Infant formula gets 1st qualified health claim – but disclaimer ripe for challenge

25-May-2011 - Last updated on 26-May-2011 at 15:29 GMT

Who's reading the small print?

The Food and Drug Administration (FDA) has concluded that Gerber Good Start milk-based formulas meet the criteria for a qualified health claim, the first such claim for infant formula.

The qualified health claim relates to a reduced risk of atopic dermatitis, and reads as follows:

"For healthy infants who are not exclusively breastfed and who have a family history of allergy, feeding a 100 percent 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 percent 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."

Ripe for challenge

The language of the health claim has aroused criticism, however. Virginia-based food law attorney Jonathan Emord from Emord & Associates, P.C., told NutraIngredients-USA that the claim crafted by FDA violates two district court orders in the ANH v. Sebelius cases.

“There the Courts ordered the agency to avoid use of negative, value-laden qualifications that contradict the claims,” explained Emord. “The Courts held such qualifications a violation of the First Amendment. Instead, FDA was ordered to rely on qualifications that reveal the absence of conclusiveness.

“The qualification required here, ‘there is little scientific evidence for the relationship,’ is a subjective, negative value-laden, and claim contradictory one that violates the ANH v. Sebelius holdings.

“Were I Nestlé’s counsel, I would demand that the agency revisit the qualification language in light of the ANH v. Sebelius holdings and would reserve the right to sue the agency if it did not. I think the matter ripe for challenge,” added Emord.

Gaining an edge

On the flip side, Cara Welch, PhD, vice president, scientific & regulatory affairs for the Natural Products Association (NPA) told NutraIngredients-USA that the announcement was an “excellent example of using extensive scientific research to your benefit.

“It’s always important to back up your product’s claim and use with research and I think the Gerber products now have the edge over other infant formulas,” added Dr Welch.

“Qualified health claims are always that, qualified, but it was important to note the conditions where these products can be effective and that your baby’s care should be under the supervision of a doctor.”

Atopic dermatitis (AD), characterised by areas of severe itching, redness and scaling, is one of the first signs of allergy during the early days of life and is said to be due to delayed development of the immune system. According to the American Academy of Dermatologists it affects between 10 to 20 per cent of all infants, but almost half of these kids will 'grow out' of eczema between the ages of five and 15.

The best way to reduce the risk of allergies in infants is breastfeeding. However, formulas are indispensable in cases where mothers are unable to feed their children - be it for health or logistical reasons. Gerber acknowledges breastfeeding as the ideal first step for new mothers and infants.

"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," said Dr Jose Saavedra, MD, FAAP, medical director, Gerber Products Company.