Survey on the Marketing, Advertising and
Distribution of Infant Formulae
and Follow-on Formulae
Survey on the Marketing, Advertising and
Distribution of Infant Formulae
and Follow-on Formulae
Published by:
Food Safety Authority of Ireland
Abbey Court, Lower Abbey Street, Dublin 1
Advice Line: 1890 336677
Tel: (01) 8171300
Fax: (01) 8171301
Web: www.fsai.ie e-mail: [email protected]
©2007
ISBN: 1-904465-48-X
CONTENTS
EXECUTIVE SUMMARY
2
1. BACKGROUND
2
2. LEGAL BASIS
3
3. METHODOLOGY
5
3.1. Maternity Units and Childrens' Hospitals' Survey
3.2. Advertisements Placed in Magazines
3.3. Information Intended for Health Care Professionals
3.4. Display and Promotional Offers in the Retail Sector
3.5. Information Provided Via the Internet
5
5
5
6
6
4. SURVEY RESULTS
7
4.1. Maternity Units and Childrens' Hospitals' Survey
a) The legislation
b) The promotion of breast milk substitutes in hospitals
c) The provision of information on infant feeding
d) The provision of breast milk substitutes
e) Samples, gifts and funding from the industry
4.2. Advertisements Placed in Magazines
a) Advertisements in professional magazines
b) Advertisements in general public magazines
7
7
8
8
8
9
9
9
9
4.3. Information Intended for Health Care Professionals
10
4.5. Information Provided Via the Internet
a) Compliance with Article 9(1) information objective and consistent
b) Compliance with Article 9(3) and 9(4)
c) Compliance with Article 9(5))
10
11
11
11
4.4. Display and Promotional Offers in the Retail Sector
10
5. DISCUSSION
12
6. CONCLUSIONS
14
7. RECOMMENDATIONS
14
ANNEX 1
16
S.I. No. 242 of 2004 European Communities
(Infant Formulae and Follow-on Formulae) Regulations
ANNEX 2
Questionnaire
ANNEX 3A List of Scientific Publications Reviewed
ANNEX 3B List of Magazines Reviewed
ANNEX 4
References
1
19
24
24
24
EXECUTIVE SUMMARY
A survey on the marketing, advertising and distribution of infant formulae and follow-on formulae was undertaken to
determine compliance of the marketing of breast milk substitutes with the current Regulations, in particular with the
legal requirements regarding:
• advertising
• the provision of information to health professionals
• the provision of information to mothers/mothers-to-be
• marketing practices.
During the course of the survey, 21 maternity units and three children’s hospitals were visited. Key staff were
interviewed by questionnaire regarding the interaction between the infant formulae manufacturing industry and
hospitals. In addition, advertisements placed in specialist publications and women's magazines were reviewed; the
display of infant formulae and follow-on formulae in retail shops was examined and the websites of infant formulae
manufacturers were checked for compliance
The legal basis for this survey was the Commission Directive 91/321/EEC on Infant Formulae and Follow-on
Formulae (as amended).This Directive is transposed into Irish legislation by the European Communities
(Infant Formulae and Follow-on Formulae) Regulations, 2004 (S.I. No. 242 of 2004).
The results of the survey show differences in the level of compliance between the different areas of marketing,
advertising and distribution of infant formula and follow-on formula.The level of compliance was generally good in
hospitals, in retail shops and in women’s magazines. On the other hand, the level of compliance was quite poor in
advertisements placed in specialist publications and in leaflets aimed at health professionals.
The survey also highlighted difficulties in assessing some aspects of the Regulations due to their subjective nature.
As a result of the survey, it is recommended that manufacturers amend some of their information leaflets,
advertisements in specialist publications and websites, and only provide health care professionals with information on
request (as required by the Regulations).
In addition, a recommendation is made on the further investigation of consumers’ knowledge regarding the difference
between infant formulae and follow-on formulae.
1. BACKGROUND
As the central competent authority for the implementation of the Commission Directive 91/321/EEC on Infant
Formulae and Follow-on Formulae (as amended) (The Directive), the Food Safety Authority of Ireland (FSAI)
receives complaints and referrals regarding the marketing practices of the manufacturers of infant formulae and
follow-on formulae.
Some of these have indicated misinterpretation of the Regulatory requirements and restrictions on the marketing of
infant formulae. In order to be better informed on the overall compliance with and understanding of the Regulations,
a survey was undertaken to assess the level of manufacturer’s compliance of the marketing of both infant formulae
and follow-on formulae.
The aim of this survey was to determine compliance of the marketing of breast milk substitutes with the current
Regulations, in particular with the legal requirements regarding:
• advertising
• provision of information to health professionals
• provision of information to mothers/mothers-to-be
• marketing practices.
2
2. LEGAL BASIS
The legislation governing infant formulae and follow-on formulae is Commission Directive 91/321/EEC on infant
formulae and follow-on formulae as amended.This Directive is transposed into Irish legislation by the European
Communities (Infant Formulae and Follow-on Formulae) Regulations, 2004 (S.I. No. 242 of 2004). All the articles of
the Regulations which were used during this survey are detailed in Annex 1.
These Regulations are the responsibility of the Food Unit, the Department of Health and Children.They are enforced
by the FSAI, by the Department of Agriculture and Food (at site of manufacture) and the Health Service Executive
(at point of distribution and retail sale), pursuant to service contracts with the FSAI, for the purposes of ensuring
compliance with these Regulations.
The Regulations cover all aspects of infant and follow-on formulae including composition, pesticide residues, export to
third country, labelling, presentation and provision of information on infant feeding. Compliance was not checked with
the complete Regulations, but only with the following specific articles:
Article 7.5 regarding the advertising and presentation of follow-on formulae
Advertising and presentation of follow-on formulae:
“shall be designed to provide the necessary information about the appropriate use of the products so as not
to discourage breast-feeding.”
“the use of the terms ‘humanised’, ‘maternalised’, or similar terms shall be prohibited.”
