Tuesday, September 30, 2008

Code Monitoring in Cameroon

Code Monitoring in Cameroon

The IBFAN Cameroon Link Group intensified its Code Monitoring strategy during the WBW 2008 due to the new aggressive methods adopted by Nestlé Cameroon to capture the market as social mobilisation activities were expanded at grassroot within the communities through door-to-door campaigns throughout the World Breastfeeding Week. The content of the message delivered in English, French and local languages was that science has established that exclusive breastfeeding for the first six motnhs of a child’s life is the single best strategy for the infant’s survival, growth and development.
But just 24% of mothers in Cameroon breastfeed exclusively for the first six months. This constitutes an alarming threat to child survival, accroding to WHO and UNICEF. It is for this reason, we hold strongly the conviction that labels on infant formulae should be designed to provide the necessary information about the appropriate use of the product in a way not to discourage breastfeeding.
One of the most prevalent violations in cameroon is one on wrong age of introduction of complementary foods. This cuts across most products of Nestlé and Danone that have wrong labelling and claims that formulae from 4 months are adapted for infants. Danone’s Bledine Multi cereals is good example of a flagrant violation.
Article 5.2 and 6.2 of the International Code and Article 5.1 of the Cameroon National Code regulating the marketing of breastmilk substitute forbids the use of health facilities for the purpose of promoting infant formulae or other products within the scope of the code.
This report comes to expose how IBFAN Cameroon Link Group and the Federation of Cameroon Breastfeeding Promotion Associations (FECABPA) efforts to protect breastfeeding through advocacy for the enforcement of the code is constantly facing new challenges.
In effect, we recommend that more training opportunities should be created to work out methods to counteract Nestlé’s new strategy of using its nutrition institute to corrupt and influence nurses and mid wives. We are recommending that the Cameroon government should put in place a Multi-sectored Code Monitoring Commission urgently, that can face the challenges with sanctions.
This request is justified by the advertisement attached to this report in the French language and translated by us from a national daily newspaper- Mutations. The turth is that Mutations attended a news conference given in Douala on the new direction of the WABA Men’s Initiative as a whistle blower, because the press conference information was later sold to Nestle Cameroun in exchange of the advert that was published as you will find below.
Due to the flagrant violations of the code in Cameroon, Cameroon Link and the Federation of Cameroon Breastfeeding Promotion Associations, FECABPA, is submitting a proposal for the text of application of the Cameroon 2005 Prime Minister order regulating the marketing of breastmilk substitutes throughout the territory.
The current law until now does not have teeth and we are proposing that sanctions be included as soon as possible if we want the companies to comply to the law.
This is just a draft that needs your opinion on the type of sanctions that should be included before the proposal is forwarded to the government through the ministry of public health

PROPOSAL 2008

TEXT OF APPLICATION OF THE REGULATIONS ON MARKETING OF INFANT AND YOUNG CHILD FEEDING PRODUCTS IN CAMEROON

ARRANGEMENT OF REGULATIONS

REGULATION

PART I – Preliminary
1. Citation and commencement
2 . Interpretation
3. Application

PART II - Monitoring, Inspection, Stocking, etc.
4. Designation of monitors
5. Duties of monitors
6.Duties of authorized officers
7. Conditions for stocking, etc, foods for infants and young children or other designated products

PART III - Prohibition against Promotion, Advertising, etc.
8. Promotion, Advertising, etc, prohibited
9. Health workers prohibited from promoting, etc, foods for infants and young children

PART 1V – Labelling, Warning, Preparation, etc.
10. Labelling of foods for infants and young children and other designated products
11 .Labelling of infant formula and follow up formula
12. Warning about improper preparation of infant formula or follow-up formula
13. Labelling of other products sometimes used as foods for infants and young children
14. Labelling requirements for feeding bottles, etc .

