October – December 2016 Quarterly Newsletter

2016 Quarterly Newsletter

October – December 2016


Board Priority: WIC Strategy

  • Congress did not take up Child Nutrition Reauthorization legislation. Staff continued to monitor reports of possible bill movement and shared updates during the October Legislative & Regulatory Strategy Session.
  • The Board agreed during its October 2016 meeting that WIC Strategy is not a priority issue for 2017. INCA will continue to monitor and address WIC issues as needed through the Legislative & Regulatory Committee.

Board Priority: Expanded Communications 

INCA Website Content – Staff continued to develop content, which included blogs, articles, quizzes and slideshows, based on input from the Communications Steering Committee that ladders up to the 2016 key issues and topics agreed upon by the Board.

Paid Advertising – Following the 2016 communications goals, a revised paid media plan was developed that drove users to the website with an integrated digital advertising approach, which leveraged website content, banner ads and Google Ads. However, the Board agreed during its October 2016 meeting that INCA’s key communication efforts for 2017 would focus on further establishing mainstream media relationships to help ensure that INCA is a trusted resource for infant and young child feeding issues and that reporters contact INCA especially during a crisis. Thus, the need for paid advertisements that targeted parents was no longer necessary. Staff along with the CSC made the decision to to cease all paid advertisement plans for the remainder of the year.

Paid Spokesperson – INCA worked out an agreement to leverage Dr. Meg’s social channels in Q1 2017 to serve up infant feeding polls to her extensive followers due to her inability to post during Q4 because of Facebook’s new policies regarding spokespeople. The poll questions are based on approved questions from INCA’s Mother’s Survey and #ModernParent Survey.

Media Lists/Pitching – Staff continued to pitch high quality media outlets and key reporters who have provided balanced reporting on infant nutrition. Pitches included: Emergency Preparedness, Debunking Spooky Infant Nutrition Myths, and Traveling with Baby. In an effort to impact our new target audience, staff researched and identified various media markets, outlets and reporters who displayed an interest in infant nutrition content, and will continue to build relationships with these individuals.

Board Priority: Enhanced FDA Outreach

  • Staff continued to follow up with FDA staff regarding INCA’s request to Dr. Susan Mayne for additional meetings to address INCA issues, including US Government agency alignment on infant formula preparation recommendations, homemade infant formula, the B-24 Project and infant formula theft. FDA staff has advised US Government agency alignment on preparation recommendations have progressed positively.
  • The Board during its October 2016 meeting agreed that Enhanced FDA Outreach is not a priority issue for 2017. INCA will continue to address FDA issues through the Legislative & Regulatory Committee.



Communications Steering Committee (CSC)

Website – A search engine optimization plan was developed that leveraged content to organically drive users to infantnutrition.org. Staff continued to develop content with optimization in mind, utilizing best practices as it regards digital media, dynamic content and keyword usage. Staff regularly monitored and managed all functions of the INCA website.

  • Media Statements– Working with the CSC and other INCA committees, staff reactively developed and distributed media statements in a timely manner for recent issues receiving media attention, as well as developed statements on topics for which member companies received media requests. These statements included follow-up/toddler formula and sugar, Cronobacter, Hexane, Nanoparticles, Radioactivity, and AAP’s Statement regarding SIDS.
    • Standby statements continue to be uploaded to the members only section of the INCA website for easy access. These files are available in a downloadable PDF form.
  • Scientific Articles– Staff continued to populate the Scientific Articles section with assistance from the Feeding & Nutrition Policy Committee to identify relevant articles for the library, as well as media statements and relevant documents.

Feeding & Nutrition Policy Committee (FNPC)

US Dietary Guidelines for Birth to Age 2 (B-24 Project)

  • The INCA Board agreed during its October meeting that the B-24 Project is a priority issue for 2017. Staff updated the 2017 FNPC action plan to incorporate this change and is working with the Committee to develop specific strategic activities to remain engaged and actively impact the project.
  • INCA’s position on the B-24 Project was shared with the Health and Medicine Division of the National Academies of Sciences, Engineering and Medicine (NAS) in response to its request for public comments related to the dissemination and implementation of the Dietary Guidelines for Americans (DGAs), specifically regarding the challenges and opportunities of the B-24 Dietary Guidelines.

Infant Formula Preparation Recommendations

  • INCA was asked to review chapters of the upcoming revisions of the Academy of Nutrition and Dietetics, Pediatric Nutrition Practice Group’s professional resource, “Infant Feedings:  Guidelines for Preparation of Human Milk and Formula in Health Care Facilities.” Staff and member companies plan to review the chapters titled “Formula Preparation & Handling” and “Microbiology & Infection Control.”
  • The Committee provided input on INCA’s letter requesting follow up meetings with FDA on specific topics, including seeking US Government agency alignment on recommendations for the preparation of powdered infant formula.

