The Hindu Business Line : Lack of clinical proof may bar cashew from FDA nut list

LACK of scientific evidence showing that cashew can reduce the risk of heart disease might turn out to be a hurdle for getting cashews included in the select list of nuts by the US Food and Drug Administration (FDA).

The US-based International Tree Nut Council Nutrition Research and Education Foundation (INCNREF) in a letter to the Cashew Export Promotion Council of India (CEPC) had pointed out this discrepancy. It said, ``unfortunately, we could only give reference about macadamias, since there are no research articles on cashews. Which brings up an important issue - the need for cashew studies.

The FDA allowed an exemption for walnuts on the grounds that there is a large body of scientific evidence showing that walnuts can reduce the risk for heart disease. Until we have clinical studies for cashews, it will be very difficult, if not impossible, to persuade FDA to allow any kind of exemption for cashew alone.''

The epidemiological data on mixed nuts, which includes cashews, is very consistent in showing that nuts can reduce the risk for heart disease.

``Therefore, all of our media efforts surrounding the claim have included cashews, macadamias, Brazils and pine nuts,'' Mr Doughlas D. Youngdahl, Chairman, INCNREF, said.

However, the global council on the representation of CEPC said it would request FDA to acknowledge that there was no evidence to suggest that the nuts not included in the qualified claim increase the risk of Coronary Heart Diseases (CHD).

Mr Sasi Verma, Secretary, CEPC, told Business Line that the council would take up the issue with the Association of Food Industry (AFI) in the US also for pursuing this issue with FDA.

However, to get the claim approved was going to be an expensive affair, he said.

Clinical studies would involve Rs 4-5 crore, which the Indian cashew industry alone cannot afford, he said. The Government assistance for such projects would be around 25 per cent of the total cost, he said.

FDA, which has just approved the first qualified health claim for select list of nuts, had disqualified cashew along with Brazil nuts and macadamias because they have more saturated fat than the prescribed disqualification levels.

CEPC had conveyed to INCNREF that the "FDA has arbitrarily set the limit for saturated fat at four grams per 50-g reference amount for any food product,'' he said.

In a communication, he told the nut council that cashews marginally fail the saturated fat disqualification level, because a technicality in the reference amount customarily consumed requires the levels in 50 g of cashews to be considered instead of the serving size of 1 oz.

Fifty grams is approximately 75 per cent higher than the recommended serving size of 1 oz. The approved health claim suggests that people eat 1.5 oz of nuts per day. If 1.5 oz were considered a "reference amount customarily consumed", cashew would not be disqualified.

"There is definitely some ambiguity here, and probably enough to ask for a waiver of the saturated fat disqualification for cashews. Since cashews are the most popular stand-alone tree-nut snack in the US, it is one of the easiest ways for people to get their tree-nut nutrients. Cashews have substantially less saturated fat than the other disqualified nuts," he said.

Cashews, he said, were specifically excluded along with some other nuts, which have more saturated fat than the maximum levels prescribed under Section 21 CFR 101.14(a)(4).

According to this section the "disqualifying nutrient levels means the levels of total fat, saturated fat, cholesterol, or sodium in a food above which the food will be disqualified from making a health claim.

These levels are13.0 grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of sodium, per reference amount customarily consumed, per label serving size, and, only for foods with reference amounts customarily consumed of 30 g or less, or two tablespoons or less, per 50 g.

The original claim statement suggested by INC to FDA referred to consumption of one Oz of nuts per day. But FDA reverted with approval of a claim statement suggesting eating of 1.5 Oz of nuts per day. Why the FDA increased the recommended daily consumption is not clear, he said.

However, it follows that 1.5 Oz could also be considered as an additional "reference amount customarily consumed" for nuts for the purpose of a proposed health claim.

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