Letter from the Publisher
In July, the US Food and Drug Administration (FDA) drafted a guidance document for industry on dietary supplements. Although the document is a draft with “non-binding” recommendations, the wording is very formal and appears ready to be implemented. The “guidance” calls for manufacturers of food supplements to report to the FDA the ingredients of all supplements marketed after 1994. The purpose of the report is to notify the FDA that food supplement ingredients are being manufactured by a specific company and to provide data to the FDA that the “new dietary ingredients” (NDIs) are safe. The guidance draft differentiates between a dietary ingredient that is wholly derived from a food and an ingredient that has undergone chemical processing. In the event that there has been enzymatic or chemical manipulation of the food or botanical ingredient, a statement is required explaining the exact manufacturing process. As a whole, the reporting process appears to be more than onerous and time-consuming – for those “new dietary ingredients” that lack safety documentation based on historical use, the FDA is requiring expensive, multistep, multiorganism, lengthy safety studies.
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