I don't think that's necessarily correct as to nutritional supplements not being tested - AFAIK, the FDA does require testing to justify whatever label claim is being made, such as 1000 mg Vitamin C per capsule, as well as maintaining records of such testing and following certain rules related to GMP - Good Manufacturing Practices.
On an actual OTC drug product, such as an antacid, I can verify there are extraordinarily strict FDA requirements in place - we were audited by the FDA at the Tums plant in St. Louis last year. It lasted the better part of a week, and I was impressed by how thorough the audit was despite being led by a newer auditor still in the process of being certified by the agency. We did extremely well, which I didn't find surprising - I've never worked anywhere as focused on quality as the Tums site is.
On Tums, we do laboratory testing to verify the label claim (either 500 mg, 750 mg, or 1000 mg of calcium carbonate per Tums tablet), as well as the corresponding acid neutralization capacity at each strength. Part of my job is reviewing that testing data. An outsider would be dumbfounded at the strictness of the rules we have to follow even though it's just an OTC drug. I worked once at another pharma company making much higher tech products, and it was very much the same environment.
On the supplements mentioned, I'm very much familiar with the omega-3 situation - these fatty acids have multiple double bonds and are extremely susceptible to damage in the manufacturing process. I used to buy cheap fish or flaxseed oil at Target, but with all the reading I've done, I no longer do. Currently, I'm using what appear to be carefully made flaxseed oil capsules (containing alpha-linolenic acid, an 18-carbon omega-3 with three double bonds), and fish oil capsules (containing eicosapentaenoic acid [EPA] - an omega-3 with 20 carbons and five double bonds, and docosahexaenoic acid [DHA] - an omega-3 with 22 carbons and six double bonds).
It states on the flaxseed oil label that the product is made from organic flax seed oil that is cold-pressed and unrefined. Those processing conditions will greatly protect the double bonds if true. I'm inclined to believe the label information is correct because the liquid itself in the capsules is a dark reddish brown, indicating to me that is unrefined. This product would be totally unsuitable as a cooking oil because of certain molecules that have not been removed and would exhibit undesirable characteristics when heated. Refining cooking oils is usually a complicated industrial process intended to remove molecules negatively affecting cooking performance. They are usually light in color at the end of the process but can suffer double bond damage from all that processing, as well as potential UV damage from typically being sold in clear plastic bottles.
The oil in the fish oil capsules I have go through a molecular disassembly and reassembly process at the manufacturer, mainly to improve purity and increase EPA and DHA content, I gather. While expensive and ostensibly high quality, I actually have more confidence in the quality of the flaxseed oil because it's less apparent to me what processing conditions were actually used in manufacturing the fish oil. If I have all the necessary micronutrients in my body and everything is working optimally, I should be able to turn the alpha-linolenic acid in the flaxseed oil myself into the two special oils contained in the fish oil, which are extremely important for good health. But I'm not positive I can actually do that, hence my use of this fish oil product.
Ah very interesting! I didn’t know about the GMP thing and you are right that apparently it is mandatory for all supplements. However Claude adds “The FDA requires manufacturers to have testing protocols under GMP (21 CFR 111), but doesn’t review or approve the results before sale. The manufacturer self-certifies. That’s fundamentally different from the Tums situation where FDA auditors actively review testing data. The supplement version is more like “keep records in case we ever audit you” — and those audits are infrequent given 80,000+ products and limited FDA resources.”
Well, my job is actually reviewing the testing data - FDA has the freedom to audit my work and that of the chemical analysts, as well as any other aspect of the process they want to examine, such as manufacturing, packaging, calibration, and training records, shredding procedures for documents, how deviations are handled, how clean the plant is, etc., etc. That scrutiny is due to our technically making a "drug product," even if you don't need a prescription to buy Tums tablets.
More on supplement regulations from a book I am currently reading: Your Blood Never Lies by James B. LaValle RPh, CCN, 2013, Page 9:
"Supplements should be GMP-certified. With the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements were placed under Food and Drug Administration (FDA) regulation, and manufacturers were required to follow good manufacturing practices (GMPs). In order to be considered a GMP-certified manufacturer, a company must be regularly inspected by two third-party organizations, such as the Natural Products Association and NSF International."
In my own case, I just ordered some supplements from Amazon manufactured by Now and Nutricost - both companies indicate on their bottles that the product complies with GMP standards. One is the flax seed oil I use, and the other is Vitamin B2.
If you're wondering the difference between a supplement and drug, I don't know if there is an official one, but in general terms, I would characterize drugs as altering the functioning of biological systems from what they would be otherwise, whereas supplements may contain, for instance, vitamins and minerals essential for normal functioning of the body and good health. An antacid tablet is a drug because it lowers stomach acidity that may be causing discomfort or a potential health issue if it persists chronically in an individual, while Vitamin C is in itself essential for normal functioning of the body and good health. Perhaps surprisingly, most mammals can make their own Vitamin C - humans are one of the few mammalian species who cannot, along with other apes, guinea pigs, and certain species of bats.
