Infant Formula Additives: Generally Recognized as Safe

Infant Formulas: Are They Safe? Infant Formula additives
may be marketed without FDA approval.
 

FDA Questions Martek's Infant Formula DHASCO/ARASCO Additives—2001

Martek Biosciences, Inc. (est. 1985) asked the FDA in 2001 to recognize the company's self-certified Generally Recognized as Safe (GRAS) status for its patented ARA fungal oil (ARASCO) and DHA algal oil (DHASCO) infant formula product ingredients. ARASCO and DHASCO contain long chain polyunsaturated fatty acids. The federal agency agreed to accept the company's safety assertions but presented evidence disputing the addition of long chain polyunsaturated fatty acids (LCPUFAs) in infant formula products:

... some studies have reported unexpected deaths among infants who consumed formula supplemented with LCPUFAs. These unexpected deaths were attributed to Sudden Infant Death Syndrome (SIDS), sepsis or necrotizing enterocolitis. Also, some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice, and apnea in infants fed LCPUFAs.

The public is likely not aware that the Generally Recognized as Safe designation is a US-industry created mechanism to avoid premarket approval and independent testing.

DHASCO and ARASCO Infant Formula Additives: Further Safety Studies "Would not be Productive"

In September 1937 the S. E. Massengill Company began marketing an antibiotic product called elixir sulfanilamide. The medication contained the dissolving agent diethylene glycol, a known toxic substance.

Elixir Sulfanilamide was responsible for 100 deaths, many of them children. To avoid trial publicity and scheduled expert testimony, Dr. Samuel E. Massengill pleaded guilty to the federal charges of adulteration/misbranding of the company's product and paid fines.

Following the "Taste of Raspberries, Taste of Death" poisoning scandal Congress expediently passed the 1938 Food, Drug, and Cosmetic Act.

Congressional actions twenty years after the fact compromised the intent of the 1938 legislation and the ability of the Federal Drug Administration to protect consumers from injurious products.

The 1958 Food Additives Amendment, aka "The GRAS Law" permits financially-positioned manufacturers to establish the safety and suitability of their products by way of industry-sponsored trials and selected approval panels.

The question of whether DHASCO and ARASCO oils are benign/beneficial infant formula additives is unknown because Martek would not support the FDA's position that "any evaluation that a use of a food ingredient is safe is a time-dependent judgment that is based on general scientific knowledge as well as specific data and information about the ingredient."

In 2001 Martek advised the FDA that further DHASCO/ARASCO safety trial studies "would not be productive":

As such it is doubtful that convening a group of experts to answer purely hypothetical concerns would be scientifically productive, but such a step would certainly and unnecessarily further delay the availability of the proven clinical benefits of Arasco/Dhasco-supplementation to preterm and term infants of American families.

The Agency and the courts have long held that GRAS determination requires neither unanimity nor the absence of a conflict in the scientific community.

Bloomberg Businessweek reported in 2005 — "A Growing Boost for Baby Formula"—that Martek's first-mover DHASCO/ARASCO status and the company's 15-24 year contracted partnerships with 14 infant formula producers were stock-enhancing factors.

A federal anti-trust lawsuit was filed against Martek Bioscience, Inc. in 2011. The plaintiff, BNLfoods, claims that Martek has a US-infant formula monopoly.

Martek's 2010 Petition for DHA Algal Oil Organic Certification

It is instructive to consider Martek's organic certification revenue strategy:

If our oils are unable to be used in organic food and beverage products, the opportunity for sales of our oils into the food and beverage market will be limited to non-organic products.

Upon consideration, the fifteen member National Organic Standards Board determined during their fall 2011 Savannah meeting that Martek's proprietary DHA algal and ARA fungal oils should be included on the National List as organic substances. This recommendation was made in spite of the fact the ARASCO® and DHASCO® additives (Formulaid®) are:

derived from genetically mutated algae and soil fungus, are processed with petrochemical solvents, grown in genetically engineered corn, and formulated for use in infant formula, dairy and other products with a myriad of other unreviewed synthetic ingredients.

