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”).
Note to R&D:
The pipeline for heart-healthy ingredients holds many that are particularly effective for women. Here are three to watch.
• Green tea / epigallocatechin gallate (EGCG)
• Cocoa and Epicatechin.
• Soy and isoflavones
Formulating with soluble fibers (such as beta-glucan from oats or psyllium) has become a leading industry trend toward adding a heart-healthy claim. The concept readily extends to other blends tailored to products for women. One soluble fiber seeing increasing use is inulin, from chicory root and artichokes. Inulin is prized for its properties as a fat substitute, carbohydrate replacement, flavor modulator and shelf-life extender.
Minneapolis-based Cargill Inc. (www.cargill.com) created two beverage blend product concepts combining calcium with its Oliggo-Fiber inulin. “Women tend to not get enough fiber, calcium and omega 3 fatty acids in their diets, so foods with these ingredients can help address shortfalls,” notes Cathy Kapica, PhD, RD, vice president of global health and wellness for Ketchum Inc. (www.ketchum.com).
Beneo inulin and oligofructose system, by Orafti Active Food Ingredients (www.orafti.com), Malvern, Pa., is being used in a growing number of successful products targeting the ticker. Anne Franck, Ph.D., Orafti's executive vice president of science and technology, points to a new study on atherosclerosis suggesting the proven benefits delivered by inulin and oligofructose extend to heart health. “While further research is needed,” she adds, “these results support evidence from clinical trials that inulin and oligofructose can modulate cholesterol and triglycerides levels in the blood.”
NutriSystem Inc., Horsham, Pa., (www.nutrisystem.com) designed its NutriSystem Advanced Women’s Program with foods that include its proprietary OmegaSol ingredient system. OmegaSol combines 40mg of EPA and DHA omega-3s with heart healthy soluble fiber. The fiber also increases satiety while masking any negative taste of fish oil.
The Plants Have It
Botanicals, too, have a firm place in heart-healthy formulations. Wild Flavors provides naturally derived flavorants and nutraceutical ingredients for the food and beverage industry. WILD created its innovative NET Turmeric and NET Curcumin, nanoencapsulated extracts demonstrating advancements in light and heat stability. Not only does the nanotechnology increase the longevity of colors in formulations, the compounds have shown strong antioxidant effects. Curcumin, especially, is known as an anti-inflammatory and anticarcinogenic compound. Both ingredients also have shown anti-microbial properties.
Resveratrol, found in red fruits such as mulberries and grapes, is a natural phytochemical ideal for formulations aimed at women’s health. In addition to its anticarcinogen properties, it may help reduce cholesterol, regulate blood sugar and blood pressure. It also has been shown to counteract osteoporosis, the inflammatory process and viral proliferation. These processes all are related to heart disease and cancer.
Resveratrol has been used by processors in mainstream products for several years, for example, Kellogg Co. (www.kelloggcompany.com), Battle Creek. Mich., uses Fresno, Calif.-based San Joaquin Valley Concentrates’ (www.activin.com) ActiVin grapeseed extract in some of its Kashi line of cereals and snacks. ActiVin is a GRAS-affirmed, water-soluble powder that can be added to the liquid portion of a food or beverage, or as a powder for dry-blending. It’s stable to heat, especially processes used in baking.
Folate is another ingredient associated with women’s health to the extent its inclusion in flour and baked products became an industry standard. Not only does it help prevent neural tube defects in fetuses, increased consumption of folate may reduce the risk of breast cancer by 44 per cent, says a new study from Sweden. But folate also regulates calcium, making it a boon for heart health as well.
Nuts are a macroingredient processors find extremely versatile in formulating heart-healthy products. A recent study from the University of Toronto found that a diet that includes almonds not only lowers cholesterol levels, as proven in numerous almond and other nut studies, but also C-reactive protein levels key markers of inflammation and an independent risk factor for heart disease. In addition to its high antioxidant content, an ounce of almonds is an excellent source of vitamin E and magnesium, a good source of protein and fiber, as well as monounsaturated fat, potassium, calcium, phosphorous and iron – all of which contribute to a heart-healthy profile.
