Regulatory Update: Soy Heart Health Claim Redux
Health claims characterize the relationship of a substance to a disease or health-related condition, and require prior FDA approval or notification to FDA of authoritative status. An unqualified health claim must be based on significant scientific agreement. On December 21, 2007, FDA published a notice seeking public comment on plans to reevaluate the scientific evidence for the health claim on soy protein and risk of coronary heart disease (21 CFR 101.82) that was authorized in 1999. A model statement for this health claim is: "Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein."
Since the health claim was authorized, numerous studies have investigated the relationship between soy protein and coronary heart disease, but the findings have been inconsistent. It is unclear, for example, whether a small beneficial effect on low-density lipoprotein (LDL)-cholesterol observed in studies was due to soy protein or to other types of soy products. FDA intends to assess relevant data to determine whether the totality of the scientific evidence continues to meet the significant scientific agreement standard. If not, FDA would publish its findings and solicit comments on a proposed change to this heart health claim.
Leslie Krasny is an attorney and microbiologist for the San Francisco law firm Keller and Heckman LLP. For more on soy and health claims, turn to “Expert Opinion.”
Until recently, heart disease in women hadn’t received the same attention as it did in men. Today, with the knowledge that heart disease kills more women than does breast cancer, and that compared to men, heart disease in women can manifest earlier and with more subtle symptoms, women and heart-health is a topic that’s come out of the shadows. Armed with this awareness, ingredient makers and food processors are stepping up to the plate to help women substantially reduce the risk of cardiovascular challenges.
When it comes to heart health (as well as bone and skin health), key ingredients, according to Heather Biehl, senior scientist in the Health Ingredients and Technology group of Cincinnati-based Wild Flavors (www.wildflavors.com), are: calcium, soy isoflavones, Co-Q10, phytosterols, polyphenols, and vitamins D and K. “Products with these nutrient blends can be more specifically targeted to women using increased levels of ingredients – more so than children or men may need,” Biehl says.
Inflammation is a major component of cardiovascular disease. Because of this, ingredients with anti-inflammatory properties have gained attention of processors developing heart-healthy products. Many of the antioxidant superfruits, such as pomegranates, cranberries, red grapes and tart cherries, have shown strong anti-inflammatory properties, yet are versatile and easily employed ingredients. This makes them perfect for formulations aimed at decreasing the risk of heart disease.
Targeting women’s health needs in a direct manner has been especially rewarding for cereal makers Quaker Foods Inc. (www.quakeroats.com), Chicago, and Kellogg’s (www.kelloggs.com), Battle Creek, Mich. Kellogg’s “Smart Start Healthy Heart” cereals were marketed as the first ready-to-eat cereal to contain oat bran fiber for lower cholesterol. Quaker, one of the first companies to market to heart health, now has its “Take Heart” line of antioxidant and fiber-rich instant oatmeals. And what’s a heart-healthy breakfast without orange juice? Atlanta-based Coca-Cola’s Minute Maid Heart Wise is the first o.j. with plant sterols (see “Not Your Momma’s Orange Juice”). Mark Andon, Ph.d, director of nutrition for Quaker, says he sees targeting women with healthy foods as an industry-wide challenge for processors.
Calcium and Vitamin K
"Two of the biggest health issues facing women today are osteoporosis and cardiovascular disease,” says Leon Schurgers, PhD, of the Cardiovascular Research Institute, University of Maastricht, Netherlands. According to Schurgers, vitamin K – specifically, Vitamin K2, also known as menaquinone-7 or MK-7 has a special place in the fight against cardiovascular disease in women. Without adequate vitamin K, calcium can build up in blood vessels and stiffen them, laying the foundation for heart disease.
“Only recently has the correlation between these two issues become understood,” Schurgers explains. “Studies show that women with osteopenia and osteoporosis have a much greater chance of developing heart disease. Called the ‘calcium paradox,’ bones become depleted of calcium while arteries and soft tissues become calcified.”
Vitamin K2 is necessary for the body to "glue" calcium into healthy bone matrix, shielding vessels from calcium. Most Americans are deficient in the K2 form of the vitamin. Interestingly, no correlation has been found for vitamin K1, the form found mostly in leafy green vegetables. PLThomas (www.plthomas.com), Morristown, N.J., markets a purified form of K2, MenaQ7, derived from fermented soy (natto). (See “Vitamin K Last but Not Least”).
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