2017 BI-ANNUAL NEWSLETTER
Following is the INCA 2017 Bi-Annual Newsletter, which provides accomplishments and progress reports on Board priority activities and Committee action plans. As appropriate, each priority/goal is noted, followed by progress to date.
BOARD PRIORITY: COMMUNICATIONS AND REPUTATION MANAGEMENT
Core Communication Activities
- Following updates from the Board in Q1 and Q2 regarding the Communications budget and plan, the Communications Steering Committee (CSC) updated the 2017 Communication Plan, including establishing new approved priorities, with appropriate measures of success.
- Staff has also continued with core communications activities, which include daily online monitoring of key infant nutrition topics (traditional and social media), maintaining infantnutrition.org and providing Communication support across INCA committees.
- Communications staff has taken a more active role working cross-functionally with other INCA Committees to ensure consistent messaging and branding for all forward facing communications (ex: INCA positions on industry issues, media statements, event collateral, etc.). As appropriate, staff will share and update the CSC.
Priority #1: Reactive Reputation Management:
Following the direction of the Board, the CSC shifted the focus of INCA’s media relations efforts to reactive, positioning INCA as a trusted media resource for credible and balanced information.
- Staff provided reactive responses for the following media requests:
- For each of these requests, Staff was able to provide a balanced point of view, shifting the tone of each story from a negative or neutral one, to a fair and balanced one.
- Staff updated all INCA media statements to ensure proper branding and the inclusion of updated spokesperson titles. The most updated INCA media statements have been uploaded to the Member’s Section of org.
- Due to often quick turnaround times for reactive media requests, staff worked with the CSC, along with internal Committee leads, to identify overarching standby statement topics for issues which have garnered regular media attention/or which have the potential for media attention based on the current climate.
- While focusing on reactive reputation management is our priority, Staff wanted to insure that key media outlets were aware of INCA. Working with the CSC, Staff developed a list of 20 key media outlets to introduce INCA as a media resource for possible early engagement opportunities, and reactive outreach when appropriate. Elements taken into account when developing the list include online reach, print circulation, syndication, location (ensuring the regional representation), and previous coverage of infant nutrition topics.
Priority #2: INCA as an Online Resource Center for Infant Nutrition
- It was decided by the Board that parents should no longer be a target audience for INCA communications, and that the media, KOLs and healthcare professionals would become the primary focus. Based on the direction of the Board, org was reorganized in order to speak to these new audiences. Additionally, added INCA expert bios to the website, and created a section to post position papers developed by INCA’s scientific committees.
- Leveraging the list of 20 key media outlets identified by the CSC, Staff has begun drafting INCA branded email blasts that introduce INCA as an infant nutrition resource and driving them to the website. These will be distributed at the end of Q3.
- In coordination with the CSC, staff developed a list of topics to create website content in the form of Fact Sheets, slide shows and articles.
- Staff continues to maintain a current and updated front page, updating it on a bi-weekly basis with relevant INCA content and infant nutrition news.
Priority #3: Crisis Preparation and Planning
- Staff reviewed historic documents and consulted with other food and nutrition associations in order to craft a plan tailored to INCA. Staff continues to research and develop an outline to build upon.
- A set of parameters were established to identify what is considered a crisis situation vs an issue that requires a media statement response. It was agreed upon by the CSC that issues or scenarios that impact the industry-at-large (ex: widespread contamination of an ingredient, or a mass product recall) and threaten the reputation of the industry would require a crisis plan to be implemented. The plan will be rolled out to the Board in advance of the final Board call.
- Because social media is not a part of INCA’s communications plan, discussion has begun about how to best leverage social media during a crisis.
- In an effort to identify and prepare for an issue before it’s upgraded to a crisis, Staff has begun to implement advanced monitoring of online and social conversations. Keywords related to infant nutrition issues were identified and, staff worked closely with the digital team to incorporate them into the program and monitor them on a consistent basis.
