Synthetic DHA and ARA
PCC has suspended the sale of four organic products because they contain ingredients not reviewed or approved by the National Organics Standards Board.
The suspended products are Earth's Best Organic Infant Formulas (soy and dairy), Spectrum's Organic Flax oil, and Yummy Bear Organic Brain Booster vitamins.
The additives are omega-3 and omega-6 fatty acids (DHA/ARA) derived chemically from fermented algae and fungus, and made by Martek Biosciences Corporation.
Federal law states that all synthetic additives must be approved by the USDA National Organic Program through a formal petition and review process, assuring safety and acceptability before they legally may be added to foods bearing the organic label.
Martek did not petition NOSB for approval until August 2010, four years after it was being added to organic products. Martek's DHA/ARA never has been reviewed or approved by the National Organic Standards Board. (There is no restriction against synthetics in non-organic foods or supplements.)
According to the Food and Drug Administration's resource, MedWatch, there are nearly 100 complaints of adverse reactions filed with the Food and Drug Administration. The complaints suggest a causal relationship between the additives and gastrointestinal problems, such as reflux, vomiting and diarrhea, in infants and young children.
U.S. Department of Agriculture (USDA) officials reportedly became aware in 2006 that infant formula manufacturers were adding these unapproved additives to products with the organic seal. A Freedom of Information Act request purportedly reveals that the Bush administration's NOP director approved them without due process and over the objections of other USDA staff.
A complaint filed in April 2008 by the Cornucopia Institute, an organic policy group, asked USDA to remove all organic products with the ingredients from store shelves and prohibit companies from using the ingredients in products labeled as organic.
Cornucopia argues that DHA and ARA should not be allowed in organics because they're not reviewed or approved. They're also sometimes extracted from algae and fungus using a toxic solvent called hexane, and organic regulations prohibit the use of hexane in processing organic foods and ingredients.
Some believe that USDA has dragged its feet on forcing removal of these unapproved additives to allow infant formula manufacturers and the nation's largest milk processor to petition NOSB and get them approved, after the fact. (Dean Foods adds Martek's DHA to Horizon organic milk.)
According to investigations by Cornucopia, no meta-analysis studies (review data from all clinical trials conducted) have been published showing any benefits to infants from DHA/ARA supplementation. One long-term study has been published suggesting possible detrimental effects, particularly higher blood pressure in girls who were given formula with DHA/ARA. The European Union recently has rejected a health claim on infant formula claiming that DHA aids brain development, based on a lack of evidence.
On March 14, 2011, the NOSB released a controversial committee proposal to allow any synthetic nutrient additive that comes to market to be added to organic foods, without review.
The committee vote was split. The NOSB as a whole is expected to make a final recommendation to the National Organic Program/USDA at its April meeting in Seattle.
Should any synthetic nutrient additives be allowed in organic products without review?
PCC's view is that all synthetic additives must be reviewed as the law clearly requires. Our assessment is that organic consumers absolutely expect all synthetic additives to go through the formal petition and review process.
Manufacturers who are using it should not get an automatic pass. We support enforcement action against companies currently adding unapproved synthetic nutrient additives, such as DHA and ARA.
Current standards do not allow unapproved nutrient additives. It is entirely reasonable to request enforcement action based on the current standards.
For more information and a summary of the literature questioning the efficacy and safety of these additives, see the Cornucopia Institute's March 21 news release.