WHAT'S IN A NAME? HUMAN MILK OLIGOSACCHARIDES FOR SALE

"But if thought corrupts language, language can also corrupt thought."
                                        --George Orwell, 1984

Words can be used to clarify human reality or they can be used to deceive our understanding of that reality.  Words sell products but they also sell ideas.  Advertising and marketing strategists use language to influence people's buying habits.

The infant formula industry is now advertising a new added ingredient to infant formula, which they name, Human Milk Oligosaccharide (HMO).  On the label of Abbott Nutrition's Similac infant formula with this added ingredient, they state in tiny, tiny, print, "Not from human milk."  Gerber (owned by Nestlé) on its formula with an added HMO makes the same statement that is also in tiny, tiny print.  An ingredient is named a Human Milk Oligosaccharide but it is not from human milk.  It reminds me of George Orwell's novel, 1984, in which "War is Peace," "Freedom is Slavery."  Or how the US War Department in 1947 became the Department of Defense.  Or how the military uses the term collateral damage rather than civilian casualties.  It is the corruption of language, what some people call double think.   It becomes the ultimate paradox to simultaneously hold two contradictory beliefs as correct.  A human milk component that is not a human milk component.  The truth gets lost in the contradiction.

According to the Codex Alimentarius, in the guidance of infant formula labeling,

9.6.3 "The terms 'humanized,' 'maternalized,'  or other similar terms shall not be used."   
http://www.fao.org/input/download/standards/288/CXS_072e_2015.pdf

In 2017 Mead Johnson challenged a number of claims made by Abbott Nutrition in its advertising of HMOs in its formulas to the National Advertising Division (NAD, part of the Council for the Better Business Bureau).

"The National Advertising Division has determined that '2'-FL human milk oligosaccharide,' a claim made by Abbott Nutrition in advertising for its Similac Pro-Advance and Pro-Sensitive infant formulas, doesn't convey a misleading message, as long as the advertiser makes the necessary disclosure, 'not from human milk,' easier for consumers to notice, read and understand."
http://www.asrcreviews.org/nad-finds-abbott-can-support-certain-claims-for-infant-formula-with-new-ingredient-but-only-when-disclosing-that-ingredient-is-not-from-human-milk/

The National Advertising Division has supposedly fore-filled its obligation to help industry to self-regulate its advertising.  After this decision in 2017, I do not think that Abbott's and Gerber's infant formula labels are any more enlightening to consumers. Self-regulation by industry is a joke, another version of double thinking.  It's like the analogy of the fox guarding the hen house.

A number of companies manufacture HMOs for the infant formula industry:  Glycom, Jennewein, Inbiose, Elicity, ZuChem, Medolac, Glycosyn.  Recently BASF announced a two-year collaboration with UC Davis regarding human milk oligosaccharides.  
https://www.basf.com/us/en/media/news-releases/2018/07/P-US-18-080.html

Glycom, a Danish biotech company, is owned by its founders, Nestlé, and other individuals.  https://www.glycom.com/about/who-we-are/

Glycom was the first company to apply for FDA GRAS for an HMO, named 2'-O-fucosyllactose (FDA GRAS #546), considered the most abundant HMO in human milk.  Yet this component is not in every woman's breast milk.  Lars Bode, human milk researcher at UC San Diego, has described human milk oligosaccharides in an article in 2012 in Glycobiology entitled, Human Milk Oligosacharides:  Every baby needs a sugar mama,

"Human milk oligosaccharides (HMOs) are a family of structurally diverse unconjugated glycans that are highly abundant in and unique to human milk."

and

"Oligosaccharide amount and composition vary between women and over the course of lactation." 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3406618/

How does one duplicate something that is unique, that varies from person to person, and individually varies over time?  Glycom states in its letter to the FDA,


"...the 2'FL manufactured by Glycom is chemically and structurally fully identical to the 2'-FL that is present in human milk.  Glycom's 2'-FL is therefore referred to as a human identical milk oligosaccharide."  FDA GRAS #546
http://wayback.archive-it.org/7993/20171031041609/https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/UCM427768.pdf

In a Glycom patent #9012625 they describe the various methods that have been used to manufacture HMOs:  isolation technology, chemical, enzymatic which uses enzymes produced in genetically modified organisms, and various biotech methods which would likely encompass genetic engineering.  All have various drawbacks.  Glycom in that particular patent describes a crystallization method that appears to be the basis for their FDA GRAS #546.

But in a later Glycom patent (#9896470) dated in 2013 called, "Enhancing the stability and purity and increasing the bioavailability of human milk oligosaccharides or precursors or blends thereof," they discuss that the crystalline process is still contaminated with small residues:  toulene and protic solvents.  And they mention in this patent that, "crystalline HMOs are relatively unstable when stored for extended periods without refrigeration."

Glycom received FDA GRAS for another 2'-O-fucosyllactose (#650) in which they use fermentation and genetic engineering techniques with the bacteria, Escherichia coli (E.coli) K-12SCR6, to produce the 2'FL HMO for infant formula.

