As I have continued to pursue my career in the medical field I studied more and more into the realm of analytical chemistry and the quality of the supplements that we take. I am writing this because I feel the entire supplement industry needs an overhaul. I am not implicating any particular company, nor am I saying that IBE's practices are on part with what my goal within the industry is set to. I feel that there has been a potent disregard for public health among all members of the supplement industry. Many companies are either neglecting proper analytical testing of their dietary supplements, trusting the certificate of analysis that originates from the suppler, use labs that cannot perform the correct analysis, or attempt to use in house methods of analytical testing. Although there are advantages and disadvantages to some of these, it must be noted that the negative effects far outweigh the positive effects here. In this respect I sort of feel like Jerry Maguire in that I could possibly black ball myself in the supplement industry among other companies, but at this point I am not concerned, I am more concerned with the health of not only my friends and fellow board members, but myself and my family as well who take health supplements on a regular basis.
With that being said lets look at the problems we are currently facing. In order to create a larger profit many new startup companies are neglecting proper analytical testing and trusting the C of A's of their suppliers. This is a monumental miscalculation since a C of A, especially one originating from a foreign country, can be easily faked or masked. Suppliers should not be trusted in the beginning nor should they be trusted at any point throughout the business relationship. They are looking for profit just as you are and they can just as easily turn on you. A new problem to even the pharmaceutical industry is masking. Masking has shown up in the most recent Heparin scare, in which foreign suppliers were using sub par ingredients and then masking what they had in it to make it look as though it contained the proper ingredient. You can also easily mask substances that are in small quantities by providing something similar in a larger quantities.
The second problem right now is companies are using any old Joe Chemistry lab to perform their testing. You should do your research before choosing companies to perform analytical testing. Yes, it is not difficult to inject a sample into a GCMS and watch the output on the screen, heck anyone can really do it. Most people can also say, "hey that looks like this" in the reference library. The problem comes in when compounds do not contain a known analytical standard. NO MATTER WHAT ANYONE SAYS FRAGMENTATION CAN RARELY BE PREDICTED. I don't care how good of a chemist you are but fragmentation predictions can only be done with very complex computing operations and are not always correct. Further testing needs to be conducted to ensure that what you think you are buying is what you actually got. Without making things too personal we conducted a myriad of tests on Epistane over a year ago to ensure the proper ingredient. Many labs don't even us a liquid chromatography. I have seen labs pass a sample and say that it 100% meets label claims, yet two paragraphs before state that there is no standard available and that they assume the retention time and fragmentation pattern is correct.
Lastly, many companies are using in house testing. There is nothing wrong here with the fact that if a company can afford the proper equipment it can help to do in house testing. This is difficult however, when a good mass spectrometer will cost around $250,000-500,000 with pharmaceutical grade machines costing around $1 million. GC and LC machines are around $100,000 depending on the resolution. Most labs utilize a gas chromatogram since most compounds run just fine on a GC. The elution is fast and results are obtained rapidly. However, there are criteria for GC, the most important being that the compound is volatile and heat stable. Many mistakes are made when injecting samples to ensure that it is indeed volatile and heat stable. Temperature programming is typically used in a GC and the temperature can well exceed twice the boiling point of water and you can imagine what that can do to some molecules. Liquid chromatography is more expensive and very few labs use it, including many labs that people outsource.
Now you might be wondering, why the heck is LMD giving us a damn chemistry lesson, we don't care! The reason is that the industry is in worse shape than you might think and I am attempting to reform it, slowly if necessary. If you don't think that the things you are putting in your body are a big concern then disregard this message. However, if you are truly concerned about your health and are curious about what truly could be contained in what you are taking then press forward. I have many studies on this but lets take a look at one of the most interesting.
