Formulating for Health Claims

December 3, 2007

12 Min Read
Formulating for Health Claims

Food products formulated for health and wellness have experienced a major shift over the past two years. According to ACNielsen, New York, the low-carbohydrate bubble peaked in 2004, but never burst. Even though the sales of food products formulated for carbohydrate-conscious consumers fell 9% in that $2.4 billon category as the industry entered 2006, sales of low-carbohydrate products still showed more than a 500% increase compared to 2001, when the trend started to dominate the market.

Eliminating trans fatty acids in food products sold at the retail level, as well as in foodservice fare, has been mostly completed, and new food products are now formulated without trans fats.

Now the industry and the consumer have refocused on looking for foods that emphasize health and wellness through claims related to antioxidants, omega-3s, organic or natural, whole-grain or multigrain, fiber, and gluten-free, among others. All of these types of food products are showing significant growth in 2007.

This shift in consumer demand brings opportunity for new food products, supplements and meal replacements. Over the long term, changing demographics in age, gender and ethnicity will drive longevity. But, along with this opportunity comes the challenge of identifying the right claim to appeal to your customer, combined with the ability to formulate a product that delivers a real benefit while staying within the maze of regulations and guidelines for label claims that reference health.

Marketers and formulators must have a comprehensive knowledge of permitted claims for conventional foods and supplements distributed and sold at retail. These claims can be separated into three areas: health claims, nutrient-content claims and structure/function claims. In each of these categories, it is important to understand where the responsibility lies for the validity of the claim.

Health-claim requirements

Health claims require two parts: a food or food ingredient, plus a health-related condition. Anything short of this does not meet the regulatory definition of a health claim.

For example, a claim that fruits and vegetables are healthpromoting is not a health claim because it does not reference a specific food or ingredient, only a general category of food, and further does not reference a health-related condition or disease. This type of claim is considered a dietary guidance statement. These statements may be used on food labels, but they must be truthful and not misleading. They are not subject to FDA approval or compliance; however, they may fall under the scrutiny of the Federal Trade Commission.

Health claims authorized by FDA and clearly defined in the regulations are provided by The Nutrition Labeling and Education Act of 1990 (NLEA), the Dietary Supplement Act of 1992, and the Dietary Supplement Health and Education Act of 1994 (DSHEA). These health claims characterize a relationship between a food, supplement or ingredient and the risk of a disease. FDA authorized these health claims based on extensive review of scientific literature documenting the food-nutrient relationship. Further, The Food and Drug Modernization Act of 1997 (FDAMA) provided for FDA authorization of health claims for foodsnot supplementsbased on an authoritative statement from a scientific body of the U.S. government or the National Academy of Sciences. FDA-approved health claims, label statements, requirements and criteria are well documented and are listed in the Code of Federal Regulations (CFR) and in FDA dockets:

  • Calcium and osteoporosis (21 CFR 101.72);

  • Sodium and hypertension (21 CFR 101.74);

  • Dietary fat and cancer (21 CFR 101.73);

  • 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 sugar alcohol and dental caries (21 CFR 101.80);

  • Soluble fiber from certain foods and risk of coronary heart disease (21 CFR 101.81);

  • Soy protein and risk of coronary heart disease (21 CFR 101.82);

  • Plant sterol/stanol esters and risk of coronary heart disease (21 CFR 101.83);

  • Whole grain foods and risk of heart disease and certain cancers (Docket No. 99P-2209);

  • Potassium and the risk of high blood pressure and stroke (Docket NO. 00Q-1582).

Formulating for these approved health claims can be tricky. It requires complete knowledge of the requirements to make the health claim, as well as having the technology to overcome some of the obstacles.

Calcium and osteoporosis claims. If a company wants to formulate foods to meet requirements for a health claim for calcium and osteoporosis, the calcium must be bioavailable and the phosphorous content of the food cannot be greater than the calcium content. Formulation challenges include textural, mouthfeel and aftertaste issues, but consumers may be willing to make some trade-offs to get their calcium in conventional foods. Typically, calcium forti- fication is used in fruit beverages such as orange juice, dairy products where calcium is naturally occurring, nutrition bars, and chews and other confections.

Sodium and hypertension claims. Formulation for the sodium and hypertension health claim usually requires the reduction or elimination of salt. Salt-replacement ingredients on the market sometimes introduce bitterness or other undesirable flavor attributes. Alternative approaches to salt substitutes include flavor enhancement, increased spices, or other innovative means that may challenge the formulator.

Dietary-fat claims. Formulating for approved health claims regarding fat may require the elimination, reduction or substitution of the fat ingredients. These changes can impact flavor, texture and other physical properties possibly inherent to the product. Historically, products formulated with reduced fat or fat substitutes are more successful than fat-free products.

Fiber claims. The approved health claims for fiber also have specific product requirements about fat content and the amount of naturally occurring dietary fiber before fortification.

Folate and neural tube defects claims. When formulating a food product for the approved health claim regarding folate and neural tube defects, the product cannot contain more than 100% of RDI for vitamin A as retinol or preformed vitamin A or vitamin D per serving or per unit.

Dietary sugar alcohol and dental caries claims. The approved health claim regarding dental caries and dietary sugar alcohol requires that food products be sugar free. Permitted sugar alcohols are specified, and if fermentable carbohydrates are present in the food, the food cannot lower plaque pH below 5.7.

