INCA Media Statement: Response to Clean Label Project Report On Arsenic & Lead/or “Trace Elements” Found In Infant Formula

INCA Media Statement
Response to Clean Label Project Report on Arsenic & Lead/or
“Trace Elements” Found In Infant Formula

CONTEXT:
On October 25, 2017 The Clean Label Project put out a report which stated that baby foods and formulas tested positive for arsenic, lead and BPA. The Clean Label Project’s website (and media stories, including one in USA Today) called out multiple brands by name, including brands from all member companies.  While the organization reports on the sensitivity of the method they used, no actual results are provided nor do they compare their results to any established benchmarks of safety set by the U.S. Food and Drug Administration.

MEDIA QUOTE:
“Safety is the top priority of infant formula manufacturers, which is why infant formula remains the most highly regulated food, with stringent protocols in place to ensure that every product meets or exceeds the expectations of consumers, health care providers and regulatory bodies around the world,” said Mardi Mountford, President of the Infant Nutrition Council. “There is no scientific or public health basis to recommend parents change their infant feeding practices based on this report.”

BACK-UP QUOTES/STATEMENTS TO POTENTIALLY INCLUDE IN AN EMAIL TO A REPORTER:

  • Neither lead nor arsenic are ingredients in infant formula.
  • Because lead and arsenic can be present in the environment, drinking water, and the food supply chain, trace levels may be found in infant formula and breast milk.
  • Parents and caregivers do not need to be concerned about the trace levels of the elements that may be present in infant formula. However, care should be taken to ensure the water used to reconstitute liquid concentrate and powdered infant formula is safe, and if parents or caregivers have concerns about their water supply, they should consider testing for contaminants or using bottled water.
  • FDA has been monitoring the levels of arsenic and lead in food for more than 20 years, and notes: “It is important for consumers to understand that some contaminants, such as heavy metals like lead or arsenic, are in the environment and cannot simply be removed from food.”
  • Parents should contact their baby’s doctor if they have any questions about infant feeding.

*The Infant Nutrition Council of America (INCA) is an association of manufacturers and marketers of formulated nutrition products, e.g., infant formulas and adult nutritionals, whose members are based predominantly in North America. INCA members are Abbott Nutrition, Gerber Products Company,  Mead Johnson Nutrition, and Perrigo Nutritionals.

INCA Media Statement: Presence of Nanoparticles in Infant Formula in Australia

Infant Nutrition Council of America

Media Statement and Backgrounder Questions:

Presence of Nanoparticles in Infant Formula in Australia

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Context

In July 2017, Friends of the Earth Australia, an environmental consumer organization, commissioned a study with Arizona State University in the U.S. which tested seven off-the-shelf baby formula products and found three products contained needle-shaped hydroxyapatite nanoparticles. Citing a study by the European Union’s Scientific Committee on Consumer Safety (SCCS) that concluded needle-like nano hydroxyapatite was potentially toxic and should not be used in oral care products such as toothpaste and mouthwash, Friends of the Earth called for the immediate recall of the brands affected. In response to the report, Food Standards Australia New Zealand (FSANZ) said they reviewed the testing and there is no new evidence to suggest that products be recalled, so parents should not be alarmed or concerned.

Media Statement

“There is no scientific or public health basis to recommend parents change their infant feeding practices based on this report,” says Mardi Mountford, President of the Infant Nutrition Council of America. “Safety is the top priority of infant formula manufacturers, which is why infant formula remains the most highly regulated food, with stringent protocols in place to ensure that every product meets or exceeds the expectations of consumers, health care providers and regulatory bodies, including the US FDA, Health Canada, the European Food Safety Authority and other regulatory agencies. Parents should contact their baby’s doctor if they have any questions about infant feeding.”

  • The term “nano” is strictly an indicator of microscopic size. Nanoparticles of various types occur naturally and commonly in the environment and can be found in many food products, sometimes as a result of the addition of certain ingredients and required nutritional components.
  • To put things in perspective, a nanometer is one one-billionth of a meter. A human hair has an average diameter of 80,000 nanometers. Generally recognized definitions, including that of the International Standardization Organization (ISO), limit the nano-range to 100 nanometers or less.
  • Infant formula manufacturers do not add engineered nanoparticles to their products. Some nano-structured materials, for example resulting from the aggregation of small particles, might occur as a result of the traditional manufacturing processes of ingredients or finished products. These are not considered engineered nanomaterials, since they are not intentionally produced to have dimensions in the nano scale (e.g., nanoparticles).

Questions and Answers

Why are nanoparticles in infant formula?

Nanoparticles are microscopic particles that can occur naturally and commonly in the environment. Infant formula manufacturers do not add engineered nanoparticles to formulas. Some nano-structured materials, for example resulting from the aggregation of small particles, might occur as a result of the traditional manufacturing processes of ingredients or finished products. These are not considered engineered nanomaterials, since they are not intentionally designed to have dimensions in the nano scale (e.g., nanoparticles).

As analytical technologies continue to evolve, the presence of certain substances can be tested at very low levels, including the nano scale. However, the very small particle size does not mean they are unsafe or should not be used in products.

What did the test for nanoparticles find?

Infant formula manufacturers do not add engineered nanoparticles to formulas. The test likely detected naturally occurring nano-sized particles in products because of the addition of certain ingredients and required nutritional components, such as calcium, which is needed for infants’ growth and development. Additionally, traditional manufacturing processes may result in the presence of finer, nano-sized particles. These are not the same as engineered nanomaterials, since they are not intentionally designed to have dimensions in the nano scale (i.e., nanoparticles). Small size particles are available for further digestion and absorption. To put things in perspective, a nanometer is one one-billionth of a meter, so something that is 100 nanometers wide would be 1/10,000th of a width of a 1 millimeter sized grain of salt. Further, it should be noted that nanoparticles can be found in the majority of foods and beverages available to consumers and can be produced in the human body.1-6

Are nanoparticles dangerous?