Adulterants in Asian Patent Medicines
To the Editor: Asian patent medicines are one component of what are called traditional Chinese medicines. Asian patent medicines comprise multiple products, including herbs, plants, animal parts, and minerals, which are formulated into tablets, pills, or liquids for ease of use. They are widely available in herbal stores and have gained acceptance by the American public as a form of alternative medicine. However, many patent medicines manufactured in Asian countries contain toxic ingredients, such as heavy metals, as well as prescription drugs or unapproved ingredients that may or may not be identified on the label.1,2 Some have caused serious illness in unsuspecting consumers.3,4
The California Department of Health Services, Food and Drug Branch, initiated a study to screen imported Asian patent medicines for undeclared pharmaceuticals and heavy-metal contamination, using gas chromatography–mass spectrometry and atomic-absorption methods. Our objectives were to establish a computer data base for these products; educate the public, the herbal industry, and the medical community about the potential danger of Asian patent medicines; and provide objective information about toxicity.
Of 260 Asian patent medicines that have been collected from California retail herbal stores, 14 had labels that declared pharmaceutical ingredients, and 3 had insufficient sample amounts. Of the remaining 243 products, 17 (7 percent) contained undeclared pharmaceuticals. The most common undeclared ingredients were ephedrine, chlorpheniramine, methyltestosterone, and phenacetin. A total of 251 products were analyzed for lead, arsenic, and mercury; 9 other samples, including the 3 noted above, were insufficient for this analysis. Twenty-four products contained lead in a quantity of at least 10 parts per million (ppm) (range, 10 to 319; median, 29.8; mean, 54.9). Thirty-six products contained arsenic (range, 20.4 to 114,000 ppm; median, 180.5; mean, 14,553). Thirty-five products contained mercury (range, 22.4 to 5070 ppm; median, 329; mean, 1046); 2 of the 35 had labels that identified only pharmaceutical ingredients. The United States Pharmacopoeia limits heavy metals in most oral pharmaceuticals to 30 ppm, with lower limits for lead, arsenic, and mercury.
Of the 260 products we investigated, at least 83 (32 percent) contained undeclared pharmaceuticals or heavy metals, and 23 had more than one adulterant. The remaining products, which contained no detectable adulterants, cannot be assumed to be safe and free of toxic ingredients, in view of their batch-to-batch inconsistency, as well as limitations in our detection methods.
Richard J. Ko, Pharm.D., Ph.D.
California Department of Health Services
Sacramento, CA 94234-7320
Now I don't know about you but this absolutely startled me when I first read it. The sad thing is there is many like it. Lets look at what was actually stated. It states that many herbal compounds contained methyl testosterone! Before you go thinking that it is a plus, think about whether this was in your PCT product and how well that could have helped. One of the most startling values was one of the compounds contained arsenic concentrations of 114,000 ppm!!!!!! Arsenic is often used as a tool for murdering someone as it is very hard to detect the cause of death when the culprit is arsenic and it doesn't take all that much and is tasteless. The FDA does not allow arsenic above I believe 10 ppm. That means they had concentrations of arsenic 11,400x higher than what the FDA allows! It means you would have to take 11,400x more of an FDA monitored supplement to get the same amount of arsenic as in one of these bottles. The next value is mercury having over 5000 ppm of mercury. People are concerned with tuna fish in the can which has less than 30 yet some of these had 5000.
So what do I propose?
-Standardized testing practices. We need to ensure that ALL companies are using a US based independent lab for testing.
-Testing of heavy metals. This is something that VERY few people do and it is something that cannot be overlooked. I am more concerned about heavy metals than I am methyltestosterone. Heavy metals must be tested using atomic spectroscopy and not molecular spectroscopy, which everyone typically uses. I am not saying that all batches need to be tested but random tests of at least 25% of your stock should be made.
-The posting of C of A's from US based independent labs on their website so that batch numbers can be matched to analysis.
-Proper testing of compounds that lack analytical standards. This will be the hardest and last thing to probably come to light but is of importance to mention.
