RESPONSE TO IBFAN ALLEGATIONS (SEPT 2004) RE UK CODE VIOLATIONS
December 2004
Allegation: Nestlé product information display was in a public area at a training event organised by an allergy charity.
Truth: The display mentioned above was part of an educational event organised by Allergy U.K and funded by Nestlé. The study day took place on 24th June 2004, at The Institute of Child Health at the Great Ormond Street Hospital for children NHS Trust. This is a dedicated institute for British Academic research for child health- by no means a public area where patients are permitted to roam. Having a stand at this venue catering specifically for Healthcare professional education and research is within the guidelines of the code.
Allegation: Nestlé's hypo-allergenic claim for the formula is misleading and cannot be used in the United States following legal action after infants fed on it suffered anaphylactic shock.
Truth: The term "hypoallergenic" literally means "less allergenic", and NAN H.A. is indeed proven to be less allergenic than any standard infant feed and is therefore much less likely to cause an allergic reaction in healthy infants. This term is no longer used for the U.S. counterpart to this formula, simply to avoid any possible consumer confusion in that very different market environment.
In Europe, hypoallergenic infant formula has been available for nearly 2 decades and is officially recognised as a category by leading regulatory bodies. As part of this range, Nestlé makes available both partially and extensively hydrolysed products.
Partially hydrolysed feeds are those that are used for primary allergy risk reduction with healthy infants who are unable to be breastfed, and not for the treatment of allergies.
Extensively hydrolysed feeds are those that can be used for both, primary allergy risk reduction and also for the treatment of allergies. Both meet the defined and accepted criteria for being described as hypoallergenic.
Extensively hydrolysed products usually (particularly in Europe) require a prescription as they are essentially for treatment of allergies. Hence, parents are able to obtain products for treatment on prescription and therefore know that those available over the counter are for prevention.
The market environment is quite different in the U.S. where both partially and extensively hydrolysed products can be purchased without a prescription. Also, when Nestlé first launched an HA formula in the United States, only extensively hydrolysed products were available there. This may have created an environment where consumers could have had difficulty distinguishing between the treatment and prevention products and hence might potentially have understood both to be "non-allergenic".
Recognising this previously unknown potential for confusion almost immediately after the U.S. launch in 1989, Nestlé USA decided to voluntarily drop the term "hypoallergenic" even though the product did meet the only definition then in place (i.e., "less allergenic"). Since there was no documented evidence of confusion, this decision to avoid any potential confusion was made purely by keeping the health of the infants as the first and most important priority. Soon after that, the American Academy of Pediatrics issued a new definition of "hypoallergenic" to be applied to U.S. formulas, leaving that term available only to extensively hydrolysed formulas in the U.S.
In the U.K. we have taken great care to ensure that the labelling of NAN H.A. is clear in its intended use and boldly states on the tin and on the lid that this product is NOT to be used for the treatment of cows' milk protein allergy. We also state clearly that 'Hypoallergenic means reduced risk of allergic reaction'.
Again, NAN H.A. is proven to be less allergenic than any standard infant feed and therefore much less likely to cause an allergic reaction in healthy infants.
