Supplements send 23,000 American's to the Emergency Room
Replies
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However it DOESN'T say each batch has to be tested. It does say visually examination needs to be employed, but that's not the same as chemically testing each batch. And results only need to be obtained IF there was a test implemented...........and that's not mandatory.Derf_Smeggle wrote: »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.
And that's the problem. Unlike drugs regulated by the FDA, the DSHEA does little to enforce testing of finished products from supplement manufacturing. Hence the issue with contamination in many of them.
While cGMP sounds great with supplements, it's more symbolism than actual substance.
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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Many of these are in "Proprietary Blends" with no research or testing on whether or not the combinations of ingredients may have a negative effect on the user.catscats222 wrote: »Most dangerous supplements that cause the most visits.
aconite
bitter orange
chaparral
colodial silver
colts foot
comfrey
country mallow
germanium
greater celandine
KAVA
lovelia
yohimbe
silly that the conversation got into vitamin C
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
0 -
catscats222 wrote: »Most dangerous supplements that cause the most visits.
aconite
bitter orange
chaparral
colodial silver
colts foot
comfrey
country mallow
germanium
greater celandine
KAVA
lovelia
yohimbe
silly that the conversation got into vitamin C
I'm not surprised to see the colloidal silver on that list. It has near mystic properties among some of the anti-vax groups out there.
I don't get why it's so hard to believe that nature just doesn't love you. It isn't there to protect you from whatever, but some people believe it very strongly. I wonder if proper labeling and dosage recommendations, like we do with vitamins, would help or not. There's a lot of Woo that surrounds the supplement industry.
ETA: This doesn't mean that I don't think they should be regulated, because they should. I'm just curious if it would help.0 -
So how much vitamin A is cause for concern? Assuming I'm logging the correct entry, this sweet potato I'm going to eat later has 743.4% of the DV. Most days I usually go over the DV for A and C, and that's just from the food I eat.0
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catscats222 wrote: »Most dangerous supplements that cause the most visits.
aconite
bitter orange
chaparral
colodial silver
colts foot
comfrey
country mallow
germanium
greater celandine
KAVA
lovelia
yohimbe
silly that the conversation got into vitamin C
If by silly, you mean "plausible," and "worth educating ones self about", then yes. Sure, it's not all that likely...doesn't mean one should take it just because, or take it in doses that are not recommended.
A lot more people take Vitamin C than the list of things above.0 -
Silly to chase down "not all that likely" when we have our young people showing up in emergency rooms from taking ephedrine laced products (mistakenly thinking natural means safe).0
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marilynxmonster wrote: »So how much vitamin A is cause for concern? Assuming I'm logging the correct entry, this sweet potato I'm going to eat later has 743.4% of the DV. Most days I usually go over the DV for A and C, and that's just from the food I eat.
If I understand it correctly, it depends on where the vitamin A is coming from. If it's from mostly plant sources, it's all good. I could definitely be wrong, though.0 -
Silly to chase down "not all that likely" when we have our young people showing up in emergency rooms from taking ephedrine laced products (mistakenly thinking natural means safe).Silly to chase down "not all that likely" when we have our young people showing up in emergency rooms from taking ephedrine laced products (mistakenly thinking natural means safe).
Less important to the general public, yes. Still no need to call me silly for having a conversation about it.0 -
marilynxmonster wrote: »So how much vitamin A is cause for concern? Assuming I'm logging the correct entry, this sweet potato I'm going to eat later has 743.4% of the DV. Most days I usually go over the DV for A and C, and that's just from the food I eat.
If I understand it correctly, it depends on where the vitamin A is coming from. If it's from mostly plant sources, it's all good. I could definitely be wrong, though.
That is how I understand it as well.0 -
marilynxmonster wrote: »So how much vitamin A is cause for concern? Assuming I'm logging the correct entry, this sweet potato I'm going to eat later has 743.4% of the DV. Most days I usually go over the DV for A and C, and that's just from the food I eat.
If I understand it correctly, it depends on where the vitamin A is coming from. If it's from mostly plant sources, it's all good. I could definitely be wrong, though.
That is how I understand it as well.
It is very hard to overdose on any vitamin if you are not supplementing and just getting them from eating plants.catscats222 wrote: »Most dangerous supplements that cause the most visits.
aconite
bitter orange
chaparral
colodial silver
colts foot
comfrey
country mallow
germanium
greater celandine
KAVA
lovelia
yohimbe
silly that the conversation got into vitamin C
Very silly.
Nice google list. However, given the high use of Vitamin C it is a concern....Vitamin C and risk of death from stroke and coronary heart disease in cohort of elderly people.