Article 8 regarding the advertising and distribution of infant formulae
Advertising of infant formulae:
“shall be restricted to publications specializing in baby care and scientific publications.”
“shall contain only information of a scientific and factual nature.”
“shall not imply or create a belief that bottle-feeding is equivalent or superior to breast-feeding.”
“shall be designed to provide the necessary information about the appropriate use of the products so as not
to discourage breast-feeding.”
“shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product.
“shall in addition bear the following mandatory particulars preceded by the words 'Important Notice' or their equivalent (a) a statement concerning the superiority of breast-feeding,
and
(b) a statement recommending that the product be used only on the advice of independent persons having qualifications in
medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care.
“There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant
formulae directly to the consumer at the retail level”
3
Article 9 regarding the provision of information
Information provided on infant nutrition for use by families and those involved in the field of infant and
young child nutrition:
“shall be objective and consistent.”
“shall include clear information on all the following points the benefits and superiority of breast-feeding,
the importance of maternal nutrition and the preparation for and maintenance of breast-feeding, the possible negative
effect on breast-feeding of introducing partial bottle-feeding,
the difficulty of reversing the decision not to breast-feed,
where needed, the proper use of infant formulae, whether manufactured industrially or home-prepared.”
information about the use of infant formulae,
“shall include information on
the social and financial implications of its use,
the health hazards of inappropriate foods or feeding methods,
the health hazards of improper use of infant formulae.”
“shall not use any pictures which may idealise the use of infant formulae.”
“Donations of informational or educational equipment or materials by manufacturers or distributors shall be made
only on request.”
Some aspects of the Regulations are quite subjective and require interpretation.To assist in this interpretation,
two Guidance Notes are referred to: “FSAI Guidance Note 6, 2001 the Implementation of European Communities
(infant formulae and follow-on formulae) Regulations” and “Infant Formula, Guidance, 1997 the UK Local Authorities
Coordinating body on Food and Trading Standards”.
It is important to note that the 1981 International Code of Marketing of Breast Milk Substitutes from the World
Health Organization (WHO) includes more rigorous standards relating to the protection of breastfeeding. Many
sectors of the health care system, individuals and professional organisation are voluntarily applying this Code.
The Code, which has been ratified by Ireland, states:
'Governments should take action to give effect to the principles and aim of this Code, as appropriate to their social
and legislative framework, including the adoption of national legislation, regulations or other suitable measures.
While the transposition of Directive 91/321/EEC into national legislation goes some way to meet this objective, there
remains some differences between the Code and the legislation.The Code is not legally binding and therefore noncompliance with the Code cannot be prosecuted.
The Baby Friendly initiative (BFI) is a global project from the WHO and UNICEF which recognises that implementing
best practices in the maternity service is crucial to promote breastfeeding.This initiative started in 1991 and came to
Ireland in 1998.The BFI is based on ten steps which includes a written breastfeeding policy, staff training and support
of mothers/mothers-to-be. Almost all the maternity units in Ireland are participating at some level with this initiative.
4
3. METHODOLOGY
The survey incorporated five sub-surveys in order to fully assess the different areas of the marketing, advertising and
distribution of breast milk substitutes.
The labelling of infant formulae and follow-on formulae products was outside the scope of this study but will be the
subject of further FSAI investigations.
3.1. Maternity Units and Children’s Hospitals Survey
All 21 maternity units and three children's hospitals of Ireland were visited. During the visit a personal interview was
conducted with a member of the unit in order to complete a questionnaire (see Annex 2).The questionnaire was
based on a questionnaire elaborated by UNICEF for auditing compliance with the International Code of Marketing of
Breast Milk Substitutes and had been circulated to the breastfeeding coordinator in the Health Promotion Unit of the
Department of Health and Children for comment.The questionnaire focused on the interaction between industry
representatives and the maternity unit, the promotion of infant feeding within the hospital and infant feeding policies.
It was divided into five sections:
a) the legislation
b) the promotion of breast milk substitutes within the hospital
c) the provision of infant feeding information
d) the supply of breast milk substitute
e) samples, gifts and funding from the industry.
3.2. Advertisements Placed in Magazines
Advertisements placed in health care professional publications (see Annex 3a) and women’s/mother magazines (see
Annex 3b) by formula manufacturers or distributors were examined for compliance with legal requirements on
advertising. In particular, infant formula advertisements should only be found in specialist publications and should:
a) contain factual and scientific information only
b) state under “important notice” the superiority of breast milk
c) state under “important notice” that the product should be used under health care professional advice only
d) not imply that infant formula is equivalent or superior to breast milk
e) not include any pictures of infants.
Advertisements for follow-on formula found in publications or women’s magazines were assessed against the
following criteria set out in the Regulations:
a) provide the necessary information for appropriate use
b) do not discourage breastfeeding
c) do not use terms such as humanised or maternalised or similar.
3.3. Information Intended for Health Care Professionals
During the course of the survey in the hospitals, any information provided by the industry to health care
professionals was collected and was checked for compliance with either the criteria of advertisement or information
depending on its nature.
5
3.4. Display and Promotional Offers in the Retail Sector
A sample of retail shops and pharmacies were visited to assess compliance with promotional requirements.
These relate to infant formula only and the following legal points were examined:
a) no point-of-sale advertising
b) no free samples
c) no promotional offers of any kind (coupons, special sales or tie-in-sales).
3.5. Information Provided Via the Internet
The provision of information by the industry via internet websites was investigated to ensure compliance with the
legislation on the provision of information on infant feeding. As specified in the Regulations, the information shall:
a) be objective and consistent
b) not use any pictures which may idealise the use of infant formula
c) include clear information on:
- the benefits and superiority of breastfeeding
- the importance of maternal nutrition and the preparation for and maintenance of breastfeeding
- the possible negative effect on breastfeeding of introducing partial bottle-feeding
- the difficulty of reversing the decision not to breastfeed.