PART V – Information and Educational Materials
15. Information and educational materials on infants and young children feeding
16. Information and educational materials on foods for infants and young children

PART VI - Offences and Penalties
17. Offences and penalties
18. Body corporate liability

IN EXERCISE of the powers conferred on the Minister of Public Health by the law n° 96/003 of 04 January 1996 on the framework of the health sector operations, the decree N° 2005/5168/PM of 01 December 2005 regulating the marketing of breastmilk substitutes in conformity with the international code and the Decree N° 1433/A/MSP/SG/DCOOP/CPNAT of 17 August 2007 fixing the framework of collaboration between the Ministry of the Public Health, Associations, Non Governmental Organizations and health facilities of the public and private sectors, the following Regulations are hereby made –

PART I –Preliminary

Citation
1. These Regulations may be cited as the marketing of foods for infants and young children text of application of the Cameroon National Code 2005 and shall come into operation six months after publication in Cameroon.

Interpretation
2. In these regulations, unless the context otherwise requires-
“Codex Alimentarius Commission” means the Joint Food Standards Programme of the Food and Agriculture Organisation of the United Nation and the World Health Organisation ;
“Codex Standard” means the latest version of the relevant Codex Standard as issued by the Codex Alimentarius Commission;
“Complementary Food” means any food suitable for use to complement breast milk or infant formula or follow-up formula;
“Container” means any packaging of food for infants and young children and other designated products for delivery as a single unit and includes wrapper ;
“Designated products” includes –
(a) infant formula;
(b) formulas for special medical purposes intended for infants;
(c) follow-up formula;
(d) complementary foods;
(e) beverages for infants and young children;
(f) any product marketed or otherwise presented as suitable for feeding infants and young children ;
(g) feeding bottles ;
(h) teats;
(i) pacifiers and dummiers;
(j) breast pumps;
(k) cups with spouts or similar receptacles for feeding infants and young children and
(l) such other products as the Minister of Public Health may, by notice published in the Official Gazette designate.
“Distributors” means a person engaged in the business, whether wholesale or retail, of marketing or distribution or sale of foods for infants and young children or any designated products, and includes any person engaged in the business of providing information, or public relations services in relation to foods for infants and young children or designated products;
“Foods for infants and young children” means a group of food products distributed, marketed or otherwise represented as suitable for infants and young children including –
(a) infant formula ;
(b) formulae for special medical purposes intended for infants;
(c) follow- up formulae;
(d) complementary foods
(e) beverages for infants and young children ;
(f) any product marketed or otherwise presented as suitable for feeding infants and young children ;
(g) feeding bottles ;
(h) teats ;
(i) pacifiers or dummies ;
(j) breast pumps ;
(k) cups with spouts or similar receptacles for feeding infants and young children and
(l) Such other products as the Minister of Public Health may , by notice published in the Official Gazette designate.
“ distributor” means a person engaged in the business ,whether wholesale or retail, of marketing or distribution or sale of food for infants and young children or any designated products, and includes any person engaged in the business of providing information, or public relations services in relation to foods for infants and young children or designated products ;
“ foods for infants and young children” means a group of food products distributed, marketed or otherwise represented as suitable for infants and young children including –
(a) infant formula ;
(b) formulae for special medical purposes intended for infants
(c) follow–up formula ;
(d) complementary foods
(e) any other product marketed or otherwise represented as suitable for feeding infants and young children ;
“follow up formula” sometimes referred to as “follow–up formula” means milk or a milk-like product of animal or vegetable origin industrially formulated in accordance with such regulations as the Minister of Public Health may make and, in the absence of regulations, in accordance with the Codex Standard for Follow–up Formula, distributed, marketed or otherwise represented as suitable for infants older than six months of age and young children;
“Formula for special medical purposes intended for infants” means infant formula which is specially manufactured to satisfy the nutritional requirements of infants during the first months of life up to the introduction of complementary feeding when medically indicated;
“ gift” includes designated product, meals and refreshments, diaries, stationery, calendars, cot tags, stickers, growth charts, prescription pads, tongue depressors or any free item of whatever value;
“ health care facility” means any governmental, non-governmental or private institution or organization engaged, directly or indirectly, in health care for mothers infants, young children, pregnant women, and includes private practice, nurseries or childcare institutions; but does not include social welfare institutions;
“Health workers” means any person working or trained to work in a health care facility, whether or not that person is a professional or non-professional and includes voluntary or unpaid workers;
“Infant” means a person from birth up to the age of 12 months;
“Infant formula” means milk or milk like product of animal or vegetable origin formulated industrially in accordance with such regulations as the Minister of Public Health may make and, in the absence of such regulations, in accordance with the Codex Standard for Infant Formula intended to satisfy the nutritional requirements of infant from birth, and include formula for special medical purposes
“ manufacturers” means any person, corporation or other entity engaged, directly or indirectly, in the business of manufacturing food for infants and young children and other designated products;
“marketing” means promoting, distributing, selling or advertising a designated products and includes product public relations and information services, including the use of professional service representatives such as mother craft nurses, or any person acting on behalf of a manufacturer or distributor;
“Monitor” means a person appointed by the Minister of Public Health or His representative to carry out any exercise necessary to reveal contravention of these Regulations;
“Promote” has the meaning assigned to it under regulation 8(1);
“Sample” means a single or a small quantity of a food for infants and young children or a designated product provided without cost;
“Social welfare institution” means any governmental or non-governmental organization engaged, directly or indirectly, in providing for the social welfare of infants and young children, but does not include health care facilities;
“Tie-in sales” means the sale of any designated product that is linked to a purchase of any other product including a designated product; and “young child” means a person aged between 12 months and 3 years.

