Journal of Public Health | Vol. 40, No. 1, pp. e1–e7 | doi:10.1093/pubmed/fdx023 | Advance Access Publication March 25, 2017
Marketing of breast-milk substitutes in Zambia: evaluation
of compliance to the international regulatory code
P. Funduluka1,2, S. Bosomprah3,4, R. Chilengi3, R.H. Mugode5, P.A. Bwembya1,
B. Mudenda1,6
1School of Public Health, University of Zambia, Box 50110, Lusaka, Zambia
2Chainama College of Health Sciences, Box 33991, Lusaka, Zambia
3Centre for Infectious Diseases Research in Zambia, Box 3481, Lusaka, Zambia
4Department of Biostatistics, School of Public Health, University of Ghana, P.O. Box LG 25 Legon, Accra
5National Food and Nutrition Commission, Lumumba Road, Box 32669, Lusaka, Zambia
6Immunomedics Inc., 300, American Rd., Morris Plains, NJ, USA
Address correspondence to P. Funduluka, E-mail: pfunduluka04@gmail.com
ABSTRACT
Background We sought to assess the level of non-compliance with the International Code of Marketing breast-milk substitutes (BMS) and/or
Statutory Instrument (SI) Number 48 of 2006 of the Laws of Zambia in two suburbs, Kalingalinga and Chelstone, in Zambia.
Methods This was a cross sectional survey. Shop owners (80), health workers (8) and mothers (214) were interviewed. BMS labels and
advertisements (62) were observed. The primary outcome was mean non-compliance defined as the number of article violations divided by the
total ‘obtainable’ violations. The score ranges from 0 to 1 with 0 representing no violations in all the articles and one representing violations in
all the articles.
Results A total of 62 BMS were assessed. The mean non-compliance score by manufacturers in terms of violations in labelling of BMS was
0.33 (SD = 0.28; 95% CI: 0.26, 0.40). These violations were mainly due to labels containing pictures or graphics representing an infant. 80
shops were also assessed with mean non-compliance score in respect of violations in tie-in-sales, special display, and contact with mothers at
the shop estimated as 0.14 (SD = 0.14; 95% CI: 0.11, 0.18).
Conclusions Non-compliance with the Code and/or the local SI is high after 10 years of domesticating the Code.
Keyword public health
Introduction relevant World Health Assembly resolutions. In Zambia, the
code is enacted as Statutory Instrument (SI) no. 48 of 2006
World Health Organization (WHO) estimates that more in the Food and Drug Act.5 Manufacturers and distributors
than one million babies could be prevented from dying each are obliged to comply with the code articles and/or regula-
year by breastfeeding.1 Breastfeeding is protective particu- tions of the local SI.
larly from otitis media, gastroenteritis and respiratory tract Manufacturers who do not comply from elsewhere have
infections in children as well as from type two diabetes, been reported to advertise BMS in the electronic and print
breast and ovarian cancers in mothers.2 The WHO Code of
marketing breast-milk substitutes (BMS) was adopted fol- P. Funduluka, Student for Master of Science in Epidemiology, Lecturer at Chainama
lowing the reports on the general decline in the prevalence College of Health Sciences
of breastfeeding in many parts of the world.3 The Code is a S. Bosomprah, Head of Analysis Department, Senior Lecturer
global public health policy frame work which restricts the R. Chilengi, Chief Scientific Officer
marketing of BMS and encourages proper use through R.H. Mugode, Chief Nutritionist
informed choice.4 Since 1981, many countries have enacted P.A. Bwembya, Lecturer School of Public Health
legislation implementing the provisions of the code and B. Mudenda, Honarary Senior Lecturer, Vice President Immunomedics Inc.
