Your letter regarding the allegations against Wyeth in IBFAN's "Breaking the Rules" has been referred to me for a reply.

Wyeth has maintained a commitment to compliance with the WHO Code since it adoption over twenty years ago. In fact, our company's principles of responsible promotion of infant formula actually date back to 1978. At that time, we established an internal standards board composed of experts from our regulatory, medical, legal, marketing and policy departments whose mandate is to review promotional material developed by our overseas affiliates to ensure compliance with the Code and company policy. Since 1979, this committee has met weekly to conduct its review.

In addition, we periodically audit our affiliates' promotional activities, and convene regional training workshops on the Code (and - where applicable - local regulations).
[Baby Milk Action comment: Promotional materials and activities are specifically banned by Article 5.1, Article 6.2 and Article 7.2 of the International Code]

This is all within the context of our broader commitment to research and produce the highest quality nutritional products for infants and children.

IBFAN Report

When the Report was issued in May of this year, we quickly contacted our staff in the countries cited. We requested each location to investigate the IBFAN claims and to provide us with documentation as to the response. Following the results of that investigation:

• There were 48 accusations against Wyeth in 2001 IBFAN Report.

• Many of the complaints in the IBFAN Report refer to follow-on formulas such as Promil or growing up milks such as Progress which are not covered by the WHO Code. Follow-on formulas are fed to babies 6 months and older; growing-up milks are fed to children ages 1-3 years.

• Several accusations related to countries where Wyeth does not market infant formula, such as the U.S., Canada and Italy. In fact, Wyeth has not marketed infant formula in Italy for many years.

• Quite a few of the accusations related to items with corporate logos or product related symbols such as "Mr. Carrot". Logos or symbols are permitted under Article 6.8 of the WHO Code. (Infant formula brand names are not permitted).

• There were complaints about product literature which in fact complies with Article 7.2 of the WHO Code and samples for professional evaluation as per Article 7.4 of the WHO Code. There were complaints about supplies of infant formula provided to institutions in accord with Article 6.6 of the WHO Code. However, some of the accusations about samples and supplies in two countries were incorrect because local regulations in Malaysia and Taiwan do not permit infant formula samples. Hence, Wyeth does not provide any infant formula samples in Malaysia or in Taiwan.

• Many of the accusations in the IBFAN Report were related to activities in Hong Kong. Hong Kong is a developed market without a national code. Nevertheless, Wyeth's Policy is to ensure that all literature relating to infant feeding states that breast milk is best and that any marketing activities in Hong Kong do not interfere with the promotion of breast-feeding or discourage a mother from breast-feeding.

• There were several complaints about retail trade practices which do not violate the WHO Code. There were also factual errors: for example, contrary to the Report's allegations, Wyeth reps do not visit pharmacies in Bolivia. Wyeth formulas in Bolivia are sold to pharmacies by distributors: Wyeth staff do not have direct contact with retailers.

• Examples of other accusations which were unsubstantiated include a baby club in Mexico, home visits to mothers in Bolivia, telephone calls to mothers in Mexico, a Mickey Mouse poster in the UAE.

• There were several accusations regarding support of professional meetings. This is permitted under Article 7.5 of the WHO Code.

• There was one accusation which we have not been able to investigate due to insufficient information: SMA posters in shops in Ghana. To the best of our knowledge, we did not send any SMA posters to Ghana; however, if we are provided with a specific location, we can visit the shop and attempt to identify the posters.

In summary, with the possible exception of posters in Ghana, the accusations against Wyeth in the 2001 IBFAN Report are not WHO Code violations when measured against the WHO Code, national codes, laws or regulations, or the Infant Food Manufacturers (IFM) policies.

Conclusions

Wyeth will continue to take the necessary steps to maintain/improve its record of compliance with the WHO Code. Our company stands by its record, and is prepared to engage in constructive dialogue regarding potential areas of misunderstanding.

We also reiterate our commitment to contributing to the science of maternal, infant, and pediatric nutrition, and to ensuring the highest quality in the production and distribution of our nutritional products. We look forward to working with WHO, Codex Alimentarius and other partners towards achieving that objective.

Sincerely,

Beverly Halchak, RN
Director
Maternal-Child Health

6 September 2001

Ms Beverly Halchak
Director
Maternal Child Health
Wyeth Nutritionals
P.O. Box 8616
Philadelphia
Pennsylvania
19101
U.S.A

Dear Ms Halchak,

Ms Annelies Allain has asked me to respond to your letter of 3 August 2001.

We are pleased to see Wyeth make a written commitment to uphold the Code as required by Article 11.3 but judging by the violations we have documented worldwide, we can only surmise that your internal mechanisms to ensure Code compliance are not functioning as they should. From the evidence reported to us, Wyeth is one of the most aggressive violators of the Code. The Breaking the Rules(BTR) report aside, we received reports from at least 2 governments in the past months, one in Asia and the other in Africa, that Wyeth has been systematically violating their National Codes.
[Baby Milk Action comment: For details of the South African Advertising Standards Authority ruling against Wyeth see the Campaign for Ethical Marketing action sheet, September/October 2001]

Allow us to list the sources of our discontent.

