Structured Product Labeling for Food and Dietary Supplements (SPLr8)

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Project Number 1229

Project Name Structured Product Labeling for Food and Dietary Supplements (SPL r8)

Project Sponsor(s) RCRIM Work Group

Description

The purpose of this project is to ensure that the structured product label V3 artifact includes all of the necessary data elements for food and dietary supplements. The goal is to allow the electronic transmission of foods, branded food products, dietary supplements and botanicals. The dietary supplements and botanicals are included to encompass those products that are currently not available in the medicinal structured product label standards. The following types of data elements will be included in the V3 DMIM: nutrient composition, ingredients, allergens, product image and GTIN barcode (GS1 standard).

| Project Scope Statement - Project 1229

Objectives / Deliverables

• To develop requirements for data elements and other functional requirements for complete electronic transmission of information contained in a food or dietary supplement label. Requirements developed will then enable a gap analysis with the current structured product labeling standard for drugs (SPL r7).

Meeting Details

Mondays from 4-5 PM Eastern

Conference Call Information: Phone Number: +1 770-657-9270 Participant Passcode: 7485962

Web Meeting Info (does not include audio connection) website Meeting ID 193 128 608 (no password).

Direct Meeting Link: Link

Next scheduled meeting: Monday, April 25, 2016 at 4 PM EDT

Meeting Agendas/Minutes

• SPL r8 Minutes for 2016-2-8

• SPL r8 Minutes for 2016-2-15

• SPL r8 Minutes for 2016-2-22

• SPL r8 Minutes for 2016-2-29

• SPL r8 Minutes for 2016-3-7

• SPL r8 Minutes for 2016-3-14

• SPL r8 Minutes for 2016-3-28

• SPL r8 Minutes with AAAAI Sub-Group for 2016-3-30

• SPL r8 Minutes with AAAAI Sub-Group for 2016-4-18

• SPL r8 Minutes for 2016-4-25

Project Requirements

Structured_Product_Labeling_for_Food_and_Dietary_Supplements_V_1.0_2016_5_15_FINAL_no_pictures.xlsx

• Project Requirements Document: *FINAL Requirements Spreadsheet 2016-5-15

• Project Requirements Document: *DRAFT Requirements Spreadsheet 2016-3-1

• Project Requirements Document: *DRAFT Requirements Spreadsheet 2016-3-13

• Project Requirements Document: *DRAFT Requirements Spreadsheet 2016-3-27

• Project Requirements Document: *DRAFT Requirements Spreadsheet 2016-3-28

• Project Requirements Document: *DRAFT Requirements Spreadsheet 2016-4-19

• Updated Project Requirements Document: *DRAFT Requirements Spreadsheet 2016-5-9

Project References

• FDA Food Label Guide: FDA Food Label Guide

• NIH Dietary Supplements Database: | Dietary Supplements Label Database

• FDA Dietary Supplement Labeling Guide: Supplement Labeling Guidance for Industry

• Allen etal. Precautionary labeling of foods for allergen content: are we ready for a global framework? World Allergy Organization Journal 2014, 7:10 Link