Supplier News Breaks Archives
FDA grants qualified health claim to Gerber Good Start
May 26th, 2011
FLORHAM PARK, N.J. – Gerber Good Start milk-based formulas are the first infant formulas that meet Food and Drug Administration criteria for a qualified health claim, according to Gerber Products Co.
The Nestle subsidiary said Thursday that the FDA concluded that current scientific evidence is appropriate for consideration of a qualified health claim relating to a reduced risk of atopic dermatitis.
"For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100% whey protein partially hydrolyzed infant formula from birth up to four months of age instead of a formula containing intact cow's milk proteins may reduce the risk of developing atopic dermatitis throughout the first year of life," according to an FDA statement provided by Gerber. "FDA has concluded that the relationship between 100% whey protein partially hydrolyzed infant formulas and the reduced risk of atopic dermatitis is uncertain, because there is little scientific evidence for the relationship. Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms. If you suspect your baby is already allergic to milk, or if your baby is on a special formula for the treatment of allergy, your baby's care and feeding choices should be under a doctor's supervision."
Leading allergy and pediatric organizations, including the American Academy of Pediatrics (AAP), the American Academy of Allergy Asthma and Immunology (AAAAI) and the National Institute of Allergy and Infectious Diseases (NIAID), have affirmed the potential role of certain hydrolyzed protein infant formulas in reducing the risk of developing atopic dermatitis, particularly in infants with a family history of allergy, according to Gerber. The company noted that partially hydrolyzed infant formulas, including its Good Start formulas, are recommended for routine use in healthy infants, but should not be used to treat children with allergy.
Gerber said Good Start uses a two-step process that starts with gentle 100% whey protein, which is then broken down (partially hydrolyzed) into smaller pieces, whereas most other milk-based formulas are made with intact cow's milk proteins. Varieties of the infant formula include Gerber Good Start Protect and Gerber Good Start Gentle.
"Gerber Good Start formulas are among the most clinically advanced on the market, and this announcement reflects Gerber's commitment to innovation and leadership in early childhood nutrition," stated Dr. Jose Saavedra, medical director for Gerber Products Co. "Now with acknowledgement from the FDA, we will be able to help parents understand the Gerber Good Start difference."