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

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

Wednesday, April 27, 2011

Human milk: the science behind infant formula

We are told that the infant formula industry lies about its products that it markets. Do they lie? Is their any truth to their marketing of their products? We are told to boycott Nestle because they are the worst of the worst in violating the WHO Code. Yet in focusing on one company, the rest go unrecognized for their violations. Although in the USA, the WHO Code (the World Health Organization Code of regulating the "marketing" of breast milk substitutes, passed in 1981 by all nations except the USA) seems to be little understood or followed. ["no advertising to the public, no free samples, no promotion of products in health care facilities...all information on artificial feeding including labels, should explain the benefits of breastfeeding and the costs and hazards associated with artificial feeding" Breastfeeding and Human Lactation, second edition, by Riordan and Auerbach, page19] I hear the cynical laughter. Yeah in the USA we have hospitals giving out free samples of infant formula. Years ago I worked with a teen mom who was nursing her baby with no problems but needed me to explain why she was given a case of formula. She presumed that the medical profession was giving it to her because she was suppose to use it. She was quite relieved when I told her that her free case of formula was...well it was just marketing. She thought the free formula from the hospital was a diagnosis that breastfeeding was not enough for her baby. This kind of marketing is slowly dying out but women get alot of free formula through various outlets-doctor's offices, the internet, marketing lists, etc. Of course, the introduction of infant formula to a breastfeeding mother is often the path to weaning from the breast (production being dependent on nipple stimulation, feeding infant formula means baby is not at the breast). I am fascinated with part of the Code that states that the benefits of breastfeeding and costs/hazards of artificial feeding should be on all information and labels of artificial milks. I don't think I have seen this anywhere. Of course, if we are asking the industry to self-regulate then the information will be sparse and psychologically geared to put their product in the best position.
Let's go back to my first question, does the infant formula industry lie about their products? Is their partial truth to their claims about their formulas for babies? Some breastfeeding advocates claim its all lies. But I tend to view their marketing of their artificial milks being closer to human milk, as a half-lie/half truth. What breastfeeding advocates fail to understand is that human milk research is the basis of the infant formula industry. Many of the researchers who are members of the International Society for Research in Human Milk and Lactation (ISRHML) are funded by the infant formula or dairy industry. Some of the members are employed by the infant formula industry. A few years back I ran across a patent application from a member of the ISRHML that was of interest to me at that time because I was writing about human milk fortifiers (I believe it was a human milk fortifier patent owned by Abbott). One of the inventors was Bridget Barrett-Reis, who is no longer listed as a member of the ISRHML. I ran across another patent where she is listed as an inventor. It's called, "Infant formulas containing docosahexaenoic acid and lutein," patent #7829326 and owned by Abbott Labs.

"Lutein has also been identified in human milk."

"Although it is not currently added to infant formulas as an isolated ingredient..."

"It has now been found, however, that lutein concentrations in infant formula must be much higher than the lutein concentrations found in human milk in order to achieve the same plasma lutein concentrations found in breast fed infants due to a lower relative bioavailability of lutein from infant formula."

This patent was filed/applied for in October of 2006 and became a patent in November 2010. Of interest is that in Abbott Nutrition press release in September 2008, the company states in its summary facts that Similac Advance EarlyShield, "supports a baby's natural defenses and digestive health. It has important immunity building blocks similiar to those found in breast milk. Similac Advance EarlyShield is the only infant formula that has a unique blend of prebiotics, nucleotides and antioxidants-nutrients found in breast milk." Under antioxidants they state, "Antioxidants play important roles in the body. Similiac AdvanceEarlyShield has a unique blend of antioxidants including lutein, lycopene, and beta-carotene found in breast milk and can help protect the eyes and skin."

Before this product became a patent, it was already on the market (for at least 2 years). Interesting. But I am amazed by the language written by the company. WHO Code violation? This was on the internet, an international community of readers. So the language suggests that the antioxidants placed in their formulas, are found in breast milk. Well, yeah, sort of....just a little language ambiguity.

"Similac® has EarlyShield®

In addition to having DHA/ARA, we're the only formula that has Lutein,* an important nutrient babies can only get from breast milk or Similac.†"

Stretching the truth, just a teensy little bit. You know marketing, a little truth mixed with a little lie=the big lie. Marketing 101 brought to you by the makers of our alternate reality....