No, as most nanoparticles are naturally occurring and common throughout our environment and the foods we eat. “Nano” is strictly an indicator of microscopic size.

In the USA, the Food and Drug Administration (FDA) regulates the use of ingredients in all foods and considers engineered nanomaterials in its premarket reviews. Engineered nanoparticles are not added to infant formula. Infant formula is the most highly regulated food and the FDA confirms that infant formulas are safe and suitable for infants prior to their market introduction, including review of all ingredients added.7-8

But what about the scary pictures shown in the report?

Any image that is blown up by a million or a billion times could appear scary, even the most harmless and innocuous of materials. For example, a sheet of glass magnified that many times would appear jagged as compared to the smooth surface we perceive, but should not be any more worrisome as a result. Even simple foods, such as blueberries or strawberries, appear alien with sufficient magnification.

Should there be labeling of nanoparticles?

The FDA establishes labeling requirements for foods to ensure that meaningful and accurate information is provided, such as health and nutrition information. This information helps consumers make informed decisions about the products they purchase. The FDA does not require any food labels to include information about the presence of certain particles just because of their very small size. It is important to note that we have been eating tiny microscopic particles as part of our food since the advent of agriculture.

What is the FDA’s stance on nanoparticles in infant formula?

The FDA states that it will regulate nanotechnology products using the specific legal standards that apply to each type of product under its jurisdiction. It distinguishes products that have added engineered nanoparticles from those products that contain materials that naturally occur in the nanoscale range. The FDA considers its current safety assessment sufficiently robust and flexible to be appropriate for a variety of materials, including engineered nanomaterials.

Optional link: http://www.fda.gov/regulatoryinformation/guidances/ucm257698

References

  1. Cai Y & Tang R. Calcium phosphate nanoparticles in biomineralization and biomaterials. J Mater Chem, 2008; 18: 3775-87.
  2. Dorozhkin SV. Nanosized and nanocrystalline calcium orthophosphates. Acta Biomater, 2010; 6(3): 715-34.
  3. Eppell SJ, Tong W, Katz JL, Kuhn L & Glimcher MJ. Shape and size of isolated bone mineralites measured using atomic force microscopy. J Orthop Res, 2001; 19(6): 1027-34.
  4. Liu Q, Huang S, Matinlinna JP, Chen Z & Pan H. Insight into biological apatite: physiochemical properties and preparation approaches. Biomed Res Int, 2013; doi: 10.1155/2013/929748.
  5. Powell JJ, Thomas-McKay E, Thoree V, Robertson J, Hewitt RE, Skeppere JN, et al. An endogenous nanomineral chaperones luminal antigen and peptidoglycan to intestinal immune cells. Nat Nanotechnol, 2015; 10(4): 361-9.
  6. Stanley S. Biological nanoparticles and their influence on organisms. Curr Opin Biotechnol, 2014; 28: 69-74.
  7. US Food and Drug Administration. 21 C.F.R. §106.120(b)(6)(ii).

US Food and Drug Administration. 21 C.F.R. §106.40(a).

2017 Bi-Annual Newsletter – Q1-Q2 Update

2017 BI-ANNUAL NEWSLETTER 

Q1-Q2 UPDATE

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.

 

INTERNATIONAL COMMITTEE

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

Reputation Management:

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.

B-24 (legislative):

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.

Trade/Export Issues:

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.

INCA Media Statement: Media Statement on Presence of Nanoparticles in Infant Formula in Australia

Infant Nutrition Council of America Media Statement and Backgrounder Questions:

Presence of Nanoparticles in Infant Formula in Australia

Context

In July 2017, Friends of the Earth Australia, an environmental consumer organization, commissioned a study with Arizona State University in the U.S. which tested seven off-the-shelf baby formula products and found three products contained needle-shaped hydroxyapatite nanoparticles. Citing a study by the European Union’s Scientific Committee on Consumer Safety (SCCS) that concluded needle-like nano hydroxyapatite was potentially toxic and should not be used in oral care products such as toothpaste and mouthwash, Friends of the Earth called for the immediate recall of the brands affected. In response to the report, Food Standards Australia New Zealand (FSANZ) said they reviewed the testing and there is no new evidence to suggest that products be recalled, so parents should not be alarmed or concerned.

Media Statement

“There is no scientific or public health basis to recommend parents change their infant feeding practices based on this report,” says Mardi Mountford, President of the Infant Nutrition Council of America. “Safety is the top priority of infant formula manufacturers, which is why infant formula remains the most highly regulated food, with stringent protocols in place to ensure that every product meets or exceeds the expectations of consumers, health care providers and regulatory bodies, including the US FDA, Health Canada, the European Food Safety Authority and other regulatory agencies. Parents should contact their baby’s doctor if they have any questions about infant feeding.”

 

  • The term “nano” is strictly an indicator of microscopic size. Nanoparticles of various types occur naturally and commonly in the environment and can be found in many food products, sometimes as a result of the addition of certain ingredients and required nutritional components.
  • To put things in perspective, a nanometer is one one-billionth of a meter. A human hair has an average diameter of 80,000 nanometers. Generally recognized definitions, including that of the International Standardization Organization (ISO), limit the nano-range to 100 nanometers or less.
  • Infant formula manufacturers do not add engineered nanoparticles to their products. Some nano-structured materials, for example resulting from the aggregation of small particles, might occur as a result of the traditional manufacturing processes of ingredients or finished products. These are not considered engineered nanomaterials, since they are not intentionally produced to have dimensions in the nano scale (e.g., nanoparticles).

