The usual mechanism to establish that scientific information is generally available is to show that the information is published in a peer-reviewed scientific journal. However, mechanisms to establish the basis for concluding that there is expert consensus about the safety of a substance are more varied. In some cases, publication in a peer- reviewed scientific journal of data such as toxicity studies on a test substance has been used to establish expert consensus in addition to general availability.
In other cases, such publication of data and information in the primary scientific literature has been supplemented by:.
Such consensus does not require unanimity among qualified experts For example, FDA would evaluate a single published report questioning the safety of use of a substance in food in the context of all the publicly available and corroborative information rather than conclude that such a report automatically disqualifies the substance from satisfying the GRAS standard Cf. Coli-Trol 80, supra, F. The rulemaking process in Sec.
To the extent that a person elected to submit a GRAS petition, the process could facilitate an awareness, by the agency as well as the domestic and international food industry, of independent GRAS determinations. However, GRAS affirmation involves the resource-intensive rulemaking process, including:. FDA believes that, in practice, this resource-intensive process deters many persons from petitioning the agency to affirm their independent GRAS determinations.
This material is intended for educational purposes only. It is not a substitute for competent legal counsel. Seek appropriate professional advice for answers to your specific questions. This material is protected by U. E-Mail agecinf ndsuext. Overview of GRAS. Best if printed in landscape. Background A. The Amendment In , in response to public concern about the increased use of chemicals in foods and food processing and with the support of the food industry, Congress enacted the Food Additives Amendment the amendment to the act.
The amendment defined the terms " food additive " section s of the act 21 U. Under the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a food additive and is subject to pre-market approval by FDA unless the use of the substance is generally recognized as safe GRAS; the GRAS provision or otherwise excepted from the definition of food additive — e. If you go into the courthouse, who is an expert? How many would have to agree to be generally recognized?
Valerio, Jr. This picture is a graphical representation of a timeline starting in when the Pure Food and Drug Act was passed. Under the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a food additive and is subject to pre-market approval by FDA unless the use of the substance is generally recognized as safe GRAS; the GRAS provision or otherwise excepted from the definition of food additive - e.
FDA issued this proposed rule to enable the agency to use its resources more efficiently and effectively. In that proposed rule, FDA invited interested persons who conclude that a use of a substance is GRAS to notify us of those conclusions during the interim between the proposed and final rules the interim period. FDA stated that the agency would determine whether its experience in administering GRAS notices suggests modifications to the proposed notification procedure.
In general, FDA's response has fallen into one of three categories:. The notice does not provide a basis for a conclusion of GRAS status. At the notifier's request, FDA ceased to evaluate the notice.
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