Supplements send 23,000 American's to the Emergency Room
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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
0 -
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 -
How about the Lamar Odom story, where it is reported he took [cocaine and] ten doses of a herbal Viagra analogue?0
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Consumer Labs has a list. Unfortunately you have to pay for it. $64 for access I believe. I'm not going to pay that to prove it to you.Derf_Smeggle wrote: »
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.
I'll leave it at whether you believe me or not, I'm sticking with what I've opined and have given sufficient evidence to back it. Again, you'd have to believe that if their isn't any issues with manufacturers on testing, there shouldn't be any compromise on methods of testing especially when it comes to the manufacturers getting to choose suitable ones. Testing should be consistent from manufacturer to manufacturer.
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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Looks like I found one:Derf_Smeggle wrote: »Again, demonstrate a cGMP product specifically recalled for contamination.
“Herberex is made with 100% all-natural, organic, high quality ingredients. To ensure the safety and quality of our product we manufacture in a cGMP certified facility… Every ingredient is analytically tested for chemicals, heavy metals, pesticides and common male enhancement steroids and every batch holds a certificate of analysis with these results. Herberex is pre-registered with FDA, Canada Health Board and European Health Board for importation. While Herberex only contains all natural ingredients, it is always suggested to you consult a licensed physician before use to ensure that you aren’t allergic to any of the natural ingredients.”
Last week Health Canada tested Herberex and found an undeclared drug, tadalafil – the active ingredient in Cialis. The manufacturer, Empire Health Distribution is recalling the drug from all Canadian stores but there is not much information on whether this is happening in the United States as well.
http://www.michiehamlett.com/sexual-enhancement-supplement-herberex-recalled-safety-concerns/
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Here's a typical Canadian recall.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/55252a-eng.php
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Probably so. Lots of people don't eat as well as they should, though, so vitamins and supplements can help "plug the leaks", so to speak. I always tell people, "They're not miracle workers. They're not going to magically fix a diet of Oreos and Twinkies and somehow make it healthy, but they're a good way to round out an already fairly balanced diet."
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?
I don't have anything against multis. I take one, and it's something that I recommend everyone take. The point that I was trying to make was that most higher-priced vitamins contain higher amounts of vitamins and/or more absorbable forms of the vitamins that they proclaim on their label. Pills of single nutrients are usually really concentrated, and the only people that really need them are those with diagnosed deficiencies -- like people with iron-deficiency anemia.
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I do have some known deficiencies, a known side-effect from bariatric surgery. So it's Vitamin D, folic acid, iron, and calcium citrate on top of the multivitamin. I pick vitamins from the discount shelf at my local pharmacy.
I'm going to try a mail-order topical patch that offers the full spectrum of vitamins for post-bariatric patients. I like the idea that it bypasses digestion altogether.0 -
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.
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.
(While I agree with you)
First point - there are a lot of cGMP recalls specifically due to contaminants - I've personally signed off for comm. on three in the last 3 yrs (and no, I won't be mentioning the company here).
Here are a few from the market (all cGMP as pharmaceuticals, devices, vacs):
http://www.aafp.org/news/health-of-the-public/20131221hpvvaccrecall.html
http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm332830.htm
http://www.fda.gov/safety/recalls/ucm465183.htm
http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm409283.htm
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My boss' liver started to shut down from his high dose supplements. Getting vitamins from our food is VERY different from high MG supplements. I do take vitamins. I know I dont get enough calcium, I always test anemic etc. I take 5 low dose supplements. Some of the water soluble vitamins are less dangerous because you urinate out the extra; fat soluble vitamins can store up in your body to very dangerous levels. The broad mentality that "if a little is good; than a lot is better" can be deadly. You can die from drink copious amounts of water.
Most of our modern day medicine originated from plants/ food. Willow bark used to be used to cure fevers (asprin). The romans used silphium as birth control. The list goes on. So its ridiculous for people or companies to say all supplements are safe, you cant overdose etc. If you can overdose on conventional drugs, than you can OD on supplements.0 -
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