Gale CR1, Martyn CN, Winter PD, Cooper C.
Author information
Abstract
OBJECTIVES:
To determine whether vitamin C status, as measured by dietary intake and plasma ascorbic acid concentration, is related to mortality from stroke and coronary heart disease in people aged 65 and over.
DESIGN:
A 20 year follow up study of a cohort of randomly selected elderly people living in the community who had taken part in the 1973-4 Department of Health and Social Security nutritional survey and for whom dietary and other data had been recorded.
SETTING:
Eight areas in Britain (five in England, two in Scotland, and one in Wales).
SUBJECTS:
730 men and women who had completed a seven day dietary record and who had no history or symptoms of stroke, cerebral arteriosclerosis, or coronary heart disease when examined by a geriatrician in 1973-4.
RESULTS:
Mortality from stroke was highest in those with the lowest vitamin C status. Those in the highest third of the distribution of vitamin C intake had a relative risk of 0.5 (95% confidence interval 0.3 to 0.8) compared with those in the lowest third, after adjustment for age, sex, and established cardiovascular risk factors. The relation between vitamin C intake and stroke was independent of social class and other dietary variables. A similar gradient in risk was present for plasma ascorbic acid concentrations. No association was found between vitamin C status and risk of death from coronary heart disease.
CONCLUSION:
In elderly people vitamin C concentration, whether measured by dietary intake or plasma concentration of ascorbic acid, is strongly related to subsequent risk of death from stroke but not from coronary heart disease.0 -
@EvgeniZyntx
That's what I meant. If you are getting it from food sources it is very hard to over do it, unless someone is adding in some sort of supplement.
(my quotes are being weird at the moment)
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@EvgeniZyntx
That's what I meant. If you are getting it from food sources it is very hard to over do it, unless someone is adding in some sort of supplement.
(my quotes are being weird at the moment)
Yup.0 -
EvgeniZyntx wrote: »marilynxmonster wrote: »So how much vitamin A is cause for concern? Assuming I'm logging the correct entry, this sweet potato I'm going to eat later has 743.4% of the DV. Most days I usually go over the DV for A and C, and that's just from the food I eat.
If I understand it correctly, it depends on where the vitamin A is coming from. If it's from mostly plant sources, it's all good. I could definitely be wrong, though.
That is how I understand it as well.
It is very hard to overdose on any vitamin if you are not supplementing and just getting them from eating plants.catscats222 wrote: »Most dangerous supplements that cause the most visits.
aconite
bitter orange
chaparral
colodial silver
colts foot
comfrey
country mallow
germanium
greater celandine
KAVA
lovelia
yohimbe
silly that the conversation got into vitamin C
Very silly. Nice google list. However, given the high use of Vitamin C it is a concern....Vitamin C and risk of death from stroke and coronary heart disease in cohort of elderly people.
Gale CR1, Martyn CN, Winter PD, Cooper C.
Author information
Abstract
OBJECTIVES:
To determine whether vitamin C status, as measured by dietary intake and plasma ascorbic acid concentration, is related to mortality from stroke and coronary heart disease in people aged 65 and over.
DESIGN:
A 20 year follow up study of a cohort of randomly selected elderly people living in the community who had taken part in the 1973-4 Department of Health and Social Security nutritional survey and for whom dietary and other data had been recorded.
SETTING:
Eight areas in Britain (five in England, two in Scotland, and one in Wales).
SUBJECTS:
730 men and women who had completed a seven day dietary record and who had no history or symptoms of stroke, cerebral arteriosclerosis, or coronary heart disease when examined by a geriatrician in 1973-4.
RESULTS:
Mortality from stroke was highest in those with the lowest vitamin C status. Those in the highest third of the distribution of vitamin C intake had a relative risk of 0.5 (95% confidence interval 0.3 to 0.8) compared with those in the lowest third, after adjustment for age, sex, and established cardiovascular risk factors. The relation between vitamin C intake and stroke was independent of social class and other dietary variables. A similar gradient in risk was present for plasma ascorbic acid concentrations. No association was found between vitamin C status and risk of death from coronary heart disease.
CONCLUSION:
In elderly people vitamin C concentration, whether measured by dietary intake or plasma concentration of ascorbic acid, is strongly related to subsequent risk of death from stroke but not from coronary heart disease.
This is why I'm in tune to it. I work with a primarily over 50 age demographic and a lot of my elderly patients have significant difficulty managing vitamin levels.0 -
@EvgeniZyntx
That's what I meant. If you are getting it from food sources it is very hard to over do it, unless someone is adding in some sort of supplement.
