Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States (2024)
Chapter: Appendix G: Description of the International Code of Marketing of Breast-Milk Substitutes
Appendix G
Description of the International Code of Marketing of Breast-Milk Substitutes
The preamble to International Code of Marketing of Breast-Milk Substitutes (the Code) recognizes that “when mothers do not breast-feed, or only do so partially, there is a legitimate market for infant formula” (WHO, 1981). It is important to note that the Code equates bottle-feeding with infant formula feeding. This was written at a time when the pumping of breastmilk was less common (Rasmussen and Geraghty, 2011), so this summary distinguishes between breastfeeding and infant formula feeding, rather than bottle feeding, when applicable. In Article 10, the Code states that it is “essential” that the quality of infant formula itself be “of a high recognized standard” to protect the health of infants (WHO, 1981). Nonetheless, the goal of the Code is that such infant formula “should not be marketed or distributed in ways that interfere with the protection or promotion of breast-feeding” (WHO, 1981 [Preamble]).
Articles 4, 6, and 7 of the Code address information. The Code states that governments “should have the responsibility to ensure that objective and consistent information” is provided to families about infant and young child feeding. Informational and educational materials “should include clear information” on the “benefits and superiority” of breastfeeding, maternal nutrition, the negative effect on breastfeeding of “introducing partial bottle-feeding,” the difficulty of reversing the decision not to breastfeed, and when needed, the proper use of infant formula (WHO, 1981 [Article 4]). Moreover, health authorities “should give appropriate information and advice to health workers” to “encourage and protect breastfeeding” (WHO, 1981 [Article 6]).
The Code does not preclude the dissemination of information by manufacturers and distributors to health professionals but limits such information to “scientific and factual matters” (WHO, 1981 [Article 7]). Such information “should not imply” that infant formula feeding is equivalent or superior to breastfeeding (WHO, 1981 [Articles 4, 7]). Moreover, the scientific and factual information “should include clear information” on the “benefits and superiority” of breastfeeding and the proper use of infant formula (WHO, 1981 [Articles 4, 7]).
The Code states that health care systems and infant formula manufacturers and distributors should not use health care facilities or systems to promote infant formula, including through the placement of advertisements such as posters (WHO, 1981 [Article 6]). However, the Code does not object to the provision of branded informational or educational equipment or materials at the request of government or health care systems as long as it does not refer to the company’s proprietary infant formula product (WHO, 1981 [Article 6]). Moreover, infant formula manufacturers and distributors may donate or provide reduced-price sales of infant formula for use by infants “who have to be fed on breastmilk substitutes” both in institutions and for distribution outside of them, as long as they are distributed by the institutions and organizations themselves (WHO, 1981 [Article 6]).
Health workers are urged to encourage and protect breastfeeding (WHO, 1981 [Article 7]). In health care facilities, the Code recommends that only health workers should demonstrate infant feeding (WHO, 1981 [Article 6]). Moreover, the Codes states that health workers should not accept financial or material inducements to promote infant formula, and manufacturers and distributors should not provide the same (WHO, 1981 [Article 7]). Therefore, any contribution made to a health worker or on their behalf should be disclosed (WHO, 1981 [Article 7]).
Manufacturers and distributors employ sales and marketing personnel. The Code states that the job responsibilities of such personnel should not include educating pregnant women or mothers of infants, nor should their bonuses be calculated based on sale of infant formula (WHO, 1981 [Article 8]).
Several articles of the Code explicitly address marketing practices. The Code states that infant formula manufacturers and distributors “should not” market infant formula to the general public, including through the use of direct-to-consumer advertising such as samples, coupons, and point-of-sale advertising, among other methods (WHO, 1981 [Article 5]). The Code further states that manufacturers and distributers “should not” directly contact pregnant women or mothers of infants, including by providing them free samples or gifts (WHO, 1981 [Article 5]). Moreover, samples should not be provided to pregnant women, moth-
ers of infants, or their families indirectly by manufacturers or distributors through health workers (WHO, 1981 [Article 7]). As such, samples should not be provided to health workers “except when necessary for purposes of professional evaluation or research at the institutional level (WHO, 1981 [Article 7]). In a guidance document issued by the World Health Organization (WHO), WHO urges against the digital promotion of infant formula, including through brand promotion, across all channels and media (WHO, 2023).
Article 9 of the Code addresses the labeling of breastmilk substitutes. Manufacturers and distributors are responsible for “clear, conspicuous and easily readable and understandable” labeling (WHO, 1981). Such labeling should provide necessary information on the appropriate use of the product as not to discourage breastfeeding (WHO, 1981 [Article 9]). Thus, the Code recognizes the importance of graphics illustrating the proper method of preparation to minimize risk. The Code states that labeling should include a statement with a demarcation such as “Important Notice” that includes a statement on the superiority of breastfeeding, a statement that the product should be used only on the advice of a health worker regarding both the need and proper use of the product, instructions for appropriate preparation, and a warning on the health hazards associated with inappropriate preparation (WHO, 1981 [Article 9]). The Code specifically states that claims that humanize infant formula, such as breastmilk equivalency or comparison claims (e.g., “closest formula to breastmilk”), should not be used on labels, nor should images that idealize infant formula (WHO, 1981 [Article 9]). In Guidance on the Code, WHO identified “demonstrated evidence of inappropriate and misleading messaging and labelling by manufacturers” that include health, nutrition and “structural claims,” such as that a breastmilk substitute will improve a child’s “intellectual performance” (WHO, 2017). WHO found that such messaging is contrary to the Code’s statement that labels should not “idealize the use of infant formula” (WHO, 1981 [Article 9]).
Some provisions of the Code are directed more broadly at the labeling of food products for infants. Under U.S. law, infant formula is a category of food, so it must abide by several labeling requirements related to all foods in addition to labeling requirements specific to infant formula. As such, some of the provisions of the Code related to the labeling of food products for infants provide a useful framework for infant formula labeling and are additionally relevant to infant formula sold in the United States. Specifically, the Code states that the labels should disclose the following: “(a) ingredients used; (b) the composition/analysis of the product; (c) the storage conditions required; and (d) the batch number and date before which the product is to be consumed” (WHO, 1981 [Article 9]).
As of April 2020, 136 (70 percent) of 194 WHO member states had enacted laws to implement provisions of the Code (WHO, 2020). According to the Code, governments are responsible for monitoring compliance with the Code, with civil service organizations collaborating to this end and highlighting noncompliance with the Code (WHO, 1981 [Article 11]). Nonetheless, the Code does not have the force of law in countries that have not adopted it into law. However, the Code provides a foundational framework for what the public health community considers to be effective strategies to support infant nutrition.
REFERENCES
Rasmussen, K. M., and S. R. Geraghty. 2011. The quiet revolution: Breastfeeding transformed with the use of breast pumps. American Journal of Public Health 101(8): 1356-1359.
WHO (World Health Organization). 1981. International code of marketing of breastmilk substitutes. Geneva, Switzerland: WHO.
WHO. 2017. Guidance on ending the inappropriate promotion of foods for infants and young children: Implementation manual. https://www.who.int/publications/i/item/9789241513470 (accessed May 10, 2024).
WHO. 2020. Marketing of breast-milk substitutes: National implementation of the international code—Status report summary. Geneva, Switzerland: WHO.
WHO. 2023. Guidance on regulatory measures aimed at restricting digital marketing of breast-milk substitutes. Geneva, Switzerland: WHO.