© The Author 2017. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com e1
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e2 JOURNAL OF PUBLIC HEALTH
media.6–8 They also engage in labelling of BMS with state- (SD = 0.30). We therefore required a total of 74 BMS sam-
ments and visuals to entice mothers.9,10 In addition, they ples to detect a 40% reduction at an 80% power using
offer gifts and samples to mothers and health workers.9–11 Satterthwaite’s t test assuming unequal variances. This was
Mothers have been offered ‘tie-in sales’ (i.e. buy two, get one performed using Stata MP 14 (StataCorp, College Station,
free) and gifts with purchase.9,11 Gifts to health workers TX, USA).
include formula, pens, note pads, obstetric stethoscopes,
leaflets, calendars as well as sponsorship for training.9,11,12 Sampling
Distributors have been reported to engage in special displays Shop owners were selected systematically, by picking every
and promoting BMS to mothers.10,11
fifth shop in consecutive order. Within each shop we ran-
Non-compliance with the Code and/or SI no. 48 could domly selected BMS for assessment of violations in labeling.
arguably lead to uncontrolled use of BMS, and reductions in These shops were also assessed for violations in terms of;
the prevalence of breastfeeding that results in mass growth low price sales, special displays and contact with mothers.
faltering and ultimately increased morbidity and mortality in Four health care workers out of 140 (3%) from Kalingalinga
infants and young children.13,14 This is so because it dis- and four out of 154 (3%) from Chelstone were conveniently
courages good dietary habits in young children.15 Feeding recruited. Only health care workers available on the day of
bottles and water used may be a source of infections.16,17 the interview were considered. A total of 214 mothers of
Many mothers who give BMS, also face difficulties to afford infants (<1year) were conveniently recruited and inter-
appropriate and adequate supplies for the period the baby viewed as they came for children’s under five clinic
will need the feed.18 (Table 2). The recruited mothers represent 3% (107/3285)
While the law has been adopted in Zambia for 10 years from Kalingalinga, and 2% (107/4549) from Chelstone.
now, there is lack of evidence on compliance with the inter-
national code or indeed the domesticated local SI. We set
out to assess the level of non-compliance with the inter- Data collection
national code and SI no. 48 of 2006 of the Laws of Zambia Six people from each site were trained to collect data using
by manufacturers and distributors. We did this assessment Standard International Baby Food Action Network
through cross sectional surveys in Kalingalinga and Monitoring (IBFAN-SIM) forms within a total of 10 days.
Chelstone suburbs in Lusaka, Zambia. SIM forms are designed to capture data on violations of arti-
cles of the Code and/or local SI4,8 (Table 1). Articles of
interest were around advertising, labeling, and sales strategy.
Methodology Samples of labels that violate the code are captured in Fig. 1.
Background of enumerators (data collectors) included
Study design
Nutritionist,2 Environmental Health Technologists (EHT),3
This was a cross sectional survey conducted between August
Nurses and Community Health Worker (CHW).1 Except for
2016 and November 2016.
the CHW, the other enumerators had tertiary education.
Pretest of the questionnaire was conducted in the pilot town-
Setting and population ships prior to start of the study. This was done in Mtendere
The study was conducted in Lusaka, the capital city of and Chipata townships, which have similar contexts with the
Zambia. Lusaka was convenient as an urban district where study areas. The tools were revised following the pretest.