Questions and Answers

Why are nanoparticles in infant formula?

Nanoparticles are microscopic particles that can occur naturally and commonly in the environment. Infant formula manufacturers do not add engineered nanoparticles to formulas. Some nano-structured materials, for example resulting from the aggregation of small particles, might occur as a result of the traditional manufacturing processes of ingredients or finished products. These are not considered engineered nanomaterials, since they are not intentionally designed to have dimensions in the nano scale (e.g., nanoparticles).

As analytical technologies continue to evolve, the presence of certain substances can be tested at very low levels, including the nano scale. However, the very small particle size does not mean they are unsafe or should not be used in products.

What did the test for nanoparticles find?

Infant formula manufacturers do not add engineered nanoparticles to formulas. The test likely detected naturally occurring nano-sized particles in products because of the addition of certain ingredients and required nutritional components, such as calcium, which is needed for infants’ growth and development. Additionally, traditional manufacturing processes may result in the presence of finer, nano-sized particles. These are not the same as engineered nanomaterials, since they are not intentionally designed to have dimensions in the nano scale (i.e., nanoparticles). Small size particles are available for further digestion and absorption. To put things in perspective, a nanometer is one one-billionth of a meter, so something that is 100 nanometers wide would be 1/10,000th of a width of a 1 millimeter sized grain of salt. Further, it should be noted that nanoparticles can be found in the majority of foods and beverages available to consumers and can be produced in the human body.1-6

Are nanoparticles dangerous?

No, as most nanoparticles are naturally occurring and common throughout our environment and the foods we eat. “Nano” is strictly an indicator of microscopic size.

In the USA, the Food and Drug Administration (FDA) regulates the use of ingredients in all foods and considers engineered nanomaterials in its premarket reviews. Engineered nanoparticles are not added to infant formula. Infant formula is the most highly regulated food and the FDA confirms that infant formulas are safe and suitable for infants prior to their market introduction, including review of all ingredients added.7-

But what about the scary pictures shown in the report?

Any image that is blown up by a million or a billion times could appear scary, even the most harmless and innocuous of materials. For example, a sheet of glass magnified that many times would appear jagged as compared to the smooth surface we perceive, but should not be any more worrisome as a result. Even simple foods, such as blueberries or strawberries, appear alien with sufficient magnification.

Should there be labeling of nanoparticles?

The FDA establishes labeling requirements for foods to ensure that meaningful and accurate information is provided, such as health and nutrition information. This information helps consumers make informed decisions about the products they purchase. The FDA does not require any food labels to include information about the presence of certain particles just because of their very small size. It is important to note that we have been eating tiny microscopic particles as part of our food since the advent of agriculture.

What is the FDA’s stance on nanoparticles in infant formula?

The FDA states that it will regulate nanotechnology products using the specific legal standards that apply to each type of product under its jurisdiction. It distinguishes products that have added engineered nanoparticles from those products that contain materials that naturally occur in the nanoscale range. The FDA considers its current safety assessment sufficiently robust and flexible to be appropriate for a variety of materials, including engineered nanomaterials.

Optional link: http://www.fda.gov/regulatoryinformation/guidances/ucm257698

 

References

 

  1. Cai Y & Tang R. Calcium phosphate nanoparticles in biomineralization and biomaterials. J Mater Chem, 2008; 18: 3775-87.
  2. Dorozhkin SV. Nanosized and nanocrystalline calcium orthophosphates. Acta Biomater, 2010; 6(3): 715-34.
  3. Eppell SJ, Tong W, Katz JL, Kuhn L & Glimcher MJ. Shape and size of isolated bone mineralites measured using atomic force microscopy. J Orthop Res, 2001; 19(6): 1027-34.
  4. Liu Q, Huang S, Matinlinna JP, Chen Z & Pan H. Insight into biological apatite: physiochemical properties and preparation approaches. Biomed Res Int, 2013; doi: 10.1155/2013/929748.
  5. Powell JJ, Thomas-McKay E, Thoree V, Robertson J, Hewitt RE, Skeppere JN, et al. An endogenous nanomineral chaperones luminal antigen and peptidoglycan to intestinal immune cells. Nat Nanotechnol, 2015; 10(4): 361-9.
  6. Stanley S. Biological nanoparticles and their influence on organisms. Curr Opin Biotechnol, 2014; 28: 69-74.
  7. US Food and Drug Administration. 21 C.F.R. §106.120(b)(6)(ii).
  8. US Food and Drug Administration. 21 C.F.R. §106.40(a).

 

Media Statement and Backgrounder: Relationship Between the American Academy of Pediatrics and Infant Formula Companies

Infant Nutrition Council of America
Media Statement and Backgrounder: Relationship Between the American Academy of Pediatrics
and Infant Formula Companies

Context

In the July 2017 issue of JAMA Pediatrics, Joshua M. Sharfstein, MD and Dana L. Silver. MD wrote an opinion piece regarding the “Relationship Between the American Academy of Pediatrics and Infant Formula Companies.” The authors suggest that the American Academy of Pediatrics (AAP) re-evaluate its relationships with companies that sell infant formula, since recent issues raise questions as to whether   these companies “enhance the quality of life for children and their families and are aligned with the AAP’s values and mission” (as recommended in a 2005 AAP policy). Issues noted include promotion of products with “a wide variety of questionable claims, including ‘supports brain development’ and ‘supports the immune system’; rising formula prices and negative impact on WIC participation; and questionable marketing tactics (e.g., hospital discharge bags).  The authors suggest the AAP consider viewpoints of both infant formula manufacturers and pediatricians and that a range of options “…from the status quo to a complete ban on all interaction” be considered.

