FDA greenlights Nutricia’s infant growth supplement Fortini

24 Sep 2021 --- The US Food and Drug Administration (FDA) has cleared a review of Nutricia North America’s new infant nutrition product Fortini. The formula is created to support children living with or at risk of growth deficiencies and those with increased energy requirements or fluid restrictions.

Nutricia, a part of Danone North America, says it is the first and only 30 kcal/fl oz formula in the US that is nutritionally complete, ready-to-feed and calibrated explicitly for term infants with or at risk of Failure to Thrive (FTT) or poor growth. 

The FDA review will make Fortini available for physicians and registered dietitians to prescribe to patients across the US by the end of September 2021. 

Steven Yannicelli, vice president of medical and scientific affairs at Nutricia.Outing old solutions 
Speaking to NutritionInsight, Steven Yannicelli, vice president of medical and scientific affairs at Nutricia, says the formula marks an essential advance for US infant growth supplements, which have until now been based on outdated techniques. 

“Before Fortini Infant, when dietitians and physicians wanted to feed babies a higher caloric concentration of formula, they typically had to incrementally increase the amount of powdered infant formula beyond intended use,” he explains.  

“Either that, or by adding modular powders or liquid fats to achieve such a high calorie-per-ounce concentration. Risks to that approach include mixing errors, unbalanced nutrition, insufficient protein intake and poor tolerance to over-concentrated infant formula.”

Fortini answers these risks by “taking the guesswork and complex recipes out of feeding, minimizing some of the risks with current approaches,” according to Yannicelli.

Bringing European solutions to the US  
Around 330,000 children in the US currently suffer from FTT, Yannicelli outlines. The most important elements when feeding these infants, he says, are meeting protein and energy intake goals with feedings that are safe and well-tolerated. 

The old techniques of merely increasing infant supplement dosages or creating ad hoc mixes have worried clinicians that inadequate hydration could result. Parents, too, may have worried about making mixing mistakes or finding special recipes difficult to follow. 

Fortini is made for infants aged up to 18 months.However, these outdated practices are confined largely to the US, he maintains. 

“For years, the standard practice in Europe when the formula is needed has been to use a ready-to-feed, energy- and protein-enriched formula. Until now, that formula has not been available in the US.” 

Clinical backing for lifelong improvements 
The product is backed by seven clinical trials and one retrospective study. In the longest study recently completed in the US, Fortini supported the recovery in weight, length and head circumference in infants with poor growth. 

“As malnutrition in infancy can have impacts on health that last into adulthood, the support Fortini Infant provides for growth improvement can be lifelong,” says Yannicelli. 

Anca Safta, a pediatric gastroenterologist and associate professor in the Department of Pediatrics, Wake Forest University School of Medicine in Winston-Salem, US, who participated in a key clinical trial, says: “Being able to see first-hand that our patients with growth failure due to cardiac and non-cardiac etiologies were able to tolerate this formula, gain weight and thrive was very exciting.”

Boosting healthy heights 
Nutricia is not the only company promoting growth supplements for infants. 

This year, Israel-based Nutritional Growth Solutions (NGS) continued an Asian expansion by bringing its flagship Healthy Height protein shake to China.

Healthy Height has been clinically proven to improve children’s height and contains 12 g whey protein per serving, without corn syrup or other additives. It is gluten-free, soy-free, no GMO and includes 350 mg of the amino acid arginine per serving. It also is low in sugar and sodium.

Recently, NGS launched the patented Healthy Height Snack Bar in the US and Canada. The bar line rolled out in Cookies & Cream and Strawberry Cupcake flavors.

By Louis Gore-Langton