that whatever b12 is unused by your body it is then eliminated at the end of the day through urine. But i think b12 needs to be confirmed with a dr as well. Ive had 1 dr tell me not to take it and another dr told me it is fine, so I take it once in a while but am still unsure if its ok to take.0 -
TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »TheDevastator wrote: »
I never suggested that it be the primary treatment. Antibiotics and vitamin C can be used at the same time.EvgeniZyntx wrote: »TheDevastator wrote: »EvgeniZyntx wrote: »Not very well. And at those doses vitamin C has risks. It have been associated with multiple adverse effects such as blood clotting, death (heart-related), kidney stones, pro-oxidant effects, etc... so much for less side effects.
And still doesn't answer "by the general use of vitamin C" which is what this thread is about.
Why have you tried it? Most if not all the side effects are lies by the medical industry. Vitamin C causes kidney stones? wrong.
General use of vitamin C is for prevention not really a treatment as with most vitamins.
Lol. And a 1960 quack doctor reference for treating pneumonia?
Good luck with that.
I've yet to see a hospital guideline that would suggest primary treatment be vitamin C.
You know why? Because it would be criminal.
Oh please, your post was one or the other. To whit "Well at least vitamins have less side effects than most drugs and actually treat a disease or issue and not just the symptoms."
Vitamin C does not treat Pneumonia - it reduces duration - the proper treatment is, gasp, drugs.
Well when all antibiotics fail, I'll fall back on vitamin C. You can do what ever you want.
Well, good luck with that.
Assuming you are taking about bacterial pneumonia the therapy of choice and generally very high success rates will include antibiotics. If antibiotics are not working and the cause is viral, well, then it is anti-virals that should be used.
Not Vitamin C.
You see - despite that poor expression that "drugs don't treat disease just symptoms" the opposite is quite true.
From AIDS to river blindness to, yes, various infectious diseases like pneumonia - these are all treated and possibly cured with drugs. Current therapies to treat and cure cancer may involve drugs - not just targeted chemotherapy but cancer necrosis factors, etc... Insulin and replacement hormones don't treat symptoms but are actual functional cures. Vaccines.
Vitamins are important - but heck, who would treat AIDS or hemorrhagic fever successfully with vitamins?
Again I never said "drugs don't treat disease just symptoms." I said "most drugs don't." I probably shouldn't say vague things like this.
Drugs are essential when one gets ill but they are not nutrients like vitamins and they should compliment each other. Most of the propaganda against high doses of vitamins is untrue.
My patients that come in with toxic levels of vitamins would disagree with your last statement.
No kidding - "at least vitamins have less side effects" is a vague statement to suggest that all vitamins are safe at any dose and it just isn't true. (something he recognises in other posts.)
Personal story - when I worked in cardio imaging at a research hospital in the US - the team that allowed me to play with equipment saw a cluster of heart issues (valve calcifications, regurgitations) with patients that also where showing proprioreceptor damage. Turned out to be Hypervitaminosis A - because they were recent immigrants I was also asked to participate in the interviews to translate (I'm bilingual). They had been taking injections of Vit A back home, "for energy", for years. I remember discussing this practice with my mom - because it was something quite common among the ladies in Guadalajara to get a vitamin "booster" shot.
Now she was a biologist so she understood this. Got the implications and all. Yet 25 years later, back in Mexico visiting family and feeling depressed, having anaemia (from a bone marrow disease) she decides to get a booster shot. Self medicates, plus depression, she gave herself 3 shots. 3.
Not the best decision - she spent a few miserable weeks with a lot of the classic overdose symptoms ...0 -
Having worked for a company that makes mainly veterinary supplements and one joint supplement for humans I can say they do send the mixes to be tested by an independent lab and a responsible manufacturer wanting to comply to cGMP would. Saying that the lab they use does studies checking whether label claims are actually met on supplements available for human use on the market and even some of the well know brands available in the UK do not meet their own label claim and are actually not worth the expense.
Saying that I am of the opinion that if you eat a balanced diet you should not need any supplements and are wasting your money.
You are basically creating very expensive wee and/or risking a build up of fat soluble vits in your body.0 -
I read misuse and immediately thought not of taking vitamins unnecessarily, but the many people that will take 3 fat burners/pre workouts/etc when the label says take 1, get sick and say it's a bad product. That happens a lot.0
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MondayJune22nd2015 wrote: »thorsmom01 wrote: »
No. She has many ongoing medical issues related to her mishap with the mlm products. I would suggest anyone thinking about taking these supplements to think twice.thorsmom01 wrote: »A lady that I used to work for fell for every type of " magic pill" that came out.
