GRAS Ingredients - What They Are

Medical food ingredients are food ingredients and therefore must be Generally Recognized As Safe (GRAS).

The category that describes all edible foods as GRAS was established in 1958 by the FDA as Food, Drug, and Cosmetic Act of 1938. The original GRAS list contained over 700 foods and food additives that had stood the test of time and of public consumption, and were believed to be harmless. Any food item in common use in the U.S. before 1958 is "grandfathered" in as GRAS. Understanding the GRAS status of Limbrel's ingredients is important since this is a major qualification to be considered a safe and consumable medical food (MF).

Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 CFR Sections 182, 184 and 186. Other ingredients may achieve self-affirmed GRAS status via a panel of experts who co-author a GRAS Report. 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. 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 FDA recognized 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. GRAS denotes safe use by sometimes million of people, as food ingredients.

It is well-recognized that all drugs have some side-effects for some percentage of the population, and the concept of "safety" for pharmaceuticals is a relative assessment based on a risk/benefit analysis, such that a harmful drug for terminal cancer patients, for example, may still be approved. As such, drugs and drug ingredients are not GRAS, whereas MFs have up-front inherent safety due to the GRAS requirement for all ingredients, and in some cases also based on centuries of traditional use of certain ingredients.