more people are likely to use BMS than in rural communi-
ties.8,11 Two study areas within the city of Lusaka were Data analysis
selected: Kalingalinga, a medium density suburb and The primary outcome was mean non-compliance score
Chelstone, a low density area with similar incomes as they defined as the number of article violations divided by the
closely reflect the urban living standards of most Zambians. total ‘obtainable’ violations assessed by each source of data
Targeted study participants were shop owners who sell BMS (Table 1). For example, Article number 4 in Table 1 has four
brands, health care staff and mothers of infants aged below obtainable violations. Therefore, if a manufacturer violated
one year. one then non-compliance score in respect of breast milk
substitute would be 0.25 (i.e. 1/4). The score ranges from 0
Sample size consideration to 1 with 0 representing no violations in all the articles and
We assumed that the mean non-compliance score by manu- one representing violations in all the articles. Non-
facturers in terms of violations in labeling BMS was 0.50 compliance by manufacturers was assessed through mothers,
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MARKETING OF BREAST-MILK SUBSTITUTES IN ZAMBIA e3
Table 1 Provisions of the International Code and/or SI no. 48 of 2006 of the Laws of Zambia on marketing breast-milk substitutes included in this study
No. Articles Category Source of data
1 No advertising of breast-milk substitutes to families Manufacturers Mothers
2 No gifts to mothers and health workers Manufacturers Mothers/health workers
3 No free samples to mothers and health workers Manufacturers Mothers/health workers
4 No labels violating the Code in the following ways:
Containing words or pictures idealizing artificial feeding Manufacturers BMS
Containing pictures or graphics representing an infant Manufacturers BMS
Indicate use of feeding bottle Manufacturers BMS
Not explaining the benefits of breastfeeding and costs and hazards associated Manufacturers BMS
with artificial feeding
5 No contact between marketing personnel and mothers at the shop Manufacturers Shops
6 No price reduction (tie-in-sales) Distributors Shops
7 No special displays Distributors Shops
8 Shop owners advertising to mothers Distributors Shops
across professions such as nurses and clinical officers. In
Kalingalinga an EHT was also recruited while in Chelstone a
Nutritionist was recruited. A total of 214 mothers of infants
(<1year) were recruited from each site. The general charac-
teristics of study population between Kalingalinga and
Fig. 1 Examples of labeling that violates the Code. Chelstone were not significantly different P> 0.05 as sum-
marized in Table 2.
health care workers and breast-milk substitutes whereas
non-compliance by distributors was assessed through obser- Non-compliance by manufacturers and distributors
vations at the shops (Table 1). To examine individual article The mean non-compliance score by manufacturers in
violations we presented bar graph with error bars for each terms of advertising, free gifts and free samples to mothers
source of data. Analysis was performed using Stata MP 14 and health workers was 0.08 (95% CI: 0.06, 0.10) (Table 3).
(StataCorp, College Station, TX, USA). Regarding violations by manufacturers in labelling, the
mean non-compliance score was 0.33 (95% CI: 0.26, 0.40).
Ethics statement Violations by manufacturers were mainly due to labels con-
The Excellence of Research Ethics and Science converge taining pictures or graphics representing an infant (Fig. 2).
Institutional Research Board reviewed and approved the study For distributors, the mean non-compliance score in respect
(ref. No. 2015-June-028). Permission was also obtained from of violations in price reduction, special display and contact
the Lusaka District Health Office to conduct the research and with mothers at the shop was 0.14 (95% CI: 0.11, 0.18)
pretest in the study sites. Written informed consent was (Table 3).
obtained from all participants.
Discussion
Results
Main findings of this study
Respondents We found that non-compliance with the Code and/or SI no
Shops in Kalingalinga included 38 retail outlets, one whole- 48 of 2006 of the Laws of Zambia by manufacturers and dis-
sale and one pharmacy (Table 2). In Chelstone shops tributors was prevalent. This is despite the efforts to control
included 39 retail outlets and one wholesale. A total number unethical marketing strategies through the implementation of
of 31 BMS labels were included in observations in each site the Infant and Young Child Feeding (IYCF) programme and
(Table 2). These were three milk cereals, 13 brands of for- enforcement of the Law.
