Contains Nonbinding Recommendations
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), 5001 Campus Drive, College Park, Maryland, 20740-3835, 301-436-1267 (Updated phone: 240-402-1267), firstname.lastname@example.org.
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)† Guidance Documents. 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:
- A request for a pre-petition meeting should be made in writing (either letter, Email, or facsimile) to FDA's Office of Food Additive Safety (OFAS) at least three weeks prior to when the sponsor would like to meet with FDA. The request should provide an agenda with a brief discussion of the purpose of the meeting (i.e., what the requestor would like to accomplish), a list of the non-FDA individuals that are expected to be in attendance, an estimate of the amount of time needed, and proposed dates for the meeting. The stated purpose of the meeting will be used to determine the technical expertise from FDA that will be needed at the meeting. In addition, it is mutually beneficial if supporting information is submitted when the meeting is first requested to provide FDA's staff with sufficient time to prepare for the consultation.
- After FDA receives the request, it will be logged into FDA's document tracking system and assigned a file number. A consumer safety officer (CSO) within OFAS will be assigned the request and will be responsible for coordinating and arranging the meeting.
- The CSO will usually be responsible for taking notes of the discussion and will prepare minutes of the meeting (usually within three weeks of the date of the meeting). The minutes will be complete and concise and represent what transpired at the meeting with emphasis on any commitments made. The minutes will not be so detailed as to constitute a transcript of the meeting. The minutes will be reviewed and initialed by the other FDA personnel in attendance at the meeting, and a copy will be placed in the file established for the pre-petition consultation.
Pre-Petition Information Submitted to FDA
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:
- Pre-petition information may be submitted in hard copy or in electronic format to OFAS. If any part of the material submitted is in a foreign language, it should be accompanied by an accurate and complete English translation. If the sponsor would like a Color Additive or Food Additive Master File established for the information, this should be stated in the transmittal letter. All pre-petition information will be logged into FDA's document tracking system and assigned a file number.
- If a Master File has been established for the information, FDA will send a letter informing the sponsor of the Master File number to which the information has been placed.
- A CSO within OFAS will be assigned to serve as the official contact point and overseeing FDA's review of the information and developing and issuing any response.
- Resources permitting, FDA intends to respond to all requests for comment on pre-petition information with a view toward efficient filing of food additive and color additive petitions. With some exceptions (e.g., reports of large toxicological studies), FDA intends to respond to such requests in writing within 90-days of receipt subject to available resources and workload. While there are statutory time frames associated with processing petitions, there are no such deadlines for pre-petition submissions. Priority will be given to petitions over pre-petition submissions; as a result there may be situations when the agency is unable to respond within 90-days to pre-petition submissions.
- Any response is based on currently available information. New information may change FDA's view. After FDA's response letter has been issued to the requestor, the Agency may become aware of additional information about the subject additive. If additional information raises questions that bear on the safety of the substance, FDA may subsequently advise the requestor.
DISCLOSABILITY of INFORMATION RELATED to a PRE-PETITION CONSULTATION
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.
† Updated web reference: Food Ingredients and Packaging