In addition, when information on infant formulae is provided, it shall include:
- the proper use of infant formulae, whether manufactured industrially or home-prepared
- information on the social and financial implications of infant formulae use
- the health hazards of inappropriate foods or feeding methods
- the health hazards of improper use of infant formulae.
6
4. SURVEY RESULTS
The results of the survey are summarised in this section.
It is important to note that not all information published by the formula feed industry could be acquired; only the
advertisements, leaflets and information found were examined.
4.1. Maternity Units and Children's Hospitals' Survey
This part of the survey took place between August 2005 and February 2006. All 21 maternity units of Ireland and
three children’s hospitals were visited and a questionnaire was completed with a relevant expert, [Clinical midwife
specialist (4), Lactation Consultant (5), Clinical Midwife Manager (6), Midwife Parent Craft (2), Clinical Midwife (3),
Senior Manager (3) and Clinical Facilitator (1)] who were, in many cases, the Baby Friendly Initiative Coordinator. All
the respondents were involved in one or several of the following activities relating to breastfeeding: education of
mothers/mothers-to-be, education of staff, audit, policy review or postnatal support.
a) The legislation
Are you familiar with the following and do you have a copy available?
Commission Directive 91/321/EEC
Irish Regulations, 2004 (S.I. No. 242 of 2004)
FSAI Guidance Note No. 6 on the Implementation of the Regulation
International Code of Marketing of Breast Milk Substitutes
How did you become familiar with the above documents?
Through education and training
Through the Baby Friendly Initiative (BFI)
Through my own study/research
Breaches of the legislation
Are you aware of any possible breaches of the legislation?
Is there a procedure in place in the hospital to monitor and report breaches?
Aware of
75%
75%
33%
100%
Copy available
46%
46%
17%
88%
58%
21%
21%
Yes
33%
33%
All respondents were familiar with the International Code of Breast Milk Substitutes from the WHO, while 75% of
them were aware of the legislation.The majority of the respondents learned about these documents during their
education and training.The BFI had a significant impact on the dissemination of these documents, while 21% of the
respondents became familiar with these on their own initiative.
A third of the respondents reported to be aware of a possible breach of the legislation such as advertising of infant
formula on radio, advertisements of infant formula in the Irish Nursing Association magazine (World of Irish Nursing),
or an industry representative providing information other than on request. Responses indicating possible breaches of
legislation do not necessarily indicate that a breach occurred.
7
b) The promotion of breast milk substitutes in hospitals
Advertising and promotion of breast milk substitutes
Is there a policy on advertising of formula within the hospital?
Are you aware of any advertisement within the hospital?
Can the industry promote their product to mothers within the hospital?
Can the industry promote their product to workers within the hospital?
No
Yes
88%
100%
96%
75%
Do you receive any information from the industry?
29%
Although not all hospitals had a policy on the display and promotion of breast milk substitutes, all the respondents
stated that there were no advertisements (posters, leaflets, etc) within the hospital and therefore, almost all of them
felt that the industry could not promote their products to mothers. One respondent queried whether the fact that
infant formula is available for free in the ward is a form of promotion? On the other hand, 75% of the respondents
felt that the industry could promote their products to workers within the hospital through information days, lectures,
and visits of industry representatives or documentation left in their office or staff room. Seven respondents (29%)
said they had received documentation while only one had requested it.
While information days, lectures and visits from representatives are permitted by the Regulations, the provision of
information material is only authorised if it is provided on request.
c) The provision of information on infant feeding
Provision of information on infant feeding
Is the industry seeking contact with mothers/mothers-to-be?
Is there a policy of regarding accepting/distributing industry leaflets?
Do you use any of the industry leaflets?
No
100%
62%
92%
No hospital reported that the industry was seeking contact with their mothers/mothers-to-be. Again, although 62% of
the hospitals do not have a policy regarding accepting/distributing leaflets from the industry, almost all hospitals (92%)
use only their own leaflets or a leaflet from the Health Promotion Unit or UNICEF to inform mothers/mothers-to-be
about infant feeding.The use of manufacturers' leaflets is permitted by the Regulation as long as there is no brand
name used in the leaflets.The three leaflets found did comply with the legislation.
d) The provision of breast milk substitutes
Provision of breast milk substitutes
No
Is there any information provided to mothers regarding the choice of breast milk substitutes?
96%
Are patients given free supply of breast milk substitutes when going home?
92%
Are all brands of breast milk substitutes available?
Are patients charged for breast milk substitutes?
Yes
79%
96%
Most hospitals offer all brands of breast milk substitutes to mothers while 21% of hospitals did not offer a particular
brand because it is not popular enough.When infants are not on prescribed milk, mothers have to decide themselves
which breast milk substitutes to use and no product is recommended over another in almost all hospitals (96%).
While a breast milk substitute is nearly always provided for free during the stay in the maternity ward (96%), in 92%
of hospitals, mothers are not given any free products when they leave hospital.
8
e) Samples, gifts and funding from the industry
Samples, gifts and funding from the industry
No
Do workers receive any gift from industry?
87%
Does industry sponsor any equipment?
100%
Does industry fund study day/conference?
Yes
33%
Most hospitals (87%) do not receive any promotional gifts from the industry.The gifts reported by three hospitals
were all bearing a company name or logo and were pens, ‘post-it’ notes, clocks and pregnancy “wheels” which are not
passed on to mothers.The interpretation of the legislation outlined in the FSAI Guidance Note 6: Guidance Note on
the Implementation of European Communities (Infant Formulae and Follow-on Formulae) Regulations, 1998 to 2000,
has been that gifts bearing the name of an infant formula should not be offered to health care professionals. However,
the name of an infant formula is not the same as the company name and therefore, the gifts found during the survey
did not contravene the Regulations. Industry does not sponsor any equipment in wards but in 33% of hospitals it
does sponsor study or conferences, which does not infringe on the legislation. Some hospitals also reported refusing
invitations to horse racing and to GAA matches.This type of “gift” has not been considered within the scope of the
legislation but the FSAI would recommend that health care professionals refuse such gifts. Finally, some hospital staff
were offered a factory tour and respondents reported difficulties in deciding whether this would be a breach of their
policies. Such visits would not constitute a breach of the legislation as they would be considered a study day, as long
as the information provided during these tours is objective and consistent.