 

Media Statement

“Though breastfeeding rates continue to increase, data shows that most parents use infant formula, including for supplementation, at some point during their infant’s first year even when breastfeeding support is provided. Therefore, it is important that parents are provided accurate information on all infant feeding options to help ensure optimal nutrition, overall well-being, and quality of life for both baby and parent,” said Mardi Mountford, President of the Infant Nutrition Council of America. “Promotion of infant nutrition should begin with health and medical professionals who can counsel and provide new mothers with resources and information on all appropriate infant feeding options, including infant formula.”

 

Background

  • Optimal healthcare involves the inter-relationships among a variety of stakeholders. (Blair et al., 2004). Health and medical professional associations often provide scientific evidence to their members to help ensure evidence-based recommendations and decisions for patient care. Many relevant health and medical professional associations, including the AAP, have policies regarding their relationships with various stakeholders.
  • As providers of nutrition for infants during critical periods of growth and development, infant formula manufacturers provide significant science-based contributions to infant nutrition. Disseminating this information to healthcare professionals is essential for evidence-based care and advice for patients.

References

  1. Blair, J.D., Nix, T.W., Payne, G.T., Rotarius, T.M., and Whitehead, C.J. 2004. “Stakeholder Management—Strategies and Styles.” In Lawrence, F. Wolper (ed.), Health Care Administration: Planning, Implementing, and Managing Organized Delivery Systems, 4th, Gaithersburg, MD: Aspen Publishers, pgs. 157-189.
  2. AAP Policy on Conflict of Interest and Relationships with Industry and Other Organizations. https://www.aap.org/en-us/about-the-aap/aap-leadership/Documents/20-IndustryRelations.pdf. Accessed July 6, 2017.
  3. American Society of Nutrition Conflicts of Interest. https://archive.nutrition.org/about-asn/asn-policies/conflict-of-interest/. Accessed July 6, 2017.

MEDIA CONTACTS

Robin Applebaum                                                                   Morgan Dukes

678-303-2980                                                                          678-303-2993

rapplebaum@kellencompany.com                                        mdukes@kellencompany.com

Media Statement and Backgrounder Questions: Presence of Nanoparticles in Infant Formula in Australia

Infant Nutrition Council of America
Media Statement and Backgrounder Questions:
Presence of Nanoparticles in Infant Formula in Australia

Context

In July 2017, Friends of the Earth Australia, an environmental consumer organization, commissioned a study with Arizona State University in the U.S. which tested seven off-the-shelf baby formula products and found three products contained needle-shaped hydroxyapatite nanoparticles. Citing a study by the European Union’s Scientific Committee on Consumer Safety (SCCS) that concluded needle-like nano hydroxyapatite was potentially toxic and should not be used in oral care products such as toothpaste and mouthwash, Friends of the Earth called for the immediate recall of the brands affected. In response to the report, Food Standards Australia New Zealand (FSANZ) said they reviewed the testing and there is no new evidence to suggest that products be recalled, so parents should not be alarmed or concerned.

 

Media Statement

“There is no scientific or public health basis to recommend parents change their infant feeding practices based on this report,” says Mardi Mountford, President of the Infant Nutrition Council of America. “Safety is the top priority of infant formula manufacturers, which is why infant formula remains the most highly regulated food, with stringent protocols in place to ensure that every product meets or exceeds the expectations of consumers, health care providers and regulatory bodies, including the US FDA, Health Canada, the European Food Safety Authority and other regulatory agencies. Parents should contact their baby’s doctor if they have any questions about infant feeding.”

 

  • The term “nano” is strictly an indicator of microscopic size. Nanoparticles of various types occur naturally and commonly in the environment and can be found in many food products, sometimes as a result of the addition of certain ingredients and required nutritional components.
  • To put things in perspective, a nanometer is one one-billionth of a meter. A human hair has an average diameter of 80,000 nanometers. Generally recognized definitions, including that of the International Standardization Organization (ISO), limit the nano-range to 100 nanometers or less.
  • Infant formula manufacturers do not add engineered nanoparticles to their products. Some nano-structured materials, for example resulting from the aggregation of small particles, might occur as a result of the traditional manufacturing processes of ingredients or finished products. These are not considered engineered nanomaterials, since they are not intentionally produced to have dimensions in the nano scale (e.g., nanoparticles).

 

Questions and Answers

Why are nanoparticles in infant formula?
Nanoparticles are microscopic particles that can occur naturally and commonly in the environment. Infant formula manufacturers do not add engineered nanoparticles to formulas. Some nano-structured materials, for example resulting from the aggregation of small particles, might occur as a result of the traditional manufacturing processes of ingredients or finished products. These are not considered engineered nanomaterials, since they are not intentionally designed to have dimensions in the nano scale (e.g., nanoparticles).

As analytical technologies continue to evolve, the presence of certain substances can be tested at very low levels, including the nano scale. However, the very small particle size does not mean they are unsafe or should not be used in products.

