Celiacs: Beware of FDA's Latest Errors on Barley

The Food and Drug Administration (FDA) has again fallen far short of public expectations. It has released the final and full report regarding "Qualified Health Claims Associating Barley Products with Reduction of Risk of Coronary Heart Disease." As far as it goes it is the usual fare of bureaucratic discourse that effectively serves the marketing needs of the manufacturers who requested the approvals for health claims relating to barley products.

The barley manufacturers will doubtless be thoroughly delighted. The FDA delivered exactly what they sought. Good for them, not so good for consumers though. Why? Well, let's just see what the FDA has said first and the consider that question.

The Food and Drug Administration announced that it has finalized a rule that allows foods containing whole grain barley to claim that they reduce the risk of coronary heart disease. Specifically, whole barley and dry milled barley products such as flakes, grits, flour, meal and barley meal, which provide at least 0.75 grams of soluble fiber per serving, may bear the following claim:

"Soluble fiber from foods such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the soluble fiber necessary per day to have this effect."

Coronary heart disease claims nearly half a million lives a year. High total cholesterol levels and high levels of low density lipoprotein (LDL) cholesterol are known to increase one's risk for heart disease, so consumers are encouraged to keep these levels as low as possible. Scientific evidence indicates that including barley in a healthy diet can help reduce the risk of coronary heart disease by lowering LDL and total cholesterol levels.

"FDA is pursuing new initiatives to help consumers improve the choices they have for healthy and nutritious diets," said FDA Deputy Commissioner Scott Gottlieb, M.D. "We firmly believe that one of the best ways to encourage healthier eating habits is to help consumers get truthful, up-to-date, science-based information about food products so that they can make choices that are based on a better understanding of the health consequences of their diets."

FDA began allowing the claim in December 2005 under an interim final rule, while at the same time accepting public comments on the rule for 75 days. During this time no comments were received that warranted changes to the interim final rule.

Yes, that's a great shame. Comments should certainly have been submitted. I completely missed the opportunity as I somehow was completely unaware of the request for comments? How about you, did you know about this issue? Well, anyway, let's answer my question from above. Why is this bad news for consumers?

There are a few reasons actually. Let's just keep them brief. They are:

1. Dr Gottlieb is using standard rhetorric when he uses phrases such as "truthful, up-to-date, science-based information about food products" because the statements the FDA makes are always colored by multiple forces endemic to FDA and even wider Americam culture that render such comments mere make-believe. These include commercial and economic interests and political realities which operate at multiple levels.
2. The claims perpetuate an approach to food that is fundamentally flawed. It encourages the continuing consumption of highly refined and manufactured foods whch undermines health. Whole foods are much better for health and wellbeing. Highly refined flours, from whatever grain, didturb the digestion, toxify the body and tend to have a higher glycemic index, contributing to development of diabetes.
3. The claims, however qualified, make consumption of barley containing products appear to be healthy to the average consumer. This enhanced health credibility is precisely what the manufacturers want and the FDA has delivered but narrow and selective reviews of questionable "science" relating barley to heart disease makes no reference to the other diseases that the products will worsen, such as bowel cancer, diabetes, and importantly, food sensitivities and worse (see next point).
4. Very importantly, this favorable review and endorsement by an FDA with tunnel vision completely ignores the substantial number of peoplle with celiac disease. All celiacs must avoid wheat, rye, oats and barley as these grains contain the gluten that damages their small intestines. Every single product containing barley, now endorsed as healthy by the FDA, is dangerous to people with celiac disease.

In my view the FDA's endorsement of barley is little more than a commercially contrived marketing device. More people will become more diseased thanks to their efforts.

If you would like to read the full transcript of the FDA's Interim final rule online, it is available at: http://www.cfsan.fda.gov/~lrd/fr051223.html