4.2. Advertisement Placed in Magazines
a) Advertisements in professional magazines
Specialist publications aimed at health care professionals involved in the field of infant and children care published in
the last six months were reviewed for advertisements.
Advertisements were only found in two publications. One advertisement was in the Journal of Neonatal Nursing
(UK journal) and several were found in the World of Irish Nursing. Some advertisements were published in several
issues and in total, five different advertisements were assessed. One advertisement was for a follow-on formula and
the other four related to infant formulae.Three of the latter were found not to comply with the legislation either
because they included a picture of an infant (breach of Article 8.2), implied equivalence of their product with breast
milk (breach of Article 8.4) or some of the information provided was not factual (breach of Article 8.3).
b) Advertisements in magazines for the general public
Magazines aimed at women, pregnant women and young parents were purchased in February 2006 in order to
acquire advertisements for infant and follow on formula.
Several advertisements were found in several magazines and in total, six different advertisements were assessed.
They were checked for compliance with Article 8.1 and Article 7.5.
As restricted by Article 8.1, no advertisements relating to infant formulae were found in magazines for the general public.
All advertisements surveyed fully complied with Article 7.5 as they included a statement designed to provide
information about the appropriate use of the product (to be used as part of a mixed diet and not for infants
under six months of age).
One advertisement included a picture of an infant being breastfed which is not prohibited under the current legislation.
9
4.3. Information Intended for Health Care Professionals
Leaflets left in staff rooms, midwife offices, given to or posted to health care professionals by manufacturers were
collected during the course of the survey in the maternity units. Hospitals would tend not to keep this type of
documentation and therefore, only seven leaflets were collected. All related to either infant formulae or both infant
and follow-on formulae and they all referred to brand names.They would therefore be classified as advertising rather
than general information. Five of these seven leaflets included pictures of infants which contravenes Article 8.2. Five
leaflets contained statements which were not strictly factual and therefore did not comply with article 8.3. Finally, four
leaflets used wording or pictures which implied equivalence between infant formula and breast milk which is not in
compliance with Article 8.4. In conclusion, only one leaflet was deemed to comply with the Regulations.
4.4. Display and Promotional Offers in the Retail Sector
During the survey, ten retail shops and eight pharmacies/chemists in the greater Dublin area were visited to check
for compliance with Article 8.5 of the Regulations.
In a large number of premises, there were promotional offers for follow-on formula or ‘growing-up’ milk which
are permitted under the Regulations. In one retail outlet there was a clearance on infant formula.This was a
non-compliance[1] with the legislation which states that there shall be no special sales at retail level.
4.5. Information Provided Via the Internet
The websites of Cow & Gate, Milupa, SMA Nutrition, Farleys and Hipp as well as general websites providing
information on baby care (Eumom.ie, Rollercoaster.ie, Irishhealth.ie) were examined for compliance with Article 9
of the Regulations which looks at the provision of information on infant feeding.
The general websites did not promote the use of infant formula.When information on bottle-feeding was provided,
it was done in accordance with the legislation. One site had a link for a manufacturer website which is allowed.
Infant formula manufacturers' websites were not considered in this survey as advertising, as consumers using these
websites would be actively seeking information, furthermore, in four out of the five websites, visitors to the sites had
to “click in” to confirm that they wish to access information on infant formulae.This would be equivalent to a request
for information.The fifth website did not have a “click in” system but the information was provided in the “Health
Care Professional” section and it was clearly stated that the website was “supplying this information at your individual
request for educational purposes”.
One website referenced brand name products in the general feeding section of the site outside the “click in” section,
while in all the other websites, brand names were only found in the “click in” section. According to the LACOTS
guidelines (see Annex 4.3), the provision of information on products outside the scope of the initial enquiry or
making undue references to brand names in a response to a request for product information might be construed as
advertising and therefore would constitute a breach of the Regulation.
It was noted that three websites had a section for health care professionals, but in only one website, this section had
a restricted access with registration.
[1]
This infringement was referred to the local Health Service Executive area office for immediate follow-up action.
10
a) Compliance with Article 9(1) information objective and consistent
It is a legal requirement under Article 9.1 that the information provided must be objective and consistent.
In four out of the five websites examined, the following wording was found in pages relating to infant formula:
1) “Closer than ever to breast milk..”
“In similar level than breast milk..”
2) “The closest to breast milk..”
“Similar to breast milk..”
“In format similar to breast milk..”
3) “Closer than ever to breast milk..”
4) “Like breast milk..”
5) “Similar to breast milk..”
“Same as breast milk..”
“Just like breast milk...”
“In both breast milk and X..”
“In the same form as breast milk..”
“As close as possible to breast milk..”
“breast milk is our “gold standard..”.
The above wording may lead consumers to believe that infant formula is equivalent to breast milk,
which is incorrect and inconsistent with the legal requirement to highlight the superiority of breastfeeding.
b) Compliance with Article 9(3) and 9(4)
Articles 9.3 and 9.4 require that all educational/informational material must provide clear information on a number
of points. In all the websites viewed, an introductory page displayed a list of short statements under the heading
“important notice” which was interpreted as aiming to comply with theses requirements.
One website did not fully comply with the requirements as no information on the “importance of maternal nutrition
and the preparation for and maintenance of breastfeeding'” was provided.
In three out of the five websites, the “Important Notice Statement” appeared on all pages relating to infant formula.
It is not specified in the legislation whether such information should be provided once or more than once.
c) Compliance with Article 9(5))
Article 9.5 states no pictures that may idealise the use of infant formulae should be used. Only two websites
complied with this requirement. One website showed a picture of a laughing mother with a baby drinking milk
from a beaker which was displayed on all pages.This may be interpreted as idealising the use of infant formula.