What did the test for nanoparticles find?
Infant formula manufacturers do not add engineered nanoparticles to formulas. The test likely detected naturally occurring nano-sized particles in products because of the addition of certain ingredients and required nutritional components, such as calcium, which is needed for infants’ growth and development. Additionally, traditional manufacturing processes may result in the presence of finer, nano-sized particles. These are not the same as engineered nanomaterials, since they are not intentionally designed to have dimensions in the nano scale (i.e., nanoparticles). Small size particles are available for further digestion and absorption. To put things in perspective, a nanometer is one one-billionth of a meter, so something that is 100 nanometers wide would be 1/10,000th of a width of a 1 millimeter sized grain of salt. Further, it should be noted that nanoparticles can be found in the majority of foods and beverages available to consumers and can be produced in the human body.1-6

Are nanoparticles dangerous?
No, as most nanoparticles are naturally occurring and common throughout our environment and the foods we eat. “Nano” is strictly an indicator of microscopic size. In the USA, the Food and Drug Administration (FDA) regulates the use of ingredients in all foods and considers engineered nanomaterials in its premarket reviews. Engineered nanoparticles are not added to infant formula. Infant formula is the most highly regulated food and the FDA confirms that infant formulas are safe and suitable for infants prior to their market introduction, including review of all ingredients added.7-8

But what about the scary pictures shown in the report?
Any image that is blown up by a million or a billion times could appear scary, even the most harmless and innocuous of materials. For example, a sheet of glass magnified that many times would appear jagged as compared to the smooth surface we perceive, but should not be any more worrisome as a result. Even simple foods, such as blueberries or strawberries, appear alien with sufficient magnification.

Should there be labeling of nanoparticles?
The FDA establishes labeling requirements for foods to ensure that meaningful and accurate information is provided, such as health and nutrition information. This information helps consumers make informed decisions about the products they purchase. The FDA does not require any food labels to include information about the presence of certain particles just because of their very small size. It is important to note that we have been eating tiny microscopic particles as part of our food since the advent of agriculture.

What is the FDA’s stance on nanoparticles in infant formula?
The FDA states that it will regulate nanotechnology products using the specific legal standards that apply to each type of product under its jurisdiction. It distinguishes products that have added engineered nanoparticles from those products that contain materials that naturally occur in the nanoscale range. The FDA considers its current safety assessment sufficiently robust and flexible to be appropriate for a variety of materials, including engineered nanomaterials.

Optional link: http://www.fda.gov/regulatoryinformation/guidances/ucm257698

 

References

  1. Cai Y & Tang R. Calcium phosphate nanoparticles in biomineralization and biomaterials. J Mater Chem, 2008; 18: 3775-87.
  2. Dorozhkin SV. Nanosized and nanocrystalline calcium orthophosphates. Acta Biomater, 2010; 6(3): 715-34.
  3. Eppell SJ, Tong W, Katz JL, Kuhn L & Glimcher MJ. Shape and size of isolated bone mineralites measured using atomic force microscopy. J Orthop Res, 2001; 19(6): 1027-34.
  4. Liu Q, Huang S, Matinlinna JP, Chen Z & Pan H. Insight into biological apatite: physiochemical properties and preparation approaches. Biomed Res Int, 2013; doi: 10.1155/2013/929748.
  5. Powell JJ, Thomas-McKay E, Thoree V, Robertson J, Hewitt RE, Skeppere JN, et al. An endogenous nanomineral chaperones luminal antigen and peptidoglycan to intestinal immune cells. Nat Nanotechnol, 2015; 10(4): 361-9.
  6. Stanley S. Biological nanoparticles and their influence on organisms. Curr Opin Biotechnol, 2014; 28: 69-74.
  7. US Food and Drug Administration. 21 C.F.R. §106.120(b)(6)(ii).
  8. US Food and Drug Administration. 21 C.F.R. §106.40(a).

Media Statement: Media Statement and Backgrounder: Soy Infant Formula

Infant Nutrition Council of America

Media Statement and Backgrounder: Soy Infant Formula

(Study: Epigenetic Modifications in Epithelial Cells of Infant Girls)

March 2017

Context

A study titled, “Soy Formula and Epigenetic Modifications: Analysis of Vaginal Epithelial Cells from Infant Girls in the IFED Study,” was published in the March 2017 issue of Environmental Health Perspectives. While originally published online in August 2016, it is now being circulated in an official volume of the journal.

In the introduction, the authors note that soy formula has previously been associated with “altered age of menarche” as well as “a risk factor for uterine fibroids and endometriosis.” It is proposed that these associations are related to the presence of the phytoestrogen genistein in soy formula as similar associations have been found in animal studies. Further, the authors note that while soy formula has been considered safe, “infants fed soy formula have blood concentrations of genistein that overlap those showing biologic effects in rodents, raising concerns about possible latent or subclinical effects.” The authors hypothesized that exposure to soy formula early in life would lead to epigenetic reproductive changes and noted “differences in DNA methylation patterns in vaginal epithelial cells between infant girls being exclusively fed either soy formula or cow milk formula during their first months of life.”

Media Statement

“According to the U.S. Food and Drug Administration and the American Academy of Pediatrics, soy based formulas are quality alternatives to traditional cow’s milk based formula and support an infant’s growth and development, while meeting their nutritional needs,” says Mardi Mountford, President of the Infant Nutrition Council of America. “There is no scientific or public health basis to recommend parents change their infant feeding practices based on this report, however parents should always consult their baby’s doctor before changing their feeding habits or to determine if a soy formula may be appropriate.”