Priority #4: Liaison for Communications Teams of KOLs:
It was agreed upon by the Board that INCA would continue to engage KOLs in an effort to build relationships and help establish INCA as the voice of the infant formula industry and reinforce the association as a respected and trusted resource for infant nutrition/feeding. That outreach included engaging key KOL communication teams from the American Academy of Pediatrics (AAP), Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA), as well as leverage relationships with member companies
- Following April’s Board call, the CSC discussed leveraging INCA as a KOL for member companies; however, after speaking with their corporate communication teams, it became clear that most member companies will be unable to leverage INCA quotes and online content via company communications and/or via owned platforms due to internal policies and practices. The CSC therefore agreed to adjust the Priority 4 tactics to only target KOL communication teams from the AAP, CDC and FDA, no longer leveraging member companies as KOLs.
- A goal was put in place at the beginning of Q2 to engage these KOLs each quarter, and obtain a response from at least two KOLs and have at least one KOL initiate communication.
BOARD PRIORITY: PREGNANCY AND BIRTH TO 24 MONTH (B-24) DIETARY GUIDELINES
Goal: Communicate science-based information and participate in the Dietary Guidelines development process.
- Staff continues to seek opportunities to participate in the process (e.g., monitoring the B-24 evidence review and congressionally mandated review of the process by the National Academies of Sciences, Engineering, and Medicine (NASEM)).
- Staff attended public workshops of the NASEM Committee to Review the Process to Update the Dietary Guidelines for Americans, whose recommendations will be considered by the Dietary Guidelines Advisory Committee.
- INCA is reviewing recommendations presented during the Robert Wood Johnson Feeding Guidelines Webinar, and other established infant feeding recommendations, for key topics of interest.
Goal: Align with like-minded organizations (e.g., food industry, nutrition, healthcare provider (HCP), regulatory) and advocate the inclusion of science-based recommendations for infant and toddler feeding.
- INCA continues to participate in industry coalitions addressing the Dietary Guidelines for Americans, led by the Grocery Manufacturers Association and Food Directions, and provides perspectives related to young infants (0-6 months of age).
- Industry coalitions have met with federal staff to address concerns of the timing and lack of transparency regarding the B-24 project.
Goal: Be a trusted resource and thought leader in advancing optimal infant nutrition, the role of infant formula, and information on infant feeding and nutrition to help ensure parents and caregivers receive appropriate support for their infant feeding decisions.
- INCA co-sponsored the American Society of Nutrition (ASN) Pediatric Nutrition Networking Reception which followed an afternoon of symposia related to pediatric nutrition at the 2017 Experimental Biology (EB) meeting to introduce INCA to nutrition researchers. A background on INCA and B-24 Dietary Guidelines were provided to interested attendees.
Goal: Explore possible impact of Dietary Guidelines on nutrition-based policies and funded programs (e.g., WIC, SNAP).
- This activity is on hold pending publications from the USDA Nutrition Evidence Library that may indicate changes to nutrition-based policies and funded programs.
FEEDING AND NUTRITION POLICY COMMITTEE
Goal: Positively impact the process for developing Dietary Guidelines for Infants and Young Children (i.e., B-24 Project) to reflect a balanced approach to infant feeding.
- INCA has drafted recommendations on five key infant feeding topics for submission during the B-24 Guidelines development process.
- INCA submitted a symposium proposal for the American Society of Nutrition (ASN) 2018 annual meeting, which is under review.
- INCA continues to discuss the need for a B-24 related program that includes other societies including the American Academy of Pediatrics (AAP) and the Academy of Nutrition and Dietetics (AND), following a previous suggestion for a program sub-committee specific for B-24.
Goal: Work to drive aligned US Government recommendations for safe infant formula preparation that incorporate sound scientific support.
- INCA followed up with the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) regarding the status of U.S. Government agency alignment on recommendations for preparing powdered infant formula. Inter-agency discussions are on-going.
