New Rules on Food Health Claims

Contrary to the labeling of our pseudo-product (above), new rules urge food processors to be scientifically accurate and conscientious in developing and substantiating health claims.

Since 1930, the FDA has regulated how foods are made and sold in the U.S. New rules allowing the use of food claims before comprehensive FDA review and approval put greater obligation on manufacturers. While the relaxed regulation is a boon for the food and dietary supplement industry, creating a flood of foods with all kinds of health-benefit claims, understanding the current regulatory environment and anticipating the market accurately is imperative for those seeking to maximize opportunities. Consumers say health claims are useful and help with food selection. Universally, they prefer succinct wording rather than long and complex statements. But they want government approval to ensure the health claims are honest. Most consumers cannot distinguish between nutrient content, structure-function and health claims. Food companies, however, invest considerable efforts and resources to get claims approved and align their marketing strategy accordingly. The new regulations are a call for food companies to be scientifically accurate and more conscientious in the development and substantiation of claims. This is especially important when considering that the "halo" effect of health claims diverts consumers from seeking further nutrition information.Writing marketing messages that resonate with consumers can be challenging, which makes the current health-claim approval process expensive. Counterintuitively, provisions in the law allow the FDA to authorize health claims if supported by an authoritative statement currently in effect and published by a U.S. government scientific body or the National Academy of Sciences. The FDA has 120 days to disallow it; otherwise, the manufacturers’ claims automatically prevail. What Health Claims Can Do for the Food IndustryWhen America’s largest juice maker, Tropicana (www.tropicana.com), Bradenton, Fla., received FDA permission in 2000 to use a health claim linking orange juice potassium content with reduced risk of stroke, it helped revived overall orange juice sales. The generic health claim benefited every orange juice company and consumers quickly came to regard orange juice as a functional food.Health claims such as these plus those promoting such benefits as bacterial anti-adhesive properties (cranberries) and cardiovascular health properties (pomegranates and some tropical fruits) all have a common theme: Their health benefits are intrinsic. Nutrition science is helping to uncover the intrinsic health benefits of many foodstuffs such as tea, olive oil, blueberries, barley, oats and whole grains, all to the excitement of food formulators.Generic claims - those not tied to a specific branded product or ingredient - can be useful to food manufacturers. But they can be a disadvantage for some ingredient vendors. The petition from Pittsburgh’s H.J. Heinz Co. (www.heinz.com) and Lycored Natural Products Industries Ltd., (www.lycored.com), La Crosse, Wis., submitted to the FDA addresses the cancer-fighting properties of lycopene via Lycored’s natural tomato complex, Lycomato.Because the petition is related to Lycomato (a Lycored product), synthetic lycopene formulators may be precluded from applying it to their products. The pending FDA decision has immense ramifications for the lycopene market, valued at $34 million and estimated to double annually. A Grain of TruthGrain-food manufacturers are delivering heart-health benefits simply by using whole-grain ingredients, intrinsically healthy foodstuffs that bring scientifically proven health benefits without adding excess cost. If a processed food label lists whole grains, the "whole-grain" part of the food is required to have virtually the same proportions of bran, germ and endosperm as the harvested kernel does before it is processed. However, with no universally accepted definition of whole grains and whole-grain foods, the FDA relies on the American Assn. of Cereal Chemists’ definition: "Foods made from the entire grain seed, usually called the kernel, which consists of the bran, germ and endosperm. If the kernel has been cracked, crushed or flaked, it must retain nearly the same relative proportions of bran, germ and endosperm as the original grain in order to be called whole-grain."

Sara Lee has jumped on the whole-grain bandwagon, but more stealthily than some, with its new Soft and Smooth bread. The product resembles white bread but is made with ConAgra Foods Ingredients' Ultragrain white whole wheat flour.

