Nature’s One CEO savages ‘flawed’ baby formula arsenic study, but author defends work

By Ben Bouckley

- Last updated on GMT

Picture Copyright: PFLY/Flickr
Picture Copyright: PFLY/Flickr

Related tags: Codex alimentarius, Fda

US organic baby formula manufacturer Nature’s One has attacked recent research suggesting that arsenic levels in its toddler formulas were a cause for concern, but the study’s lead author defended the work, even stating that new data published by the firm supported his conclusions.

Nature’s One claimed to have conducted independent tests, via Food and Drug Administration (FDA) recognised laboratory Applied Speciation, refuting the findings of a study led by Dartmouth College researcher Dr. Brian Jackson.

Published online in Environmental Health Perspectives on February 16, this study analysed arsenic​ (derived from organic brown rice syrup, OBRS) levels in foods, with the authors noting that levels of the carcinogen were usually higher in ‘unpolished’ brown rice favoured by organic producers.

‘Significant’ dietary concentrations…

Two of Nature’s One toddler formulas (dairy and soy varieties) were tested for arsenic, and while tests on 15 other formulas without OBRS found “relatively low”​ (2-12ng/g) arsenic concentrations, the two organic offerings were found to have a >20x arsenic concentration of these products.

Jackson et al. wrote: “Our findings suggest that the OBRS products we evaluated may introduce significant concentrations…to an individual’s diet. Thus, we conclude that there is an urgent need for regulatory limits on arsenic in food.”

But Nature’s One CEO, Jay Highman, hit out at the study, which he said was “flawed in its testing methodology, which may have contributed to their exaggerated levels of arsenic”.

He added: “The researchers failed to use the FDA-certified testing method for rice, or use a quality control material standard reflecting the high sugar content of organic brown rice syrup.”

The FDA continues to work on establishing a food standard for arsenic, but Highman said that establishing arsenic content standards was complex, due to components in foods – such as protein, fatty acids, carbohydrate, vitamins and minerals in formula – that may cause reporting errors.

“Experts discovered that carbon atoms from sugar were creating ‘false positives’ for arsenic,” ​he added, expressing related concerns that the Dartmouth team had used a low sugar rice flour as its laboratory ‘quality control standard’, since organic brown rice syrup contained higher levels.

 ‘Sensationalised opinions’

Highman said the Dartmouth team used “many sensationalized ‘opinions’ regarding safety levels of arsenic in an effort to pressure the FDA” ​to regulate, and that, in any case, the scientists only found arsenic levels within brown rice that were consistent with the CODEX safety standard.

But since the scientists suggested that there was still cause for concern, Highman said that there was “no way a product with brown rice syrup was going to receive balanced analysis when the authors were predisposed to their opinion”.

Nature’s One’s said its new data showed that all three Baby’s Only Organic formulas in its range met CODEX Committee on Contaminants in Food (CCCF) guidelines of 0.2mg/kg of arsenic in ‘rice based foods for infants (up to 12 months) and young children (12-36 months).

Applied Speciation found that the firm’s dairy-based formula had 0.053mg/kg of inorganic arsenic, 73.5% below CODEX guidelines, and also met World Health Organisation (WHO) standards withdrawn in 2012.

Researcher stands by study

But Dartmouth study author Brian Jackson told he stood by his research results: “After a month with no data to pass on to consumers, I’d say that Nature's One has published data that supports our general conclusions,” ​he said.

“Namely that toddler formula using rice syrup can contain 20x the arsenic concentration of other baby formulas, and that two out of three of their formulas have inorganic arsenic concentrations in the reconstituted formula at higher levels than the US or World Health Organisation (WHO) safe drinking water limit.”

We asked Dr. Jackson to explain what seemed quite a basic error, since the paper was recently corrected online after publication (on February 24) to reflect the fact that toddler formula (not intended for infants under 1 year) rather than infant formula (as first stated) was tested.

Did this affect the research conclusions at all?

Jackson said: “From the many e-mails I received, it is clear that many people used these formulas for infants.  Even for toddlers, I'm sure parents would like to be aware that rice syrup-based formulas could have inorganic arsenic levels higher than the safe drinking water limits.”

Related topics: R&D, Regulation & Safety

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The Difference Between Formula & Rice-based Foods

Posted by Karla,

Please be aware that there is no formula on the world market today that consists solely of rice ingredients. Dairy and soy formulas do not contain 100% rice. Baby’s Only Organic formulas contain about 40% of organic brown rice syrup while by weight the remaining 60% consists of protein (dairy or soy), fats (sunflower/safflower, soy, coconut oils), vitamins and minerals. To be clear, Baby’s Only Organic® formulas fall 58.5% to 73.5% BELOW the CODEX proposed world standard. For these reasons, we agree with the Mom writer at FiftyFiftyMom in that infant formulas are significantly different from 100% rice based foods for infants. Because the FDA has not established arsenic standards for U.S. manufacturers, the CODEX world standard is presently the most appropriate method for measuring safe arsenic levels in Baby’s Only Organic formulas.

Additionally, the standard used by Jackson in the Dartmouth study was withdrawn in 2010 by the World Health Organization (WHO). Nature’s One has never suggested that this standard is strict or arbitrary; instead we have noted that the Dartmouth study referenced outdated standards when in March 2011 the CODEX Committee proposed the following standard of measure: “inorganic arsenic in rice-based foods for infants (up to 12 months) and young children (12 to 36 months): 0.2 mg/kg." Again, our formulas are 58.5% to 73.5% BELOW this standard. Until the scientific community develops better testing methodology and tolerance values for specific foods including infant formulas and as noted previously, we believe the CODEX world standard is presently the most appropriate.

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Unacceptable arsenic levels for children

Posted by Distressed Mother,

I am a mother whose child's main source of nutrition was Nature's One Baby's Only Organic Dairy formula for 10 months. An arsenic hair test analyzed by Mayo Clinical Labs showed my child's hair levels were 0.5 mcg/g. While I understand that the reference range is 0.0 - 0.9 mcg/g I am also aware that this range is for ages 16 years and over. There is no reference range for infants.

I am personally beyond disgusted with Nature's One and the way they have handled this situation. They actively marketed this formula to parents of infants by publishing comparison charts of their formula with other brands of infant formula and telling parents they were advocates of breastfeeding for the first year hence the "toddler" labeling. Of course, since the media attention they are now stressing that their formula is only meant for ages 12 months and older.

As I am personally too angry to comment intelligently so I will quote Dr. Gary Ginsberg: "However, saying that Dartmouth doesn't know how to measure arsenic is like saying Roger Federer doesn't know how to play tennis."

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