Thursday, January 31, 2008

We need to monitor the safety of new ingredients in formula - don't begrudge formula-fed infants this protection

I wrote yesterday of information obtained from the US Food and Drug Administration (FDA) about the adverse health impacts some parents have logged with this government body after feeding their children with formula containing LCPs (Long Chain Polyunsaturated Fatty Acids). The FDA had written to the manufacturer, Martek, suggesting that studies have shown an adverse reaction from some infants. These ingredients are, however, permitted in formulas in the US, the European Union and some other countries. See:

Perhaps I should not be surprised that on one discussion board where the US evidence has come up it has been dismissed immediately as coming from a campaign organisation.

No, the information has come from the Food and Drug Administration.

This blog includes an appeal to focus on the real issue here: how best to monitor the adverse effects that new ingredients in formula may have on some infants, so as to reduce the risk of harm.

Our partners in the US in the International Baby Food Action Network (IBFAN) and their partners are calling for warnings on labels so that should there be an adverse reaction, parents using the formula are aware it may be due to the LCPs. An independent review of these ingredients has found no benefit from adding them to formulas for term infants, despite
claims from companies that they aid 'brain and eye development'. Accordingly companies are not required to add LCPs to formula. So if parents or carers using formula do suspect an adverse reaction they should consult their health worker about alternatives.

It is because of this need for independent advice that the World Health Assembly adopted marketing requirement for breastmilk substitutes, to protect those babies fed on formula as well as to protect breastfeeding.

The US has a pre-authorisation procedure for formula. In the UK the Baby Feeding Law Group, a coalition of health worker and mother support groups, is calling for the same. This was one of the recommendations in the report Protecting breastfeeding - Protecting babies fed on formula rejected by the government. Instead companies will only be required to submit a copy of the label to the Food Standards Agency and only then in the case of infant formula. This notification procedure isn't being applied to follow-on formulas. The BFLG also recommended a monitoring system for health workers and parents to report concerns they may have, particularly with novel ingredients being added to formula. More are coming soon, by the way.

This is not an unreasonable request. Nor should those who's automatic response is to dismiss anything coming from health advocates be so quick to turn away from the need to protect babies fed on formula.

The US Food and Drug Administration has such a monitoring system in place and also expects companies to monitor its customers for possible adverse effects. This is what it says in one of its responses to an application from a company (in this case Mead Johnson) to have its formula containing LCP formulations ARASCO and DHASCO declared Generally Recognised as Safe (GRAS) . See:


Based on the information provided by Mead Johnson, as well as other information available to FDA, the agency has no questions at this time regarding Mead Johnson's conclusion that ARASCO is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of ARASCO. As always, it is the continuing responsibility of Mead Johnson to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

As you know, under section 412 of the Federal Food, Drug, and Cosmetic Act (the FFDCA), a manufacturer of a new infant formula must make a submission to FDA, providing required assurances about the formula, at least 90 days before the formula is marketed. FDA's response to your GRAS notice does not alleviate your responsibility to make the submission required by section 412 for any new infant formula that you manufacture to contain ARASCO and DHASCO under the conditions of use described in your GRAS notice.

As you are aware, in our response to GRN 000041 FDA informed Martek that it is FDA's view that any evaluation that a use of a food ingredient is safe is a time-dependent judgment that is based on general scientific knowledge as well as specific data and information about the ingredient. For this reason, FDA would expect any infant formula manufacturer who lawfully markets infant formula containing ARASCO and DHASCO to monitor, through scientific studies and rigorous post-market surveillance, infants who consume such a formula.

Importantly, because the broader scientific community could contribute to this continuing evaluation, and because the use of ARASCO and DHASCO in infant formula would be based on the GRAS provision of the FFDCA, we also would expect that any reports to FDA about such studies would not be considered to be confidential.


Companies claim their studies show no adverse reactions.

The FDA claimed in its response of 17 May 2001 to Martek's application GRN 000041 mentioned above: "Some studies have reported unexpected deaths among infants who consumed formula supplemented with long-chain polyunsaturated fatty acids." It said it would convene an expert panel, despite Martek's suggestion this was unnecessary, and said it had no further questions at that time.

The Martek report on its investors website on the same date is headlined: "Martek's Oils for Use in Infant Formula Receive Favorable Review by FDA." See:

It states: "
The agency has issued a letter informing the company that the FDA has no questions regarding the company's conclusion that Martek's DHASCO(R) and ARASCO(R) oil blend is GRAS when used in specified ratios in infant formulas. Infant formulas containing Martek's oils will become available in the United States as soon as infant formula manufacturers satisfy FDA's pre-market notification procedures relating to infant formula."

So what happened next?
The FDA response to GRN 000041 is referenced in other responses as recently as last week (example here) so I am still seeking information about whether the expert panel Martek was opposing did indeed meet.

Companies wishing to use LCP's in their formulas made their applications for pre-market approval and this was granted. In the example of Mead Johnson's application for Generally Recognised as Safe status for its formula quoted above, the company was told it has to monitor any adverse effects of the formula.

Now it seems to me perfectly reasonable that this sort of monitoring should take place and should be backed by an independent system as they have in the US. The FDA has registered 98 cases of adverse effects reported by parents, details of which were released under the Freedom of Information Act. This information is important for evaluating safety. It will also help to determine whether information for parents who use formula should alert them to the possibility of an adverse reaction to LCPs. The more data there is, the better.

If you are one of that select group that will read this blog and launch into a 'stop making mothers who use formula feel guilty' attack, then please don't. Whether you believe it or not I happen to think that babies fed on formula have a right to be protected and that if there is a problem for a small group of infants from these ingredients then monitoring systems are essential. If you use the formula and your baby is fine, then please don't begrudge those who have concerns the opportunity to report them.

And if you are breastfeeding and are feeling pleased that your breastmilk is tailored to your baby so this discussion is not relevant to you, then that is wonderful, but also please let the discussion take place without it immediately turning into a breastfeeding/bottle feeding debate.

Sometimes discussion of infant feeding becomes so heated and emotional the real issues can be lost. This is about
how best to monitor the adverse effects that new ingredients in formula may have on some infants, so as to reduce the risk of harm.

Baby Milk Action has a group on facebook specifically for discussions around our safer formula campaign, so please do drop by there if you are using formula. Click here. You won't find medical advice, but it is a forum to discuss these regulatory issues.

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