Third party reviews play an important role in securing FDA approval for the food labeling and health claims that food manufacturers may make to the public. Companies are allowed to make health claims about their product only when there is sufficient scientific evidence to establish a relationship between a food or ingredient and prevention of a health condition or disease. (A health claim can also be made when a relevant scientific arm of the US government makes published authoritative statements about a relationship.)
For example, the makers of Tropicana® orange juice are permitted to use a health claim on their labeling because a link between insufficient potassium intake, high blood pressure and risk of stroke has been shown to exist. The company has used the food labeling health claim to enhance its positioning in the marketplace. As a result, other companies are following suit.
LSRO is among the most active assessment firms for helping companies determine whether their science meets the necessary level of proof, and recommends what research is needed to comply with the FDA's requirements. Contact us at LSRO@LSRO.ORG for more information.
Our experience with health claims is among the most extensive in the industry; Examples include:
Analyzing the potential association between calcium and osteoporosis.
This report investigated the potential scientific association between calcium and osteoporosis. It was among the central findings the FDA used in its landmark decision permitting companies to make a claim about a beneficial association between the ingredient and the disease.
Examining the claim of a beneficial relationship between walnuts and coronary heart disease.
Walnuts are one of the oldest known tree foods, with historical references dating back to Persia in 7000 BC. This nut is rich in Vitamin E and magnesium and is a high-energy food; but it is also fatty. Fats and fatty acids - such as those found in nuts - are known to increase cholesterol levels, leading, in turn to increased risk for coronary heart disease. Could a fatty nut actually be good for the heart? Click here to read findings that may surprise you.
Evaluating the evidence for a relationship between colorectal cancer risk and calcium, vitamin D, or dairy intake.
There is considerable animal-based research addressing the role of dietary calcium in the prevention of colorectal cancer. The epidemiological data and clinical studies of putative biomarkers provide results from human populations. Results from animal studies provide a biological mechanism for protection by showing that calcium may be important in decreasing cellular proliferation that occurs in the colon when the chemical carcinogen-exposed exposed animals are exposed to bile acids and fatty acids. Though the evidence was found insufficient to support an unqualified health claim, the report identified research gaps that would help clarify the relationship.
For additional reports, visit our e-bookstore.