Application
3. These Regulations apply to the marketing, and practices related thereto, of foods for infants and young children and other designated products, when imported into, marketed, distributed, sold or manufactured in, Botswana.

PART II - Monitoring, Inspection, Stocking, etc.

Designation of Monitors
4. (1) The minister or his representative may designate, as monitors, such number of persons he or she considers appropriate, who have undergone training on monitoring of violations of the International Code of the marketing of Breastmilk Substitutes and these Regulations .
(2) The minister or his representative shall issue to any person designated as a monitor, a letter of appointment and the monitors shall have such letters in his or her possession when performing any function in terms of these regulations.


Duties of Monitors
5. (1) A monitor in exercise of his or her duties shall investigate, observe and record information regarding the marketing practices of manufacturers and distributors at any points of sale, heath care facilities, border posts and offices, through media, institutions and elsewhere .
(2) A monitor may for the purpose of monitoring violations of these Regulations enter, at any time, any premises which are used for dealing in foods for infants and children or other designated products and may –
(a) require any person in the premises to furnish any information including documents in his or her possession as the monitor may require;
(b) caution the person on the premises regarding any violation of these Regulations,
(c) seize any goods, or promotional materials or documents where the goods or promotional material or documents in question contravene these regulations.
(3) A monitor shall, after monitoring sub-regulation (1), submit a report in writing, in relation to his or her findings to the Board.
(4) In any proceedings under these Regulations, a report signed by a monitor shall be accepted as prima facie evidence of the facts stated therein.
(5) No monitor shall have any direct or indirect commercial interest in infant and young child feeding.
(6) A monitor, acting in accordance with these Regulations, shall if required by any person, provide proof of his or her authority.
(7) An owner, occupier or person in charge of any premises entered by a monitor shall give to the monitor all reasonable assistance and shall furnish him or her with such information as the monitor may reasonably require.
(8) No person may obstruct or impede a monitor in the course of performance of his or her duties.
(9) No person may knowingly make any false or misleading statement, either verbally or in writing, any monitor engaged in carrying out his or her duties.

Duties of authorized officer
6. (1) An authorized officer shall implement these Regulations under the powers vested on him or her by the provisions of Section 6 of the Food Control Act;
(2) No authorized officer shall have any direct or indirect commercial interest in infant and young child feeding.

Conditions for stocking designated products
7. (1) No person shall stock, distribute, sell or exhibit any foods for infants and young children which have expired or are beyond their shelf life.
(2) No person shall stock, distributed, sell or exhibit any food for infant and young children or other designated products which are not in their original containers.
(3) A container of foods for infant and young children, for sale or distribution, shall be free from dents or any other form of damage and shall be kept-
(a) In a cool and dry place;
(b) At least 50 cm from the floor; and
(c) In a hygienic manner.

PART III – Prohibition against Promotion, Advertising, etc.