I am not saying that IBE currently does all of these things, but I promise you I am working towards it. I am trying to get all of our C of A's on our website possibly within the week or the month, depending on how well the webmasters work with me. I want to try and see others to follow in IBE's footsteps (some have already done so and I give them credit). I also would like to see you as the consumer push for these things. Remember it is YOUR health not theirs that can be affected and the direct effect could be very detrimental, especially later in life since heavy metals could be a concern.
Let me know how everyone feels about this. Thoughts, concerns, and suggestions. Together we can make the supplement industry safer and make the health of everyone better.
With that being said lets look at the problems we are currently facing. In order to create a larger profit many new startup companies are neglecting proper analytical testing and trusting the C of A's of their suppliers. This is a monumental miscalculation since a C of A, especially one originating from a foreign country, can be easily faked or masked. Suppliers should not be trusted in the beginning nor should they be trusted at any point throughout the business relationship. They are looking for profit just as you are and they can just as easily turn on you. A new problem to even the pharmaceutical industry is masking. Masking has shown up in the most recent Heparin scare, in which foreign suppliers were using sub par ingredients and then masking what they had in it to make it look as though it contained the proper ingredient. You can also easily mask substances that are in small quantities by providing something similar in a larger quantities.
The second problem right now is companies are using any old Joe Chemistry lab to perform their testing. You should do your research before choosing companies to perform analytical testing. Yes, it is not difficult to inject a sample into a GCMS and watch the output on the screen, heck anyone can really do it. Most people can also say, "hey that looks like this" in the reference library. The problem comes in when compounds do not contain a known analytical standard. NO MATTER WHAT ANYONE SAYS FRAGMENTATION CAN RARELY BE PREDICTED. I don't care how good of a chemist you are but fragmentation predictions can only be done with very complex computing operations and are not always correct. Further testing needs to be conducted to ensure that what you think you are buying is what you actually got. Without making things too personal we conducted a myriad of tests on Epistane over a year ago to ensure the proper ingredient. Many labs don't even us a liquid chromatography. I have seen labs pass a sample and say that it 100% meets label claims, yet two paragraphs before state that there is no standard available and that they assume the retention time and fragmentation pattern is correct.
Lastly, many companies are using in house testing. There is nothing wrong here with the fact that if a company can afford the proper equipment it can help to do in house testing. This is difficult however, when a good mass spectrometer will cost around $250,000-500,000 with pharmaceutical grade machines costing around $1 million. GC and LC machines are around $100,000 depending on the resolution. Most labs utilize a gas chromatogram since most compounds run just fine on a GC. The elution is fast and results are obtained rapidly. However, there are criteria for GC, the most important being that the compound is volatile and heat stable. Many mistakes are made when injecting samples to ensure that it is indeed volatile and heat stable. Temperature programming is typically used in a GC and the temperature can well exceed twice the boiling point of water and you can imagine what that can do to some molecules. Liquid chromatography is more expensive and very few labs use it, including many labs that people outsource.
Now you might be wondering, why the heck is LMD giving us a damn chemistry lesson, we don't care! The reason is that the industry is in worse shape than you might think and I am attempting to reform it, slowly if necessary. If you don't think that the things you are putting in your body are a big concern then disregard this message. However, if you are truly concerned about your health and are curious about what truly could be contained in what you are taking then press forward. I have many studies on this but lets take a look at one of the most interesting.
Adulterants in Asian Patent Medicines
To the Editor: Asian patent medicines are one component of what are called traditional Chinese medicines. Asian patent medicines comprise multiple products, including herbs, plants, animal parts, and minerals, which are formulated into tablets, pills, or liquids for ease of use. They are widely available in herbal stores and have gained acceptance by the American public as a form of alternative medicine. However, many patent medicines manufactured in Asian countries contain toxic ingredients, such as heavy metals, as well as prescription drugs or unapproved ingredients that may or may not be identified on the label.1,2 Some have caused serious illness in unsuspecting consumers.3,4
The California Department of Health Services, Food and Drug Branch, initiated a study to screen imported Asian patent medicines for undeclared pharmaceuticals and heavy-metal contamination, using gas chromatography–mass spectrometry and atomic-absorption methods. Our objectives were to establish a computer data base for these products; educate the public, the herbal industry, and the medical community about the potential danger of Asian patent medicines; and provide objective information about toxicity.
