Health Claims- Is It Really Heart Healthy

Although shoppers obtain information on health and nutrition from various outlets, approximately half of American shoppers use food labels, which serve as a primary medium for delivering nutrition information. Qualified health claims provide consumers with a valuable opportunity to learn about new or evolving relationships between diet and disease and develop an awareness of the health benefits of common foods to improve their buying and consumption habits. However, suppose shoppers are unable to differentiate between the claims properly. In that case, they could not make adequately informed decisions regarding the possibility that a food will have the health advantage claimed (Berhaupt-Glickstein & Hallman, 2017).

Health-related claims are statements about a food's nutritional quality (nutrition claims) or suggest a correlation between a food and a health result (health claims). Health-related claims have a considerable influence on eating choices. Current research shows that items with a health-related claim are 75% more likely to be selected than an equivalent product without a health-related claim (Kaur, Scarborough, & Rayner, 2017).

Health claims, nutrition content claims, and structure and function claims are the three types of claims that can legally be used on food and nutritional supplement labeling in the United States. Health claims are founded on a very high level of scientific evidence. A topic of considerable debate has been the issue of what constitutes significant scientific consensus. The FDA outlines a framework for evaluating the strength and accuracy of scientific evidence leading to significant scientific consensus. Without exception, the "gold standard" for health claim certification is randomized, controlled clinical intervention trials. However, the number of randomized, controlled clinical intervention trials required for a health claim to have significant scientific consensus is unclear. Significant scientific consensus claims are often permitted based on statements issued by certain governmental authorities. The FDA developed a rating scale for qualified health claims from moderate/good, 'B' level, to extremely bad, 'D' level, representing the relative strength of the empirical evidence supporting the proposed claim. Authorized health claims are 'A' level claims that satisfy the requirement of significant scientific consensus (Hasler, 2008).

It has been estimated that health claims and labeling caused the increased consumption of high-fiber cereals by 2 million more households between 1985-1987 (Hasler, 2008). There is a significant scientific consensus based on a high level of scientific evidence that high levels of fiber intake and, in particular, the consumption of whole grains is correlated with a considerably lower prevalence of Coronary Heart Disease (CHD). This makes the health claim that food containing high levels of fiber and meeting the standards below is heart-healthy, an FDA-approved 'A' level health claim (Anderson et al., 2009).

The following is the preapproved authorized health claim regarding fiber and CHD.

"Soluble fiber from foods such as [*Insert name of applicable soluble fiber]) of this section and, if desired, the name of food product], 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 ____ grams of the [grams of soluble fiber applicable soluble fiber specified] soluble fiber from [*Insert name of applicable soluble fiber] necessary per day to have this effect."

Requirements for using these claims:

  • The food product must include at least 0.75g (per amount of the food typically consumed) of one of the following:
    • Oat Bran
    • Rolled oats
    • Whole wheat flour
    • Whole grain barley and dry milled barley
  • The food containing oatrim must contain ≥0.75g of beta-glucan soluble fiber per amount of the food typically consumed.
  • The food containing psyllium husk must contain ≥01.7g of soluble fiber per amount of the food typically consumed.
  • The amount of soluble fiber must be claimed in the nutrition information label.
  • The food must meet the requirement for a "low saturated fat" The only acceptable exception is if the food exceeds the requirement for "low fat" food due to fat derived from the whole oat sources.
  • The food must meet the requirement for a "low cholesterol food".

(FDA Reader, 2018)

However, assuming the presence of high fiber makes a food likely to cause a decreased risk of CHD without examining the effects of other ingredients would be unwise. For example, if a Cheerios label meets the criteria above but has a great deal of added sugar, what is the sugar consumption's effect on CHD risk? A systematic review and meta-analysis of randomized controlled trials by Morenga et al. (2014) reveal that higher sugar intakes caused increased triglycerides, total and LDL cholesterol, and blood pressure. It is well known that hyperlipidemia and hypertension are correlated with CHD. Sugar consumption tends to be a predisposing factor for CHD through inflammatory, thrombotic, oxidative, and hormonal pathways. Sugar consumption is also a precipitating factor via increased demand for myocardial oxygen, activation of the cardiac sympathetic nerve, and the adhesiveness of platelets. Many lines of evidence correlate added sugars as etiologic in CHD (Dinicolantonio, Lucan, & O’keefe, 2015). Conflicting ingredients can essentially reverse the beneficial effects of the other ingredient. Clinicians need to be aware of the current scientific evidence and consensus on food claims while at the same time educating patients on how to read a food label for other conflicting ingredients. So if a food claims to be heart-healthy and meets the above criteria without the presence of conflicting ingredients, then the claim is evidenced. However, if there are additional added sugars, for example, then the claim that the product is heart-healthy is unsubstantiated. Therefore, more regulation by the FDA is needed to ensure that certain conflicting ingredients, such as added sugar, are not in a product with an authorized health claim.


Anderson, J. W., Baird, P., Davis, R. H., Ferreri, S., Knudtson, M., Koraym, A., Waters, V., & Williams, C. L. (2009). Health benefits of dietary fiber. Nutrition Reviews, 67(4), 188–205. https://doi.org/10.1111/j.1753-4887.2009.00189.x

Berhaupt-Glickstein, A., & Hallman, W. K. (2017). Communicating scientific evidence in qualified health claims. Critical Reviews in Food Science and Nutrition, 57(13), 2811–2824. https://doi.org/10.1080/10408398.2015.1069730

Dinicolantonio, J. J., Lucan, S. C., & O’keefe, J. H. (2015). The Evidence for Saturated Fat and for Sugar Related to Coronary Heart Disease. Progress in Cardiovascular Diseases. https://doi.org/10.1016/j.pcad.2015.11.006

FDA Reader. (2018). Authorized Health Claims You Can Use On Your Label. Retrieved January 9, 2021, from https://kazoo-polygon-mbxl.squarespace.com/blog/2018/12/17/pre-approved-health-claims-you-can-use-on-your-label#anchor-soluble-fiber-and

Hasler, C. M. (2008). Health claims in the United States: An aid to the public or a source of confusion? Journal of Nutrition, 138(6), 1216–1221. https://doi.org/10.1093/jn/138.6.1216s

Kaur, A., Scarborough, P., & Rayner, M. (2017). A systematic review, and meta-analyses, of the impact of health-related claims on dietary choices. International Journal of Behavioral Nutrition and Physical Activity, 14(1), 1–17. https://doi.org/10.1186/s12966-017-0548-1

Morenga, L. A. Te, Howatson, A. J., Jones, R. M., & Mann, J. (2014). Dietary sugars and cardiometabolic risk: systematic review and meta-analyses of randomized controlled trials of the effects on blood pressure and lipids 1-3. Am J Clin Nutr, 100, 65–79. https://doi.org/10.3945/ajcn.113.081521