Prohibition of promotion and advertising
8. (1) For the purpose of this regulation, “promote” includes –
(a) Any direct or indirect method of introducing a designated product or encouraging the buying or use of a designated product;
(b) sale devices such as rebates, special displays to promote sales, tie-in sales, loss leaders, grant of rewards, discount coupons, premiums, special sales, prizes, gifts and giving of samples to mothers;
(c) direct or indirect contact between marketing personnel and members of the public in furtherance of or for the purpose of promoting the business of designated products and indirect contact includes television and radio, telephone or internet help lines, mother and baby clubs and baby competition;
(d) Electronic communication including website, internet and electronic mail;
(e) Promotional items such as clothing, stationery or items that refer to a designated product or to a brand name of a designated product;
(f) Outdoor advertisements such as billboards;
(g) Placard and newspaper or magazine inserts;
(h) Practices that create an association between a manufacturer or distributor and breastfeeding.

(2) No person shall –
(a) promote or cause to be promoted, foods for infants and young children or other designated products ;
(b) engage in promotional activities of any designated product;
(c) publish or cause to be publish any advertisement for any designated product;
(d) Advertise or cause to be advertised any designated product.

(3) No manufacturer or distributor shall -
(a) Distribute or cause to be distributed any information or educational material
relating to infant or young children nutrition or feeding, except in accordance with these regulations.
(b) offer or give or cause to be offered or given, any benefit to a health worker, including, fellowships, study grants, funding for attendance of meetings, seminars, continuing education or conferences;
(c) Fund any research, clinical or otherwise, carried out by any health worker on any designated product, except in accordance with a protocol approved by the relevant authority in writing;
(d) Directly or indirectly, provide any support financial or otherwise, to any health worker;
(e) employ any person to provide to health workers in health care facilities, pregnant women or mothers of infants and young children or any person with education or introductions regarding the use of a designated product;
(f) Sell, donate or distribute or cause to be sold, donate or distribute in a health care facility, any-
(i) Equipment, materials or any other services with any reference to any designated products or contain the name or logo of any manufacturer or distributor of any designated product;
(ii) Foods for infants and young children or other designated products at a price lower than the published wholesale price or in the absence of such price, lower than 80% of the retail price.
(g) Calculate a bonus payment based on the volume of sales of any designated product; or
(h) Set a quota for the sale of any designated product as a sales incentive.

(4) notwithstanding the provisions of sub-regulation (3) (a), manufacturers and distributions may give information about designated products to health professionals if such information is restricted to scientific and factual matters regarding the technical aspects and methods of use of designated products, and in accordance with regulations 15 and 16.
(5) Sub-regulation 3 (f) (ii) shall not apply where a donation or low price sale is made to an orphanage or other social welfare institution for infants who have to be fed on designated products and shall not prevent the government from procuring foods for infants and young children, for its feeding programme or for social welfare purposes, at the lowest possible price through bidding procedures.
(6) Donation or low price sales made to orphanages or other social welfare institutions, whether for use in the institutions or for distribution outside them, as provided for under sub-regulation (5) should be sustained once started and should continue as long the beneficiaries need them.
(7) Manufacturers shall not make donations as referred to in sub-regulation (5) or set low price sales as sales inducements.
(8) Marketing personnel in their business capacity shall not seek direct or indirect contact of any kind with pregnant women, or with caregivers, or mothers of infants and young children intended to further commercial interest.

Prohibition of promotion by health workers
(9) (1)health workers shall
(a) promote and support breast-feeding, unless medically indicated;
(b) keep a records register of contraventions of the provisions of these regulations by manufacturers or distributors in their respective health care facilities; and
(c) Provide the records under sub-regulation (1) (b) to monitors and authorized officers.
(2) health workers shall not-
(a) accept from manufacturers or distributors any of the following offers :
(i) gift,
(ii) financial assistance,
(iii) fellowships, study tours, research grants, funding for attendance of conferences,
(iv) samples of goods for infants and young children or other designated products, or
(v) quantities of foods for infants and young children or mother designated products at a price lower than the published wholesale price, or in the absence of such price, lower than 80% of the retail price, or
(b) Display foods for infants and young children or other designated products.
(3) sub regulation shall not apply to –
(a) research activities approved by the health research authority in writing, or
(b) Quantities of foods for infants and young children or other designated products for social welfare purposes provided under the government feeding progammes and in terms of such guidelines as the board may from time approve.



PART IV - Labelling, Warning, preparation, etc.

