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Clarifying the Definition of Breast-Milk Substitutes

Grummer-Strawn, Laurence M.

Journal of Pediatric Gastroenterology and Nutrition: December 2018 - Volume 67 - Issue 6 - p 683
doi: 10.1097/MPG.0000000000002137
Invited Commentary

World Health Organisation, Geneva, Switzerland.

Address correspondence and reprint requests to Laurence M. Grummer-Strawn, PhD, World Health Organisation, Geneva, Switzerland (e-mail:

Received 3 August, 2018

Accepted 13 August, 2018

Disclaimer: The author is a staff member of the World Health Organization. The author alone is responsible for the views expressed in this commentary and they do not necessarily represent the decisions, policy or views of the World Health Organization.

I declare that I have no conflicts of interest to report. As an employee of the World Health Organisation, my salary is covered through the WHO budget.

This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

See “Is the WHO Creating Unnecessary Confusion Over Breast Milk Substitutes?” by Forsyth on page 760.

In his article “Is the WHO creating unnecessary confusion over breast milk substitutes?,” Steward Forsyth claims that WHO inappropriately changed the definition of breast-milk substitutes in 2016 and did so without consultation and endorsement (1). In fact, the 2016 WHO Guidance on Ending Inappropriate Promotion of Foods for Infants and Young Children (2) clarified the original definition contained in the International Code (3) to address ambiguities in its interpretation. The clarification is completely consistent with the original definition. The Guidance was developed by a Scientific and Technical Advisory Group (STAG) working over the course of 2 years.

The International Code clearly recognized that the category breast-milk substitutes is broader than just infant formula, describing the scope of the Code as applying to “breast-milk substitutes, including infant formula” (Article 2). The Code provided no upper age limit on the definition of breast-milk substitutes. Given that WHO has long recommended the continuation of breastfeeding for 2 years and beyond, it is logical that the protection of breastfeeding from inappropriate promotion of breast-milk substitutes must extend into the third year of life. The Code made a clear distinction between foods that “replace” breast-milk (and are thereby breast-milk substitutes) and those that “complement” breast-milk when it becomes insufficient to meet nutritional requirements. Thus, distinguishing between a breast-milk substitute and a complementary food hinges on whether the food directly reduces breast-milk consumption or adds to it. The STAG that developed the recommendations concluded that there was sufficient evidence that milks targeted specifically to children under age 3 years do replace the intake of breast milk. Breast-feeding mothers either reduce the number of breast-milk feedings a day or stop breastfeeding altogether when other milks are introduced. Forsyth provides no evidence to the contrary. Thus, the clarification provided in 2016 is perfectly consistent with the original definition of breast-milk substitutes.

Forsyth asserts that the clarification of the definition of breast-milk substitutes emerged without evidence of consultation with key stakeholders. In fact, the opportunities for input across multiple stakeholders were extensive. The draft WHO recommendations were released publicly in July 2015 along with the report from the STAG. Contrary to what Forsyth claimed, the STAG recommendations similarly stated that the scope of the Code “should include any milk products (liquid or powdered) marketed for young children up to two years or beyond (including follow-up formula and growing-up milks) (4).” The draft recommendations were made available for public comments between July and August 2015. Over 300 comments were received from industry, nongovernmental organizations, and academicians. WHO held a consultation with Member States and United Nations organizations in August in addition to dialogue meetings with nongovernmental organizations and representatives of manufacturers of infant formula to discuss any concerns. The WHO Executive Board discussed a revised version in January 2016 and additional comments from WHO Member States were reviewed in the spring of 2016. Throughout this process, the issue of the definition of breast-milk substitutes was discussed at length. The consultation process was open and widespread.

While the World Health Assembly did not use the word “endorse” in resolution 69.9, it did “welcome with appreciation” the Guidance (5). But more importantly, the resolution urged Member States “to take all necessary measures in the interest of public health to end the inappropriate promotion of foods for infants and young children, including, in particular, implementation of the guidance recommendations.” The Assembly further called upon manufacturers and distributors of foods for infants and young children “to end all forms of inappropriate promotion, as set forth in the guidance recommendations.” It also called upon health care professionals to implement the guidance recommendations and urged the media and creative industries to ensure that their activities “are carried out in accordance with the guidance recommendations.” Finally, it requested the Director-General “to provide technical support to Member States in implementing the guidance recommendations.” It seems hard to argue that the WHA did not accept the Guidance recommendations when it called for implementation by all relevant stakeholders.

Forsyth concludes by suggesting that inappropriate promotion of foods for infants and young children should be addressed through effective regulation of composition and labeling standards. This is certainly true, but regulation of food promotion must go well beyond composition and labeling standards, to include advertising, marketing through the health care system, direct communications, and others. Effective regulation to address the multiple forms of marketing must be based on appropriate definitions. The WHO Guidance on Ending Inappropriate Promotion of Foods for Infants and Young Children helps to clarify some of these definitions for countries implementing regulations.

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1. Forsyth S. Is the WHO creating unnecessary confusion over breast milk substitutes? J Pediatr Gastroenterol Nutr 2018; 67:760–762.
2. World Health Organisation. Maternal, infant, and young child nutrition. Guidance on ending the inappropriate promotion of foods for infants and young children. Sixty-ninth World Health Assembly. Document A69/7 Add.1 2016. Accessed August 20, 2018.
3. World Health Organisation. International code of marketing of breast-milk substitutes. World Health Organization, 1981. Accessed August 20, 2018.
4. World Health Organisation. Draft clarification and guidance on inappropriate promotion of foods for infants and young children: report of the Scientific and Technical Advisory Group (STAG) on Inappropriate Promotion of Foods for Infants and Young Children. Accessed August 20, 2018.
5. World Health Organisation. Ending inappropriate promotion of foods for infants and young children. WHA 69.9. May 2016. Accessed August 20, 2018.
© 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,