Talking Points

  • There is no evidence of negative effects on babies fed soy-based foods and formulas or on adults who were fed soy-based foods and formulas as adults.1,2
  • The National Institute of Environmental Health Sciences (NIEHS) reviewed available data and concluded that consumption of soy at any age does not present a risk to developmental or reproductive health.3
  • The NIEHS panel also addressed the use of animal studies which raised concerns about effects of genistein, an isoflavone found in soy, on sexual maturity. Its conclusion was that animal studies are not an appropriate measure of the safety of soy foods. Injecting or consuming a very concentrated source of one specific isoflavone, such as genistein, is very different from the way isoflavones are digested from food. Additionally, there are important differences in how mice and rats metabolize genistein compared to humans.4,5
  • Babies fed a soy-based infant formula will have higher blood levels of phytoestrogens compared to babies fed cow milk-based formulas,6 but no adverse effects have been attributed to this natural food component.

Background

  • For over 60 years, millions of babies have been fed soy-based infant formulas containing phytoestrogens, and they have grown and developed normally. There is no evidence of negative effects on babies fed soy-based formulas or on adults who were fed soy-based formulas as babies.
  • Scientists have known for decades that phytoestrogens such as genistein occur naturally in many foods of plant origin, such as wheat, rice, and soybeans. Phytoestrogens have some similarity in structure to the hormone estrogen, but are thousands of times weaker in activity.  Estrogen compounds are also present in human milk.
  • If parents choose or need to formula-feed their infant, it is important that there are high quality alternatives to traditional cow’s milk based formula to support growth and development and meet infant nutritional needs. Physicians and other health care professionals are best qualified to help parents decide when a soy formula may be appropriate for their infant and should be consulted on any changes in an infant’s feeding regimen.
  • Because many babies are given soy formula for medical reasons, it is essential that parents not change feeding practices without consulting with their baby’s doctor.

 

References

  1. Strom BL, Schinnar R, Ziegler EE, Barnhart KT, Sammel MD, Macones GA, et al. Exposure to soy-based formula in infancy and endocrinological and reproductive outcomes in young adulthood. JAMA 2001; 286(7): 807-14.
  2. Giampietro PG, Bruno G, Furcolo G, Casati A, Brunetti E, Spadoni GL, et al. Soy protein formulas in children: no hormonal effects in long-term feeding. J Pediatr Endocrinol Metab 2004; 17(2): 191-6.
  3. Rozman KK, Bhatia J, Calafat AM, Chambers C, Culty M, Etzel RA, Flaws JA, et al. NTP-CERHR expert panel report on the reproductive and developmental toxicity of soy formula. Birth Defects Res B Dev Reprod Toxicol 2006; 77(4): 280-397.
  4. Setchell KD, Brown NM, Lydeking-Olsen E. The clinical importance of the metabolite equol-a clue to the effectiveness of soy and its isoflavones. J Nutr 2002; 132(12): 3577-84.
  5. Rowland I, Faughnan M, Hoey L, Wähälä K, Williamson G, Cassidy A. Bioavailability of phyto-oestrogens. Br J Nutr 2003; Suppl 1: S45-58.
  6. Setchell KD, Zimmer-Nechemias L, Cai J, Heubi JE. Exposure of infants to phyto-oestrogens from soy-based infant formula. Lancet 1997; 350(9070): 23-7.

Media Statement: Media Statement on DHA/ARA and Infant Formula

Infant Nutrition Council of America

Media Statement: DHA/ARA and Infant Formula

Context

Parents and health professionals can be assured infant formula is safe and nutritious. U.S. infant formula manufacturers take very seriously their responsibility to provide safe and nutritious infant formulas to the millions of infants fed infant formula. The addition of DHA and ARA to infant formula is modeled on the levels present in breast milk and is supported by many government and non-profit health organizations, worldwide.

Infant formula innovations are the result of decades of research and dedication to nutrition science and represent our commitment to providing what babies need to grow and develop. Formulas with added docosahexaenoic acid (DHA) and arachidonic acid (ARA) have been shown to provide visual and mental development similar to that of the breastfed infant. Thus, U.S. infant formula manufacturers currently offer formulas containing DHA and ARA.

Media Statement

“U.S. manufacturers added DHA and ARA to infant formulas because it is best for babies,” says Mardi Mountford, President of the Infant Nutrition Council of America (INCA). “DHA and ARA are in breast milk and it makes sense that they are in infant formulas as well. The industry has done years of scientific research on these nutrients and after reviewing more than 100 safety-related studies, including very extensive compositional analyses, the FDA determined the safety of DHA in infant formulas and granted GRAS status.”

Background

INCA supports breastfeeding and the position of the World Health Organization, the American Academy of Pediatrics and other leading health organizations that breastfeeding is ideal, and offers specific child and maternal benefits. However, for those mothers who cannot or choose not to breastfeed, infant formula is recommended.2 Years of product development and careful clinical research have resulted in commercially available infant formulas that provide the appropriate levels of protein, fat, carbohydrate, vitamins, and minerals for a baby to sustain a rapid rate of growth and development without stressing the infant’s delicate and developing organ systems. With the addition of DHA and ARA to infant formulas, the industry continues its commitment to provide the best nutrition for infants whose mothers cannot or choose not to breastfeed.

After reviewing the recent literature and current recommendations regarding LC-PUFA for term infant nutrition during the first months of life, a 2008 international expert working group on LC-PUFAs in perinatal practice led by B. Koletzko concluded that “the available evidence strongly supports benefits of adding DHA and ARA to infant formula.” 1 Furthermore, the authors stated that, “a large database exists concerning not only the safety, but also the efficacy, of infant formula containing both ARA and DHA . These facts, together, support the addition of both ARA and DHA when LC-PUFAs are added to formula.”