Labelling of foods of Infants and Young Children
10. (1) Except to the extent otherwise provided in these regulations or any other regulations made under the act, every food for infants and young children shall be labelled in accordance with the Labelling of pre-packaged foods regulations.
(2) Every label on the container of a food for infants or young children shall contain, in written and simple English and French, the following information which shall appear in bold and conspicuous characters in a prominent position on the container –

(a) Instructions for the appropriate preparation in words or easily understood graphics;
(b) instructions for the proper sterilization of equipment and utensils;
(c) a warning about the health hazards of incorrect preparation or use of the product;
(d) the recommended age for use of the product, which in the case of complementary foods should not be before the age of 6 months;
(e) the danger to introducing the product prior to the recommended age;
(f) the name of the product;
(g) the composition and analysis of the product;
(h) nutritional information of the product;
(i) the batch number of the product;
(j) correct storage instructions of the product;
(k) the country of origin of the product;
(l) the date of manufacture of the product;
(m) the net weight of a solid product;
(n) the net volume of a liquid product;
(o) the name and address of the manufacturer of the product;
(p) the date of expiry of the product, which shall be indented and stated in order of day, month and year; and
(q) The list of ingredients used.
(3) A label on a container for food for infants and young children shall not contain
(a) pictures of infants, women, animals or toys nor any other picture or text or any symbol depicting a health advantage which idealizes food for infants and young children or other designated product;
(b) Any information comparing breast-milk to food for infants and young children or other designated products.
(4) No nutrition or health claims shall be made with regard to ingredients or nutrients or young children.;
(5) Only infant formula may be marketed or otherwise presented as suitable for infants younger than 6 months of age.

Labelling of infant formula and follow up formula
11. (1) no person shall sell infant formula or follow-up formula unless the container or label affixed thereto, contains the following information in written and simple English and French –
(a) In bold and conspicuous characters in a prominent position and in not less than 50% of the size of the largest words on the container or label and not less than 2mm in height -
“IMPORTANT NOTICE: A MOTHER’S BREAST-MILK IS BEST FOR HER BABY. CONSULT YOUR HEALTH WORKER BEFORE YOU DECIDE TO USE THIS PRODUCT”; and
(b) Stating the dangers of using left over formula.
(2) The label on any container of infant formula or follow up formula shall not include words such as “materialized”, “humanized” or terms similar thereto nor any comparison to breast-milk.

Warning about inappropriate preparation

12. (1) The label on any container of infant formula or follow up formula shall contain the following words in bold and conspicuous characters in a prominent position and in not less than 50% of the size largest words on the label not less than 1.5 mm in height –
“WARNING:
FOLLOW THE INSTRUCTIONS FOR PREPARATION CAREFULLY OR YOUR BABY MAY BECOME ILL. DO NOT USE MORE OR LESS THAN THE QUANTITIES INDICATED. CUP FEEDING IS SAFER THAN FEEDING FROM A BOTLE”.

(2)The label on any container follow-up formula shall also state the product shall not be use for infants younger than six months.
(3)The label shall have graphic representations illustrating the method of preparation of the product and methods of feeding cups and feeding bottles.

Labelling of other products used as foods for infants and children

13. The label on any container of the following types of milk –
(a) sweetened;
(b) condensed;
(c) evaporated;
(d) dried;
(e) skimmed;
(f) low fat;
(g) imitation milk-like dairy products; or
(h) standardized milk
Shall contain words in bold and conspicuous characters not less than 2 mm in height-
“THIS PRODUCT IS NOT SUITABLE FOR FEEDING BABIES”

Labelling requirements for feeding bottles, etc.