Of 260 Asian patent medicines that have been collected from California retail herbal stores, 14 had labels that declared pharmaceutical ingredients, and 3 had insufficient sample amounts. Of the remaining 243 products, 17 (7 percent) contained undeclared pharmaceuticals. The most common undeclared ingredients were ephedrine, chlorpheniramine, methyltestosterone, and phenacetin. A total of 251 products were analyzed for lead, arsenic, and mercury; 9 other samples, including the 3 noted above, were insufficient for this analysis. Twenty-four products contained lead in a quantity of at least 10 parts per million (ppm) (range, 10 to 319; median, 29.8; mean, 54.9). Thirty-six products contained arsenic (range, 20.4 to 114,000 ppm; median, 180.5; mean, 14,553). Thirty-five products contained mercury (range, 22.4 to 5070 ppm; median, 329; mean, 1046); 2 of the 35 had labels that identified only pharmaceutical ingredients. The United States Pharmacopoeia limits heavy metals in most oral pharmaceuticals to 30 ppm, with lower limits for lead, arsenic, and mercury.
Of the 260 products we investigated, at least 83 (32 percent) contained undeclared pharmaceuticals or heavy metals, and 23 had more than one adulterant. The remaining products, which contained no detectable adulterants, cannot be assumed to be safe and free of toxic ingredients, in view of their batch-to-batch inconsistency, as well as limitations in our detection methods.
Richard J. Ko, Pharm.D., Ph.D.
California Department of Health Services
Sacramento, CA 94234-7320
Now I don't know about you but this absolutely startled me when I first read it. The sad thing is there is many like it. Lets look at what was actually stated. It states that many herbal compounds contained methyl testosterone! Before you go thinking that it is a plus, think about whether this was in your PCT product and how well that could have helped. One of the most startling values was one of the compounds contained arsenic concentrations of 114,000 ppm!!!!!! Arsenic is often used as a tool for murdering someone as it is very hard to detect the cause of death when the culprit is arsenic and it doesn't take all that much and is tasteless. The FDA does not allow arsenic above I believe 10 ppm. That means they had concentrations of arsenic 11,400x higher than what the FDA allows! It means you would have to take 11,400x more of an FDA monitored supplement to get the same amount of arsenic as in one of these bottles. The next value is mercury having over 5000 ppm of mercury. People are concerned with tuna fish in the can which has less than 30 yet some of these had 5000.
So what do I propose?
-Standardized testing practices. We need to ensure that ALL companies are using a US based independent lab for testing.
-Testing of heavy metals. This is something that VERY few people do and it is something that cannot be overlooked. I am more concerned about heavy metals than I am methyltestosterone. Heavy metals must be tested using atomic spectroscopy and not molecular spectroscopy, which everyone typically uses. I am not saying that all batches need to be tested but random tests of at least 25% of your stock should be made.
-The posting of C of A's from US based independent labs on their website so that batch numbers can be matched to analysis.
-Proper testing of compounds that lack analytical standards. This will be the hardest and last thing to probably come to light but is of importance to mention.
I am not saying that IBE currently does all of these things, but I promise you I am working towards it. I am trying to get all of our C of A's on our website possibly within the week or the month, depending on how well the webmasters work with me. I want to try and see others to follow in IBE's footsteps (some have already done so and I give them credit). I also would like to see you as the consumer push for these things. Remember it is YOUR health not theirs that can be affected and the direct effect could be very detrimental, especially later in life since heavy metals could be a concern.
Let me know how everyone feels about this. Thoughts, concerns, and suggestions. Together we can make the supplement industry safer and make the health of everyone better.