Effects of GRAS substances on pharmacologic effects of drugs.

Abstract

First, let me explain what GRAS means. GRAS is an acronym for “generally recognized as safe.” It refers to a large number of chemical compounds that the FDA considers to be safe when added to foods. The legal basis for GRAS status is rather complicated and goes back over many years to early federal regulations dealing with food additives. In 1958 the FDA solicited opinions from the scientific community about the usefulness and safety of all the substances then added to foods, and in 1959 and 1960 had lists published in the Federal Register of those that were considered GRAS and had not received adverse comments.! No further testing of the safety of these initial GRAS compounds was required, but any new additions to the list were expected to be adequately evaluated for usefulness and safety. Over the years, GRAS status was granted to other compounds by the FDA officials by letters of approval, and the present number of GRAS substances is probably in excess of 700 compounds. There are also approximately 1,200 natural and synthetic flavoring agents added to foods which are generally recognized as safe by scientific experts but listed separately in the Code of Federal Regulations.2