(my quotes are being weird at the moment)
<nods>0 -
However it DOESN'T say each batch has to be tested. It does say visually examination needs to be employed, but that's not the same as chemically testing each batch. And results only need to be obtained IF there was a test implemented...........and that's not mandatory.Derf_Smeggle wrote: »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.
And that's the problem. Unlike drugs regulated by the FDA, the DSHEA does little to enforce testing of finished products from supplement manufacturing. Hence the issue with contamination in many of them.
While cGMP sounds great with supplements, it's more symbolism than actual substance.
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
I disagree with you.0 -
I know it was mentioned up thread, but I can't remember which page it was on. USP is also an independent testing laboratory. I know off hand that Nature Made has their products tested through them. I'm sure there are others, but I can't remember off the top of my head.
http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements
Edit: I forgot my link.0 -
OP:
Hope this links works--->
http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/verified-supplements
Kirkland, I think, is the brand you can purchase from wholesale places like BJ's and/or Costco. Not sure about Costco but maybe. (edit) Additional companies are listed on a link below the four listed in the link.(edit)0 -
_Terrapin_ wrote: »OP:
Hope this links works--->
http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/verified-supplements
Kirkland, I think, is the brand you can purchase from wholesale places like BJ's and/or Costco. Not sure about Costco but maybe. (edit) Additional companies are listed on a link below the four listed in the link.(edit)
Kirkland is Costco's brand. I don't know what BJ's is.0 -
_Terrapin_ wrote: »OP:
Hope this links works--->
http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/verified-supplements
Kirkland, I think, is the brand you can purchase from wholesale places like BJ's and/or Costco. Not sure about Costco but maybe. (edit) Additional companies are listed on a link below the four listed in the link.(edit)
Kirkland is Costco's brand. I don't know what BJ's is.
Thanks, yep brain fart on my part.
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Cheers,
JustSomeEm0 -
_Terrapin_ wrote: »OP:
Hope this links works--->
http://www.usp.org/usp-verification-services/usp-verified-dietary-supplements/verified-supplements
Kirkland, I think, is the brand you can purchase from wholesale places like BJ's and/or Costco. Not sure about Costco but maybe. (edit) Additional companies are listed on a link below the four listed in the link.(edit)
Thanks for the link! I'll have to check that out.0 -
No prob, however stating that every batch of supplements manufactured gets tested is incorrect information. Information like that would lead people to believe that they are safe when in truth they really don't know what they're getting on their purchase.Derf_Smeggle wrote: »
However it DOESN'T say each batch has to be tested. It does say visually examination needs to be employed, but that's not the same as chemically testing each batch. And results only need to be obtained IF there was a test implemented...........and that's not mandatory.Derf_Smeggle wrote: »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.
And that's the problem. Unlike drugs regulated by the FDA, the DSHEA does little to enforce testing of finished products from supplement manufacturing. Hence the issue with contamination in many of them.
While cGMP sounds great with supplements, it's more symbolism than actual substance.
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
I disagree with you.
If there's an exempt clause for testing, why is that considered safe? Also under the ruling why do companies have the "flexibility" to what methods are appropriate and suitable to test their products?
When dealing with a product that has an impact on millions of people, that shouldn't be a compromise. The FDA should have full access to testing any supplement if called upon, on how they see fit to ensure a higher safety standard.
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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I disagree with you because you are incorrect. While you are correct that cGMP doesn't explicitly state in plain writing that batches must be tested, that is in effect what happens when you actually read the fine print.
No prob, however stating that every batch of supplements manufactured gets tested is incorrect information. Information like that would lead people to believe that they are safe when in truth they really don't know what they're getting on their purchase.Derf_Smeggle wrote: »
However it DOESN'T say each batch has to be tested. It does say visually examination needs to be employed, but that's not the same as chemically testing each batch. And results only need to be obtained IF there was a test implemented...........and that's not mandatory.Derf_Smeggle wrote: »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.
And that's the problem. Unlike drugs regulated by the FDA, the DSHEA does little to enforce testing of finished products from supplement manufacturing. Hence the issue with contamination in many of them.
While cGMP sounds great with supplements, it's more symbolism than actual substance.
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
I disagree with you.
If there's an exempt clause for testing, why is that considered safe? Also under the ruling why do companies have the "flexibility" to what methods are appropriate and suitable to test their products?
When dealing with a product that has an impact on millions of people, that shouldn't be a compromise. The FDA should have full access to testing any supplement if called upon, on how they see fit to ensure a higher safety standard.
