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 disease1, 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.
Requests also have been made for a qualified health claim for monounsaturated fatty acids and reduced risk of coronary heart disease18, and for eggs with an enhanced omega fatty acid profile.19 Another petition has been submitted to the FDA for qualified health claims relating to chromium picolinate for dietary supplements.20 For example, one proposed health claim reads "chromium picolinate may reduce the risk of cardiovascular disease when caused by insulin resistance."
Although dietary supplements and foods must abide by different regulatory parameters, the EPA and DHA omega-3 fatty acid health and nutrient content claims situation shows that the line can blur. Thus, it is interesting to see what the future holds for compounds such as the popular dietary supplement ingredient chromium picolinate, for which one patent-holder has undergone GRAS self-affirmation for its use in nutritional bar and beverage applications.
Many other dietary components, such as L-carnitine, policosanol and phytoestrogens (to name a few), have been linked to heart or other types of cardiovascular health.
It can be said that L-carnitine has galvanized the nutraceutical revolution since Dr. Stephen DeFelice, author of The Carnitine Defense, coined the term "nutraceutical." ? In his book, DeFelice discusses evidence supporting the ingredient's ability to prevent fatty buildup in the heart and to reduce the health risks posed by poor metabolism, especially for those suffering from heart disease and diabetes.
Research also has given a "thumbs up"? to policosanol, a mixture of higher primary aliphatic alcohols with the main component octacosanol, which is isolated from sugar cane wax (among other sources). The mixture has been shown to lower cholesterol in animal models, healthy volunteers and patients with type II hypercholesterolemia.21
Policosanol is a key component in BeneCardia, a supplement launched last year by Natrol (Chatsworth, Calif.). "Consumers that shop in the health food channel understand the potential benefits of this ingredient. It was popular about two years ago, but the popularity seems to have waned,"? says Vin Kutty, brand manager, Natrol.
Phytoestrogens can be classified into the category isoflavones, lignans or coumestans (a few also add resorcylic acid lactones). Isoflavones are found primarily in legumes, with soybeans being the primary example. Lignans are found in soybeans as well as flaxseed.
Some felt that isoflavones are so key to soy's heart health benefits that they should have been required as part of the soy protein heart health claim.
One study published in 2002 showed that women, particularly older women with increased dietary isoflavone and lignan intake, experienced a decreased risk for atherosclerosis and arterial degeneration.22 The researchers published a second study the same year that showed women who consumed the highest amount of isoflavones and lignans had significantly lower triglyceride levels than those who ingested the least amount of phytoestrogens. And, those who ate significant amounts of lignan-rich foods had less weight concentrated around their waists (a risk factor for heart disease) than those who ate little or no lignan-rich foods.23
Through research, and the efforts of food and supplement manufacturers to communicate with the FDA to obtain health claims, consumers will have more options in choosing healthful foods and supplements.
Sidebar 1:
Hearty Omegas
The belief that consumers understand the heart health benefits of omega fatty acids is not limited to either dietary supplement marketers or to North American companies. In 2004, Kerry Foods' Dawn Dairies (Killarney, Ireland) launched Omega Fresh Milk, fortified with vitamins A, D and E and omega-3 in the form of highly-refined fish oil. "A special dosing system in the manufacturing process allows omega-3 to be added to the fresh milk quickly and easily, and fish oil is used as it is said to be a more direct source of fatty acids EPA and DHA than vegetable sources," ? notes Mintel International's (Chicago) GNPD. Both full- and reduced-fat versions are available, with the product meeting the Irish Heart Foundation's (Ballsbridge, Ireland) approval as a component in a healthy diet.
Toward the end of 2003, in Spain, Biocentury (Quart, Girona) introduced cookies made with olive oil and walnuts that also contain omega-3s. Said to be "good for the heart," ? they are promoted as part of a new line of foods for the "Dieta Mediterrane" (Mediterranean diet). Also in 2003, the Philippines-based company, Monde Denmark Nissin Biscuit, launched crackers fortified with omega-3 fatty acids that "may help reduce the risk of heart disease, thereby making the crackers an important part of a healthy diet."
Other companies, such as Sweden's Onsala, introduced Onsalakorv Balans Sausage toward the end of 2003 (not shown), which it claims as "rich in omega-3, ready to slice for use in sandwiches." Heart health and convenience all rolled into one product!
References
1 Fang J., et al. Exercise, body mass index, caloric intake and cardiovascular mortality. American Journal of Preventive Medicine, 25(4): 283-289; November 2003
2 www.fda.gov/fdac/features/1998/698_labl.html
3 www.cce.cornell.edu/food/fdharchives/030498/psyllium.html
4 vm.cfsan.fda.gov/~dms/flgrains.html
5 www.cfsan.fda.gov/~lrd/tpsoypr2.html
6 vm.cfsan.fda.gov/~lrd/tpsterol.html
7 vm.cfsan.fda.gov/~dms/hclm-k.html
8 www.cfsan.fda.gov/~dms/qhcnuts2.html
9 www.cfsan.fda.gov/~dms/qhc-sum.html#walnuts
10 www.cfsan.fda.gov/~dms/qhc-sum.html#omega3
11 www.fda.gov/ohrms/dockets/dockets/03q0401/03q0401.htm
12 www.PreparedFoods.com/FILES/HTML/PF_newsletter184/
13 murkowski.senate.gov/pressapp/record.cfm?id=221874
14 www.cfsan.fda.gov/~dms/ds-hclbv.html
15 www.cfsan.fda.gov/~dms/ds-ltr12.html
16 www.cfsan.fda.gov/~dms/ds-ltr16.html
17 www.cnn.com/HEALTH/library/HB/00018.html (from a Mayo Clinic newsletter
18 www.fda.gov/ohrms/dockets/dockets/03q0559/03q0559.htm
19 www.fda.gov/ohrms/dockets/dockets/04q0072/04q0072.htm
20 www.fda.gov/ohrms/dockets/dockets/04q0144/04q0144.htm
21 Gouni-Berthold I and Berthold HK, 2002. Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent. Am Heart J., 143(2):356-65
22 Van der Schouw YT et al., 2002. Higher usual dietary intake of phytoestrogens is associated with lower aortic stiffness in postmenopausal women. Arterioscler. Thromb. Vasc. Biol. 22:1316-22
23 De Kleijn MJJ, et al., 2002. Dietary intake of phytoestrogens is associated with a favorable metabolic cardiovascular risk profile in postmenopausal U.S. women: the Framingham Study. J Nutr. 132:276-282
