Supplements send 23,000 American's to the Emergency Room

Derf_Smeggle wrote: »

ninerbuff 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#XI

The 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.

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

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

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.

EvgeniZyntx wrote: »

Azexas wrote: »

snikkins 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.

ninerbuff wrote: »

Derf_Smeggle wrote: »

ninerbuff 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#XI

The 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.

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.
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

snikkins wrote: »

_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.