January 29, 2013 Update
Please click here if you are looking for information on Neocate Junior with improved vitamin and mineral levels, which will first become available in February 2013 (manufacture date January 2013).
This page provides answers to questions about Neocate Junior Unflavored manufactured before January 2013.
January 11, 2013 Update
We have been in touch with fifteen families in the United States who have reported that their children with unique and extremely sensitive medical conditions have had varying degrees of difficulty tolerating Neocate® Junior Unflavored. Neocate Junior is primarily used for children with symptoms of cow milk allergy, and it is also indicated for other conditions, including gastroesophageal reflux disease (GERD) and eosinophilic esophagitis (EoE). In addition, as a hypoallergenic formula, it is sometimes used for children with Food Protein-Induced Enterocolitis Syndrome (FPIES). In some of the cases reported, these children may have more sensitive conditions than those described above.
We understand there have been questions about the Neocate Junior formulation, and whether any changes we have recently made in our factory affected this formulation and caused the children of these families to develop tolerability difficulties with the product.
In August 2012, we redesigned the graphics on the package for Neocate Junior Unflavored to provide clearer flavor communication and simpler, easy to read preparation instructions. The product formulation and ingredients did not change.
Neocate Junior is manufactured in a facility that makes a number of specialized and very specialized products for vulnerable children and adults. One of these products is Neocate® Nutra. In May 2012, we replaced the corn starch in Neocate Nutra with rice starch. This change was necessary to ensure the supply and quality of Neocate Nutra as a result of limited supply of hypoallergenic corn starch. We made this change only after we completed extensive analysis to ensure no product would be at risk for cross-contamination with this new ingredient.
As soon as we learned of concerns about tolerability in these few cases, we began working diligently to respond to each family’s situation and we initiated extensive testing and analysis to determine what was happening. In consultation with the FDA, we completed an exhaustive evaluation of the product and our manufacturing facility internally and by external labs.
All tests confirmed that Neocate Junior Unflavored has not been changed or altered. In addition, no rice starch presence was detected (please click here for summary of results).
We know families urgently need solutions for their children that will address each of their unique and highly-sensitive needs, and we are committed to partnering with those who share our deep interest in finding resolution.In some cases, we have offered to introduce families and their physicians to medical experts to help explore nutritional solutions.
Additionally, we are continuing to consult with leading allergy and immunology experts to determine what else we can do to help these children.
As with all of our products, we will continue to work to develop and improve the Neocate Junior formula in line with the latest scientific knowledge and medical consensus. When changes to the formula are planned, we will communicate them in advance both to healthcare professionals and to parents and caregivers through various communications channels, including letters, online and patient resources.
We urge any families with questions or those experiencing any difficulties with any of our products to please call our dedicated team of nutrition specialists at 1-800-365-7354.
What changes have been made to Neocate® Junior Unflavored in the past year?
There have been no changes to the formulation or ingredients of Neocate Junior Unflavored in the past year. In August 2012, we updated the graphics on the Neocate Junior packages to more simply illustrate information about the product, including the flavor and preparation instructions.
Why did the osmolality figures on Neocate Junior package change?
We slightly lowered the osmolality figures on Neocate Junior packaging following review of data earlier this year, but there have been no changes to the actual osmolality or product formula. Nutricia conducts osmolality label claim monitoring of its products on a regular basis. The longer a product has been on the market, the more data we have. Periodically this data is reviewed and if necessary labels are updated. The revised osmolality values therefore reflect the results from our most recent data review. Although reported values are more accurate than before, there has been no change to the actual osmolality or to the formula.
What changes were made to the Neocate Junior product in the UK? Why weren’t these changes announced in the United States?
Neocate Junior is not available in the UK.
What changes have been made to Neocate® Nutra in the past year? How does this impact Neocate Junior?
In May 2012, in consultation with external medical experts, we made an ingredient change to Neocate Nutra. This product launched later that summer. The change was to replace corn starch in Neocate Nutra with highly refined rice starch. The change was made to ensure the supply and quality of Neocate Nutra as a result of limited availability of hypoallergenic corn starch.
Neocate Nutra is manufactured in a facility that makes a number of products, including Neocate Junior.
We made this change only after we completed extensive analysis to be certain other products would not be at risk for cross contamination with rice starch.
You can read our communication about the changes here
What are causing the tolerability reports with Neocate Junior Unflavored?
This is a complex situation that we continue to explore. Since mid November 2012, we have received reports from 15 families of children with unique and extremely sensitive conditions who have had varying levels of difficulties tolerating Neocate Junior Unflavored. Upon learning of the first reports, we undertook extensive internal and external testing and analyses to determine if concerns could be related to the product. Review of lab test results, production records and supplier information for more than ten lots of Neocate Junior Unflavored confirms there has been no change to or contamination of the product. (outlined here). However, we recognize the special and urgent situations each of these families face, and so are doing everything we can to find answers and individual solutions for each family.
If tests indicate there were no changes to or contamination of Neocate Junior Unflavored, why does it look, smell and taste different?
We have looked at product samples manufactured before and after May 2012 for differences in smell, look and taste, but have not been able to determine any difference. Specifically to date, sensory analysis (smell, look, taste) was conducted on two complaint lots. We also tested the samples we received from families for tube feed testing. All results were normal. We are continuing to reevaluate all of our tests on smell, look and taste, and will provide updates on this page. If you notice any differences in or have any concerns about any Nutricia product, please call our Nutrition Services team at 1-800-365-7354.
