July – September 2016 Quarterly Newsletter

10127-1712_INCA_ltrhd_final (2)

10127-1712_INCA_ltrhd_final (2)

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Quarterly Newsletter

July – September 2016

Board Priority: WIC

  • Congress has not taken up Child Nutrition Reauthorization legislation. Staff continues to monitor media reports of possible bill movement and remains in touch with the WIC Steering Committee. An INCA Legislative & Regulatory Strategy Session will take place October 27 to review all relevant topics, including WIC, and plan for possible 2017 activities.

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Board Priority: Expanded Communications 

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Board Priority: FDA 

  • Working with the Legislative & Regulatory Steering Committee, INCA submitted a letter to Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, following up on our May meeting and requesting additional meetings to continue dialogue on key INCA issues, including aligning US government agency recommendations on infant formula preparation, concerns about the use of homemade infant formula and mitigating infant formula theft.

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COMMITTEE UPDATES

Communications Steering Committee (CSC)

  • Website – Following the website’s refresh that included improved navigation and user experience, staff conducted a Search Engine Optimization evaluation of org to organically drive users to the site, and made recommended adjustments. (SEO optimization will be an ongoing effort.)
  • Member Section of Website– Staff continues to populate the Scientific Articles section with assistance from the Feeding & Nutrition Policy Committee to identify relevant articles for the library on a weekly basis, as well as media statements and relevant documents.
  • Media Statements– Developed for recent issues receiving media attention, including carrageenan, Cronobacter, and the World Health Organization Guidance on ending inappropriate marketing of foods for infants and young children.

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Feeding & Nutrition Policy Committee (FNPC)
  • US Dietary Guidelines for Birth to Age 2 (B-24 Project)
    • Staff continues to share INCA’s position on the B-24 Project with third parties and encourage alignment, participate in industry coalitions aimed at supporting robust and transparent processes for the B-24 Project and development of Dietary Guidelines for the general population, and seek insights from government agencies regarding the status of the Evidence Analysis.
    • INCA staff participated in a broad industry meeting with representatives from the US Department of Agriculture (USDA), including Undersecretary Concannon and the Executive Director of USDA’s Center for Nutrition Policy and Promotion (CNPP), regarding Dietary Guidelines for Americans (DGAs) and the B-24 Project.
    • The FNPC is reviewing U.S. and global recommendations related to infant feeding to identify areas of general consensus as well as differences that may warrant further discussion and possible INCA action.
  • Infant Formula Preparation Recommendations
    • INCA’s position on aligning US government agency recommendations for powdered formula preparation is being incorporated into comments on FDA’s draft guidance on infant formula labeling.
    • INCA shared information documenting safety and nutritional concerns regarding PIF preparation with very hot water in FDA follow up letter.
    • Potential safety concerns regarding the Baby Brezza infant formula preparation device were shared with the manufacturer and the US Consumer Product Safety Commission.
  • Scientific Publications and Research Summaries
    • Staff continues to alert members to publications, research initiatives, and presentations of interest and provides critiques of prioritized topics.
    • Staff has reviewed articles related to the impact of animal science research on maternal and child nutrition and health.

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International Committee
  • Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)
    • INCA staff continues to prepare for the December CCNFSDU meeting in Hamburg, Germany (December 3-9). Staff will attend the meeting on the US delegation with new head delegate Dr. Douglas Balentine, Director of the Office of Nutrition Labeling at the US Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN).
    • INCA is planning to meet with the US delegation ahead of the December meeting to share the INCA positions for the meeting. Staff will also attend the November 15 US public meeting.
    • INCA will coordinate positions for the meeting with the International Special Dietary Foods Industries (ISDI), as feasible and appropriate. Staff is also meeting with the US delegation on October 27 to share the INCA positions.
  • Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Methods
    • In July, five SPIFAN methods were adopted by the Codex Alimentarius Commission as Type II (i.e., Vitamin A, Pantothenic Acid, Total Nucleotides and Iodine) or Type II (i.e., Chromium/Molybdenum/Selenium).
    • SPIFAN stakeholders are working to respond to feedback provided by the Codex Committee on Methods of Analysis and Sampling regarding four SPIFAN methods (i.e., Myo-Inositol, Vitamin E, Fatty Acids, Vitamin B12), which will be provided for consideration at the December CCNFSDU meeting.
    • One new SPIFAN method for Vitamin C will be introduced at CCNFSDU in December.
  • International Special Dietary Foods Industries (ISDI)
    • As a member of ISDI, INCA staff continues to actively participate in ISDI Board and Working Group activities, including leadership of the Food Safety Working Group which addresses food additives and contaminants.
    • INCA staff is also participating in ISDI work to prepare for the December CCNFSDU meeting, including work related to the Codex Follow-Up Formula Standard.
    • Additionally, INCA staff has contributed to the development of a manuscript on the safety of food additives for use in products intended for infants less than 12 weeks to complement the review of these additives by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the European Food Safety Authority (EFSA).

