Industry Watchdog / Washington Post Investigation Brings Down Old Leadership

Washington, DC: In a strong departure from Bush-era policy, the USDA’s National Organic Program released a memo today banning synthetic “accessory nutrients” — ending a scandal that brought down its former organic leadership.

At issue were some of the nation’s leading manufacturers of infant formula that had been illegally adding synthetic forms of omega-3 and omega-6 oils to their organic products after a sweetheart deal between a powerful industry lobbyist and Dr. Barbara Robinson, the former head of the USDA’s organic program—exposed by a 2009 investigative report in the Washington Post.

Documents obtained through the Freedom of Information Act (FOIA), by The Cornucopia Institute and shared with the Washington Post, indicated that Robinson, after meeting with Jay Friedman, a lawyer and lobbyist with the powerful Washington law firm of Covington Burling, rescinded a ruling made by USDA career civil servants who found the inclusion of synthetic oils in organic infant formula to be illegal.

“Justice prevailed in this matter but it took a change in the administration in Washington to make this happen,” said Mark A. Kastel, Codirector of The Cornucopia Institute.

Cornucopia, an organic industry watchdog, first investigated the use of these “novel” nutritional oils, derived from soil fungus and algae, in infant formula, because they are extracted using a neurotoxic chemical, hexane, which is explicitly banned in organic production. “We couldn’t understand why the USDA was allowing this to happen,” Kastel said.

Congress passed the Organic Foods Production Act, as part of the 1990 farm bill, charging the USDA with defending the interests of ethical industry participants and protecting organic consumers against fraud.

Cornucopia researchers were shocked when they started investigating the DHA/ARA oils, manufactured by Martek Biosciences Corporation, Columbia, MD, and found they were implicated by parents and healthcare professionals in severe and chronic health problems in infants around the country.

“Organics should be the last bastion of pure, natural and unadulterated food for consumers,” said Charlotte Vallaeys, lead author of Cornucopia’s report, Replacing Mother — Imitating Human Breast Milk in the Laboratory.

Through a separate FOIA request to the FDA, Cornucopia learned that there was an apparent correlation between the use of Martek’s nutritional oils and severe gastrointestinal problems sometimes resulting in highly-invasive testing procedures and hospitalizations.

“Based on FDA adverse reaction reports, we discovered that many parents, physicians and healthcare practitioners found that chronic problems with infants, often resulting in ‘failure to thrive,’ acute dehydration (caused by dangerous diarrhea/vomiting) and severe emotional stress on the babies and their families, were often immediately resolved when switching to formula without DHA/ARA supplementation,” stated Vallaeys.

After learning about the health problems, Cornucopia immediately stepped up its legal efforts at the USDA to remove Martek’s oils not only from organic infant formula, but also from organic baby food and organic milk manufactured by the nation’s leading brand, Horizon, owned by the dairy giant Dean Foods.

“It’s concerning enough that these Martek oils are being widely introduced in the marketplace, in both organic and conventional products, but there is no authoritative research that suggests they actually benefit children’s development, as is claimed by the industry,” said Marsha Walker, RN, IBCLC, Executive Director of the National Alliance for Breastfeeding Advocacy.

Infant formula manufacturers like Enfamil (Mead Johnson) promote their products as being “our closest formula to breast milk,” and research indicates such advertisements might have discouraged some women from breastfeeding, which is universally recognized as being superior to formula in numerous ways, including for the health and development of babies.

“This seems to be a crass marketing gimmick, using our children as guinea pigs to enhance the bottom line at the major pharmaceutical companies that manufacture infant formula,” lamented Kastel. “The fact that this material is being illegally added to certified organic formula is highly repugnant and left mothers, who could not breastfeed for whatever reason, with few alternatives in the marketplace.”

Over the past few years, infant formula manufacturers have raised their prices after adding Martek oils to their products. With the exception of some prescription formulas, available with approval from pediatricians, only one over-the-counter formula is available without synthetic DHA/ARA, Baby’s Only, an organic product manufactured by Nature’s One in Columbus, Ohio.

“After today’s official announcement by the USDA, all other organic formula manufacturers will need to remove Martek’s oils from their products,” Cornucopia’s Vallaeys stated.

In the meantime, The Cornucopia Institute also has filed petitions with the FDA requesting that their Generally Recognized as Safe (GRAS) designation for the Martek oils be revoked.

“When Martek’s additives were originally granted GRAS status, it was with extreme reservations on the part of the FDA review panel because of adverse reactions to these oils” said Valleys. “When we reviewed FOIA documents, we were astonished to find that none of the infant formula manufacturers had complied with the FDA’s request to monitor adverse reactions and perform post-market surveillance of these materials.”

Like baking soda or any other synthetic ingredient that manufacturers would like to use in organic products, Martek and the infant formula manufacturers who would like to use synthetic DHA/ARA oils will now be allowed to petition the National Organic Standards Board for a safety review. Cornucopia projects an aggressive lobbying fight with public interest groups and powerful manufacturers once again squaring off.

“We have to say we are continuing to be impressed by the ethical turnaround at the USDA, in their oversight of the organic industry, since the new administration took control in Washington and Secretary Vilsack promised members of the organic community that he would appoint leadership who ‘shares our values’,” Kastel affirmed.

According to The Cornucopia Institute, widely recognized as one of the industry’s most aggressive independent watchdogs, organic consumers have every reason to feel more confident every day in the integrity of the USDA organic label.


USDA memorandum reversing previous position on nutrient vitamins and minerals in organic foods, available upon request: [email protected]

Link to The Cornucopia Institute report, and other background documents: Replacing Mother — Imitating Human Breast Milk in the Laboratory:

The manufacturing process for Martek’s oils likely includes genetically engineered organisms and neurotoxic synthetic solvents, which are both explicitly banned in organic production. According documents submitted by Martek to the FDA, the process to make their oils includes growing algae and fungus in a medium that is made primarily of dextrose derived from corn, yeast extract or a hydrolyzed vegetable protein, which is usually derived from soybeans. Given that the vast majority of corn and soybean products in the food supply are produced through genetic engineering, the likelihood that Martek’s DHA and ARA oils are grown in a medium of genetically engineered organisms is almost certain. The use of genetic engineering is, of course, strictly prohibited in organics.

In a document submitted to the Food and Drug Administration, Martek also specifies that they use a neurotoxic chemical solvent, hexane, to extract the oil. Martek writes: “The oil is first extracted by blending the dried biomass with hexane in a continuous extraction process.” Synthetic solvents such as hexane, which carry serious environmental and occupational safety concerns, are also prohibited in organic food processing.

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