Corn refiners’ opposition to petition based on outdated data, misreading of FDA rule

Posted by
August 7, 2014


To hear the Corn Refiners Association tell it, consumers should have no concerns about the fructose content of the high fructose corn syrup still found in all manner of processed foods, because this caloric substitute for sugar long ago was declared to be generally recognized as safe, or GRAS, by the Food and Drug Administration.

So why all the fuss and bother about it now?

Let’s just say it has a lot to do with the fact that approval was given “long ago,” using outdated data. That, and the CRA’s seeming misinterpretation of what the FDA meant by that GRAS designation.

In our previous blog, we reported on our sponsoring organization, Citizens for Health, having amended its petition to the FDA seeking labeling of specific amounts of fructose in products containing HFCS – and notification to companies who market products with levels higher than the approved 55% that those products will be considered adulterated. But the petition also contains a response to the CRA’s objection to it – the sole opposition it has received, as contrasted to more than 10,000 favorable comments posted thus far. (Post your comment here).

The CFH answer begins by acknowledging that the Corn Refiners Association is correct “that in 1996, when FDA affirmed HFCS as GRAS – based on data from the 1970s and 1980s – the agency declined to require identity of which HFCS was used in the product.” At that time, the FDA “determined that because the components of HFCS-55 are similar to HFCS-42, and there are no safety concerns with these components, there is no need to differentiate between these two HFCS’s on product labels for consumers.” The response further notes that the FDA had also ruled “that it could not find any basis for an adverse effect in diabetics from increased fructose consumption.”

However, as CFH points out, the FDA “was relying on ten-year-old data in 1996” when it made that determination. “Eighteen years later, we now know that increased fructose consumption does play a significant role in diabetes” – and relying on that kind of dated information demonstrates the lack of merit in the CRA’s opposition. “We also have a modern consumer base dealing with numerous health conditions that require intricate knowledge of what is going into their bodies,” such as the identity of ingredients.

Such factors, CFH contends, further demonstrate why  “the CRA’s desire to operate in secrecy has no merit,” since “without labeling, a consumer is blind to his own fructose intake and must misguidedly rely upon an outdated 1996 understanding of fructose and HFCS before large studies of population trends highlighted this connection.”

As for the CRA’s claim that there is no evidence “those consumers are aware of or care about the differences in fructose content between HFCS 42 and 55,” CFH cites the outpouring of support for its petition, as well as thousands of signatures it elecited, as evidence of “overwhelming consumer demand for this exact type of information on the label “

No carte blanche for GRAS

Also disputed by CFH is the corn refiners’ contention that HFCS was given a GRAS designation without regard to the concentration of fructose it contained, when, in fact, the FDA was quite unambiguous in specifying that it was approving HFCS with fructose concentrations of approximately 42% or 55%. If the definition allowed “for fluctuations upwards and without limit, then there would be no need for the FDA to use both HFCS 42 and 55,” it pointed out.

The belief that there was no actual limitation placed on the amount of fructose HFCS contains may help explain the rationale for the excessive levels found in a recent study of beverages and the reported addition of HFCS-90 (that is, 90% fructose) to some products, even though its use is specifically prohibited by the FDA because, according to CFH, its fructose/glucose ratio is so completely out of balance.

“Our food should not have HFCS with a fructose concentration above 55%,” CFH maintained, adding that if a food company wishes to use a higher amount than that, it must file a food additive petition for the amount it seeks to use and at all times “identify the percent of fructose in HFCS that it is using.”

In other words, you can’t make the fructose any higher in high fructose corn syrup than the FDA allows. Not without first bringing about a change in the rule that now exists.