On the second website, a picture of an infant breastfeeding and a picture of an infant bottle-feeding were side by side
on the page displaying the “Important Notice statement”.This may imply equivalence between infant formula and
breastfeeding. Further pictures of infants were also seen on a Q&A page on infant feeding. Finally, the third website
had a picture of an infant beside a section called “Infant milk” and under a section called “bottle feeding” there were
several pictures of a young infant drinking from a bottle. Compliance with Article 9.5 is subjective; here it is
considered that these three websites were in breach of Article 9.
11
5. DISCUSSION
During the survey, no advertisements for infant formulae were found in any hospitals, as is required by the legislation.
Some gifts were received by staff but these were not passed on to mothers/mothers-to-be and did not show any
infant formula name but only company logo and therefore, did comply with the legislation.Three booklets sponsored
by manufacturers were found to be used within hospitals.They bear the logo of the manufacturer but no infant
formula brand name. Again, this is not a breach of the Irish legislation.
Some confusion between what constitutes a breach of the legislation was noted during the survey.This is due to the
fact that hospitals aim to work under the Baby Friendly Initiative rules which have close links with the International
Code of Marketing of Breast Milk Substitutes.The Code states that ‘There should be no advertising or other forms
of promotion to the general public of products within the scope of this Code’ which includes not only infant
formulae and follow on formulae, but also other milk products, food and bottlefed complimentary foods, bottles
and teats.The scope of the Regulations is much narrower and only applies to infant formulae and follow-on formulae.
The Regulations also provide for different advertising and promotion restrictions on follow-on formulae compared to
infant formulae. Also under the Code, no reference to brand name or company name would be acceptable within a
maternity hospital. Therefore, in some cases, what is considered as complying with the legislation is a breach of the
Code.This may lead health care professionals who are only familiar with the Code to report breaches as legislative
breaches.While the Code has been ratified by Ireland, it is outside the FSAI’s remit to enforce it as the Regulations
are derived from an EU Directive and not the Code.
A third of the hospitals reported that their staff were attending, from time to time, study days or conferences
sponsored by manufacturers of breast milk substitutes.This is legal and some managers stated that these were useful
to train staff when no other funding was available.
Three quarters of the respondents felt that the industry could advertise to health care professionals through
information days. From the information gathered during the survey, information days run by the industry take place
once every year to every two years within the hospital and staff are informed of their occurrence by post or posters.
Staff are free to choose to attend them or not. Such information days are not a breach of the legislation as only staff
wishing to attend them go to these information days.
The only non-compliance noted during the course of the survey in hospitals was the provision of information on
breast milk substitutes to six hospitals by post or left by manufacturer representatives when such information was
not requested. Article 9.6 relates to the provision of information and the interpretation of this article in the FSAI
Guidance Note No.6 is that information should only be provided on request except datasheets.The FSAI opinion is
that a datasheet is a leaflet containing information on the product such as a list of ingredients, composition, nutritional
information, preparations information and condition of use. Some of the information provided could not be
considered as just datasheets because of the use pictures of infants and the content was not limited to factual
information only.
The level of compliance in maternity units and hospitals was very good.The staff met during the survey were very
passionate about breastfeeding and its promotion within the hospital.They almost all reported major improvement
regarding compliance with the code and the legislation mainly through the BFI. Such level of compliance could be
credited to staff information, training and commitment.
The legislation has been drafted so that mothers/mothers-to-be receive objective, consistent and independent
information regarding breastfeeding and bottle-feeding. For that purpose, it would seem appropriate for health care
professionals to provide infant feeding information to their patients.While maternity units advised that they all teach
mothers how to prepare and use bottles, all units reported not recommending one formula over another.When
mothers asked which formula to choose, the staff in hospitals would reply along the lines of “they are all the same”.
Formulae do vary in composition but this information is not provided to mothers by the hospitals. Instead, this
information is provided by the manufacturers themselves via their websites or other means.
While all advertisements found in non-specialist magazines were fully compliant with the legislation, all infant formulae
advertisements found in Irish professional publications were found to be in breach of the Regulations. In addition,
most of the leaflets aimed at the health sector did not comply with the legislation.This may explain the fact that
health care professionals are not inclined to pass on information about infant formula to their patient since the
information they receive is not strictly factual.
12
As required by the legislation, in all but one retail premises visited during the survey, there were no promotional
offers relating to infant formulae. Some offers were made on follow-on formulae, growing-up milk or baby food, which
is permitted under the current Regulations.These practices may be ambiguous for consumers who may not be able
to distinguish between the controls on infant formulae and other products.This should be investigated further.
The industry websites displayed several non-compliances with the legislation. Even though the message “breast milk is
the best milk” was put in evidence in all websites, the wording used to describe branded infant formula often implied
that they are equivalent to breast milk which is neither accurate nor legal.
The Regulations specify that the information provided must be consistent and objective and should not create the
belief that bottle feeding is equivalent to breastfeeding.These requirements are very subjective and therefore hard to
implement as each person would have a different opinion or interpretation of what creates the belief that bottle
feeding is equivalent to breastfeeding.The industry is using many claims such as “next to breast milk, the best for
infant”, this has been interpreted by the FSAI as implying equivalence.
Another area of the Regulations which requires interpretation is “No pictures which may idealise the use of infant
formula should be used”.The FSAI’s opinion is that any picture showing a baby drinking from a bottle may be
idealising infant formula.
The legislation requires under article 9:
“that when informational and educational materials, dealing with the feeding of infants and intended to reach pregnant women
and mothers of infants and young children, shall include clear information on all the following points (a) the benefits and superiority of breast-feeding,
(b) the importance of maternal nutrition and the preparation for and maintenance of breast-feeding,
(c) the possible negative effect on breast-feeding of introducing partial bottle-feeding,
(d) the difficulty of reversing the decision not to breast-feed,
(e) where needed, the proper use of infant formulae, whether manufactured industrially or home-prepared.