- INCA has identified two collaborative opportunities to encourage continued alignment with healthcare providers on infant formula preparation methods and support U.S. Government agency alignment:
- INCA was invited to provide input on the upcoming revisions of the AAP Pediatric Nutrition Handbook. Interested members are sharing relevant research with Russell Merritt, MD, PhD who will be authoring the infant formula chapter.
- INCA staff has reviewed and will provide feedback on the AND Pediatric Nutrition Practice Group’s resource “Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities”), specifically the chapters “Formula Preparation and Handling” and “Microbiology and Infection Prevention.”
Goal: Communicate INCA members’ strong and ongoing commitment to the advancement of product quality, safety, and best practices.
- INCA coordinated with the Healthcare Nutrition Council (HNC) to develop and submit joint comments in response to FDA’s draft guidance for industry and scientific review related to the Agency’s review of non-digestible carbohydrates for consideration to be termed dietary fibers.
- INCA submitted a list of relevant publications for an upcoming Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Center (EPC) “Systematic Review of Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries” that is expected to include comparisons to infant formula feeding.
- Staff monitors and shares relevant research and public notices related to infant formula and infant feeding practices. To date, staff has shared summaries, and in some cases critiques, of 10 studies. The member’s only library was updated with 297 abstracts of relevant studies.
Priority: Codex Alimentarius
Goal: Successfully advocate industry positions at Codex level
- Codex Committee on Food Additives (CCFA): In March, INCA staff and members actively participated in the 49th CCFA Session in Macao SAR, China. Staff met with the U.S. delegation before the meeting to provide industry positions, which incorporated INCA member input. During the meeting, CCFA agreed to maintain gellan gum on the Joint FAO/WHO Expert Committee on Food Additives (JECFA) priority list, which was the position of INCA and supported by the U.S. delegation.
- Codex Committee on Contaminants in Foods: In April, INCA members participated in the 11th CCCF Session in the Netherlands. One item of interest was the work on 3-MCPD and glycidyl esters (GE) in infant formula, and INCA supported the initiation of new work to develop a Code of Practice for the reduction of 3-MCPD and GE in infant formula rather than establishing a Maximum Level (ML). The Committee agreed to this approach and an electronic Working Group (eWG), led by the U.S., was formed to develop the Code of Practice. INCA will work through the International Special Dietary Foods Industries (ISDI) to participate in this eWG.
- Codex Committee on Methods of Analysis and Sampling: In May, INCA members participated in the 38th CCMAS Session in Hungary, where a number of the analytical methods developed through the INCA/AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) project were considered. Prior to the meeting, INCA worked with SPIFAN stakeholders to develop positions related to the methods, which were shared with the U.S. and other key delegations. Staff also participated in the U.S. public meeting to prepare for CCMAS. As a result of INCA’s actions, all SPIFAN methods that were considered (i.e., vitamin B12, total fatty acid profile, vitamin E, myo-inositol, chromium/molybdenum/selenium and vitamin C) were endorsed by CCMAS and were adopted as Type II methods by the Codex Alimentarius Commission (CAC) in July.
- Codex Committee on Nutrition and Foods for Special Dietary Uses: In advance of the December 2017 CCNFSDU meeting, staff has been in contact with the U.S. delegation on several items of interest, including the guidelines for ready-to-use therapeutic foods (RUTF). Staff has shared the final ISDI responses to both consultations with the U.S. delegation, and encouraged their support. Staff has also shared a background document on the technological use of food additives in infant formula ahead of the first consultation from the CCNFSDU eWG on food additives with the U.S. delegation. This background document was prepared by INCA and ISDI members and staff.
Priority: Revision of the Codex Follow-up Formula (FUF) Standard
Goal: Regulatory decisions that reflect industry positions
- As of June 2017, the CCNFSDU eWG working to revise the FUF Standard has held two consultations on scope and labeling and one additional consultation on nutrient composition for the two sections of the Standard for 6-12 months and 12-36 months. INCA staff and members have participated in the development of the ISDI positions on all three consultations.