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
First, each bulk ingredient has to be verified through both visual inspection and... You guessed it. Testing. Second, each batch must match the Master Records. This is part of the Batch Record. In order to verify the batch to the Master Record the batch must be... You got it! Tested.
My complaint would be that cGMP certification is not mandatory, but a choice that manufacturers have.
I also agree with you that spreading misinformation is an issue.0 -
If you believe that that sort of "testing" is legitimate enough to pass a supplement off without it's actual product being tested off the line (for fear of possible contamination and recall), then our definitions of "testing" are much different. I see it as SOP (standard operating procedure) and not "testing". We'll hear almost daily about a recall on food or drinks and even vehicles, but not so much on supplements. Again sad because millions of people take them without knowing if they are truly safe or uncontaminated.Derf_Smeggle wrote: »
I disagree with you because you are incorrect. While you are correct that cGMP doesn't explicitly state in plain writing that batches must be tested, that is in effect what happens when you actually read the fine print.
No prob, however stating that every batch of supplements manufactured gets tested is incorrect information. Information like that would lead people to believe that they are safe when in truth they really don't know what they're getting on their purchase.Derf_Smeggle wrote: »
However it DOESN'T say each batch has to be tested. It does say visually examination needs to be employed, but that's not the same as chemically testing each batch. And results only need to be obtained IF there was a test implemented...........and that's not mandatory.Derf_Smeggle wrote: »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.
And that's the problem. Unlike drugs regulated by the FDA, the DSHEA does little to enforce testing of finished products from supplement manufacturing. Hence the issue with contamination in many of them.
While cGMP sounds great with supplements, it's more symbolism than actual substance.
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
I disagree with you.
If there's an exempt clause for testing, why is that considered safe? Also under the ruling why do companies have the "flexibility" to what methods are appropriate and suitable to test their products?
When dealing with a product that has an impact on millions of people, that shouldn't be a compromise. The FDA should have full access to testing any supplement if called upon, on how they see fit to ensure a higher safety standard.
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
First, each bulk ingredient has to be verified through both visual inspection and... You guessed it. Testing. Second, each batch must match the Master Records. This is part of the Batch Record. In order to verify the batch to the Master Record the batch must be... You got it! Tested.
My complaint would be that cGMP certification is not mandatory, but a choice that manufacturers have.
I also agree with you that spreading misinformation is an issue.
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
0 -
Three points.If you believe that that sort of "testing" is legitimate enough to pass a supplement off without it's actual product being tested off the line (for fear of possible contamination and recall), then our definitions of "testing" are much different. I see it as SOP (standard operating procedure) and not "testing". We'll hear almost daily about a recall on food or drinks and even vehicles, but not so much on supplements. Again sad because millions of people take them without knowing if they are truly safe or uncontaminated.
First point - Please post an example of a cGMP product with a recall due to specifically an issue of contamination. I do agree with you that things get recalled all the time, but cGMP guidelines and the implicit testing within those guidelines are there to insure the risk of contamination is reduced to as near to eliminated as possible.
Second - You throw out the words "truly safe". This is completely ambiguous and a red herring. cGMP guidelines are about regulating what manufacturers claim is in their product, and establishes a chain of evidence for the procedures, equipment, and the ingredients that go into those products. These steps severely limit the possibility of contamination, alteration, and, adulteration.
Finally - Your concerned about product being "tested off the line". A batch of product comes off the line. A sample is taken. Said sample is tested and the results are compared against the Master Record to make sure there is no deviation, contamination, or adulteration.0 -
About a quarter (24%) of the recalled supplements were manufactured outside the U.S., a concern given that manufacturing practices in foreign countries may not be held to the same standard, the researchers wrote. They noted, however, that the FDA has found CGMP violations in at least half of the domestic dietary supplement firms it has inspected.Derf_Smeggle wrote: »
Three points.If you believe that that sort of "testing" is legitimate enough to pass a supplement off without it's actual product being tested off the line (for fear of possible contamination and recall), then our definitions of "testing" are much different. I see it as SOP (standard operating procedure) and not "testing". We'll hear almost daily about a recall on food or drinks and even vehicles, but not so much on supplements. Again sad because millions of people take them without knowing if they are truly safe or uncontaminated.
