FDA sets new infant formula standards

The interim final rule on infant formula quality and nutrition announced recently by the US Food and Drug Administration (FDA) will set standards going forward.

For now, the rules will influence change only in a few technical areas because the 4 major manufacturers that produce 100% of formula sold domestically are probably already 95% compliant, according to a key FDA official. Some of the 4 manufacturers also make store brands.

Among other things, the rules establish requirements to prevent adulteration of powdered formula and ensure that adequate and well-controlled studies are done on infants’ physical growth when taking formula.

Benson Silverman, MD, a neonatologist who heads the FDA’s infant formula initiative and who has worked on the effort for 11 years, says the rules will prevent companies from newly entering the field and not following correct procedures.

In addition, the American Academy of Pediatrics said in its recent handbook on child nutrition, “[F]ormulas are continuously being modified as new nutritional information, ingredients, and technology become available.”

Under the requirement for growth monitoring studies for currently or previously marketed formula, more flexible rules allow companies “to rely on existing scientific data and information” and voluntarily submit information on specific formulations for FDA evaluation.

There are 22 infant formula plants nationally and each is inspected about once a year, although inspections can occur more often if there are any issues, says Silverman. The FDA inspectors go in for about a week and examine the production lines, warehouses, and other areas, he says. They also inspect records pulled at random and take samples of formula to be tested for nutrient quality and microbiologicals.

One of the 4 manufacturers imports formula made in a foreign country, he says, indicating those facilities undergo the same type of FDA inspections.

The FDA estimates the rules’ costs will be $7.29 million in the first year and $4.06 million in subsequent years, but the annual public health benefit will be $10 million. The benefit is based in great part on the rules’ requirements aimed at preventing Cronobacter contamination in powdered formula, Silverman says.

Packages are to be coded to facilitate tracing of all stages of manufacture. For formula made for export, the rules indicate that manufacturers don’t have to meet all the requirements, but they must submit a statement certifying that, among other things, the formula does not conflict with the laws of the importing country and that the outside of the shipping package is labeled for export only.

The rules implement remaining provisions of 1986 amendments to the Infant Formula Act. There were periods of hearings and reconsideration, but Silverman said reasons for the delay included that manufacturers were already being regulated under the legislation itself; that there have not been problems with formula in some time; and that the agency was pressed with other priorities.

The standards will impact most babies. Nationally, 77% of infants begin breastfeeding, according to the 2013 Centers for Disease Control and Prevention’s Breastfeeding Report Card. However, as of 2010, only 49% were breastfeeding at 6 months, up from 35% over 10 years. At 12 months, the rate was 27%, up from 16%.

The comment period on the FDA rules closed March 27.

The FDA also issued draft guidance on the demonstration of quality factor requirements for “eligible” infant formula (comments were due March 27) and draft guidance for production of “exempt” formula for use by infants with unusual medical or dietary problems (comments are due by May 12). All the documents are available on www.regulations.gov.

Ms Foxhall is a freelance writer in the Washington, DC, area. She has nothing to disclose in regard to affiliations with or financial interests in any organizations that might have an interest in any part of this article.