All of our products currently sold in the Philippines, including Alactagrow and Sustagen Junior, have passed stringent Philippine FDA health and safety requirements and are considered to be safe for consumption and of high quality. While the fat level requirement does not relate to the safety or quality of the product, Mead Johnson is taking steps to meet that requirement also.
Mead Johnson is launching today a reformulated version of Alactagrow that meets the new regulatory requirements. Work is underway to develop an updated version of Sustagen to meet the revised standards.
PRESS ADVISORY
INTERNATIONAL BABY FOOD ACTION NETWORK (IBFAN) STATEMENT
CONTACT PERSON: Velvet Roxas 0915-7741614
RE: DOH and FDA ADVISORY 2010-010:
Product Recall Order For Alactagrow Bibo Trio Milk Supplement Covered by Registration No. FR-71538
The International Baby Food Action Network urges the FDA to fully implement the Product Recall Order for Alactagrow Bibo Trio Milk Supplement, manufactured by Mead Johnson covered by Registration No. FR-71538.
Infants and young children are our most vulnerable consumers and deserve the utmost protection from harmful products. Such protection is vital for milk products marketed for older infants and young children and intended to support growth and development.
The failure of Alactagrow Bibo Trio Milk Supplement to provide the fat content of 3 to 6g. per 100 kcal. as set by FDA regulations and the Codex STAN 156-1987 for milk supplements, potentially puts older infants and young children at serious risk for undernutrition related to insufficient fat intake.
Fats in the diet of older infants and young children are critical because they are essential for brain and neurological development. Brain and neural growth remains rapid during the second year of life. As well, fats have 2.5 times the energy density of carbohydrates and proteins and therefore are critical to providing adequate energy for growth.
Alactagrow has no added fats; hence the only fats present are those from the whole milk powder, which as the 4th listed ingredient, after skim milk powder (no fat) and corn syrup solids and sucrose, is likely to be minimal. Indeed the total fat content as determined by the FDA is a mere 1.34g. per 100 kcal.
The deception and misrepresentation of the label is confounded by the confusing and contradictory messages regarding the recommended age for the use of this product – which on the one hand states 1-3 years old and on the other hand states that a milk supplement should not be introduced before the sixth month. This conveys the clear message that the product is suitable for infants after 6 months. The need for essential fats for infants between the ages of six to 12 months is even greater, so this increases the risk to health.
The product is primarily a fat reduced milk powder, with sugar, fortified with minerals and vitamins. An expensive product that is deficient in the essential level of fat required by older infants and young children.
Since milk (unmodified with added sugars and reduced fats) remains the most important component of a young child’s diet providing:
· 55% of energy - 9-11 months
· 40% of energy - 12-23 months
The marketing of Alactagrow by MJ is fraudulent, misleads parents and risks less than optimal growth and development, especially brain and neurological development for older infants and young children.
Thus we urge FDA to enforce a full recall of Alactagrow Bibo Trio Milk Supplement Covered by Registration No. FR-71538 and any other milk products that violate the nutritional and labeling standards of the Codex-STAN 156-1987, the International Code of Marketing of Breastmilk Substitutes and relevant WHA resolutions.
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Contact Persons:
Velvet Roxas, IBFAN and Arugaan (0915-7741614)
Ma. Ines Av. Fernandez, Save Babies Coalition (0908-8889153)
Atty. Ipat Luna, Health Justice (0928-5048265)
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