Where the materials contain information about the use of infant formulae, they shall include information on the social and
financial implications of its use, the health hazards of inappropriate foods or feeding methods, and, in particular, the health
hazards of improper use of infant formulae”
All manufacturers have made attempts to comply with this requirement by providing a statement alongside the
information they provide in websites, or other leaflets.The statement is often only a replicate of Article 9 rather than
providing substantial information. For example, the requirement for clear information on the benefits and superiority
of breastfeeding is often fulfilled by stating:
“Breastfeeding is best for your baby and provides many benefits”
or “Breastfeeding is best for babies”.
In order to fully comply with the legislation, the benefits should be more clearly explained.The FSAI Guidance Note
No.6 interpreted this article as a requirement for a longer and more comprehensive version of the “important
notice“ statement found on labels. It should include reference to the benefits of breastfeeding, e.g. the benefits in
relation to the protection against gastroenteritis and respiratory tract infection.
The Regulations allow follow-on formulae to be advertised more widely and the requirements applying to follow-on
formulae are less stringent than for infant formulae.Two surveys (See Annex 4.1 and 4.2) recently carried out in the
UK showed that consumers may not necessarily understand that there is a difference between infant formula and
follow-on formula. In that prospect, any advertisement of follow-on formula, on radio,TV, in magazine or promotional
offers in retail outlets, as observed during this survey may act indirectly as a promotion of infant formula.This would
also need future investigation.
13
6. CONCLUSIONS
The level of compliance within maternity hospitals and children’s hospitals was very high. Infant formulae are not
promoted within the units which would appear to be the result of the Baby Friendly Initiative and the commitment of
staff to breastfeeding policies.
During the ante-natal education and their stay in hospital, mothers-to-be/mothers receive clear independent
information on how to make and use bottles.They do not receive any information from the health care system on
the actual composition of product. If they wish to obtain such information in order to choose an infant formula,
they have to rely on the information provided by manufacturers.
The level of compliance at retail level was high with only one non-compliance observed.
The advertisements of infant formula, the information provided to health care workers and manufacturer’s websites
all presented non-compliances with the Regulations. Some of these non-compliances are straightforward such as the
use of a picture of an infant in advertisements for infant formula which is clearly prohibited. Other non-compliances
are less straight forward as they are based on the interpretation of the legislation such as what constitutes “idealising
the use of infant formula” or “does not imply that bottle feeding is equivalent to breastfeeding”. From the results of
the survey, manufacturers are taking advantage of these grey areas to promote their products.
The Regulations impose fewer restrictions on the promotion of follow-on formula and it remains to be assessed
whether the promotion of follow-on formula results in indirect promotion of infant formula.
7. RECOMMENDATIONS
It is recommended that:
• manufacturers amend their advertisements placed in specialist publications
• manufacturers do not provide health care professionals with information/advertisements unless requested
• manufacturers websites remove any pictures of infants drinking from a bottle
• websites and information leaflets for the public regarding infant feeding ensure that they incorporate substantial
information to comply with Article 9.3 and 9.4
• health care professionals consider providing independent information to their patients on the composition
of infant formula.
The use of ambiguous terms to promote products, such as “closer than ever to breast milk” is considered to
undermine the requirement to state the superiority and benefits of breastfeeding and should therefore not be used
on information leaflets or in advertising material.The message that breast milk substitutes will never equal breast milk
should be reinforced rather than industry claiming that their products are “the closest to breast milk”.
The results of the survey have been discussed with the marketing representative of the infant and follow-on formula
manufacturers based in Ireland.They have agreed to review their documents and to take into consideration our
recommendations in their review.
It is also recommended that further work be carried out on:
• investigating consumers knowledge on the difference between infant formulae and follow-on formulae
• reviewing the labelling of infant formulae including claims and general presentation.
14
ANNEXES
ANNEX 1
S.I. NO. 242 OF 2004 EUROPEAN COMMUNITIES
(INFANT FORMULAE AND FOLLOW-ON FORMULAE) REGULATIONS
ANNEX 2
QUESTIONNAIRE
ANNEX 3A LIST OF SCIENTIFIC PUBLICATIONS REVIEWED
ANNEX 3B LIST OF MAGAZINES REVIEWED
ANNEX 4
REFERENCES
15
ANNEX 1 - S.I. NO. 242 OF 2004 EUROPEAN COMMUNITIES
(INFANT FORMULAE AND FOLLOW-ON FORMULAE) REGULATIONS
http://www.fsai.ie/legislation/food/eu_docs/Parnuts/Infant_formulae_etc/SI.242%20of%202004.pdf
Statutory Instrument
S.I. No. 242 of 2004
EUROPEAN COMMUNITIES (INFANT FORMULAE AND FOLLOW-ON FORMULAE)
REGULATIONS 2004
Published by the Stationery Office Dublin
To be purchased directly from the Government Publications Sale Office, Sun Alliance House, Molesworth Street,
Dublin 2, Or by mail order from Government Publications, Postal Trade Section, 51 St. Stephen's Green, Dublin 2,
(Tel: 01-647 6834/35/36/37; Fax 01-647 6843) or through any bookseller.
Prn. 2746
Price €4.57
PART 2
Infant Formulae and Follow-On Formulae Intended to be Placed on the Market in a Member State
3. (1) These Regulations concern infant formulae and follow-on formulae, and this Part is concerned with infant
formulae and follow-on formulae intended to be placed on the market in a Member State.
(2) A person shall not -
(a) manufacture infant formulae or place infant formulae on the market unless the requirements of this Part
applicable to infant formulae are complied with,
(b) use the descriptions 'infant formula' or 'infant formulae' in the marketing of any product which is not infant
formula as defined in Regulation 2(1), or
(c) represent any product which is not infant formula as defined in Regulation 2(1) as being suitable for
satisfying by itself the nutritional requirements of normal healthy infants during the first 4 to 6 months
of life.
