FDA grants barley claim, but denies two others

The Food and Drug Administration in May granted a qualified health claim for whole grain barley's ability to reduce the risk of coronary heart disease, while it denied health claim petitions for two other applications.

One denial related to green tea's effect on cardiovascular disease, which followed on last year's denied petition for green tea and most kinds of cancer. The second denial related to whey-protein infant formula's ability to reduce the risk of food allergy symptoms, in particular skin rash.

The barley claim is 'positively worded,' unlike many qualified health claims that begrudgingly accept a link between a nutrient and health. Many of these are so convoluted in their wording as to turn off manufacturers from using the claim on packaging.

A barley claim can state that '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.'

To qualify, foods must provide at least 0.75g of soluble fibre per serving.

"We firmly believe that one of the best ways to encourage healthier eating habits is to help consumers get science-based information about food products," said FDA deputy commissioner Scott Gottleib, MD.

For green tea, the FDA concluded that this threshold was not met. In a letter to petitioner Ito En tea company, the FDA said, "There is no credible evidence to support qualified health claims for green tea or green tea extract and a reduction of a number of risk factors associated with CVD."

Nestle had petitioned the FDA to claim that feeding an infant 100 per cent whey-protein partially hydrolysed formulas can reduce the risk of atopic dermatitis. The FDA concluded that a majority of the 36 studies submitted did not properly control for casein, the other major allergen found in cow's milk.

The barley claim was submitted by the National Barley Foods Council and partially underwritten by Cargill, which has a barley beta-glucan ingredient, Barliv. "The acceptance of barley supports our initiative to petition for future health claims that will include Barliv," said Pam Stauffer, marketing programs manager for Cargill Health & Food Technologies.

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