"As discussed, 2'-FL produced by fermentation with Escherichia coli (E. coli) K12 SCR6 is chemically and structually identical to the 2'-FL produced by chemical synthesis methods described in GRN 546 and to 2'-FL that is present in human breast milk as confirmed by ¹H- and 2D-NMR spectroscopy, mass spectrometry and x-ray crystallography."
https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm513832.pdf

Glycom states in patent #9234225 entitled, "Method for generating human milk oligosaccharides (HMOs) or precursors thereof," in 2013
"The large variety of oligosaccharides in human milk and colostrum and the difference to other species, however, makes it difficult to prepare suitable replacements in foods, particularly in infant food formulae, which display at least part of the entire spectrum of human milk oligosaccharides. Furthermore, their recognized importance in the maturation of the immune system and their prognostic use as immunomodulators underlines their importance as a possible immunomodulator."

The infant formula industry has decided to name a novel ingredient they are adding to infant formula, calling that ingredient a Human Milk Oligosaccharide.  The US FDA in the GRAS process does not question this name.  And it has no questions regarding statements by companies that manufacture HMOs in which they declare their product to be exactly identical to the real HMO.  Substantial equivalence has been the FDA's view of novel/genetically engineered ingredients.  The understanding was that genetic engineering does not exactly duplicate the natural ingredient.  It seems that this FDA policy has now changed and the FDA accepts a company's belief that their genetically engineered product is identical to the natural component in human milk.

FDA GRAS #650 by Glycom in which the FDA had no questions,  

"2'FL produced by fermentation with Escherichia coli (E. coli) K-12 SCR6 is chemically and structurally identical to the 2'-FL produced from Glycom's chemical synthesis methods as described in GRN 546, and to 2'FL that is present in human breast milk..."
https://www.fda.gov/downloads/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm513832.pdf

In the USA both Abbott Nutrition and Gerber (Nestlé), have added  a so-called Human Milk Oligosaccharide (HMO) to some of their formulas. Abbott has Similac Pro-Total Comfort™, Similac Pro-Advance™ and Similac Pro-Sensitive™, "closer to breast milk than ever before."  Gerber has Good Start® Gentle HM-O, "closest formula to breast milk." Close, closer, closest:  who should we believe? 


The challenge to human milk researchers who are funded by industry is to create and imitate a component of human milk so that infant formula is more like real human milk. It's a tall order creating a substance that is unique and diverse.  There are some 200 different HMOs in a woman's breast milk.  Although the number of different HMOs seems to not really be known.  Some papers state that there are over 100 different HMOs, some say over 200 HMOs, and some state over 500.

Why does the infant formula industry try to imitiate human milk components? It would appear that the Federal United States Code definition of infant formula may be the reason why the industry studies human milk and tries to simulate it.


" The term 'infant formula' means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk."
--from 21 U.S.C. §321 (z), United States Code

So we are now suppose to believe that industry can chemically and structurally duplicate a human milk component?  A process that uses various toxic solvents to extract the substance.  And this particular substance is identical to a genetically engineered and fermented bacteria?  So all 3 substances are supposedly identical and named a Human Milk Oligosaccharide?  What will parents believe about our newest infant formula?  Will they believe that what is made in a factory lab is exactly identical to what nature makes?  Since the FDA has no questions regarding these statements, then it would seem the FDA believes that genetic engineering is an exact science that duplicates nature.  The human mammary gland is quite amazing but I don't think it needs toxic solvents like toulene to produce an HMO.  Nor can I imagine that the human mammary gland uses E. coli to produce an HMO. So how can the real human milk component be identical to the manufactured?

As disturbing as this is, what seems little noticed is that Medolac, a for-profit milk bank is listed as a manufacturer of HMOs.  Prolacta Bioscience, another for-profit milk bank, has a US patent and World Organization Patent on Human Milk Permeate which contains human milk oligosaccharides.  In patent #8927027, they state,

"The present inventors have found that, surprisingly, permeate (which had been thought to be a waste product lacking significant nutritional value) contains high biologically active content, including human oligosaccharides. Because the starting material, from which permeate is obtained, is pooled human milk, permeate can contain more discrete molecular forms or types of oligosaccharides than individual mother's milk.

The permeate can be added to non-human or human milk to increase its nutritional value. For example, the permeate can be added to human milk fortifiers and standardized milk compositions described in application U.S. Ser. No. 11/947,580, filed on Nov. 29, 2007, the contents of which are incorporated herein by reference in their entirety. The permeate can also be added to non-human milk formula, e.g., bovine milk formulations or mixtures of human and non-human milk formulations."
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8927027.PN.&OS=PN/8927027&RS=PN/8927027

It would appear that a human milk oligosaccharide should have a clear definition so that consumers know what is contained in baby formulas.  It is possible that at some future time the real HMO from donated human milk may become part of the composition of infant formula. Prolacta and Medolac appear to be moving in that direction.  Of course, a pasteurized HMO from donor milk that stores for months, cannot be considered equivalent to the HMOs a mom provides when she is breastfeeding.  For after all, HMOs are genetically specific for each mom and vary over time.  If a genetically engineered bacteria or an extracted crystallized version with added solvents is considered equivalent to an HMO made in the mammary gland, then maybe we should consider that we are living in a Orwellian nightmare.
Copyright 2018 Valerie W. McClain