Foods that carry the whole-grain health claim are required to contain 51 percent or more whole-grain ingredients by weight, and they must also be low in fat. There is no current test to measure the whole-grain levels the FDA approves for whole-grain claims (fiber content is used instead). This has led to abuse of the whole-grain claim by some manufacturers.Many health experts regard the whole-grain health claim to be flawed. They argue that if there is no test, there should be no claim. They recommend instead that foods fortified with whole grains make a fiber health claim if that’s what is being measured.Formulation with whole grains accelerated early in 2004, primarily in anticipation of the new Dietary Guidelines. General Mills (www.generalmills.com), Minneapolis, converted all its cereal formulations to whole-grain. Nestlé (www.nestle.com), New Milford, Conn., launched a 100-percent whole-grain frozen entrée line. Sara Lee Bakery Group (www.saralee.com), Chicago, released Soft and Smooth whole-grain white bread made with ConAgra Foods Ingredients' Ultragrain white whole wheat flour. The wheat, milled with an extra refining step from hard white winter wheat, makes whole-grain products that resemble those from refined wheat.Companies such as General Mills have introduced new descriptors for whole-grain products. These include "excellent source" (16 g or more per serving), "good source" (8-15 g) or "made with" (at least 8 g). In May 2004, the company submitted a "Whole-Grain Descriptive Claims Citizen Petition" to the FDA with suggestions to raise the threshold level for "good" and "excellent source" of whole-grain ingredients from 5 g to 8 g and 10 g to 16 g, respectively.The proposition allows the whole-grain health claim to apply exclusively to only very high-density flour/low-moisture products, such as dry cereals and crackers. In June 2005, ConAgra publicly highlighted that the petition essentially sought to create a whole new category of foods for which content claims can be made - in this case "whole grains and whole-grain ingredients" - and urged that the criteria for whole-grain content claims remain as already established. Condition-Driven ClaimsHeart health is attracting two conflicting ingredient strategies. One leverages "hidden nutritional assets" - nutrition marketing of the intrinsic benefits of foodstuffs already available to consumers. This approach has worked well for General Mills. The heart-health claim of whole-grain products has resulted in double-digit volume growth for products like Cheerios.The other strategy focuses on demonstrating the effectiveness of specific new ingredients with heart health or cholesterol-lowering potential, incorporated into foods that generally do not contain these ingredients in significant amounts. Plant sterols and stanol esters are the most conspicuous examples of where unique, patent-protected and branded ingredients are positioned to command premium prices from the heart-health-conscious market. But "heart health" and "cholesterol-lowering" claims may no longer be an advantage, considering the FDA’s generic health claims for heart health in connection with a number of other ingredients, such as soy and oats.One of the earliest health claim types, claims of cholesterol-lowering ability/improved heart health, is still eagerly applied. One example of an emerging claim in this arena is the proprietary, cholesterol-lowering plant sterol Reducol from Forbes Medi-Tech, Vancouver, B.C. With backing from commodity giant Archer Daniels Midland, Decatur, Ill., Reducol recently received European Commission approval for use in margarine, fermented milk-type products, soy drinks, low-fat cheese products, yogurt products, sauces and dressings.

Omega-3s remain something of a niche product due to FDA's lukewarm endorsement language and consumers' inability to distinguish between types of omega-3s.

From Fish to NutsThe FDA-approved qualified health claim for omega-3 oils was "B quality" language, according to industry leaders, despite what they believed was "A quality" scientific justification. Disappointed omega-3 vendors, much like walnut growers (recipients of the first new "qualified" claim granted by the FDA; see "Responsible Use" sidebar below), blame the claim for sluggishness of manufacturers to field new omega-3 ingredients.Docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) from fish oil, proven the most effective types of omega-3s, are still not differentiated from less expensive and less effective forms of omega-3s by the average consumer. Moreover, the terms DHA or EPA on the label do not translate value to most consumers.In light of the new qualified claim, there is little incentive for companies to change from less expensive, plant-derived omega-3s to the higher efficacy, higher-cost marine omega-3s.Omega-3s, while a big hit with the medical profession and in dietary supplement aisles, are most likely to remain niche products despite having an approved health claim.Effective use of a health claim involves more than just slapping it onto a label. Creative technology and clever branding can overcome such hurdles as misperceived or unclear perceptions. Simplifying label "legalese" has not helped DHA-fortified Intelligent Eating Healthy Eggs from Stonegate Farms. The British egg market leader presented health claims in simple, clear words: "Omega-3 DHA is proven to play a role in: brain development and structure, eye structure and maintenance, heart health and maintenance." Yet the eggs remain at the fringe, mirroring the story of omega-3 food products in the U.S.Technological advances preserve sensitive fish oil while neutralizing taste and aroma for non-traditional applications such as bakery products or beverages. National Starch Food Innovation (www.foodinnovation.com), Bridgewater, N.J., released Novomega, an odorless, tasteless encapsulated long-chain omega-3 powder. Nova Scotia-based Ocean Nutrition (www.ocean-nutrition.com) also produces concentrated omega-3s used in applications requiring a neutral flavor profile. Manufacturers gain the most benefit when health claims support the original intent of the FDA - to encourage consumers to make wise food choices in the context of a healthful diet and provide an incentive to produce more genuinely healthful products. The new interest in food and health is powerful motivation for the food industry to design and test effective health claims to educate and maximize the public health potential of their offerings.

