Friday, April 29, 2011

Global lutein market

"The global lutein market is set to hit $124.5 million in 2013, according to a 2007 report from Frost & Sullivan."

The article was entitled, "Pfizer study supports lutein safety for infant formula," and written in 2010. For those who forgot, Pfizer bought out Wyeth. The study they are announcing lutein safety is from the Nutrition Journal and named, "Lutein-fortified infant formula fed to healthy term infants: evaluation of growth effects and safety." The study was done in the Philippines at the Asian Hospital and Medical Center in Muntiniupa City, Philippines. The authors were either funded by Pfizer or were employees of Pfizer Nutrition. Some of the authors were/are employed by Wyeth Philippines, Martek, Pfizer. So let me see, a safety study on a specially designed infant formula is done by the industry. Does anyone see any problems with this? No?

"The primary objective of this clinical trial was to compare the growth of healthy term infants fed either Wyeth S-26 Gold (designated as Gold), and infant formula currently marketed by Wyeth Nutrition, or Wyeth S-26 Gold fortified with lutein at 200 mcg/l (designated as Gold + Lutein) for 16 weeks."

The lutein was sourced from Kemin Health, remember them from yesterday's post? The study goes on to say that the "lutein has been determined by the WHO/FAO/Codex Joint Evaluation Committee on Food Additives (JECFA) to be safe for use as a nutrient fortification..." The study population was 240 healthy full term Asian infants ages up to 14 days.

"Two serious SEs were reported for the Gold + Lutein group during the study period, while none were reported in the Gold group. Of the 2 serious SEs, one infant was diagnosed with acute gastroenteritis and the other was diagnosed with bronchopneumonia. Both events were considered by the PI to be unrelated to formula administration. In each case, the infant was hospitalized and the serious SE resolved completely."

Yes, the availability of a hospital is crucial when formula feeding. Of course the conclusion is that "Lutein fortification of S-26 Gold at 200 mcg/l is safe and allows normal infant growth."

Wyeth is advertising their product with lutein, "As a parent wouldn't you take precautions to protect your child from blue light?" "Lutein, as a predominant macular pigment in the retina, is able to filter blue light and may protect the eye."

On the Asian Parent a article on Pfizer/Wyeth's new formula with lutein. "Wyeth introduces its new milk formula, incorporating the new and advanced Wyeth Biofactors System, to provide the very best for your growing child." and "Wyeth Nutrion is the only local nutritional formula manufacturer to be granted Food Safety partner status by the Agri-Food & Veterinary Authority of Singapore."

And so we study a new formulation for 16 weeks and we let industry do the safety study. We dismiss any problems observed as unrelated to the new formulation and then we advertise to the public about its safety and we make our health claims. Health claims that are based on human milk. Human milk has leutin therefore we will put leutin into our formulations. Why are consumers believing that the leutin in breastmilk is the same leutin that is being manufactured by industry? How is marigolds extracted by hexane the same as leutin in breastmilk?

My understanding was that any new ingredient placed into infant formula had to be registered with the FDA. I went to the FDA website, I can't find a public record of the infant formula companies registering their new ingredients. If anyone out there in the Virtual has seen that list at the FDA website, would they contact me? One would suppose that it should be easy to access a list of companies and dates when a standard infant formula was changed and registered to the FDA. I think I am pretty good at navigating the web, but this has me stumped.

And so life goes on, babies get fed infant formula, babies get sick, babies go to hospitals, some babies die. And they say, it isn't because of the formula. It's cause of something else, the microbial conundrum of planetary shifts causes the tilt in the hemisphere to make some babies sick. Or maybe we should blame the mother? Hey it couldn't be the industry that is making billions on breastfeeding failing? Okay is lutein a dye or a supplement? I say a dye.
Copyright 2011 Valerie W. McClain

"Only within the moment of time represented by the present century has one species-man-acquired significant power to alter the nature of his world."
--Rachel Carson


  1. Formula's are not fda approved. I would imagine this is why you cannot find fda information on them.

  2. Jennifer,
    This is a briefing paper from the FDA docket from the Food Advisory Committee on Infant Formula.

    Requirements specific to infant formula

    Manufacturers must provide FDA with assurances that the requirements specific to infant formula have been met for each "new" infant formula product prior to marketing. A "new infant formula" includes:

    (1) An infant formula manufactured by a person which has not previously manufactured an infant formula, and

    (2) An infant formula manufactured by a person that has previously manufactured infant formula and in which there is a major change in processing or formulation from a current or any previous formulation produced by such manufacturer.

    (21 U.S.C. 350a(c)(2).

    A "major change" is defined in an infant formula as:

    any new formulation, or any change in ingredients or processes where experience or theory would predict a possible significant adverse impact on levels of nutrients or availability of nutrients.

    ((21 C.F.R. 106.30 (c)(2))

    Examples of "new" infant formulas include:

    Any infant formula produced by a manufacturer who is entering the U.S. market;
    Any infant formula powder processed and introduced for commercial or charitable distribution by a manufacturer who previously only produced liquids (or vice versa);
    Any infant formula having a significant revision, addition, or substitution of a macronutrient (i.e., protein, fat, or carbohydrate), with which the manufacturer has not had previous experience;
    Any infant formula manufactured on a new processing line or in a new plant;
    Any infant formula manufactured containing a new constituent not listed as a required nutrient under the act, such as taurine or L-carnitine;
    Any infant formula processed by a manufacturer on new equipment that utilizes a new technology or principle (e.g., a change from terminal sterilization to aseptic processing); and
    An infant formula for which there has been a fundamental change in the type of packaging used (e.g., changing from metal cans to plastic pouches), as cited in FDA Guidelines Concerning Notification and Testing of Infant Formulas (1986) as cited in 21 U.S.C. 350a(c)(2).