- The INCA/ISDI final responses for the consultations on scope and labeling were shared with the U.S. delegation and, for the first consultation, staff and members held a conference call with the U.S. delegation to review the positions. The U.S. delegation is aligned on key industry positions, including that there should be no reference to the World Health Assembly (WHA) or World Health Organization (WHO) resolutions and texts in Codex standards, such as the FUF Standard.
- With regard to the consultation on the remaining nutrient composition aspects, while INCA could not gain alignment on positions for protein and DHA for the 6-12 month section of the standard, there is general alignment between industry and U.S. positions on the 12-36 month section.
Priority: ISDI Participation
Goal: Ensure INCA views are reflected in ISDI activities
- INCA staff and members continue to actively participate in ISDI activities, including conference calls and meetings, and attended the March ISDI General Assembly in Brussels.
- Staff and members participate in all ISDI Working Groups and staff is represented on the ISDI Board and leads the Food Safety Working Group.
LEGISLATIVE AND REGULATORY COMMITTEE
Goal: Identify, recruit and work with at least one champion from the House and Senate to achieve a tangible action.
- INCA worked with Representative Jackie Walorski (R-IN) and other stakeholders to draft and send a letter to Health and Human Services (HHS) Secretary Dr. Tom Price regarding the World Health Organization’s (WHO) Guidance on Ending the Inappropriate Marketing of Foods to Young Children and encourage a more inclusive U.S. Government process to develop and relay policy positions to WHO. INCA was successful in getting additional Members of Congress to sign onto the letter, and Representative Walorski urged Dr. Price to oppose the WHO Guidance during a June Committee hearing.
- INCA has held introductory meetings with 16 House and Senate offices, held several follow up meetings and have identified relevant offices/staff for additional follow up. Topics of interest include workforce modernization, the B-24 Dietary Guidelines, regulatory reform, and healthcare provisions related to maternity care.
- INCA has drafted letters of support for two pieces of federal legislation: the Preventing Maternal Deaths Act (HR. 1318) and the Friendly Airports for Mothers Act (S.1110 / HR. 2375). These letters have been shared with relevant Congressional offices along with requests to co-sponsor the legislation.
Goal: Identify, recruit and work with at least one respected third-party champion to engage on behalf of INCA.
- INCA signed onto a Healthcare Nutrition Council (HNC) letter to the editor of the Food and Drug Law Journal correcting an inaccurate article regarding medical foods industry best practices. The letter was also signed by the Council for Responsible Nutrition.
- INCA is looking to engage with additional stakeholders to draft and send a Congressional letter requesting more transparency in the B-24 process.
Goal: Positively influence at least one regulatory priority.
- INCA developed a list of all regulations/guidance documents for possible reform for prioritization and possible actions.
- INCA formed a Steering Committee which prioritized the U.S. Food and Drug Administration’s (FDA) Guidance on the Substantiation of Structure/Function Claims in Infant Formula Labeling. Next steps include development of INCA positions and meeting with FDA staff.
Goal: Initiate congressional oversight of the B-24 process.
- Staff shared general information about B-24 during most introductory meetings with Congressional offices to ensure awareness. Additional details were provided as requested.
- INCA held a follow up meeting with Representative Jaime Herrera Beutler’s (R-WA) office to discuss B-24 specifically and followed up with language and additional information for a possible Congressional letter to HHS and USDA to encourage increased transparency in the guidelines development process.
- Several other potential INCA Champions have expressed interest in learning more about the B-24 process and current information laid out by HHS and USDA. INCA continues to keep Congressional staffers up to date with the B-24 progress and connect them with other offices who are interested.
Goal: Have a credible third-party comment on the need for balance in the process.
- INCA participates in an industry B-24 coalition, which is led by Food Directions and is meeting with USDA to discuss the transparency, timeline, and research being used to develop the guidelines.
Address Industry-wide state legislative/regulatory challenges:
Goal: Influence legislation on priority issues.
