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Our products are based on the fundamental principle that they be safe to the patient, without sacrificing effectiveness. We have purposely selected and developed ingredients and ingredient compositions which are safe because of either their food status or their long standing historical use. For our prescription medical food products, our ingredients meet the strict FDA safety standard of GRAS (Generally Recognized As Safe, see below). For our prescription drug products, our ingredients have been widely used in the U.S. and other countries for decades, and were classified as meeting certain FDA safety standards in the 1960’s.
Medical food ingredients are food ingredients and therefore must be Generally Recognized As Safe (GRAS). The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition and agreement on that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 CFR Section 582. Other ingredients may achieve self-affirmed GRAS status via a panel of experts who co-author a GRAS Report. Finally, a few ingredients have been specifically permitted by FDA as medical foods ingredients, e.g., Folic acid in Volume 21 CFR Section 172.345(f). Some experts believe achieving GRAS status is an even higher standard of safety than the standard applied to drug products where a given compound is considered safe for a particular indication in a particular patient population at a particular dose for a specified duration of use. While considered safe under these or similar limitations, most prescription drugs are not considered safe on a general (i.e., GRAS) basis.
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