Reference— Cornucopia Institute white paper report: "The Organic Watergate"
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DNA-altered corn seed is not only an organic issue: Does the consumption of genetically-engineered herbicide-resistant corn products pose a health risk? A recently released two-year study indicates that the novel Monsanto NK603 food/feed product can significantly promote tumor growth, impair organ function and shorten life expectancy.

Other investigative articles such as "GM food nightmare unfolding in the regulatory sham" (2007) and The Very Real Danger of Genetically Modified Foods (2012) stress the urgent need for further study.

Photos of rats used in the  “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize”  study
 

The Monsanto Company Genetically Modified Food Safety website ignores the precautionary principle by stating:

There is no need for, or value in testing the safety of GM foods in humans. So long as the introduced protein is determined safe, food from GM crops determined to be substantially equivalent is not expected to pose any health risks. Further, it is impossible to design a long-term safety test in humans, which would require, for example, intake of large amounts of a particular GM product over a very large portion of the human life span. There is simply no practical way to learn anything via human studies of whole foods. This is why no existing food--conventional or GM--or food ingredient/additive has been subjected to this type of testing.

South Africa, Russia, France, Egypt and EU regulatory agencies are finding the Seralini documentation cause for investigation.  Gilles-Eric Seralini led the “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize” research trial.
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Martek Bioscience, Inc. notified the National Organic Standards Board in its 2010 petition that the inclusion of negative DHA algal/ANA fungal oil information was unwarranted:

Martek also is concerned that by quoting the Cornucopia report, the TAP (Technical Advisory Panel) could be creating the unintentional impression that it has reviewed the underlying data and believes that there is some legitimacy to the positions advanced by Cornucopia.

Organic Business Concerns

The May 2012 International Formula Council's letter to the National Organic Standards Board warned that unfavorable determinations on the part of the Board re infant formula product substances such as choline, inositol, carrageenan, and arachididontic acid might result in market disruption and force manufacturers to reconsider whether to continue in the organic baby formula business.

International Formula Council members: Abbott Nutrition, Mead Johnson Nutrition, Nestlé Infant Nutrition, PBM Products, LLC, A Perrigo Company, and Pfizer Nutrition are of the opinion that hexane-extracted ingredients are suitable for inclusion on the National Organic List.

For a historic perspective on harmful industry marketing concepts please read the 1981 NYT report: "The Controversy Over Infant Formula."  Summary: The World Health Organization agreed by a vote of 118 to l that infant-formula advertising should be restricted. The U.S. was the lone opponent.

Is the U.S.D.A. certified-organic label meaningless? That issue is under debate. Evidence supplied by The New York Times and others indicate that the National Organic Standards Board is and has been unduly influenced by corporate petitioners.

National Organic Standards Board May 25, 2012 recommendations: add synthetic ingredients, choline and inositol to the National Organic List. Carrageenan, another synthetic product, was allowed to remain on the National Organic List but is considered unsuitable for use in infant, under six months, formula. The World Health Organization advises that carrageenan should not be added to infant formulas. Some studies referenced by WHO suggest that degraded carrageenan may be a "possible human carcinogen." This manufactured product is present in food products, pet food and pharmaceuticals. Carrageenan's primary production site is the Philippines.

ARASCO® and DHASCO® Synthetic Oils 1999—Generally Recognized as Safe Expert Panel Infant Formula Approval

Martek marketing strategy 1996:

Even if [the DHA/ARA blend] has no benefit, we think it would be widely incorporated into formulas, as a marketing tool and to allow companies to promote their formula as ‘closest to human milk.'

The Martek Biosciences, Inc. Generally Recognized as Safe [GRAS] panel concluded in 1999 that Martek's proprietary products— ARASCO® and DHASCO® —single cell oils were suitable for inclusion in infant formula and children's food.
Manufacturer's logic: Since widely varying amounts of DHA and ARA triglycerides docosahexaenoic acid (DHA) and arachidonic acid (ARA), are naturally present in human milk, these substances are appropriate infant formula supplements.

FDA response: There is no independent scientific data to support Martek's assertion that the digestion and absorption of DHA from DHASCO, and ARA from ARASCO, would be the same as that of DHA and ARA from triglycerides present in human milk.