Phytosterols, also called plant sterols, are associated with lower LDL cholesterol (considered a primary factor in heart disease) without affecting HDL cholesterol levels. This is because fat-soluble plant sterol esters (“stanols”) compete with cholesterol for uptake. The FDA has approved the following food health claim for phytosterols: “Foods containing at least 0.65g per serving of plant sterol esters or 0.4g of plant sterols, eaten twice a day with meals for a daily intake of at least 1.3g of plant sterols or 0.8g of sterols as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease.”
More on the Web
There’s a lot more on heart and women’s health at WellnessFoodsOnline.com and FoodProcessing.com – more than 300 articles, news items and products.
To qualify for FDA's health claim, foods and beverages must contain at least 800mg of sterols per serving. Unilever, Englewood Cliffs, NJ (www.unilever.com) addressed this issue with Promise Activ SuperShots yogurt each 3-oz shot delivering 2g of plant sterols. Cargill makes CoroWise – a free plant sterol that is easier to incorporate than its counterparts. Los Angeles based Corazonas Foods Inc in collaboration with Brandeis University, Waltham, Mass., makes Heart-Healthy Tortilla Chips in a number of flavors. The chip provides 400mg of sterols per serving.
Ingredients makers are witnessing an increased interest in phytosterols, polyphenols and probiotics for heart health. Probiotics, by helping increase friendly gut flora are believed to help manage cholesterol metabolism. Manufacturers have been including probiotics in yogurt and other dairy products for several years, but recently they successfully jumped to bars, cereals and chocolate confections. The Dannon Activia yogurt product line, by Groupe Danone (www.danone.com), Paris, is one particularly successful example, showing double-digit sales increases for two years. and billions of dollars in worldwide sales.
Polyphenols act as antioxidants to protect cells and body chemicals against free radicals damage. One of the reasons olive oil is heart healthy is because it contains polyphenols. Olive oil is part of the Mediterranean diet. “The Mediterranean Diet is perfect for women,” says Sara Baer-Sinnott, executive vice president of Oldways Preservation Trust (www.oldwayspt.org), the Boston food issues think tank. “It’s time-tested, and numerous studies confirm its healthfulness in terms of longevity and disease prevention.”
The Mediterranean Diet just celebrated its 15th year with Oldways creating its “Med Mark,” stamp for those manufacturing products that conform to the Mediterranean diet. Processors already branding with the mark include Sabra Corp.’s line of hummus dips and salads, Lucini Italia’s olive oil products, Liberty Richter Inc.’s International Collection brand of olive oils and dipping oils, and Davina olives.
Complexes of multiple ingredients are popular too. LycoRed Ltd. (www.lycored.com), Orange, N.J., a global supplier of lycopene and other carotenoid antioxidant ingredients important to health, teamed with Tara Dairy Ltd. in developing “YOU” an innovative line of fortified dairy products targeting women 30-40 years old. YOU contains a unique vitamin and mineral formulation to help protect women's health, including heart health, via calcium, a full complement of B vitamins and iron, plus vitamins D and E.
Avoiding flavor clash of the functional ingredient blend comes via LycoRed’s microencapsulation technology. “Manufacturers can’t afford to risk negatively impacting taste or aroma when they fortify products with multiple nutraceuticals,” explains Udi Alroy, vice president of global marketing. “Our fortification capabilities allow us to combine ingredients without cross-interaction to create the neutral flavor profile demanded by functional foods.” Although YOU currently is not marketed in the U.S., the companies hope to penetrate the local market soon.
A recent survey commissioned by the IFIC showed that about half of consumers (53 percent) mention their heart and circulatory conditions as a top health concern. This puts processors in a position to cater to the needs of a burgeoning market easily served by a variety of functional ingredients ready-made to effectively serve the growing need.