FDA, GRAS and what does algae, fungus & hexane have to do with baby formula

babyThe Food and Drug Administration (FDA) regulates infant formula. All infant formulas marketed in the United States must meet the FDA’s nutrient specifications (although some child health advocates contend that the nutrition requirements are out of date). In any event, what this means is that while infant formula manufacturers may have their own formulation, at a minimum, formula must contain at least the minimum levels of nutrients specified, without exceeding any maximum levels.  Although manufacturers must notify the FDA prior to marketing a new formula, the FDA does not approve infant formulas before they can be marketed.

So what does this have to do with algae and fungus?

To explain that, let me first explain how the FDA regulates food contact substances. Food contact substances are those items that are not directly added to food, but are in contact with food, such as packaging materials.  If a new food contact substance is proposed, or a new use of an existing food contact substance is proposed, a manufacturer must give the FDA notice of it unless there are existing regulation related to the used or the substance or use is considered “Generally Recognized as Safe” (or “GRAS”).

This voluntary GRAS notification program was proposed in 1997.  In 1997, the FDA abolished its existing procedure by which it approved petitions to designate substances because the FDA did not have the resources to review and approve the petitions.  Under the GRAS notification process, a manufacturer informs the FDA that it has determined that a substance or use is GRAS, as opposed to petitioning the FDA to approve the use or a substance is GRAS.  As explained by the FDA, if the manufacturer’s determination is correct, the use or the substance is not subject to any legal requirement for FDA review and approval.  In fact, since the GRAS notification process is voluntary, a manufacturer may market the substance or use without informing FDA if the manufacturer determines it is GRAS or, if FDA is so informed, while FDA is reviewing that information.  Sounds crazy, doesn’t it?  As long as a manufacturer determines the food contact substance or use is GRAS, it can go ahead and market it.

What is “safe” for these regulations?  According to the implementing regulations, the term “safe” means “that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.  It is impossible in the present state of scientific knowledge to establish with complete certainty the absolute harmlessness of the use of any substance.  Safety may be determined by scientific procedures or by general recognition of safety.”

So how does this voluntary GRAS notification process work?  Well, this is where infant formula comes in.

If you’ve used or are using formula, you probably know some manufacturers supplement their infant formula with DHA and ARA.  But, some manufacturers use DHA and ARA extracted from laboratory-grown fermented algae and fungus and processed with hexane, known as DHASCO and ARASCO, although not identified as such on the list of ingredients.

DHASCO and ARASCO are structurally different from the DHA and ARA found in breast milk, which doesn’t necessarily mean that they cause problems. The manufacturer of DHASCO and ARASCO submitted a notice to the FDA stating that DHASCO and ARASCO added to infant formula are GRAS. The FDA responded to the notice that it had no further questions. But, the FDA and the manufacturer recognize that some infants have adverse reactions from consuming infant formula with DHASCO and ARASCO such as diarrhea, bloating, vomiting, jaundice, apnea, flatulence, and other gastrointestinal problems. Nevertheless, the manufacturer maintains they are GRAS, so the manufacturer is free to market them. And these infant formula products are not labeled to indicate the presence of DHASCO and ARASCO (as opposed to DHA and ARA), so you can’t tell when buying formula.

So, if your baby experiences problems with formula, it may not be an allergy but a reaction to the DHASCO and/or ARASCO, but you can’t even tell by looking at the formula label.

And the GRAS program doesn’t really seem to determine safety.

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  1. I am researching any connection between excessive amounts of DHA and ARA in baby formula & a possible link between hormone issues and pituary tumors. My grandaughter is overly large for her 11 months – she looks more like 14 – 18 months and has developed small breasts. Doctors want to test her blood and do X-rays for the aforementioned. As Enfamil formula has been her main source on nourishment and our family history is to normally breast feed I am concerned about the formula and her health. Anyone elses opinion/experience would be greatly appreciated.

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