The inclusion of LCPUFAs in infant formulas has been reviewed and supported by the U.S. Food and Drug Administration, the French Food Safety Authority, the Codex Alimentarius Commission, the European Society for Paediatric Gastroenterology and Nutrition, the World Association of Perinatal Medicine and Child Health Foundation, the Food and Agriculture Organization and World Health Organization, the Commission of European Communities and the National Academy of Sciences.

U.S. infant formula manufacturers record (and follow-up, where required) all reports of concern or dissatisfaction relating to infant formulas– as required by the Infant Formula Act – and have not observed significant differences in such reports for formulas containing DHA and ARA compared to prior formulations that did not contain DHA and ARA.

DHA and ARA are considered to be “building blocks” for the development of brain and eye tissue. Research has demonstrated that DHA and ARA, both present in human milk, are physiologically important in prenatal and postnatal life during the period of rapid brain and eye development and throughout life as well. DHA and ARA have been shown to rapidly accumulate in the brain during the last trimester prenatally and the first two years postnatal, and pre-clinical studies have also demonstrated their importance in visual and neural systems.

DHA is particularly required for the development of the cerebral cortex, the region of the brain responsible for language development and information processing, and plays a vital function in developing visual sharpness (acuity). ARA is an important precursor for modulators/mediators of a variety of essential biological processes (e.g., the inflammatory response, regulation of blood pressure, regulation of sleep/wake cycle). DHA and ARA are synthesized in the body from the precursor essential fatty acids, α-linolenic acid (ALA) and linoleic acid (LA), respectively, that are also present in human milk and infant formula.

Evidence that blood levels of DHA and ARA are typically higher in breastfed infants than in infants fed formulas not containing these LCPUFAs provided a basis for investigating the addition of DHA and ARA to infant formulas. Studies suggest that premature infants may benefit the most from direct consumption of DHA and ARA. Throughout the third trimester, a mother passes DHA and ARA to the baby through the placenta. Postnatal, these nutrients are passed through human milk. In the event that a baby is born prematurely, placental transport of DHA and ARA is interrupted, thereby reducing the baby’s total accumulation of ARA and DHA prior to birth. Addition of the GRAS sources of DHA and ARA to preterm formula provides these important nutrients safely. Studies show that formulas containing added DHA and ARA are safe and support visual and cognitive development.

U.S. infant formula manufacturers continue to evaluate the potential benefits of adding nutritional fatty acids to infant formulas. Millions of infants in the U.S. and worldwide have safely been fed infant formula with DHA and ARA and millions more continue to be fed every day.

U.S. Food and Drug Administration (FDA)

In May 2001, following an extensive review of the available scientific data supporting the safety of DHA and ARA, the FDA agreed that oils containing DHA and ARA are generally recognized as safe (GRAS) for use in infant formula.3 Additionally, in accordance with the requirements of the Infant Formula Act of 1980 and its subsequent amendments, any manufacturer wishing to add these oils to a specific infant formula was required to notify the FDA 90 days prior to the introduction of such a new formula, so that the agency could conduct an appropriate review of the scientific literature and testing that has been assembled by the manufacturer to demonstrate the formula’s ability to support growth as a substitute for breast milk.4

French Food Safety Authority (AFSSA)

In March 2010, AFSSA published Dietary Reference Intakes (DRIs) for Fatty Acids, including DRIs for infants 0-6 months and infants and young children 6-36 months. AFSSA also recognized DHA as an essential fatty acid for its role in structure and function of the brain and eye.

Codex Alimentarius Commission (CAC)

The CAC, a global body formed by the United Nations’ Food and Agriculture Organization and the World Health Organization, adopted in July 2007 the Revised Standard for Infant Formula and Formula for Special Medical Purposes Intended for Infants, which upholds the safety and provides for the optional addition of LCPUFAs to infant formulas.5

European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)

ESPGHAN recommends the addition of LCPUFAs to infant formulas. In 2005, an ESPGHAN-coordinated International Expert Group supported the addition of DHA and ARA to infant formulas.6 In 2006, the ESPGHAN Committee on Nutrition concluded that pre-term infants, when formula fed, should receive infant formula with provision of LCPUFAs.7

World Association of Perinatal Medicine (WAPM) and the Child Health Foundation

In 2001, the Child Health Foundation, under guidance from the WAPM, asked investigators in the field of LCPUFAs to review available scientific data and form a recommendation. That working group supported the addition of DHA and ARA to infant formulas for term and premature infants.8 Further, a recommendation from the 2001 workshop was that investigators update its recommendation as additional data became available. Therefore, in 2008, the same group of investigators reviewed the available scientific literature and endorsed its previous position.19

Food Agriculture Organization (FAO) and the World Health Organization (WHO)

FAO and WHO have recommended the addition of DHA and ARA to infant formula at the levels found in human breast milk. In October 1993, a joint expert consultation concluded: “In view of the evidence on the higher efficiency of long-chain polyunsaturated fatty acids for neural development…and the data on premature infants…the long-chain polyunsaturated fatty acids should be included in infant formula.”10

Commission of the European Communities (EC)

The EC states that DHA and ARA are considered safe for use as an optional ingredient for infant formulas.11

National Academy of Sciences (NAS)

In 2005, a panel organized by NAS developed a report on dietary reference intakes for various macronutrients, including dietary fatty acids like LCPUFAs, and supports the addition of DHA to infant formula in the amounts found in breast milk. According to NAS, “n-3 polyunsaturated fatty acids provide DHA that is important for developing brain and retina.”12


References Cited:

1 Koletzko, B. Lien, E. Agostoni, C. et al. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations. J. Perinat. Med. 2008; 36: 5-14.

