Substantiation for Heart Health Claims

Companies marketing heart healthy products have been targeted by FTC over claims made in advertisements. Due to a lack of “reliable and competent" evidence in support, FTC charged Tropicana with false advertising over claims that orange juice could lower blood pressure, low-density lipoprotein (LDL) cholesterol, and homocysteine levels while increasing high-density lipoprotein (HDL) cholesterol and folate concentrations in the blood.^1,2,3,4 FTC has also fined POM Wonderful for making claims its products could reduce risk of heart disease in the absence of reliable, competent scientific evidence. While regular intake of orange or pomegranate juice can provide nutrients related to heart health, FTC reasoned Tropicana and POM overstated this fact and did not provide the scientific evidence required for claim substantiation.^5,6,7,8

Obtaining evidence for claim substantiation is an important avenue to expand product demand.  Regulators assess the totality of evidence regarding a claim, but hold the randomized, controlled trial (RCT) as the highest level of evidence, making it a necessity for substantiating claims. A well designed RCT helps to control for confounding variables and minimize bias to provide evidence of a causal relationship between an intervention and outcome.

In order to run a successful study to substantiate a claim, a suitable population must be chosen that limits confounding factors. Importantly, regulations require only healthy populations be studied for structure/function claims. Yet, as healthy people do not always present consistently with the indication of interest, the resulting fluctuations contribute to inconclusive results.

When choosing endpoints, it is important to consider the specific wording and requirements of the claim and select endpoints that pertain to this, which may not always be clear in nutrition studies.

Read more about the challenges associated with substantiation for hearth health claims, along with advice on how to design effective clinical trials, by downloading INSIDER’s Heart Health Digital Magazine.

Matthew Roberts is an accomplished innovation executive with more than 25 years of success at Abbott, Nestle and NBTY. He is focused on driving growth-phase market opportunities across the food, nutrition and agricultural sectors. He learns by doing, which means that, in addition to managing, he enjoys riding with the sales force, working a shift in the factory or field, and participating in the laboratory whenever possible. He is a principal at GSM Advisors, which works with nutrition businesses to access capital and empower growth in the market, as well as a member of the Cold Spring Harbor Laboratory Corporate Advisory Board, and a member of the Scientific Advisory Board at KGK Synergize.