Wednesday, January 9, 2008

Despite Wyeth's claims, addition of lutein is questionable

Photo: "Through a child's eye" by DownTown Pictures

Beginning around the time that the Supreme Court released its ruling on the Revised Implementing Rules and Regulations of the Philippines Milk Code, Wyeth launched a massive campaign to promote its milk supplement with lutein. Wyeth's advertising and other promotional and marketing materials have emphasized the addition of a substance called "lutein" and claim that this enhances the visual development of children -- a claim that is in violation of the Supreme Court's ruling.

Perhaps many parents are falling for these claims. What they do not know is that the New Zealand Food Safety Authority (NZFSA) has concluded that the addition of lutein in infant formula and follow-on formula is not justified.

In a document entitled, "Application A594 - Addition of Lutein as a Nutritive Substance to Infant Formula and Follow-on Formula - Draft Assessment Report" dated 13 November 2007, NZFSA made the following points:

The evidence is not sufficient that milk companies should be allowed to add lutein for eye health.

The data presented is insufficient and presents a high level of uncertainty. Moreover, most of the data presented were from research conducted by the milk company itself and have neither been published nor subjected to peer review.

The proposed levels (amount) of lutein to be added does not have any sound basis in science.

The proposed maximum levels of 250ug/L in infant formula and 500ug/L in follow-on formula do not have any sound basis in science. These levels are much higher than what is present in human breastmilk. Manufacturers did not consider bioavailability and the instability of lutein, which would lead to reductions in lutein content due to storage and time. NZFSA is concerned that this might lead to overdosing to make up for the losses.

The addition of lutein cannot be claimed anywhere on the label.

The NZFSA recommends that the only reference to the addition of lutein is in the ingredient list and the nutrition information panel." Like the Philippines, New Zealand law prohibits nutrition, health and related claims in infant formula products.

The analysis that the NZFSA made to assess the addition of lutein shows the kind of scientific rigour that the Department of Health needs to exercise to properly implement the Milk Code.

Based on their actions, milk companies are not concerned with clear eyesight. They are, rather, clouding our vision.

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