The USP is a compendium of purity standards that can have a profound impact on the safety of nutritional supplements. Consumers and physicians who are serious about safety should become informed of what it means and how it is applied. Misunderstanding the USP standards can be dangerous.
USP stands for United States Pharmacopeia, a two-volume set of books that details safety limits for contaminants and the tests for consumable ingredients . The USP organization that establishes the standards and publishes the USP books seeks to cover a wide range of ingredients that are likely to be found in nutritional supplements, pharmaceuticals, and over-the-counter drugs. Closely aligned with the USP is the FCC, Food Chemical Codex, that overlaps the USP but pertains more to ingredients peculiar to processed food. A lot can be said about the organizations that establish these standards, but here we want to focus more on the standards themselves.
Each ingredient typically has a multipage monograph that specifies the acceptable limits for contaminants potentially found in ingredients, including the acceptable level of various heavy metal, organic volatile impurities, and microbiological infectious agents. In addition, specifications are provided for the testing techniques and instruments to be used. The USP takes no position on the benefits of an ingredient... only on the safety markers that need to be monitored.
The overall principle behind this service seems to be sound, and many other nations have adopted all or part of the USP. It needs to be noted, though, that many have not. Several of these are nations that have a long history of medical standards, including Britain (BP), Japan (JP), and the European Union (EP). It is true that they have much in common because they serve essentially the same industries and patient populations, and there is much overlap, but we believe there are serious differences.
To take, for example, the amino acid, L-Tryptophan, neither the USP nor the JP has changed their monograph much since 1990, when a rogue manufacturer in Japan succeeded in poisoning consumers. Over sixty one contaminants were identified in poisonous batches. No laboratory animal could be found that responded to these contaminants the way humans did, so the most toxic ones could not be pinpointed with certainty. The challenge that evolved, then, was to specify tests that would somehow encompass all of these contaminants, but in a way that was economically feasible, and would not put manufactureres out of business.
The point here is that the organizing body behind the EP has made remarkable efforts to identify the contaminants responsible for the poisonings, and, furthermore, to specify a battery of tests that is reasonable in cost. Back in 1990, none of the certifying organizations, JP, BP, USP, or EP had testing procedures or contaminant limits that would have stopped the poisonings. Today, only the EP seems to have made progress in this regard. This means that for much of the world, the same L-Tryptophan that caused the poisonings in 1990 would be certified as safe today.
We have had many conversations with scientists at the FDA and the CDC, and we have generated many HPLC chromatograms of L-Tryptophan from around the world, testing for the contaminant EBT - and some samples are truly scary - nevertheless, government financial backing for further research has dried up. So, what does this say about safety. As one chemist stated, "there still are monographs with holes you could drive a truck through."
Another caveat is that a certificate of analysis with the stamp USP, JP, BP or EP does not implies that an ingredient is safe for injections. There is a higher standard for that. Ingredients used in biological media in laboratories or in IV solutions must pass a test for pyrogens. Pyrogens are contaminants, known or unknown, that cause a fever or immune response when injected. Although some doctors purchase USP materials from chemical supply houses and prepare their own injectibles, this is not a good idea.
This is where a misunderstanding of USP or any other standard could be dangerous. The fact is that special testing must be undertaken to prove that pyrogens are within safe limits. Even so, such materials must be opened or unsealed only in clean-room environments. If not, all bets are off because disease-causing particles in an average room are nearly everywhere in the air, and if injected would simply bypass a huge part of your defense systems.
The bottom line here, from our perspective as a manufacturer of health-promoting products, is that there is no single authority, no single book, and no single test that gives an easy answer to quality and safety. Quality control is a continuous process of learning and implementing safeguards.
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