Wyeth's preference to interpret the term "breastmilk substitutes" to mean only "infant formula" distorts the Code and the historical events and documents which led to its adoption by the World Health Assembly. There is no justification for the term "breastmilk substitutes" to be so narrowly confined. If the Code was meant to apply to infant formula alone, the wording of Article 2 would be that the Code applies to "infant formula" full stop. But it is not. The Code applies to all breastmilk substitutes "marketed or otherwise represented to be suitable... for use as a partial or total replacement of breastmilk" and infant formula is just one variety out of a range of infant feeding products.
[Baby Milk Action comment: This point was also made by UNICEF's Legal Officer in a submission to the European Parliament Public Hearing into Nestlé's marketing malpractice in November 2000. See the full text of UNICEF's submission]

Subsequent World Health Assembly Resolutions enjoy the same status as the Code. You must surely be aware of the global public health recommendations in WHA Resolution 47.5 (1994) and lately in WHA 54.2 (2001) that call for infants to be exclusively breastfed for 6 months with continued breastfeeding for 2 years and beyond. By promoting follow-up formula, Wyeth breaches the Code and relevant World Health Assembly Resolutions.

Even going on Wyeth's narrow interpretation, the company's marketing behaviour is found wanting as witnessed by the promotion for S26, SMA and other infant formulas in the countries we monitored in. You have conveniently ignored our recorded evidence in relation to infant formula. It is not sufficient to proclaim your support of the Code. We have compiled sufficient evidence to prove that Wyeth's deeds are not matched by its promises.

Regarding your few complaints on the BTR report in specific countries, we take issue with your general rebuttals and have the following points to make:

United States - The Code is of universal application and applies to both manufacturers and distributors. For a marketing device which breaks all the rules, please refer to the website www.parentschoiceformula.com. which purportedly is meant for the US market but accessible worldwide.

Canada -We are aware that as of January 21, 2000, Wyeth's infant formula business in Canada belongs to Nestlé. However, our monitors did find supplies of Wyeth's Nursoy and SMA AR in health care facilities in Canada. Why this is so is beyond us. Did Wyeth carry out a total recall of its products after the acquisition by Nestlé? Could it be that the products our monitors came across are excess supplies prior to the takeover? These are questions only Wyeth can answer. Our monitors only report what they see.

Italy - You misconstrue us. We reported the posters because they were found in the work places of midwives and paediatricians not because they relate to infant formula. In this regard, we rely on Article 6.3 of the Code which disallows the distribution of materials provided by companies in health care facilities.

Hong Kong - You call Mr. Carrot a "product-related" symbol. Such promotional symbols are not permitted in health care facilities under Article 6.2 and 6.3. You gave gold S-26 Carrot symbols to mothers in Hong Kong. Clearly, S-26 is a formula, the product Mr. Carrot is "related" to. Article 5.4 forbids any such gifts. Putting a mortarboard on Mr. Carrot to imply that babies will have high IQs from Wyeth's formula is also objectionable and forbidden under Article 5.1

Your complaint that the BTR harps on your activities in a "developed market" like Hong Kong implies that babies in Hong Kong deserves less than the best. There is no justification at all to exclude Hong Kong or any other country from full compliance with the Code and subsequent Resolutions. The preamble of the Code speaks of the right of every child to be adequately nourished. This right is also entrenched in the main human rights instruments. The best way to ensure its fulfilment is through breastfeeding. The promotion of your products undermines this right. Simply stating in fine print that breastfeeding is best in all your literature does not mean a thing if overshadowing that statement is an image of a high IQ Mr. S-26 Carrot or of a smart graduate baby with a can of your formula. Your literature promotes S-26. The corollary is that it discourages breastfeeding.
[Baby Milk Action comment: In its submission to the European Parliament Public Hearing into Nestlé's marketing malpractice in November 2000, UNICEF stressed that the International Code and Resolutions apply to all countries. See the full text of UNICEF's submission]

Malaysia and Taiwan - Precisely because local regulations do not permit samples, the evidence we found is all the more damning. We stand by our report and think honest internal investigation will reveal the same evidence or worse.

Bolivia - We think it strange that you are denying responsibility for your agents or as you put it - affiliates - when they are marketing your products. The Code applies to all those in your employ as well as those acting as your agents or distributors.

Unsubstantiated claims in Bolivia, Mexico and the UAE - Article 5.5 bans all kinds of direct and indirect contact with pregnant women and mothers. Wyeth was found to seek direct contact in the countries you mention and our report is based on feedback from mothers and monitors who are out in the field. By the way, our report states "baby expo" in Mexico; the baby club is in Hong Kong. In view of the many yellow leaflets inviting mothers to join the Wyeth Baby Club which are still floating in health care facilities in Hong Kong, we welcome your comments.

Professional meetings - Our statements come under the heading "Stretching the Rules" which says what it means. In making our stand we rely on WHA49.15 (1996).

Ghana - Thank you for acknowledging that Wyeth produces and distributes SMA posters. It would help to know why your team of experts allows such promotional material in breach of Article 5.1. Our records say that posters were seen on display in rural Akwatia, Ghana, in a monitoring exercise carried out on 8/8/2000. No doubt, your distributors will know exactly which shops in Ghana have the posters and it would be good to have them removed.

Conclusion

This response answers your specific complaints on the BTR. You counted only 48 entries for Wyeth. To avoid being repetitive in the BTR, we combine violations we found in different places if they concern the same product in the same country. But even going on the number of times a specific violation is mentioned, we count 46 instances which mention your "infant formula" products: S-26, SMA, Nursoy, Parent's Choice, Baby Mil and Baby Soy. Since you did not say anything about these 46 entries, we take it that the reports on these violations are justified and that you will take action on them.

We trust you will look into setting right Wyeth's internal mechanism so that in future no more violations of the Code will occur. Monitoring is not our favourite activity but we take our responsibility under Article 11.4 seriously and will continue the surveillance.

Yours sincerely,

Yeong Joo Kean
Legal Advisor

cc. WHO
UNICEF