Martek panel members certifying Arasco/Dhasco limited-term (90 days or less) trials as credible research were: Joseph Borzelleca, Ph.D.; Gary Flamm, Ph.D.; Bruce German, Ph.D.; Walter Glinsman, M.D..; David Kritchevsky, Ph.D.; and David Bechtal, Ph.D. These, under-contract often-invited, expert panel reviewers:

independently and critically evaluated materials submitted by Martek Biosciences Corporation and other material deemed appropriate and conferred by telephone several times before preparation of this report.

Much of the affirmative DHASCO/ARASCO test data supplied to the GRAS panel was industry-reliant. Short term preclinical/clinical trial periods, though cost effective, can produce unreliable results.

Industry players conducting 1990s ARASCO®/DHASCO® trials were: Wyeth Ayerst/Pfizer acquisition as of 2009, Martek Biosciences/ Royal DSM N.V. acquisition as of 2011, Mead Johnson, Numico (Nutricia) and Gist-Brocades/ Royal DSM N.V acquisition as of 1998.

In their 1999 Generally Recognized as Safe support documents, the Martek panel reported that the novel ARASCO®/ DHASCO® oils had been tested in 12 animal species and 1478 human babies.

The Martek team noted that cited ARASCO®/ DHASCO® research was modeled after FDA Redbook guidelines and conducted in Good Laboratory Practice facilities.

Wyeth-Ayerst 1998 Notice of Claim to the FDA For Arasco/Dhasco Oils' Exemption From Premarket Approval

In its FDA waiver request letter, Wyeth-Ayerst affirmed that the products:

...conditions of use are such that ARASCO and DHASCO will comprise less than 3.5% of an infant formula fat blend, their use does not meaningfully affect the overall content of heavy metals, pesticides, trans fatty acids, residual extraction solvent, or non-saponifiables in the infant formulas in which they are used.

Wythe initiated research trials found that (US/Canada) infant study groups supplied with ARASCO/DHASCO enhanced formula "grew significantly better than the human milk fed group." The Wythe promotional claim is not true.

As a result of its and other industry-funded animal/infant research projects, Wythe concludes that "the safety and tolerance of the of the Arasco and Dhasco-supplemented formula" is well documented and needs no further inquiry.

ARASCO®/DHASCO® Oils Alleged Health Benefits

The Royal DSM N.V. owner of Martek Bioscience, Inc. as of 2011, corporate website references its DHA product as:

An omega-3 with proven brain, eye and heart health benefits for all stages of life - from pregnant and nursing women to infants, children and adults. Life's DHA is a fish-free and sustainable source of DHA from algae. It is a trusted vegetarian source of DHA found in hundreds of foods, supplements and infant formulas worldwide.

The Federal Trade Commission cautioned Martek Biosciences, Inc in 2004 re the company's practice of unsubstantiated health benefit advertising.

Pharmaceutical Business Review September 2012: A Royal DSM N.V. supported study has found that daily use of the company's DHA algal oil dietary supplemental product will improve a child's reading ability and lesson behavioral problems.

Failure to Communicate Consumer Product Health Risks

Companies manufacturing consumer goods are expected, but not obliged, to report health complaints and defects to the FDA. This conflict of business interest notification system is illogical.

Case in point: St. Jude Medical, Inc faulty defibrillator Riata wires. In November 2011 the company reported that less than 1% of the 80,000 U.S. patients using the surgically implanted device were adversely affected by product failure. St. Jude Medical acknowledged in July 2012 that approximately 19% of its defibrillator product patients are likely to experience harmful, potentially life-threatening Riata wire malfunction. Both the FDA and St. Jude Medical were aware of the increased patient risk. It was a Freedom of Information Act request that prompted St. Jude Medical to revise its numbers. For additional information please read The New York Times report, "Unpredictable Danger Looms Close to the Heart."

Cornucopia Institute Freedom of Information Act Request re DHASCO/ARASCO Infant Formula Additives

Various studies referenced by the FDA in 2001 indicated that infants fed with Omega 3-fatty acids enhanced formula can and have experienced harmful reactions.