First point - Please post an example of a cGMP product with a recall due to specifically an issue of contamination. I do agree with you that things get recalled all the time, but cGMP guidelines and the implicit testing within those guidelines are there to insure the risk of contamination is reduced to as near to eliminated as possible.
http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/38451
While that's the intention, the unfortunate result is that contamination of undesired ingredients in products continue. Remember, a manufacturer who does get a request for testing, gets to submit their sample and choose the guidelines of how it should be tested. You believe that's an accurate way to deem safety?Second - You throw out the words "truly safe". This is completely ambiguous and a red herring. cGMP guidelines are about regulating what manufacturers claim is in their product, and establishes a chain of evidence for the procedures, equipment, and the ingredients that go into those products. These steps severely limit the possibility of contamination, alteration, and, adulteration.
Then there's a big issue on how they're "tested" due to many studies showing supplements having contamination. We're speaking of raw material to make a product more than likely not even being checked for purity before being manufactured.Finally - Your concerned about product being "tested off the line". A batch of product comes off the line. A sample is taken. Said sample is tested and the results are compared against the Master Record to make sure there is no deviation, contamination, or adulteration.
I look at the results. The results are that there are entirely too many supplements out there that contain ingredients not even shown on the labels of supplements. Studies show that many supplements have this issue whether or not they are cGMP regulated. To this point cGMP doesn't do much to help regulate the safety of supplements. People who are inclined to believe that buying a cGMP regulated product is "much" safer, should actually know that this really isn't the case at all.
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 0 -
This is a great article on the overall issue. One of the major issues is that cGMP is not mandatory and given more oversight to insure all supplements are meeting those guidelines.
About a quarter (24%) of the recalled supplements were manufactured outside the U.S., a concern given that manufacturing practices in foreign countries may not be held to the same standard, the researchers wrote. They noted, however, that the FDA has found CGMP violations in at least half of the domestic dietary supplement firms it has inspected.Derf_Smeggle wrote: »
Three points.If you believe that that sort of "testing" is legitimate enough to pass a supplement off without it's actual product being tested off the line (for fear of possible contamination and recall), then our definitions of "testing" are much different. I see it as SOP (standard operating procedure) and not "testing". We'll hear almost daily about a recall on food or drinks and even vehicles, but not so much on supplements. Again sad because millions of people take them without knowing if they are truly safe or uncontaminated.
First point - Please post an example of a cGMP product with a recall due to specifically an issue of contamination. I do agree with you that things get recalled all the time, but cGMP guidelines and the implicit testing within those guidelines are there to insure the risk of contamination is reduced to as near to eliminated as possible.
http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/38451
I'm going to address two points you quoted above. First, you can find manufacturers from overseas that adhere to United States FDA cGMP guidelines. For example, reputable Chinese herbal formula manufacturers in particular adhere to cGMP because of the many issues with adulterated products from less reputable manufacturers in China.
the FDA has found CGMP violations in at least half of the domestic dietary supplement firms it has inspected. Second, what do they mean by cGMP violations? It is never explained. Violations is vague and does not explicitly state that the violations were for contamination/adulteration. Violations might mean anything from someone wasn't wearing a hair net in required area, to a label deemed illegible, to adulteration/contamination. Voilation does not equal proof of contamination. It indicates a code violation.
Again, demonstrate a cGMP product specifically recalled for contamination.0 -
With supplements, as with most other things in life, you get what you pay for. If you bought an $8 bottle of Vitafusion gummies from Walmart, you shouldn't expect to be getting the same quality as you would if you had spent $20 or $30 on another brand. That said, I do think that there should be some kind of regulation that forces companies to actually put what they say they are putting in the supplement.
Personally, I think that most hospital visits are due to reactions with medication or incorrect dosages. For example, whenever someone comes into the store where I work looking for a particular supplement, we ask what medications they're on, why they want to take it, and what results they're expecting. Only after that do we show them the section they're interested in and discuss the pros and cons of different brands. Quite often we end up steering people away from something that they originally wanted, because they tell us that they have a prescription that we know would interact badly with the supplement. Other times, we give them directions on how to take the supplement they want (how big the dose is, whether or not you need to take it with food, if you can have alcohol while taking it, ect). A lot of places don't do that, so I think that a lot of emergency room visits are due to consumer ignorance.
But I agree that those companies who knowingly sell dangerous supplements, especially the weight loss ones, need to be shut down. They give companies who sell supplements that can really help people, as well as the retailers that sell them, a bad name.0 -
I am sure this is what the MLM marketing schemes are counting on. I remember my mother-in-law bought in to one of these vitamin regimens which amounted to several horse pills at each meal. The pills were all lovely shades of natural sawdust. She was told that the body can't absorb all the vitamins we take with a single pill.With supplements, as with most other things in life, you get what you pay for.
One wonders if a good salad would have done as much?0
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