Copyright 2011 Valerie W. McClain

Tuesday, April 26, 2011

on the edge of rationality and insanity

Another garbage day, the sun rises and the moon is just a shadow of its former self. Oil washes around the sandy shores of Louisiana and radiation continues to leak into the ocean near Japan. We discard another car, another computer, another thing into the landfill of our minds. It is the tidal wave, the tsunami of our desires jettisoned because its lost its "shiny." We do this with our things, but we do this with people, too. We are just lovers of the newest flash, our media's newest tricks. Like the alcoholic we get a whiff of the object of our desire and we intoxicate ourselves for a few days and then we sober up. Happy, depressed, happy, depressed: we are all bi-polar. One big happy-depressed family self-medicating ourselves on "things." Who needs discussion when the media can write its version of reality to the masses. Don't worry, a little radiation is good for you. Don't worry, a little oil in the sea is beneficial. Don't worry, let's "liberate" another country with bombs and bullets. War is beneficial for the economy. No job? Don't worry. Home repossessed? Don't worry. Whose worried? I believe. I believe. The media tells me that the economy is getting better, less unemployment. I can keep my eyes shut. I don't see the people on the streets, begging for jobs or food. Yeah, I don't see them because the homeless aren't allowed to be on the streets. So it doesn't exist. The media writes its lies and repeats them until we all become rationally insane. A nuclear meltdown won't hurt ya. Three wars waging at the same time will improve the economy. Whose economy? Don't ask, don't tell. Truth is lies, lies are truth.

Death to rationality, hurrah for the insanity of our green technology called nuclear energy. Hurrah for the insanity of promoting a safer infant formula, most like mom's milk. Mother's milk in a can, comes with it's own surgically enhanced boob to lean on. Of course the appendage while anatomically correct is non-functional. Yeah, on the edge, on the edge.

"The present invention discloses a prophetic inclination, based upon a 15-year study of human milk, that new form of gammaglobulin referred to herein as 'panaglobulin,' 'mammaglobulin,' or 'lactopanaglobulin' may replace the current gamma globulin. Because higher lievels of IgA and IgM are present in human milk and colostrums, and a more diverse form of IgG as well, panaglobulins may provide protection beyond the scope of current gamma globulin therapy."

Patent # 7914822 "Method of producing nutritional products from human milk tissue and compositions." Inventor: Elena Medo Assignee: Prolacta Bioscience

We have a society where more and more people have immune deficiencies thus creating a need for gamma globulin therapy. Breastfeeding would seem to be the answer to that problem. Does our society invest in breastfeeding? Nope. The investment will be in products from human milk....rational but irrational on so many levels.
Copyright 2011 Valerie W. McClain

"Emancipate yourself from mental slavery.
None but ourselves can free our minds." --Bob Marley

Tuesday, April 5, 2011

Chinese cows and future shock

How about those Chinese cows making human milk?

I learned that on Lactnet. What news!! American cows are so behind the times. Get with the "Program Miss Bossy" (our cute bovine with velvet brown eyes and the longest eyelashes). Oh wait, we do have Miss Bossy making human milk. Yes dear readers, I have been writing about that since 2000 or 2001. Yes, a decade ago and suddenly the Chinese get all the credit. That's science for ya, do the work and someone else takes the work and runs with it. Unless, unless...your PR program is working in high gear. Maybe in China they are running headlines that say UK cows or USA cows are producing human milk. (Yeah, actually its one or two components, cause they have some kind of job doing "all" the components)

What do people think "cloned" milk is and why do they think it is approved for public consumption in the USA? I love the media. If the news is going to get out about cows making human milk, let's blame the Chinese. What makes people think that this technology isn't already being used in infant formula? They are adding lactoferrin to infant formula, that's human lactoferrin (cause cow's make very little or none). Fonterra in New Zealand manufactures lactoferrin for use in infant formulas. One way to genetically engineer human lactoferrin is through cows (remember Herman the Bull? that was 1990-two decades ago). Another way is through genetic engineering of yeast or bacteria (what is being done by Agennix in the USA).

Anybody read Future Shock? Time to read it and understand that the general public is way, way behind technological advances. With genetic engineering of our foods, we are being told about it after the fact, after its on the market. Why? Because those that govern think that their populations are too stupid to understand the technology. So do it, put it on the market, and then have regulatory bodies like the FDA rule that genetic engineering is equivalent to the real thing, no need for labels.

So now breastfeeding advocates suddenly get the picture because the media says that the Chinese are doing the research. Oh yeah and its not being manufactured into products yet. (cough-cough) Old news, geared to create another illusion. The world is so so very messed up by people in power and their dutiful dogs, the media.

Congratulations to Prolacta and Elena Medo. Their patent application is now a patent at the US Patent & Trademark Office. "Method of producing nutritional products from human milk tissue and compositions thereof." (patent # 7914822) Their claims are on a "method." Welcome to the 21st century readers.
Copyright 2011 Valerie W. McClain