In response to organic activist complaints, the U.S. Department of Agriculture’s National Organic Program is taking steps to review the approval of certain nutrients such as docosahexaenoic acid (DHA) and arachidonic acid (ALA) that are used in products such as organic infant formula and organic milk. The omega-3 fatty acid DHA and the omega-6 fatty acid ARA are added to such foods to help support heart, brain and eye health.
“It’s not a question of safety, but [the substances] didn’t go through the accepted process for allowed and prohibited materials [for organic foods],” said Barbara Haumann, spokeswoman for the Washington, D.C.-based Organic Trade Association. DHA and ARA are synthetic ingredients that are not currently on the NOP’s National List of Allowed and Prohibited Substances, a list of non-organic ingredients that are permitted for use in organic products because they are not available in organic form.
“It is important to remember that the affected products remain in good organic standing with NOP, and will continue to be found on store shelves while the National Organic Standards Board reviews the specific ingredients,” said Christine Bushway, OTA’s executive director.
The review is being spurred on by organic watchdog group The Cornucopia Institute, based in Cornucopia, Wisc., which had filed legal complaints with the USDA calling for the removal of the additives from organic infant formula.
“Consumers rightfully expect organic foods to be purer and safer than conventional foods—in part because federal regulations require that they be free from potentially harmful synthetic additives,” said Charlotte Vallaeys, farm and food policy analyst with The Cornucopia Institute, in a release. “But in the case of the synthetic, chemically extracted additives DHA and ARA, the system of federal regulations ensuring organic integrity was undermined by corporate lobbying and backroom deals during the Bush Administration.”
In 2007, the NOP permitted the use of DHA and ARA in organic foods, reasoning that these nutrients are GRAS—generally recognized as safe—under U.S. Food and Drug Administration regulations, according to a memorandum released yesterday by Miles McEvoy, deputy administrator for the NOP. However, NOP staff recently met with FDA staff and discovered that the FDA policy “does not apply to the use of substances such as ARA, DHA, taurine or sterols that have been added to products such as infant formula, milk, pet food or energy bars as nutrients,” the memorandum noted.
Several popular organic products may be affected, such as Earth’s Best Organic Infant Formula, which includes DHA and ARA to mimic breast milk, and Horizon milk products that contain DHA.
"Horizon, like many other companies, began using omega-3 DHA supplements in its organic products based on the USDA's prior approval of DHA as one of many acceptable safe and effective nutrients to add to organic products," said Jarod Ballentine of WhiteWave Foods, makers of Horizon products. "Products made with DHA supplements continue to be one of the most in-demand among consumers."
Both companies said they are complying with government rules on DHA and ARA use. “We use the only forms of DHA and ARA approved for use in infant formula at optimal levels, and which are produced from all-natural, vegetarian, and non-GMO sources,” said New York-based The Hain Celestial Group, marketers of Earth’s Best products, in a company-prepared statement.
According to The Cornucopia Institute, the nutrients are extracted from fermented algae and soil fungus with the solvent hexane and have been linked to illnesses in children.
Some experts and manufacturers disagree.
“Consumers have enjoyed, trusted and chosen these products because they are looking for both certified organic products and supplementation with specific nutrients," Bushway said. "OTA is pleased that the safety and efficacy of these added nutrients are not in question, but rather the process by which they were approved for use in these products.” Bushway noted that omega-3 DHA and other accessory nutrients continue to be recognized as safe for use in human and pet food products.
“USDA regulations do not prohibit the use of solvents for the extraction of these nutrients, which is the only method presently available,” The Hain Celestial Group stated. “The solvents are completely removed following the extraction process. No residual solvent is present in the DHA and ARA or the finished product, and there is no safety concern.”
In yesterday’s memo, McEvoy admitted that the NOP erred in 2007 by not seeking public comment, and he announced plans to publish draft guidance later this year and to seek public comment. The guidance will provide a transition time for businesses to comply with any new regulations.
“We don’t want an industry that acted in good faith to be harmed,” said Kathleen Merrigan, the USDA’s deputy secretary, to The Wall Street Journal. “On the other hand, we have a rule to uphold."
During the transition period, companies can petition to add substances to the National List of Allowed and Prohibited Substances.
"We support the USDA’s decision to revisit how efficacious nutritional supplements are approved for certified organic products, and look forward to working closely with the USDA and the organic community to address this new interpretation in an open and transparent manner," said WhiteWave's Ballentine.
Note: The original story published on April 27, 2010 was revised on April 30, 2010 in light of new information from the OTA.