(3) Infant formula shall be placed on the market under the name 'infant formula' or 'infant formulae', save where it
is manufactured entirely from cows' milk proteins, in which case it shall be sold under the name 'infant milk'.
(4) A person shall not -
(a) manufacture follow-on formulae or place follow-on formulae on the market unless the requirements of
this Part applicable to follow-on formulae are complied with,
or
(b) use the descriptions ‘follow-on formula’ or ‘follow-on formulae’ in the marketing of any product which is
not follow-on formula as defined in Regulation 2(1).
(5) Follow-on formula shall be placed on the market under the name 'follow-on formula' or 'follow-on formulae',
save where it is manufactured entirely from cows' milk proteins, in which case it shall be sold under the name
‘follow-on milk’.
(6) A person shall not distribute, publish or issue any materials containing information on infant or young
child feeding, unless the requirements of this Part are complied with.
16
6. (3) The labelling of infant formulae shall be designed to provide the necessary information about the appropriate
use of the products so as not to discourage breast-feeding.
(4) In the labelling of infant formulae, the use of the terms 'humanised', 'maternalised', or similar terms shall be
prohibited.
(5) The labelling of infant formulae -
(a) may use the term 'adapted' only in the case listed in Schedule 4, and
(b) may bear claims concerning the special composition of infant formulae only in the cases listed in Schedule 4,
and only in accordance with the conditions laid down in Schedule 4.
(6) The labelling of infant formulae shall in addition bear the following mandatory particulars preceded by the
words 'Important Notice' or their equivalent (a) a statement concerning the superiority of breast-feeding, and
(b) a statement recommending that the product be used only on the advice of independent persons
having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal
and child care.
(7) The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures
or text which may idealise the use of the product. It may, however, include graphic representations for easy
identification of the product and for illustrating methods of preparation.
(8) The requirements, prohibitions and restrictions referred to in paragraphs (3) to (7) shall also apply to the
presentation of the products concerned, in particular their shape, appearance or packaging, the packaging
materials used, the way in which they are arranged and the setting in which they are displayed.
7. (3) The labelling of follow-on formulae shall be designed to provide the necessary information about the
appropriate use of the products so as not to discourage breast-feeding.
(4) In the labelling of follow-on formulae, the use of the terms 'humanised', 'maternalised', or similar terms
shall be prohibited.
(5) The requirements, prohibitions and restrictions referred to in paragraphs (3) and (4) shall also apply to -
(a) the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging
materials used, the way in which they are arranged and the setting in which they are displayed, and
(b) advertising.
8. (1) Advertising of infant formulae shall be restricted to publications specializing in baby care
and scientific publications.
(2) The requirements, prohibitions and restrictions referred to in paragraphs (3) to (7) of Regulation 6 shall also
apply to advertising, and advertisements for infant formulae shall be subject to the conditions laid down therein.
(3) Advertisements for infant formulae shall contain only information of a scientific and factual nature.
(4) Advertisements for infant formulae shall not imply or create a belief that bottle-feeding is equivalent or
superior to breast-feeding.
(5) There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales
of infant formulae directly to the consumer at the retail level, such as special displays, discount coupons,
premiums, special sales, loss-leaders and tie-in sales.
(6) Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant
women, mothers or members of their families, free or low-priced products, samples or any other promotional
gifts, either directly or indirectly via the health care system or health workers.
(7) In accordance with Article 8 of the Directive, the Minister may by Order impose further restrictions on the
advertising or promotion of infant formulae.
17
9. (1) Where information is provided on infant and young child feeding for use by families and those involved in the
field of infant and young child nutrition, such information shall be objective and consistent.
(2) Paragraph (1) shall apply to the planning, provision, design and dissemination of information and their control.
(3) Informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and
intended to reach pregnant women and mothers of infants and young children, shall include clear information
on all the following points (a) the benefits and superiority of breast-feeding,
(b) the importance of maternal nutrition and the preparation for and maintenance of breast-feeding,
(c) the possible negative effect on breast-feeding of introducing partial bottle-feeding,
(d) the difficulty of reversing the decision not to breast-feed, and
(e) where needed, the proper use of infant formulae, whether manufactured industrially or home-prepared.
(4) Where the materials referred to at paragraph (3) contain information about the use of infant formulae, they
shall include information on the social and financial implications of its use, the health hazards of inappropriate
foods or feeding methods, and, in particular, the health hazards of improper use of infant formulae.
(5) The materials referred to at paragraph (3) shall not use any pictures which may idealise the use
of infant formulae.
(6) Donations of informational or educational equipment or materials by manufacturers or distributors shall be
made only on request and with the written approval of the Authority or within guidelines issued by the
Authority for that purpose.
(7) The equipment and materials referred to at paragraph (6) may bear the donating company’s name or logo,
but shall not refer to a proprietary brand of infant formulae and shall be distributed only through the health
care system.
(8) Donations and low-price sales of supplies of infant formulae to institutions or organisations, whether for use in
the institutions or for distribution outside them, shall only be used by or distributed for infants who have to
be fed on infant formulae and only for as long as required by such infants.
18
ANNEX 2 - QUESTIONNAIRE
The FSAI is carrying out a survey on the marketing, advertising and distribution of infant formula and follow-on
formula to determine level of compliance with the legislation.
For that purpose all the maternity hospitals are visited and asked to answer this questionnaire to assess the practices
in place in hospitals, particularly regarding the information provided to pregnant women and young mothers on infant
feeding and the provision of formulae by the industry.
Industry in this questionnaire means Manufacturer and/or distributors of infant formulae and/or Follow-on Formulae
Date
Hospital:
Name:
First about yourself:
Your job title
What are your main responsibilities in the hospital (e.g. reviewing policy, etc.)?
1.
2.
3.
4.