US Food and Drug Administration’s (FDA) Draft Guidance on Structure/Function Claims

  • INCA requested an extension to the comment period regarding FDA Draft Guidance for Industry on the “Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling.” INCA drafted comments on the guidance, which will be submitted in February 2017.
  • Staff engaged additional stakeholders to gauge possible interest in commenting or coordinating joint comments, including possible detailed legal comments, on the guidance.

Scientific Publications and Research Summaries

  • Staff continues to alert members to publications, research initiatives, and presentations of interest and to provide critiques of prioritized topics
  • The Committee provides input on the development of standby statements for possible response to media inquiries.

International Committee

Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)

  • The Committee met with the US delegation to CCNFSDU, including head delegate Dr. Douglas Balentine, in October to share INCA positions on CCNFSDU agenda items and further prepare for the 38th Session in December. INCA also participated in the US public meeting in November to review US draft positions and participated in meetings with the US delegation while at CCNFSDU.
  • The Committee developed positions for CCNFSDU, in coordination with the International Special Dietary Foods Industries (ISDI), on the revision of the Codex Follow-Up Formula Standard, the use of food additives in infant formula and methods of analysis for infant formula. INCA positions were shared with the US delegation in advance of CCNFSDU.
  • INCA staff and members attended and actively participated in the CCNFSDU meeting as part of the US, ISDI, International Food Additives Council (IFAC) and AOAC International delegations. INCA staff participating on the IFAC delegation intervened to provide support for INCA/ISDI positions related to the use of food additives in infant formula.
  • Work progressed on the Codex Follow-Up Formula Standard and will continue at the 2017 meeting. INCA positions on food additives in infant formula were not incorporated but will continue to be addressed through CCNFSDU through an electronic Working Group (eWG) whose work will be presented at the 39th All INCA positions on methods of analysis were incorporated. The final report of the 38th CCNFSDU Session can be found here.

Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Methods

  • INCA staff led SPIFAN Codex Strategy activities, including developing materials to respond to questions by the Codex Committee on Methods of Analysis and Sampling (CCMAS) and support CCNFSDU endorsement of SPIFAN methods. Staff also led in the mapping of CCNFSDU delegations and worked with ISDI in the coordination of communicating SPIFAN Codex method positions to key delegations.
  • During CCNFSDU, the Committee agreed to refer SPIFAN methods for vitamin B12, fatty acid profile, myo-inositol, vitamin E and chromium/molybdenum/selenium to the Codex Alimentarius Commission for adoption in July 2017 as Type II dispute resolution methods. CCNFSDU also referred the SPIFAN method to vitamin C to the Codex Committee on Methods of Analysis and Sampling for technical review and typing in May 2017. If endorsed, this method will also be sent to CAC for adoption as Type II in July 2017.

International Special Dietary Foods Industries (ISDI)

  • The Committee continues to be actively involved in ISDI activities, including INCA staff leadership of the Food Safety Working Group, which oversees the work on food additives and contaminants. Staff also participates in the Infant and Young Child Nutrition (IYCN) Working Group, which led the work on the Codex Follow-Up Formula Standard for the 38th CCNFSDU Session, and the Medical and Adult Nutrition (MADN) Working Group.
  • During the 38th CCNFSDU Session, INCA staff and Committee members participated in ISDI preparatory meetings and continually engaged with ISDI staff regarding development of INCA positions and incorporation into ISDI positions. Additionally, INCA staff and members acted as a liaison between ISDI and the US delegation during CCNFSDU, and worked to gain US delegation support of ISDI/INCA positions.

Legislative/Regulatory Committee

Leg/Reg Strategy Session

  • INCA held a Legislative & Regulatory Strategy Session October 27 in Washington, D.C. to review 2016 activities and plan key legislative/regulatory issues/strategies for 2017.
  • The Committee developed and refined a list of key 2017 priorities, goals and measures of success, which have since been approved by the Committee. Activities will address: reputation management; the B-24 Project; state legislative and regulatory issues management; and trade/export issues.
  • The Committee is finalizing a 2017 Legislative and Regulatory Committee Action Plan, which includes tactics to achieve the goals. The approach to develop goals and measures of success for the Action Plan is being utilized by other INCA Committees.

China Infant Formula Issues

  • In follow up to INCA organized meetings with Chinese Government agencies in September, outreach was conducted to identify opportunities for future exchanges with the Chinese government on U.S. export issues and technical capacity.
  • INCA China Key Contacts agreed in November that INCA should explore holding a Chinese regulator training/capacity building session to coincide with the September 2017 Regulatory Affairs Professional Society (RAPS) Annual Meeting in Maryland.
    • The activity will likely include an exchange between Chinese and U.S. regulators, would be facilitated by INCA and may include a plant visit/tour.
    • S. Department of Agriculture (USDA) staff is supportive of the activity and indicated they would be willing to help secure U.S. Government participation.
    • INCA members are working with colleagues in China to encourage relevant Chinese Government contacts to request travel authorization as soon as possible for the event.

