Thursday, April 28, 2011

Lutein: a dye? a supplement?

Abbott owns another patent regarding the use of lutein in artificial baby milks. And one must question whether this company is trying to improve the health of infants through the use of lutein or whether they have other motives. The Abbott Patent is #6811801 and called, "Methods and compositions for brightening the color of thermally processed nutritionals," filed in 2001 and accepted in 2004.
"In accordance with the present invention, it has been discovered that the addition of lutein compounds to thermally processed nutritionals brightens the nutritional resulting in a more appealing color."

"Thermally processed liquid and powder nutritionals typically present brown and gray hues in the final color, which negatively impact the overall appeal of the nutritional."

Wow, I thought lutein was being placed in baby formulas because of its health benefits. Yes, yes, of course it is. Baby's need lutein because its in human milk and infant formula doesn't have it without adding it into the milk. Yet it seems that lutein is a dye or considered a dye by the FDA. In a FDA Agency Response letter GRAS notice No. GRN 000140 dated June 14, 2004 written to lutein manufacturer, Kemin,

"Kemin describes the method of manufacture for crystalline lutein. The process begins with marigold oleoresin, which is derived from the hexane extraction of dried marigold flower petals (Tagetes erecta). The oleoresin is extracted with a basic solution, organic solvent, and water yielding a crystalline product containing lutein and zeaxanthin."

"FDA notes that Kemin's crystalline lutein product has the potential to impart color in food products that contain it. As such, the use of crystalline lutein in food products may constitue the use of a color additive under section 201(t)(1) of the Federal Food, Drug and Cosmetic Act..."

Later in 2007 the FDA Agency Response Letter GRAS Notice No. GRN 000221 to Kemin is regarding "suspended lutein" for placement in baby formulas. The FDA wanted to know why the company considered its suspended (derived from crystalline lutein suspended in safflower oil) lutein exempt from the definition of color additive. The letter goes on to say that, "Based on the information provided by Kemin, as well as other information available to FDA, the agency has no questions at this time regarding Kemin's conclusion that suspende lutein is GRAS under the intended conditions of use." and then "Kemin should be aware that FDA's response to Kemin's GRAS notice does not alleviate the responsibility of any infant formula manufacturer who intends to market an infant formula that contains suspended lutein to make the submission required by section 412."

Wow, who would have thought of such a beneficial supplement to infant formula, not only does lutein improve health but it also makes the formula a brighter color. Wow and double wow.

From the Abbott Patent#6811801 on the use of lutein as a dye,

"Clearly, a brightening agent is required that can mask the brown and gray hues of thermally processed nutritional products. The brighter color would enhance the overall sensory acceptability of the product by the consumer."

The consumer is a baby. But of course, it is the adult who buys it and needs to see the product looking nice and white. So now we have a dye in our infant formula. Nope we don't, its a nutritional additive. Nope its a dye, nope its a necessary ingredient cause its in breastmilk. Yes, I know many marigold eating mothers who breastfeed. Insanity.
Copyright 2011 Valerie W. McClain

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