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CFSAN/Office of Food Additive Safety
April 2005
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach can be used if such approach satisfies the requirements of the applicable statutes and regulations. For questions regarding this document contact Andrew Zajac at FDA's Office of Food Additive Safety, Division of Petition Review (HFS-265), 5100 Paint Branch Parkway, College Park, Maryland, 20740-3835, 301-436-1267, andrew.zajac@fda.hhs.gov.
Additional copies of this guidance are available at http://www.cfsan.fda.gov/~dms/guidance.html
This document is intended to clarify FDA's procedures for conducting pre-petition consultations with stakeholders for new uses of food additives and color additives. These procedures will help ensure that pre-petition consultations are conducted efficiently and are as productive as possible.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Pre-petition consultations are interactions between FDA and industry pertaining to possible future food additive or color additive petitions. Pre-petition consultations are of two types: (1) Meetings with FDA to discuss the requirements and procedures for a future petition (e.g., regulatory requirements under 21 CFR 171.1 or 71.1), and (2) Information submitted to FDA for review and comment pertaining to a future petition (e.g., proposed data submission, test protocols, etc).
FDA encourages pre-petition consultations, including meetings, to facilitate the development of food additive and color additive petitions. A pre-petition consultation may be used to verify whether a petition is required or to ensure that the quality and quantity of information meets the minimum requirements for filing a petition. Pre-petition consultations are encouraged especially when there are questions about how to establish safe conditions of use. In addition, FDA recommends a pre-petition consultation when there are uncertainties about how certain data may be interpreted and when those uncertainties are of such magnitude that they may affect the outcome of the overall safety determination. For example, a consultation is recommended if different but reasonable interpretations of data in a bioassay could change the conclusion regarding the likely carcinogenicity of the substance.
FDA has issued a number of guidance documents related to the petition process that are available on our Website at http://www.cfsan.fda.gov/~dms/guidance.html. FDA believes that many questions related to preparing a petition can be answered by consulting these guidance documents. Therefore, stakeholders are urged to consult FDA's petition guidance before requesting a pre-petition consultation.
The following procedures should be followed for pre-petition meetings:
Pre-petition information submitted voluntarily to FDA (e.g., test protocols, analytical methods, toxicology or exposure assessment strategies, etc.) will be treated by FDA in the following manner:
Any information submitted to FDA is considered a record and is subject to Freedom of Information Act requests under 21 CFR Part 20. However, information submitted as part of a pre-petition consultation is considered information submitted voluntarily to the FDA relating to a developmental ingredient or product. In accordance with 21 CFR 20.111(d), such data and information ordinarily would not be available for public disclosure until referenced in a filed food additive or color additive petition. If pre-petition information is later referenced in a petition that has been submitted to FDA, that information would be subject to the disclosure provisions under 21 CFR 171.1(h) or 21 CFR 71.15, depending on whether the information is being referenced in a food additive or color additive petition.