When the FDA asked the company to defend its Generally Recognized as Safe conclusion, Martek countered:

ARASCO and DHASCO pose unique testing problems because it can be difficult to distinguish whether an observed effect related to the test material is a normal physiological response to the high dietary load of that particular macronutrient, a dietary deficiency that is related to presence of a large amount of the test material in the diet, or a toxicological effect.

...studies conducted in term and preterm infants with balanced addition of ARASCO and DHASCO as sources of both bioactive fatty acids showed no difference in deaths between treatment and control groups.

 ...some studies have reported changes attributed to possible effects on the kidney. Martek presents an analysis of these studies and concludes that there are no consistent treatment related effects of DHASCO and ARASCO, either alone or in combination, with respect to kidney weight, kidney function or kidney histopathology.
 

The Cornucopia Institute and the National Alliance for Breastfeeding Advocacy petitioned the FDA in 2008 to revise infant formula labeling to include a warning that products containing DHA/ARA oils may cause gastrointestinal distress. There is no consumer product warning regarding this matter on infant formula products.

In 2009 the FDA reported the following to the Cornucopia Institute's Freedom of Information Act request:

We have no responsive information in our files. FDA has never received any reports or studies regarding post-market surveillance or scientific studies monitoring or evaluating the safety of DHASCO and ARASCO (DHA and ANA) in infant formula.

Arsenic in Food and Infant Formula Alert

The World Health Organization and the EPA designate arsenic a carcinogen.

Children chronically exposed to unsafe arsenic levels via water, soil, air and food are likely to experience acute and perennial physical harm. Resource TEACH: Toxicity, Exposure, Assessment Children's Health Database.

In January 2012 Consumer Reports published its findings on arsenic-contaminated fruit juices, products commonly consumed by infants and children. In September 2012, Consumer Reports followed with its arsenic in rice study. Scientific tests confirm that rice and rice-based products, including infant formula, contain arsenic exceeding federal drinking water thresholds.

The 2001 EPA Arsenic Rule set 10 parts per billion as a acceptable drinking water requirement and does not distinguish whether the referenced chemical element is inorganic or organic:

The 10 ppb protects public health based on the best available science and ensures that the cost of the standard is achievable.

This revision will provide additional protection for 13 million Americans against cancer and other health problems, including cardiovascular disease and diabetes, as well as neurological effects.

New Jersey's arsenic safety benchmark is 5 parts per billion.

Even though rice has long been identified as an arsenic absorbent grain, government agencies have not established protocols governing production sites, post-harvest testing, acceptable contamination levels or health risk disclosure.

In view of the Consumer Reports arsenic test results, some pediatricians and medical professionals suggest limiting rice and rice-contained byproducts. This advice is not easily achievable because rice has many breakdown components.

Steve Peirce, president of RIBUS (Rice Business US), with rice husks, the basis of his business which produces rice-based additives for food products. Finely ground round rice husks, for example, are added to spices to stop them from clumping together. Photo by Robert Cohen, rcohen@post-dispatch.com
 St. Louis Post-Dispatch July 2012 Georgina Gustin

Mr. Peirce explains the RIBUS business plan:

Rice is like a peanut. The outer layers are the husk, and that's about 20 percent of the crop. We're able to take that off and put it in the food system. When you take off that husk, you get brown rice, and when you take that off the skin – the bran – you get white rice. The bran is where 90 percent of the nutrients are. Since they throw that away or feed it to livestock, we take it and extract the nutrients from the bran. For 20 years we've worked with the bran, and over the last four years – and we're patent pending – we've worked on utilizing the hull.

RIBUS notified the FDA in February 2012 that because its certified organic ground rice hull fiber, (nu-FLOW and nu-FLAC) products had been designated Generally Recognized as Safe food additives by Drs. Robert Nicolosi, Joseph Borzelleca, and Michael Pariza, the products were exempt from premarket approval.

RIBUS product applications include, but are not restricted to, "prepared foods, nutraceuticals, functional foods, general foods (such as snack foods, bakery products, cereals, crackers, pasta products, dough conditioners, beverages, sports beverages), meal replacement, gluten-free foods, and medical foods."