CURRENT PERMITTED HEALTH CLAIMS I. Health Claims that Meet Significant Scientific Agreement (SSA) Calcium and osteoporosis (21 CFR 101.72) Dietary lipids and cancer (21 CFR 101.73) Sodium and hypertension (21 CFR 101.74) Dietary saturated fat and cholesterol and risk of coronary heart disease (21 CFR 101.75) Fiber-containing grain products, fruits, and vegetables and cancer (21 CFR 101.76) Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease (21 CFR 101.77) Fruits and vegetables and cancer (21 CFR 101.78) Folate and neural tube defects (21 CFR 101.79) Dietary non-carcinogenic carbohydrate sweeteners and sugar alcohols and dental caries (21 CFR 101.80) Soluble fiber from certain foods and risk of coronary heart disease (CHD) (21 CFR 101.81) Soy protein and risk of coronary heart disease (CHD) (21 CFR 101.82) Plant sterol/stanol esters and risk of coronary heart disease (CHD) (21 CFR 101.83) II. Qualified Claims about Cardiovascular Disease Risk Nuts and Heart Disease Claim: "Scientific evidence suggests but does not prove that eating 1.5 oz. per day of most nuts such as [name of specific nut] as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease." Walnuts and Heart Disease Claim: "Supportive but not conclusive research shows that eating 1.5 oz. per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease." Omega-3 Fatty Acids and Coronary Heart Disease Claim: "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of food] provides [ ] g of EPA and DHA omega-3 fatty acids." The claim is allowed for conventional foods and dietary supplements that contain EPA and DHA omega-3 fatty acids. Monounsaturated Fatty Acids from Olive Oil and Heart Disease Claim: Limited and not conclusive scientific evidence suggests that eating about 2 tbsp. (23 g) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains [x] g of olive oil. III. Structure/Function Claims for Dietary Supplements and Conventional Foods Structure/function (S/F) claims and disease claims for conventional foods focus on effects derived from nutritive value. The FDA does not require conventional food manufactures to notify the FDA about their S/F claims, and disclaimers are not required for conventional foods.

RESPONSIBLE USE Walnut producers were dismayed when semantics and "nutritional accuracy" of the FDA-approved health claim created more constraints for their industry. Processors, lacking clear guidelines for use of walnuts as an ingredient, hesitated to utilize the tentative language of the claim. Qualifiers such as "supportive but not conclusive" and "may" appeared wishy-washy and were perceived to do little for consumer confidence or sales. Then, the FDA affirmed an earlier version of a qualified claim for walnuts and added a phrase about "limiting caloric intake" in reflection of its concern about America’s growing overall caloric intake. The FDA also wanted to use the claim to inform consumers that "walnuts are high in fats" and "should substitute for other high-calorie foods and not be an addition." The result was to impede incentive for manufacturers to use this vitamin-, mineral- and antioxidant-rich nut. In addition to communicating the superiority of their products, processors also need to know that not all consumers have ready access to the plethora of science on cholesterol-lowering foods to determine if soy milk or oatmeal is more effective for their needs. Health-conscious consumers who drive the growth of functional food products often rely on professionals for recommendations. This is an opening for astute companies to position their wares.

About the AuthorsKantha Shelke is a principal at Corvus Blue LLC, a Chicago firm that specializes in competitive intelligence and expert witness services. Contact her at [email protected] or 312-951-5810. Rakesh M. Amin is a registered pharmacist and attorney specializing in FDA and regulatory issues related to herbal products and dietary supplements.