1. What is the announcement from FDA about a health claim?
We are sharing a very positive announcement that the FDA is now allowing the use of a qualified health claim for 100% whey protein partially hydrolyzed infant formula.
FDA concluded that the current scientific evidence is appropriate for consideration of a qualified health claim regarding the relationship between the consumption of 100% whey protein partially hydrolyzed infant formula and a reduced risk of atopic dermatitis. The complete claim language can be found below.
2. What does the final FDA qualified health claim say?
Claim language which FDA has permitted is as follows:
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 4 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. 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.
3. Exactly what is a health claim?
Health claims are part of an FDA initiative to provide Americans with information to help them make healthier dietary choices. A health claim “characterize[s] a relationship between a substance and its role in reducing the risk of a disease or health-related condition.” Usually, a health claim is visible to consumers as a benefit statement on the product label. A qualified health claim is one which such a benefit statement must include qualifying language indicating any limitations on the degree to which the science supports the claim.
4. How does the FDA evaluate a Qualified Health Claim?
In reviewing a qualified health claim (QHC) petition, the FDA carefully reviews each scientific study that has been submitted in support of the claim. Their goal is to determine the certainty of the relationship between a substance (100% whey protein partially hydrolyzed infant formula, in this case) and a disease (like atopic dermatitis). In this case, the FDA concluded “that the current scientific evidence is appropriate for consideration of a QHC.”
Once the FDA has assessed the strength and relevance of the science to support the specific claim, they determine the most appropriate “qualifying” language to use to describe their level of comfort with the science regarding the relationship between the substance and disease. Examples of these qualifiers of the scientific support for previously granted qualified health claims include “Highly unlikely evidence”, “very limited and not conclusive evidence”, “Very limited and preliminary”, “Limited but not conclusive”.
5. Why does the claim say “the relationship is uncertain” or “little scientific evidence”?
A qualified health claim (QHC) describes a relationship between a substance and disease that has not yet reached an absolute level of certainty. In such a case, the FDA determines the appropriate qualifiers (e.g. limited, inconclusive, uncertain, preliminary, etc) that can be used to describe the level of evidence for the claim. For the relationship between 100% whey protein partially hydrolyzed infant formula and atopic dermatitis, FDA concluded “that the current scientific evidence is appropriate for consideration of a QHC,” as long as the claim language makes clear that the evidence to establish this relationship is not absolutely certain.
6. Is GERBER® GOOD START® the only formula that can make a qualified health claim?
Yes. GERBER GOOD START milk based formulas are the first and only routine infant formulas that meet the criteria for a qualified health claim.
7. Do you have scientific evidence to support your claim?
Yes, as indicated in the qualified health claim language. Gerber submitted scientific evidence and clinical studies to support its petition for a qualified health claim. The FDA concluded that the current scientific evidence is appropriate for consideration of a qualified health claim regarding the relationship between the consumption of 100% whey protein partially hydrolyzed infant formula and a reduced risk of atopic dermatitis.
8. What is atopic dermatitis and how prevalent is it in infancy?
Atopic dermatitis, a form of eczema, is a persistent, itchy, red skin rash that is the most common allergic disease in infants. In the U.S., nearly one in five infants will develop atopic dermatitis.
9. What is 100% whey protein?
Whey protein is a protein component of milk. Milk has two primary proteins – whey and casein – of which whey has a higher nutritional quality.
100% whey protein relates to the fact that the only protein used is whey.
10. What do you mean by partially hydrolyzed proteins in infant formula?
Hydrolyzed proteins are proteins that have been broken down into smaller pieces (peptides) in a way similar to how a baby’s digestive system would break down the proteins. “Partial hydrolysis” refers to the degree to which the proteins are broken down. Partially hydrolyzed proteins are used in GOOD START infant formulas. “Extensively hydrolyzed proteins” (broken into even smaller pieces) are used in specialty formulas used to treat existing allergy in infants.
11. Why do you hydrolyze the protein?
We hydrolyze the proteins for two primary reasons. First, cow proteins are harder to digest than human-milk proteins. We break down (hydrolyze) the proteins to make them easy for baby to digest. The second reason to hydrolyze the protein is to make it less likely to be recognized by baby’s immune system as coming from a cow. Recognition as a non-human protein may lead to an allergic response.
12. What current formulas contain 100% whey protein partially hydrolyzed?
GERBER GOOD START Gentle and GERBER GOOD START Protect milk-based formulas are the only routine infant formulas that are made with 100% whey protein, partially hydrolyzed. While other routine infant formulas may contain some partially hydrolyzed whey protein, they also contain casein, and these formulas do not have published data demonstrating the same benefits relating to the risk of atopic dermatitis.
13. Can GERBER GOOD START prevent my child from developing atopic dermatitis?
No. Risk for atopic dermatitis is affected by several factors, including family history of allergy. There are steps you can take to help reduce the risk, such as breastfeeding. Or, if not exclusively breastfeeding, initiating formula feeding with certain hydrolyzed infant formulas may also provide a benefit according to the AAP and the American Association of Allergy, Asthma and Immunology.
14. My baby suffers from atopic dermatitis. Will GERBER GOOD START cure this condition?
No. GERBER GOOD START formulas should not be used for treatment or for feeding infants with allergies. They will not cure or prevent atopic dermatitis.
15. Does GERBER GOOD START cost more than other infant formula brands?
No. GERBER GOOD START is competitively priced with other routine infant formulas such as Similac® Advance® and Enfamil® Premium®.
16. Is there something new that’s been added to your infant formula?
No. Long-known for its easy digestibility, GERBER GOOD START has always been a 100% whey protein partially hydrolyzed formula.
17. Will the claim be applicable to your entire line of infant formula?
No. The claim would apply only to our routine milk-based formulas, GOOD START Gentle and GOOD START Protect, which are all made with 100% whey protein, partially hydrolyzed.
18. What is Gerber’s view on breastfeeding?
Gerber recommends breastfeeding as the ideal entry point into its Start Healthy, Stay Healthy™ Nutrition System and supports the World Health Organization (WHO) recommendation of exclusive breastfeeding for the first six months. Breastfeeding is the best way to reduce the risk of allergies in infants. This is just one of the reasons why Gerber believes that breastfeeding is the best way to nourish infants.