FDA Guidance Documents

  • Staff developed and submitted in December comments on FDA’s draft guidance on infant formula labeling, which also requested that FDA continue to seek government agency alignment on infant formula preparation recommendations.
  • Staff continued to monitor and remain engaged with industry stakeholders on other FDA guidance documents, including draft guidance for industry on dietary fiber, guidance on Investigational New Drug Applications and revised guidance on medical foods. INCA will be submitting joint comments with the Healthcare Nutrition Council (HNC) in early 2017 regarding FDA’s draft guidance and scientific review on dietary fiber.


  • INCA continued to monitor for announcements from the USDA regarding an advanced notice of proposed rulemaking to implement the federal biotech labeling statute enacted in July 2016. INCA plans to evaluate comment opportunities and other chances to engage the Agency as it implements the law.
  • INCA staff continued to participate in the Coalition for Safe Affordable Food, including sharing coalition updates with the Committee and participating in a coalition meeting in September.

WHO Marketing Issues: Thailand Milk Code

  • INCA staff attended an October 24 coalition meeting with Ambassador Darci Vetter, Chief Agricultural Negotiator a the U.S. Trade Representative’s Office (USTR), to review efforts to address a proposal to amend the Thai milk code to limit marketing of milk products, including follow-up formula, in Thailand.
  • INCA staff/members and other stakeholders, including the Grocery Manufacturers Association (GMA), National Milk Producers Federation, and International Dairy Foods Association (IDFA), raised concerns with the proposal and reviewed the Thai legislative process. Concerns noted included:
    • The importance of Codex standards being the recognized international standards for infant formula and follow-up formula.
    • The possibility of raising the World Health Organization (WHO) Guidance on the Inappropriate Marketing of Milk-Based Products for Infants and Young Children at the December 2016 CCNFSDU meeting.
  • Ambassador Vetter offered her support and advised that the issue was on USTR’s radar and appropriate follow up would be undertaken. She also noted that USTR would consult with the US Delegation to CCNFSDU.

Scientific and Technical Committee (STC)

Oils and Infant Formula

  • The Committee continues to address activities related to 3-MCPD and glycidyl esters (GE) in infant formula. Staff coordinated with other industry groups, including the Grocery Manufacturers Association (GMA), the Institute of Shortenings and Edible Oils (ISEO), Specialised Nutrition Europe (SNE) and ISDI, to share information and explore collaboration opportunities to increase the Tolerable Daily Intake (TDI) levels for 3-MCPD and GE.
  • In October, INCA staff participated in a GMA meeting with the US Food and Drug Administration (FDA) regarding the recent publication from the Toxicology Excellence Risk Assessment (TERA) Center from the University of Cincinnati, which evaluated the benchmark dose (BMD) procedure used by the European Food Safety Authority (EFSA) for their May 2016 scientific opinion on 3-MCPD. A review of the TERA publication was presented to FDA in advance of the November Joint FAO/WHO Expert Committee on Food Additives (JECFA) meeting, which was reviewing the TDI for 3-MCPD and GE.
  • Staff shared JECFA’s conclusions related to its evaluation of 3-MCPD and GE in November. JECFA set TDI levels higher than those proposed in the May 2016 EFSA report. In response, INCA prepared a background document to be used, as needed, to address the report and the issue surrounding 3-MCPD and GE in infant formula.
  • In December, INCA staff was approached by FDA to schedule a meeting to review the Agency’s latest research on 3-MCPD and infant formula. This meeting has been scheduled for mid-January.

Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Project Update

  • Good progress has been made on SPIFAN goals. To date, SPIFAN has developed Standard Method Performance Requirements (SMPRs) for 29 priority nutrients/groups of nutrients, 44 AOAC Official First Action Methods for 25 priority nutrients/groups of nutrients and 12 AOAC Official Final Action Methods for 11 priority nutrients/groups of nutrients.
  • Follow up was conducted after the September SPIFAN meetings, including sharing meeting reports with INCA members, contacting AOAC to coordinate next steps and organizing calls with Codex and Multi-Laboratory Test Study Directors on upcoming activities.
  • Staff continues to work with manufacturers on the development of an agreement to continue SPIFAN activities, as the current agreement ends in March 2017. Staff and member companies met with members of the AOAC Board of Directors in December to communicate INCA strategic objectives for future SPIFAN work, which was supported by the Board and will be incorporated into the next agreement.
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