14.(1) in label, package or container of a feeding bottle or teat shall include, in simple written English and French –
(a) a statement of the superiority of breast-milk for feeding infants;
(b) a statement that feeding with a cup is safer bottle than feeding;
(c) Instruction for proper cleaning and sterilization of feeding bottle and teat;
(d) a warning of potential health hazards of using feeding bottle especially if it is not properly sterilized;
(e)the need to follow preparation instructions carefully;
(f)The name and address of manufacturer or distributor.
(2)In label, package or container of a feeding bottle or teat shall not contain pictures of infants, women or infant toys nor any other picture or text or any symbol depicting a health advantage which idealizes artificial feeding.
(3)A label of a dummy shall include, in simple written English and French–
(a) a notice that the use of such dummy can interfere with breastfeeding;
(b) Instructions for proper cleaning and sterilization of the dummy;
(c)a warning on potential health hazards of using a dummy especially if it is not properly sterilized;
(4)A label of a dummy shall not contain pictures of infants, women, animals or toys nor any other picture or text or any symbol depicting a health advantage which idealizes artificial feeding over breastfeeding.
(5)A label of a breast pump shall have written instructions in simple English and French, for proper use, cleaning and sterilization of the breast pump.

PART V - Information and Educational Materials

Information and educational materials on infant and young children feeding

15. (1) notwithstanding any other provision of these regulations, no person shall directly or indirectly, distribute any education material or any information relating to infant or young child feeding in Cameroon without the approval of the national monitoring board.
(2) Any educational material or information, written, audio or visual electronic or otherwise, relating to infant feeding shall explain –
(a) the importance, benefits and superiority of breastfeeding during the first 2 years of the life of a child;
(b) the value of exclusive breastfeeding for the first six months of life followed by sustained breastfeeding for at least the first 2 years of the life of a child;
(c) the preparation for and the continuance of breastfeeding;
(d) factual and current information and shall not use any pictures or text discouraging breastfeeding;
(e) how bottle-feeding interferes with breastfeeding;
(f) the difficulty in reverting to breastfeeding after a period of formula feeding; and
(g) How the early introduction of complementary foods interferes with breastfeeding.
(2) The educational material or information referred to in subregulation (2) shall not make any reference to the brand name of food for infants and young children or many designated product or the name or logo of any manufacturer or distributor.

Information and educational materials on foods for infant feeding

16 (1) where the educational material or information referred to in regulation 15 includes the topic of the feeding of infants with infant formula or follow-up formula, it shall include: -
(a) instructions for the proper preparation and use of the product in question including the cleaning and sterilization of feeding utensils;
(b) the health hazard or bottle feeding and improper preparation of the product;
(c) the importance and proper instructions on cup feeding; and
(d) The approximate financial cost of the product in question if used in recommended quantities for a period of six months.
(2) Where the material referred to in regulation 15 includes the topic of infant with complementary food, it shall explain –
(a) The health hazards of introducing complementary foods too soon or too late; and
(b) That complementary food can easily be prepared at home using indigenous ingredients.
(3) Feeding with infant formula, follow-up formula or complementary foods whether manufactured or home prepared, shall be demonstrated only by health workers or other community workers if necessary, and only to the mothers or family members who need to use it and the information given shall include a clear explanation of the hazards of improper use.

PART VI - Offenses and Penalties

Offences and penalties
17. (1) a person who contravenes a provision of these regulations commits an offence and is liable –
(a) for a first offence, to a fine not exceeding CFA 500.000 or to imprisonment for a term not exceeding 3 months, and where the offence is a continuing offence, to an additional fine not exceeding CFA 500.000 or imprisonment for a term not exceeding one month for each day on which the offence continues; and
(b) for a second or subsequent offense, to a fine not exceeding CFA 500.000 or to imprisonment for a term not exceeding six months and where the offence is a continuing offence, to an additional fine not exceeding two months for each on which the offence continues.
(2) Notwithstanding the provision of sub-regulation (1) the national monitoring board may recommend to the minister of public health, any other action to be taken against any manufacturer, distributor, health worker or other person who contravenes the provisions of these regulations.
(3) On the conviction of any person for an offence under these regulations, the minister of public health may cancel, or suspend any license issued to that person which is relevant to the offence committed.
(4) Where the person has been convicted of an offence under these regulations, the minister of public health may order that any article relevant to the offence be forfeited and that it be destroyed or otherwise disposed of, as the minister of public health considers appropriate.

Body corporate liability

18. where an offence under these regulations which has been committed by a body corporate is provide to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a director, manager, secretary or other similar officer of the body corporate, or any person who was purporting to act in such capacity, he or she as well as the body corporate, shall be guilty of an offence and liable to fine not exceeding CFA 500.000 or to imprisonment for a term not exceeding 3 months, or to both.

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