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There’s at the very least one exception to that rule, however. If an organization desires to use what the FDA calls a “new dietary ingredient”-meaning an ingredient that was not marketed in supplements within the US earlier than October 15, 1994-it will need to have proof for concluding the substance can moderately be anticipated to be secure for folks to soak up a supplement. Either the supplement’s ingredient must have been a part of the food provide in its present type, or the company needs to provide its proof for the FDA to evaluate at the least 75 days before it introduces the complement to the market. The main ingredient in Prevagen is a synthetic copy of the jellyfish protein referred to as apoaequorin, and is made solely in a lab. It had by no means been a part of the human food regimen, not to mention sold in supplements. But as a substitute of submitting the documents with the required 75 days’ notice, Underwood signed the mandatory forms on August 31, 2007, simply at some point earlier than Quincy Bioscience started selling Prevagen, in line with a copy of the file obtained by WIRED.