- INCA has submitted letters of support regarding pending legislation in Nebraska, New York and Mississippi on a variety of topics involving infant formula and infant/child nutrition. Nebraska Legislative Bill 427, which expanded protections for breastfeeding in public, was enacted into law on May 8, 2017.
- INCA continues to track state legislative sessions and bills on organized retail theft/crime, itinerant vendors, hospital feeding policies, taxation, green chemistry bills and others. A monthly state legislative matrix is circulated for member review and feedback.
- INCA remains engaged in California Proposition 65 activities and monitor for developments.
Goal: Encourage streamlining of export requirements for U.S. produced infant formula sold in China.
- In February, INCA submitted comments to the China Food and Drug Administration (CFDA) and the U.S. Government regarding proposed CFDA regulations on the registration and stability testing infant formulas and the licensing of foods for special medical purposes (FSMP) intended for export to China.
- INCA remained in close contact with the U.S. FDA and USDA Foreign Agricultural Service (FAS) regarding development and completion of a Memorandum of Understanding between FDA and the Certification and Accreditation Administration of the People’s Republic of China (CNCA) to help facilitate the export of infant formula and formulas for young children to China. The MOU was signed on June 15 and related FDA guidance was published on June 29.
SCIENTIFIC & TECHNICAL COMMITTEE
Priority: 3-MCPD and Glycidyl Esters and Infant Formula
Goal: Regulatory decisions that reflect industry positions
- In January, INCA staff and members met with U.S. Food and Drug Administration (FDA) representatives to review the results of FDA’s research on 3-MCPD and GE in infant formula, which indicated the Agency believes enough is not being done to mitigate levels in U.S. infant formula. In response to FDA’s request for industry to do more, members agreed to provide blinded samples of oils and finished product to FDA to assist the Agency in validating their method. The submission of these samples is ongoing and FDA has provided staff with results of the testing of those samples which have been submitted.
- In early 2017, several INCA members agreed to support the development of a manuscript from Dr. Michael Dourson and his team at the University of Cincinnati’s Toxicology Excellence Risk Assessment (TERA) Center. This manuscript, which included a case study for benchmark dosing of 3-MCPD, was submitted for publication in Critical Reviews in Toxicology in March.
- INCA continues to coordinate with relevant organizations on the 3-MCPD and GE issue, including the Institute of Shortening and Edible Oils (ISEO). In April, staff met with ISEO staff and members to discuss INCA activities and ISEO initiatives, including an ISEO survey of mitigation efforts.
- During the March Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) meeting, work was initiated to develop analytical method criteria and review available analytical methods for the detection of 2-MCPD, 3-MCPD and GE in infant formula. This Working Group, which includes representatives from the U.S. FDA, the European Commission, Food Standards Australia New Zealand and Germany’s Federal Institute for Risk Assessment, has met twice since the March meeting to review existing regulatory requirements and begin developing method criteria.
Priority: Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Project
Goal: Continued SPIFAN activities that achieve industry goals
- INCA continued to drive progress regarding the “SPIFAN II” project, which ran through April 2017. Staff actively participated in SPIFAN meetings that took place in March, including presenting on the status of Codex review of SPIFAN methods and future priorities, and reviewing progress and next steps with manufacturers.
- Staff continued to facilitate the organization and completion of Multi-Lab Testing studies to demonstrate reproducibility on SPIFAN methods. MLT studies were completed for biotin, vitamin D, chloride, and minerals & trace elements and reviewed during the March SPIFAN meetings.
- Staff led efforts to seek Codex adoption of SPIFAN methods. As of June 2017, it is expected Codex will have adopted new Type II methods for vitamins A, B12, C, E, total nucleotides, pantothenic acid, iodine, total fatty acid profile, myo-inositol, chromium, molybdenum and selenium.
- As the SPIFAN II agreement ended in April, staff has coordinated with AOAC and manufacturers on the development of the “SPIFAN III” agreement. Staff confirmed manufacturer support and the agreement was signed in late June.