FDA Concerns re DHASCO®/ARASCO® Infant Formula Additives
In 2001 Martek Biosciences, Inc. petitioned the FDA to recognize the company's self-certified Generally Recognized as Safe (GRAS) status for its ARA fungal oil (ARASCO®) and DHA algal oil (DHASCO®) infant formula ingredients.
The Generally Recognized as Safe designation is a U.S. industry devised mechanism to avoid due diligence. Additives, classified generally recognized as safe, enter consumer products without premarket approval and independent testing.
Some researchers are of the opinion that the ARASCO®/DHASCO® products, which contain long-chain polyunsaturated fatty acids (LCPUFAs), are infant health risks.
The FDA agreed to accept the Martek Biosciences, generally recognized as safe, claims but countered that further DHASCO®/ARASCO®, testing was warranted because:
... 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.Diethylene Glycol Deaths Prompt Regulatory Action
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. Dr. Samuel E. Massengill pleaded guilty to the federal charges of adulteration/misbranding of the company's product and paid fines.
Congressional actions twenty years later compromised the intent of the 1938 legislation and the ability of the Federal Drug Administration to protect consumers from injurious products.
The 1958 pro-industry Food Additives Amendment, aka "The GRAS Law" permits
financially-positioned entities to establish the safety and suitability of their products by way of industry-sponsored trials and selected approval panels.
Martek Biosciences Response to FDA: Supplemental DHASCO®/ARASCO® Safety Studies "Would not be Productive"
Martek Biosciences informed the FDA that further, DHASCO®/ARASCO®, safety 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.
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 question of whether the DHASCO® and ARASCO® oils are benign/beneficial infant formula additives remains unknown because Martek Biosciences 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.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-Ayerst 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-Ayerst claim is not supportable.
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.
Martek Biosciences DHASCO® ARASCO® Business Matters
Bloomberg Businessweek advised interested parties— "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 favorable investment factors.
A federal anti-trust lawsuit was filed against Martek Biosciences, Inc. in 2011. The plaintiff, BNLfoods, claimed that Martek Biosciences had achieved a U.S. infant formula ARA fungal oil/DHA algal oil additives monopoly.
DHASCO®/ARASCO® Oils Classified Organic
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.The fifteen member National Organic Standards Board determined during their fall 2011 Savannah meeting that Martek Biosciences 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: The Organic Watergate—Cornucopia Institute
Martek Biosciences 2010 Petition to the National Organic Standards Board for Organic Certification
Martek Bioscience, Inc. notified the National Organic Standards Board in its 2010 request that the inclusion of negative DHA algal/ANA fungal oil information was unjustified:
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.International Formula Council Complaints
The May 2012 International Formula Council's letter to the National Organic Standards Board warned that unfavorable findings 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." In 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? Evidence supplied by The New York Times and others indicate that the National Organic Standards Board is and has been unduly influenced by financial interests.
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." Carrageenan is present in food products, pet food and pharmaceuticals. Carrageenan's primary production site is the Philippines.