I don't think that's necessarily correct as to nutritional supplements not being tested - AFAIK, the FDA does require testing to justify whatever label claim is being made, such as 1000 mg Vitamin C per capsule, as well as maintaining records of such testing and following certain rules related to GMP - Good Manufacturing Practices.
On an actual OTC drug product, such as an antacid, I can verify there are extraordinarily strict FDA requirements in place - we were audited by the FDA at the Tums plant in St. Louis last year. It lasted the better part of a week, and I was impressed by how thorough the audit was despite being led by a newer auditor still in the process of being certified by the agency. We did extremely well, which I didn't find surprising - I've never worked anywhere as focused on quality as the Tums site is.
On Tums, we do laboratory testing to verify the label claim (either 500 mg, 750 mg, or 1000 mg of calcium carbonate per Tums tablet), as well as the corresponding acid neutralization capacity at each strength. Part of my job is reviewing that testing data. An outsider would be dumbfounded at the strictness of the rules we have to follow even though it's just an OTC drug. I worked once at another pharma company making much higher tech products, and it was very much the same environment.
On the supplements mentioned, I'm very much familiar with the omega-3 situation - these fatty acids have multiple double bonds and are extremely susceptible to damage in the manufacturing process. I used to buy cheap fish or flaxseed oil at Target, but with all the reading I've done, I no longer do. Currently, I'm using what appear to be carefully made flaxseed oil capsules (containing alpha-linolenic acid, an 18-carbon omega-3 with three double bonds), and fish oil capsules (containing eicosapentaenoic acid [EPA] - an omega-3 with 20 carbons and five double bonds, and docosahexaenoic acid [DHA] - an omega-3 with 22 carbons and six double bonds).
It states on the flaxseed oil label that the product is made from organic flax seed oil that is cold-pressed and unrefined. Those processing conditions will greatly protect the double bonds if true. I'm inclined to believe the label information is correct because the liquid itself in the capsules is a dark reddish brown, indicating to me that is unrefined. This product would be totally unsuitable as a cooking oil because of certain molecules that have not been removed and would exhibit undesirable characteristics when heated. Refining cooking oils is usually a complicated industrial process intended to remove molecules negatively affecting cooking performance. They are usually light in color at the end of the process but can suffer double bond damage from all that processing, as well as potential UV damage from typically being sold in clear plastic bottles.
The oil in the fish oil capsules I have go through a molecular disassembly and reassembly process at the manufacturer, mainly to improve purity and increase EPA and DHA content, I gather. While expensive and ostensibly high quality, I actually have more confidence in the quality of the flaxseed oil because it's less apparent to me what processing conditions were actually used in manufacturing the fish oil. If I have all the necessary micronutrients in my body and everything is working optimally, I should be able to turn the alpha-linolenic acid in the flaxseed oil myself into the two special oils contained in the fish oil, which are extremely important for good health. But I'm not positive I can actually do that, hence my use of this fish oil product.
Ah very interesting! I didn’t know about the GMP thing and you are right that apparently it is mandatory for all supplements. However Claude adds “The FDA requires manufacturers to have testing protocols under GMP (21 CFR 111), but doesn’t review or approve the results before sale. The manufacturer self-certifies. That’s fundamentally different from the Tums situation where FDA auditors actively review testing data. The supplement version is more like “keep records in case we ever audit you” — and those audits are infrequent given 80,000+ products and limited FDA resources.”
Well, my job is actually reviewing the testing data - FDA has the freedom to audit my work and that of the chemical analysts, as well as any other aspect of the process they want to examine, such as manufacturing, packaging, calibration, and training records, shredding procedures for documents, how deviations are handled, how clean the plant is, etc., etc. That scrutiny is due to our technically making a "drug product," even if you don't need a prescription to buy Tums tablets.
More on supplement regulations from a book I am currently reading: Your Blood Never Lies by James B. LaValle RPh, CCN, 2013, Page 9:
"Supplements should be GMP-certified. With the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements were placed under Food and Drug Administration (FDA) regulation, and manufacturers were required to follow good manufacturing practices (GMPs). In order to be considered a GMP-certified manufacturer, a company must be regularly inspected by two third-party organizations, such as the Natural Products Association and NSF International."
In my own case, I just ordered some supplements from Amazon manufactured by Now and Nutricost - both companies indicate on their bottles that the product complies with GMP standards. One is the flax seed oil I use, and the other is Vitamin B2.
If you're wondering the difference between a supplement and drug, I don't know if there is an official one, but in general terms, I would characterize drugs as altering the functioning of biological systems from what they would be otherwise, whereas supplements may contain, for instance, vitamins and minerals essential for normal functioning of the body and good health. An antacid tablet is a drug because it lowers stomach acidity that may be causing discomfort or a potential health issue if it persists chronically in an individual, while Vitamin C is in itself essential for normal functioning of the body and good health. Perhaps surprisingly, most mammals can make their own Vitamin C - humans are one of the few mammalian species who cannot, along with other apes, guinea pigs, and certain species of bats.