She was so desperate to lose weight, but yet wouldn't listen to the truth ( she was consuming too many calories )
She got involved with a popular mlm company I warned her that this may not be a good idea. She insisted that her "coach" knew everything about weight loss and health supplements .
So I left the topic alone. She started using all of their shakes, pills, powders and creams. She ate more pills and powders per day then anyone I ever knew. She said her coach told her to order the entire set and take each daily.
She ended up in the emergency room after 14 weeks of doing this. She had heart troubles and toxic levels of these drugs in her system.
She spent 8 weeks in the hospital. While there , the doctors told her exactly what @ninerbuff mentioned above. They said these pills and shakes and powders aren't regulated and often contain other fillers that can be potentially harmful .
IMO, its not worth the risk at all.
And the 11lbs she lost while on the pills, she gained it right back while in the hospital. So it was all a waste anyway.
Has your friend fully recovered?
Very saddening but did she learn her lesson & has she lost any weight on her own, after regaining what she had lost?
No, she is still suffering from the repercussions of these terrible mlm products so weight loss is the least of her problems now.
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Not for supplements that I know of. (1)Please highlight the line in the cGMP that states that every batch has to be tested.
The interim final rule allows manufacturers to petition FDA for an exemption from the requirement of 100 percent identity testing of one or more dietary ingredients used in manufacturing the dietary supplement. The manufacturer would provide data to demonstrate that its proposed reduced frequency of identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient. Each petition will be considered on a case by case basis.
Interim Final Rule:
The interim final rule (IFR) establishes a petition process for a manufacturer to apply for exemption from the 100 percent identity testing requirements for dietary ingredients used in manufacturing dietary supplements.
If a manufacturer is granted an exemption, the manufacturer would still be responsible for ensuring the quality of the final dietary supplement product.
(2) The manufacturer would have to provide data in its petition demonstrating that less than 100% identity testing does not materially diminish assurance that the dietary ingredient is the correct dietary ingredient.
The IFR is effective in June 2008 when the CGMP final rule becomes effective. However, there is a 90-day comment period. Based on the comments received, the IFR may be revised. [Edited to highlight specific point]
http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm
(1) Here is the list of batch record requirements. As you get into nitty-gritty details for verification of actual yield versus theoretical yield and verification of other record requirements, it has been explained to me by a manufacturer that it breaks down to laboratory testing of each batch to maintain compliance. The testing results include what is contained in the supplement as a matter of course.
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm238182.htm#XIThe DS CGMP rule requires the batch production record to include complete information relating to the production and control of each batch (21 CFR 111.255(b)). Specifically, the DS CGMP rule requires the batch production record to include:
The batch, lot, or control number of the finished batch of dietary supplement, each lot of packaged and labeled dietary supplement from the finished batch of dietary supplement, and each lot of dietary supplement, from the finished batch of dietary supplement, that you distribute to another person for packaging or labeling (21 CFR 111.260(a));
The identity of equipment and processing lines used in producing the batch (21 CFR 111.260(b));
The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained (21 CFR 111.260(c));
The unique identifier you assigned to each component (or, when applicable, to a product that you receive from a supplier for packaging or labeling as a dietary supplement), packaging, and label used (21 CFR 111.260(d));
The identity and weight or measure of each component used (21 CFR 111.260(e));
A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing (21 CFR 111.260(f));
The actual results obtained during any monitoring operation (21 CFR 111.260(g));
The results of any testing or examination performed during the batch production, or a cross-reference to such results (21 CFR 111.260(h));
Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) (21 CFR 111.260(i));
Documentation, at the time of performance, of the manufacture of the batch, including the date on which each step of the master manufacturing record was performed and the initials of the persons performing each step (21 CFR 111.260(j));
Documentation, at the time of performance, of packaging and labeling operations, including:
The unique identifier you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels (21 CFR 111.260(k)(1));
An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record (21 CFR 111.260(k)(2)); and
The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results (21 CFR 111.260(k)(1));
Documentation at the time of performance that quality control personnel reviewed the batch production record, approved or rejected any reprocessing or repackaging, approved and released (or rejected) the batch for distribution, and approved and released (or rejected) the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement (21 CFR 111.260(l));
Documentation at the time of performance of any required material review and disposition decision (21 CFR 111.260(m)); and
Documentation at the time of performance of any reprocessing (21 CFR 111.260(n)).
(2) Yes, we pulled the same information from the same source. The requirement is that you can only petition for less testing if, and only if, you can demonstrate that doing so will not materially effect your product.0
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