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Legislative/Regulatory Committee    
  • China Infant Formula Issues
    • INCA organized a series of meetings in September in Beijing to discuss with Chinese Government agencies potential barriers to U.S. exports of infant formula and foods for special medical purposes (FSMP) to China. Meetings were held with the China Certification and Accreditation Administration (CNCA); the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ); and Chinese Food and Drug Administration (CFDA).
    • The meetings established INCA as a resource for the Chinese Government and garnered key intelligence about how key Chinese regulations will be implemented for U.S. manufacturers shipping product to China.
    • Based upon the relationships established through these meetings, INCA will have opportunities for future exchanges and interaction with the Chinese government on U.S. export issues and technical capacity.
  • FDA Guidance Documents
    • Staff has engaged FDA, member companies and other stakeholders on Agency guidance regarding substantiating structure/function claims for infant formula labeling and labeling. INCA contacted FDA to seek clarification on the guidance. INCA developed a comment extension request, which was submitted to the docket. INCA is developing detailed comments on the guidance. INCA has contacted key stakeholder groups, including the Grocery Manufacturers Association, Council for Responsible Nutrition and others to raise awareness and encourage comments.
    • Staff has engaged members and FDA on draft guidance regarding infant formula labeling in general, including seeking clarification from FDA and developing INCA comments.
    • Staff continues to follow and stay engaged with industry stakeholders regarding FDA guidance on Investigational New Drug Applications and Medical Foods.
  • Biotechnology
    • On July 29, President Obama signed 764, the Roberts-Stabenow federal biotech labeling preemption bill, into law. The legislation nullifies mandatory biotech labeling laws in Vermont, Connecticut and Maine, and preempts all future state biotech labeling laws.
    • The U.S. Department of Agriculture (USDA) now has two years to complete rulemaking to implement the statute. INCA plans to continue to participate in the process by engaging in the USDA rulemaking and continuing to participate in the Coalition for Safe Affordable Food, the industry coalition that organized and executed the lobbying effort that led to passage of S. 764.
  • Leg/Reg Start Session – On October 27, members of the INCA Legislative and Regulatory Committee will meet at the Kellen office in Washington, D.C. for a Legislative and Regulatory Committee strategy session. The purpose of the meeting is to review 2016 activities, plan for the remainder of 2016 and identify key legislative/regulatory issues/strategies for 2017.

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Scientific and Technical Committee (STC)
  • Oils and Infant Formula
    • Staff has remained in contact with the Grocery Manufacturers Association (GMA), the Institute of Shortenings and Edible Oils (ISEO), ISDI and Specialised Nutrition Europe (SNE) related to 3-MCPD and glycidyl esters (GE) in oils used in infant formula.
    • INCA is closely monitoring European Commission (EC) discussion on 3-MCPD and GE, especially with regard to the EFSA report suggesting a decrease in the Tolerable Daily Intake (TDI) for 3-MCPD. INCA continues to work with the ISDI Contaminants Working Group regarding possibly submitting data to JECFA for their evaluation.
    • INCA staff is also in contact with ISDI regarding possibly supporting a manuscript on best practices for benchmark dose (BMD), which could be used for 3-MCPD and GE, as well as other potential contaminants, by JECFA for their evaluations.
  • Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) Project Update
    • Staff attended the September SPIFAN meetings in Dallas, where three new methods were approved as AOAC Official First Action. In addition, two methods were recommended for AOAC Official Final Action status and one additional method was recommended to advance to Multi-Laboratory Reproducibility Testing study.
    • INCA staff has been working with manufacturers to develop a contract to continue SPIFAN activities in 2017. In addition to method development, the contract will focus on raising awareness, acceptance and use of SPIFAN methods globally.
    • INCA continues to lead SPIFAN Working Groups related to infant formula sample matrices, coordination of Multi-Laboratory Testing collaborative studies and Codex strategy.

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