Delivering heart health: the FDA is allowing an increased number of health claims that link dietary components with reduced risk of cardiovascular disease

Prepared Foods, July, 2004 by Claudia Dziuk O'Donnell

Vaughn Hansen had just turned 51. Having recently completed a year's apprenticeship, he was looking forward to a new job in metal working that would provide his family with a solid income and enable their high school son to attend college.

On Christmas Eve, increasing nausea, cold sweats and a very slight pressure on his chest drove Vaughn to seek out the local hospital's emergency room. Diagnosed with pneumonia, he was given an antibiotic and sent home. The antibiotic did indeed help reduce the symptoms, but four days later, Vaughn died of a massive coronary.

This story is true. This story, or ones much like it, is repeated hundreds of thousands times every year. According to the American Heart Association (Dallas), cardiovascular disease (CVD) kills over 930,000 Americans each year and was the cause of 38.5% of all deaths in 2001 (with more women than men dying of the disease in every year since 1984). Its economic toll is estimated to be $368.4 billion in 2004. Costs include healthcare and lost wages ... but not a child's missed educational opportunities or the hardship visited upon friends and families left behind.

A Regulatory Thumbs Up

Risk factors for CVD include genetics (e.g., a determining factor for cholesterol levels in some), environment (e.g., stress, pollution), socio-economic status (e.g., access to healthcare and information) and behavior (e.g., diet and lifestyle including exercise).

Although overall CVD statistics include deaths from non-diet-related conditions (such as congenital heart defects), and research indicates that exercise may play a role even more important than diet in heart disease (1), both the healthcare community and consumers are well aware of the importance of food choices and food components to cardiovascular health.

Indeed, the diet-health link is so strong that the FDA allows cardiovascular health claims in association with a variety of foods and dietary supplements. Although food marketers can make cardiovascular health claims for foods with reduced levels of certain nutrients such as fat or sodium, the list for products containing healthful components is longer and continues to grow. In order for a product to make a health claim associated with the presence of a beneficial ingredient, other criteria--such as maximum fat levels--must also be met. FDA health claims are allowed for:

1. Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber. Some 0.6g soluble fiber must be present per reference amount without fortification. (2)

2. Dietary soluble fiber, such as that found in whole oats and psyllium seed husk. Foods that contain whole oats must contain at least 0.75g of soluble fiber per serving, and those that contain psyllium seed husk must contain at least 1.7g of soluble fiber per serving. (2,3)

3. Whole grains. Foods must contain at least 51% whole grains (which must contain all three layers of the grain: the endosperm, the bran and the germ). (4)

4. Soy proteins. Foods must contain 6.25g soy protein per serving. (5)

5. Sterol and stanol esters. A food must contain at least 0.65g of plant sterol esters per serving or at least 1.7g of plant stanol esters per serving. (6)

6. Potassium. In October 2000, the FDA authorized the claim "Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke." (7)

Additionally, the FDA allows qualified health claims for:

7. Tree nuts (such as almonds and walnuts) and peanuts. A "qualified" health claim has been approved for nuts. "Qualified health claims" are statements that must be qualified to convey to the consumer that the noted diet-disease relationship is supported by less than significant scientific agreement. (8,9)

8. Omega-3 fatty acids (EPA and DHA). The FDA encourages manufacturers of dietary supplements to limit suggestions of intakes to 1g or less per day of EPA and DHA omega-3 fatty acids. (10) The FDA has been petitioned to allow a similar health claim for foods. (11) And, recently, the agency said it would allow foods to carry a nutrient content claim for certain omega-3 fatty acids. (12,13)

9. B-vitamin dietary supplements. Part of the claim may read: "As part of a well-balanced diet that is low in saturated fat and cholesterol, folic acid, vitamin B6 and vitamin B12 may reduce the risk of vascular disease." (14,15) Folic acid is known to reduce homocysteine levels, important risk factors for CVD. Another vitamin (B3 or niacin) was physicians' treatment of choice for lowering cholesterol before today's more effective prescription medications. It has been shown to decrease LDL and increase HDL in a way not dissimilar to some statin drugs.

Waiting in the Wings The FDA has received petitions on other components positively associated with cardiovascular health. For example, a health claim has been requested for vitamin E dietary supplements (for 100-800IU/day depending on the form). (16) Much evidence exists for the CVD benefits of vitamin E and other antioxidants, both in supplement and food forms. (17) The FDA previously ruled against allowing a claim linking antioxidants (which would include vitamin E) to reduced risk of cancer.