mula and 15 other BMS labels (teats, teethers and feeding Of note, manufacturers’ labels with visuals violating the
bottles). Eight health workers were included in the study Code and/or SI no. 48 included graphs representing infant
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e4 JOURNAL OF PUBLIC HEALTH
Table 2 Characteristics of study population
Characteristics Kalingalinga* Chelstone*
n % n %
Manufacturers’ BMS 31 100.00 31 100.00
Milk cereals 3 9.68 3 9.68
Formula 13 41.94 13 41.94
Othera 15 48.39 15 48.39
Distributors 40 100.00 40 100.00
Retail outlets 38 95.00 39 98.00
Pharmacies 1 2.50 0 0.00
Whole sales 1 2.50 1 2.50
Health workers 4 100.00 4 100.00
General nurse/midwife 2 50.00 2 50.00
Clinical officer 1 25.00 1 25.00
EHT/nutritionist 1 25.00 1 25.00
Mothers of children below 1 year 107 100.00 107 100.00
Introduced children on BMS < 6 months 31 28.97 35 32.71
Milk cereal 6 5.61 12 11.21
Formula 17 15.89 16 14.95
Otherb 9 8.41 12 11.21
Introduced children on BMS > 6 months 76 71.03 72 67.29
*Pearson’s χ2 P > 0.05.
aTeats, teethers and feeding bottles.
bMaize porridge, nshima, supa maheu, fresh/sour milk.
Table 3 Mean non-compliance scores, articles of violation by suburb
Articles of violation Kalingalinga Chelstone Total
Advertising, gifts and free samples to mothers Number of mothers/health workers 111 111 222
Mean score 0.06 0.1 0.08
SD 0.13 0.15 0.14
95% CI [0.04, 0.09] [0.07, 0.13] [0.06, 0.10]
Labelling (feeding bottle, photo of infant, Number of manufacturers breast milk samples 31 31 62
idealizing feeding, missing breastfeeding explanation) Mean score 0.35 0.31 0.33
SD 0.28 0.29 0.28
95% CI [0.25, 0.45] [0.20, 0.41] [0.26, 0.40]
Promotions (price reduction, special displays, Number of distributors 40 40 80
contact with mothers at shop) Mean score 0.14 0.15 0.14
SD 0.18 0.16 0.17
95% CI [0.08, 0.19] [0.10, 0.20] [0.11, 0.18]
wellbeing and text idealizing use of the product. These inad- and cereal products. This gives an impression that the pro-
vertently attract mothers to buy the BMS, and can be con- ducts could also be used for infant feeding. It also reduces
strued as encouraging artificial feeding; especially among opportunities for receiving relevant information that may
mothers not so well educated. Distributors were also found support mothers’ feeding and child care practices.19
to employ special displays of unsuitable products close to Generally, setting BMS apart was common and particularly
reputable brands of BMS. These include other types of milk so at outlets that were closer to health facilities; this practice
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MARKETING OF BREAST-MILK SUBSTITUTES IN ZAMBIA e5
Fig. 2 Mean non-compliance by article violations.
abrogates the stipulations of the Code as it can be seen as Turkey.11,21 Perhaps there may be a lack of local law enact-
enticing mothers to buy. ment of or complete failure to enforce the international
code.
What is already known
Similar findings elsewhere have shown that manufacturers What this study adds
and distributors who do not comply engage in labelling To the best of our understanding, this is the first evaluation
BMS with visuals and text that violate the Code as well on compliance to laws governing ethical advertising for
as special displays.11 Contrary to our findings, in the BMS in Zambia. We also could not find much on this sub-
Philippines and China advertising on TV and radio were sig- ject from countries of similar settings as Zambia, therefore
ni cant.7,11fi Additionally, health workers who were aware of our report may be broadly applicable within the Sub-
the Law in Pakistan have been reported to be more likely to Saharan Africa region.
receive gifts and free samples.12 In this study advertising was Foremost, we here report that the international code and
not significant and we hardly found any practices that under- indeed SI no. 48 of the laws of Zambia is presently not well
mine breastfeeding at health facility level similar to findings adhered to by both manufacturers and distributors of BMS.
in Ghana.20 While many manufacturers will generally point While there are justifiable situations when these supplements
to the value of breastfeeding, albeit in small print and less can be beneficial, the broad message of exclusive breastfeed-
catchy, we found it hard to explain why the breastfeeding ing for newborns which is national policy, is negatively
messages were reportedly missing on the labels in Lao and impacted by these non-compliant commercial practices. It is
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e6 JOURNAL OF PUBLIC HEALTH
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