About the Legislation
Are you aware of? :
• The International Code of Marketing of Breast-milk Substitutes
(and subsequent relevant WHA Resolutions)
Yes ❑
No ❑
• Commission Directive 91/321/EEC
• European Communities (infant Formulae and follow-on formulae)
Regulations SI No. 242 of 2004
Yes ❑
Yes ❑
No ❑
• FSAI Guidance Note 6
Yes ❑
No ❑
No ❑
Is there any formal procedure by which you/other staff become familiar with these as they relate to
health workers' responsibilities?
Yes ❑
No ❑
If yes, briefly explain
Are there copies of these documents readily available for you to read?
Yes ❑
No ❑
If any, which one?
Don’t Know ❑
19
In your opinion, what impact have the Regulatory controls had on:
a) The marketing and promotion of breast-milk substitutes?
b) The appropriate preparation and use of breast-milk substitutes?
Regarding the display and promotion of breast-milk substitutes in maternity hospitals:
Are you aware of any advertising of breast-milk substitutes in the hospital?
Yes ❑
No ❑
If yes, please give details:
Do you consider that the industry is able to promote breast-milk substitutes within the hospital?
b.To health care workers
Yes ❑
Yes ❑
No ❑
a. through company posters
Yes ❑
No ❑
c. free orders
Yes ❑
No ❑
a.To mothers
If yes to either, how is it done?
b. information
d. other
Yes ❑
No ❑
No ❑
Have you received any publications or information from the industry?
Yes ❑
No ❑
If yes please give details:
20
Does the hospital have a policy on the display and promotion to mothers of breast-milk substitutes?
Yes ❑
No ❑
If yes please give details:
Regarding information on infant feeding which is given to pregnant women and families with young children:
Does the hospital have a policy regarding accepting/distributing donated educational materials produced by the
industry?
Yes ❑
No ❑
If yes, please give details:
Are you aware of any company representatives who seek contact with pregnant women or mothers?
Yes ❑
No ❑
If yes, how do they do so?
If donations of information are made and either distributed to patients or used in patient service areas, do they bear
product names/logos or information about any products manufactured by the company which donated them?
Yes ❑
No ❑
If yes, please give details:
Regarding free or subsidized provision of supplies of infant formula or other products
Which infant formulae are available to mothers?
Is any information given to the mothers for them to choose which infant formulae they will give their baby?
Yes ❑
No ❑
Don’t Know ❑
If yes, please outline
21
Is any infant formula or other product given to the ward free or at subsidized cost?
Yes ❑
No ❑
Don’t Know ❑
If yes, please outline
Regarding samples and gifts to mothers:
When mothers are leaving the hospital, do they receive samples or free supply of infant formula?
Yes ❑
No ❑
Don’t Know ❑
If yes, please outline
When mothers are leaving the hospital do they receive discharge packs which contain any discount or special offers
for samples of formula or other products?
Yes ❑
No ❑
Don’t Know ❑
If yes, please outline
Regarding samples and gifts to health workers:
Does the Industry give health workers product samples or gifts
(such as pens, stationary items, invitations to dine out…etc)?
Yes ❑
No ❑
Don’t Know ❑
If yes, please outline
Has your hospital, health area or any member of staff, received any equipment from the industry
(e.g. sterilizers, bottles, display stands etc.)?
Yes ❑
No ❑
Don’t Know ❑
If yes, please outline
22
Do these have logos or other details identifying the donating company?
Yes ❑
No ❑
Don’t Know ❑
Regarding funding of research, fellowships, study tours, conferences, etc:
Has the industry ever offered / supported you or your colleagues participation in any of the following:?
a) Fellowships
Yes ❑
No ❑
Yes ❑
No ❑
b) Study tours
Yes ❑
d) In-service seminars
Yes ❑
c) Conference attendance
If yes to any please give details
No ❑
No ❑
Regarding manufacturers' compliance with national measures:
Are you aware of any instances in the area of marketing where the industry practices appear to have been
in breach of legislation?
Yes ❑
No ❑
If yes, please outline
Was any action taken or referral made?
Regarding the monitoring of compliance with national legislative marketing restrictions:
Does your hospital have in place procedures for monitoring and reporting possible breaches of this legislation?
Yes ❑
No ❑
If yes, what are these procedures
I would like to thank you for taking the time to answer this questionnaire.
Annabel Finnegan
Food Safety Authority of Ireland
23
ANNEX 3A - LIST OF SCIENTIFIC PUBLICATIONS REVIEWED
Midwifery Digest
The Practising Midwife
Nursing Times
Journal of Neonatal Nursing
Irish Medical Time
Irish Medical News
World of Irish Nursing
Irish Practice Nurse
ANNEX 3B - LIST OF MAGAZINES REVIEWED
I'm Pregnant
Woman Way
Woman's weekly
Best
Real People
Pregnancy, Baby and You
Practical Parenting
Pregnancy and Birth
Modern Mum
New Baby and Toddler Gear
ANNEX 4 - REFERENCES
1) Attitudes to Feeding, August 2005
http://www.dh.gov.uk/assetRoot/04/11/88/54/04118854.pdf
This Survey was commissioned by the UK Department of Health and was conducted in July/August 2005 on 2000
pregnant woman/ young mothers.
2) UNICEF survey/Mori formula/Follow on Milk Questionnaire
Survey commissioned by National Childbirth Trust and United Nations Children's Fund (UNICEF UK), conducted in
August 2005 on 1,000 mothers and pregnant women.
3) Infant Formula: LACOTS guidance
http://www.lacors.gov.uk/lacors/ContentDetails.aspx?authCode=39AC7C2&id=3899
LACORS (LACOTS) issued guidance on the Infant Formula and Follow-on Formula Regulations 1995 dated 27 June
1997.These UK Regulations implement EC Directive 91/321/EEC.
For further details on these contact the FSAI.
24
Published by:
Food Safety Authority of Ireland
Abbey Court, Lower Abbey Street, Dublin 1
Advice Line: 1890 336677
Tel: 01 8171 300 Fax: 01 8171 301
www.fsai.ie [email protected]
©2007