However, the strict wording of the claim also shows that while the agency may be willing to give an inch when it comes to saturated fat, it will not let manufacturers and suppliers take a foot.
According to the new qualified health claim, companies can now state that “supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease.”
The July 24 announcement that the claim may be used immediately is notable because it deviates from FDA’s long-standing position that foods bearing coronary heart disease related claims must be low in saturated fat and cholesterol.
The agency acknowledges that while whole or chopped macadamia nuts contain no cholesterol, they do not meet the regulatory definition of low saturated fat or low fat.
According to the regulations, products with saturated fat above 4 grams per reference amount customarily consumed or 50 grams cannot qualify for a health claim, but raw macadamia nuts have 6.03 grams of saturated fat per 50 grams.
“However,” the agency explains of its exception to the rule, “macadamia nuts have a favorable ratio of unsaturated fat to saturated fat (5:1) and contain other potentially beneficial substances such as dietary fiber and phytosterols” which are known to help reduce the risk of heart disease.
As such, FDA says, “a qualified health claim about macadamia nuts and reduced risk of CHD might assist consumers in maintaining healthy dietary practices.”
It also notes that it is willing to make the exception because it “concurs with the current 2015-2020 Dietary Guidelines for Americans that nuts in general are nutrient dense foods that can serve as a protein source and contribute to a healthy US-style eating pattern.”
Despite this level- and modern-day reading of the regulations and evolving nutritional science, the agency clearly wants to keep health claims for products with saturated fat on a short leash, hence the caveat in the qualified health claim that for macadamia nuts to potentially convey a risk reduction benefit they must be consumed “as part of a diet low in saturated fat … and not resulting in increased intake of saturated fat or calories.”
The agency explains that this disclaimer aims to “assist consumers in understanding the relative significance of this claim in the context of the total daily diet,” and the fact that the credible evidence currently available shows the benefit of macadamia in lowering TC and LDL-C when they replace other sources of saturated fat and calories in the diet.
A 'milestone' decision
FDA’s decision is in response to a petition filed by the Royal Hawaiian Macadamia Nut, Inc., nearly two years ago asking the agency to approve the qualified health claim.
The petition included 74 publications that the company said substantiated the relationship between the nuts and the health claim, including 5 human intervention studies – only three of which FDA said met its stringent standards.
Those studies showed that consuming 1.5 ounces of macadamia nuts daily lowered TC and LDL-C compared to the average American diet, but not when compared to a low-fat diet.
The decision is a “milestone” that “marks a significant evolution in the recognition of macadamia nuts as a potentially healthful food, which will positively benefit the entire macadamia nut industry,” the Royal Hawaiian Macadamia Nut said in same-day statement.
The company, which sells a variety of macadamia products under the Royal Hawaiian Orchard brand, added that the claim will help place the macadamia nut on more even footing with almonds, walnuts and pistachios, which consumers already associate with better health.
“We want consumers to know that there is real, supportive evidence with respect to the benefits of consuming macadamia nuts,” the company’s CEO Scott Wallace said in the statement.
He added that in addition to potentially reducing bad cholesterol levels and the risk of heart disease and stroke, “one ounce of macadamia nuts (about 15 nuts) is also an excellent source of thiamin and manganese, a good source of dietary fiber and copper, and contains protein, magnesium, iron and phytosterols.”