2 The American Academy of Pediatrics, Section on Breastfeeding. Breastfeeding and the Use of Human Milk. Pediatrics. 2005; 115 :496-506.

3 The U.S. Food and Drug Administration, 2001. Agency Response Letter GRAS Notice No. GRN 000041.

4 The Infant Formula Act of 1980. Public Law No. 96-359, 94 Stat. 1190 [codified at 21 U.S.C. §350(a), 301, 321 (aa), 331, 374(a)]. September 26, 1980.

6Alinorm 07/30/26.

7 Koletzko et al. Global Standard for the Composition of Infant Formula: Recommendations of an ESPGHAN Coordinated International Expert Group. Journal of Pediatric Gastroenterology and Nutrition 2005; 41:584-99.. http://www.espghan.med.up.pt/position_papers/con_23.pdf

8 ESPGHAN Committee on Nutrition. Feeding Preterm Infants After Hospital Discharge. Journal of Pediatric Gastroenterology and Nutrition 2006; 42: 596-603,. http://www.espghan.med.up.pt/position_papers/con_25.pdf

9 Koletzko B, Agostini C, Carlson SE, Clandinin T, Hornstra G, Neuringer M, et al. Long chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001; 90: 460-4.

10 Koletzko et al. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations. J. Perinat. Med. 2008; 36: 5-14.

11 Food Agriculture Organization/ World Health Organization. Fats and oils in human nutrition: Report of a joint expert consultation. Chapter 7. M-80 ISBN 92-5-103621-7, 1994. http://www.fao.org/docrep/V4700E/V4700E00.HTM

12 Commission of the European Communities. Working Document Draft Commission Directive of infant formulae and follow on formulae (Recast version). http://www.epha.org/IMG/pdf/Working_document_infant_formulae_EC_20040925.pdf

13 Food and Nutrition Board. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. 2005. http://books.nap.edu/openbook.php?record_id=10490&page=R2

 

March 2014

 

MEDIA CONTACTS

Robin Applebaum                                                                                                Morgan Dukes

678-303-2980                                                                                                      678-303-2993

rapplebaum@kellencompany.com                                                                  mdukes@kellencompany.com

Media Statement: Media Statement on Furan

Infant Nutrition Council of America

Media Statement: Furan

Context

Furan is a naturally occurring chemical that can be found in a variety of heat-treated canned and jarred foods at extremely low levels, the presence of which has long been known and considered to be safe.  The U.S. Food and Drug Administration’s (FDA) preliminary estimate of consumer exposure to furan in foods is well below what FDA expects would cause harmful effects, and FDA has not initiated regulatory action on furan.  FDA recommends consumers not change their current eating habits.

Based on current scientific evidence, no safety problem is presented by extremely low levels of furan that may be contained in infant formulas.  Parents and health professionals can be assured that infant formula is safe and nutritious.

Background

Furan is a colorless, volatile liquid used in some chemical manufacturing industries and has occasionally been reported to be found in foods.  It is believed furan forms as a result of traditional heat treatment techniques, such as cooking, jarring, and canning, which have long been essential methods of safe food preparation and preservation.

In September 2005, FDA issued an Action Plan for Furan in Food, which outlined FDA’s proposed goals and actions.  Goals included assessing dietary exposure to furan, characterizing possible risks and uncertainties, and updating consumers and food processors as appropriate.  As part of its action plan, FDA has posted on its website exploratory data on furan in foods that has been gathered since 2004.  To date, 42 infant formula samples have been tested, and furan levels have ranged from below the limit of detection to 26.9 parts per billion (ppb)

Additionally, in April 2007, FDA posted in its website an updated exposure assessment for furan from the consumption of adult and baby foods.  Based on these levels, FDA estimated infant exposure to furan at 0.9 ppb body weight/day.

 

September 2010

 

MEDIA CONTACTS

Robin Applebaum                                                                                                Morgan Dukes

678-303-2980                                                                                                      678-303-2993

rapplebaum@kellencompany.com                                                                  mdukes@kellencompany.com

Media Statement: Media Statement on Carbohydrates and Infant Formulas

Infant Nutrition Council of America

Media Statement: Carbohydrates and Infant Formulas

Similar to breast milk, most milk-based infant formulas contain a carbohydrate called lactose, which is the sugar found in milk.  In some formulas, corn syrup solids, maltodextrin, or sucrose are used to replace some or all of the lactose to maintain a carbohydrate level, similar to human milk. Corn syrup solids are NOT the same as high-fructose corn syrup.

Lactose, corn syrup, corn syrup solids, maltodextrin, and sucrose are safe ingredients and some of the carbohydrates that may be used to provide calories for energy needed by term infants.  All of these carbohydrates have been shown in clinical studies and many years of consumer use to be safe, and support normal growth and development in infants. The Infant Nutrition Council of America (INCA) members select infant formula ingredients for their ability to meet nutritional targets and assure product quality.

Infant formulas are highly regulated and must meet rigorous safety and quality standards set by national and international regulatory authorities, including the U.S. Food and Drug Administration (FDA), Health Canada, the European Union and other regulatory agencies.

According to 21 CFR 107.10, the labels on infant formula packaging must declare total carbohydrates.  Individual carbohydrates are not required to be listed on the nutrient panel for infant formulas, but are provided on the product label’s ingredient list.

Parents and health professionals can be assured infant formula is safe and nutritious.

 

February 2012

 

MEDIA CONTACTS

Robin Applebaum                                                                                                Morgan Dukes

678-303-2980                                                                                                      678-303-2993

rapplebaum@kellencompany.com                                                                  mdukes@kellencompany.com

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