What does Nutricia think is actually happening?
This is a complex situation that we continue to explore. Results from all available tests, review of production records and supplier information do not indicate any changes to or contamination of the products; however, we are doing everything we can to help find answers by continuing to reexamine all of our data and explore all potential scientific and manufacturing avenues. We will continue to promptly post updates to this site.
What are you doing to resolve it?
We do everything we can to try to help each and every patient find a successful nutritional solution. If one of our products is not successful or is no longer successful for a particular child, we commit to working to help find something that does work. In this situation, we are continuing to reach out to the families who have reported difficulties, and we are examining and reexamining clinical and manufacturing avenues to help find a solution that works for those families.
What are potential health risks to my child?
Our products are intended to feed and support the healthy growth of vulnerable and very vulnerable children. As with any medical food, we encourage parents and caregivers to please consult with your child’s physician regarding any specific questions about treatment. Our dedicated Nutrition Services Team at 1-800-365-7354 is available to help answer questions about our products.
What can I do if my child is having problems?
First, consult with your child’s physician before making any changes to your child’s diet. Additionally, we urge you to contact our dedicated Nutrition Services Team at 1-800-365-7354 if you have questions about our products or concerns. Every child is different, particularly children with severe conditions and allergies, and so the reasons why each child may respond to or react to any food or product, including Neocate products, may be different.
Are children outside the US, including Canada, affected?
Reports have been limited to the US. Neocate Junior Unflavored is available in the United States, Germany and Australia.
What tests were conducted?
From November 2012 through January 2013 we conducted all available, proven tests and reviews of Neocate Junior and our manufacturing process. The evaluations were conducted internally and through external labs, in consultation with the U.S. Food & Drug Administration and with the guidance of leading experts in food allergies, manufacturing and contamination.
We evaluated a range of potential triggers from the ingredients we use (including reviewing our suppliers) to product packaging. We also evaluated whether the ingredients we use could have been altered or changed and if there was evidence of contamination or cross-contamination in our manufacturing facility. We conducted tests of Neocate Junior Unflavored products manufactured prior to and after May 2012. These products were samples returned from customers as well as warehouse samples.
The product tests included measuring nutrition levels, formulation, ingredients, and the presence of prebiotic fiber (fructo-oligosaccahrides), fructose, sucrose, milk protein (beta-lactoglobulin), rice DNA (as a marker of rice material), mold, yeast and bacteria.
What are the risks that there is rice contamination that hasn’t been detected with your tests?
We consulted with various experts to ensure we conducted all currently available, proven tests for rice starch. While review of internal manufacturing records and independent, external tests on rice DNA indicate that there was no rice presence, all tests have limits as to what they can measure. The detection limit for the test we conducted for presence of rice is 100 ppm (parts per million, which means 1 mg in 1 kg).
According to Dr. Steve Taylor (MS, PhD, Professor, Food Science and Technology Department and co-Director, Food Allergy Research & Resource Program, University of Nebraska-Lincoln), an international expert in food allergen residue testing and allergen control practices in food manufacturing facilities:
“Rice starch may contain trace quantities of rice protein and rice DNA. However, because rice protein is very rarely allergenic and is not commonly involved in food allergies, the clinical community does not have any specific tests for rice protein like those we have for the more common allergenic foods such as milk, eggs, and peanuts, among other ingredients. However, we can test for rice DNA. When Nutricia tested the Neocate Nutra product, the company obtained positive tests for rice DNA. When Nutricia used the same rice DNA test on Neocate Junior, negative results were obtained. These results of the specific rice DNA test indicate there is no evidence of any cross contamination between the Neocate Nutra product that contains rice starch and the Neocate Junior product that does not contain any rice.”
How do we know undetected/measured trace levels of potential allergens will not cause harm to "ultra sensitive" children?
There are currently no clinical guidelines for determining thresholds for trace amounts of all potential allergens that a person might detect. At our Liverpool facility, which is a grade D pharma level facility, we produce many different nutritional and metabolic products for highly sensitive patients, and so it is critical that we adhere to the most stringent manufacturing and cleaning policies to ensure the safety of the people we serve. These measures and control procedures have served successfully for many years. Our manufacturing processes are included here.
How is hypoallergenicity of Neocate® ensured?
Ingredients are selected (e.g. amino acids, oils, carbohydrates) in accordance with a strict procedure to ensure there is no allergenic risk. This means that raw materials are free from allergenic milk protein and suppliers have validated quality systems preventing cross contamination. The raw materials are then manufactured into finished products in a protein-free environment. Every batch is carefully tested, including for formulation and sensory, before being approved for release.
Has there been cross contamination?
Review of internal manufacturing records and independent, external tests confirms that it is highly unlikely. We produce many products in the same grade D pharma and FDA-compliant manufacturing facility for people with the most severe metabolic and nutritional conditions and sensitivities. It is therefore critical that we abide by the most stringent standards to ensure the safety of every person. Each product is manufactured under controlled conditions, and more than one product is never in production or handled at the same time. Before each product goes into production, the facility is thoroughly cleaned and sanitized in accordance with good manufacturing practices to prevent cross contamination. You can read more about our manufacturing process works here.
Are you making changes to your manufacturing facility as a result of reports?