Soluble fiber from certain foods and risk of coronary heart disease claims. Formulating for the health claim regarding soluble fiber and coronary heart disease has become one of the leading trends in the industry. Soluble fiber is formulated into a variety of products, including beverages, liquid-egg and egg-white products, nutrition bars, snacks, baked goods, puddings, and grains and cereals. Formulating beverages or other liquids with soluble fiber can be a challenge, due to its thixotropic nature, which causes it to thicken upon standing and thin out with shaking.

The products under this health claim must be low in fat, cholesterol and saturated fat. In addition, the food must contain either one or more eligible sources of whole oats with a minimum of 0.75 grams of whole-oat soluble fiber per serving, or psyllium seed husk with a minimum of 1.7 grams of psyllium seed husk soluble fiber per serving. The eligible sources of soluble fiber include beta glucan soluble fiber from oat bran, rolled oats (or oatmeal), whole oat flour, and Oatrim, an amylase-hydrolyzed whole-oat flour or bran. The oat bran must have at least 5.5% beta glucan soluble fiber, and the rolled oats and whole-oat flour must have at least 4% beta glucan soluble fiber. Psyllium husk must have purity of no less than 95%.

Soy protein and risk of coronary heart disease claims. Formulating products for the health claim regarding soy protein and coronary heart disease is not new, but it is still a mainstay in health and wellness products. Issues about flavor, texture, stability and oxidation surrounding products formulated with soy ingredients have been mitigated by improved ingredients and technology driven by consumer demand. Companies need to formulate 6.25 grams of soy protein into any product they develop, to meet the criteria for low fat, saturated fat and cholesterol. Products that meet this health claimfrom nutrition bars to beveragesare being improved and are regularly introduced into the market.

Plant sterol and/or stanol esters and risk of coronary heart disease claims. Phytosterols are formulated into products to meet requirements for the plant sterol and/or stanol esters and coronary heart disease health claim. Spreads and dressings must have at least 0.65 grams per serving of plant sterol esters to make the claim, or 1.7 grams of stanol esters per serving in dressings, spreads, snack bars or supplements. Also, the products must be low in saturated fat and cholesterol.

Whole-grain foods and risk of heart disease and certain cancers claims. Whole grains are formulated into virtually every grain-containing food catagory, from snacks to breads. In order to make the health claim for whole-grain foods and heart disease and certain cancers, the food product must contain at least 51% whole-grain ingredients per serving. In addition, the product needs to meet the low-fat criteria and contain from 1.7 grams to 3.0 grams of dietary fiber, depending on the serving size.

Potassium and the risk of high blood pressure and stroke claims. Foods formulated to meet the health claim for potassium reducing the risk of high blood pressure and stroke must be a good source of potassium and be low in sodium, fat, saturated fat and cholesterol. Foods with significant levels of naturally occurring potassium include seafood, shell- fish, dried fruits, meats, dairy products, beans and vegetables.

Also, criteria for all foods formulated to meet any of the health claims must have, without fortification, at least 10% of the Daily Value for either vitamin A, vitamin C, iron, calcium, protein or fiber. Also, the food must contain less than the specified level of four disqualifying ingredients: fat, saturated fat, cholesterol and sodium. The specified levels are for foods, main dishes and meal products and can be found on the FDA website at

Qualified health claims

FDAs 2003 Consumer Health Information for Better Nutrition Initiative provides for the use of qualified health claims where there is emerging evidence for a relationship between a food, ingredient or supplement and reduced risk of a disease or health-related condition. However, since the evidence has not yet met the significant scientific agreement standard required by FDA to issue an authorizing regulation, these claims must include a statement that the evidence supporting the claim is limited. FDA has a petition process to request a qualified health claim. The FDA will evaluate and rank the quality and strength of the scientific evidence provided and issue an enforcement discretion letter to the petitioner with specified conditions for the qualified claim. The letter includes claim statements, eligible foods, and factors identifying conditions that have to be met, including levels of the particular nutrient being petitioned. Qualified Health Claim Petitions are available for public review and comment.

A summary of this claim category, Qualified Health Claims Subject to Enforcement Discretion, is available on the FDA website and has been updated through April 2007.

The qualified claims about cancer risk are related to tomato products, calcium, green tea, selenium and antioxidant vitamins. Certain qualified claims link cardiovascular disease benefits to nuts, walnuts, omega 3s, B vitamins, olive oil, canola oil and corn oil. Other qualified claims for dietary supplements concern cognitive function and soy-derived phophatidylserine, diabetes and chromium picolinate, hypertension and calcium, and neural tube defects and folic acid. Formulation around any of these qualified health claims requires full knowledge of FDAs position on these claims.

Nutrient-content claims

Nutrient-content claims fall under NLEA, which permits the use of label claims that characterize the level of a nutrient identified on the Nutrition Facts Panel in accordance with FDA regulations such as high, low or free, or compare the level of a nutrient using terms such as more, reduced or light. Although nutrient-content claims are not health claims per se, they frequently accompany health claims on the label, and the regulations provide the details required for formulating these products. In addition, a claim on the label, such as healthy, in relation to a nutrient, does imply a content claim that would have to comply with these regulations.

In the Jan. 23, 2007 Federal Register, FDA published a proposed rule for a nutrient-content claim for gluten free. The proposed regulation defines gluten-free in detail and identi- fies the prohibited grains as wheat, rye, barley or crossbred hybrids of the prohibited grains. Also, if prohibited grains with gluten removed are used in gluten-free foods, they cannot have a gluten content of 20 ppm or more. Even though this regulation has not yet been approved, it would be advisable to consider the proposed definition of gluten free in any formulation work for products considering this claim.

Structure/function claims

DSHEA established special regulations for structure/ function claims made on supplements, including a requirement for FDA notification and a disclaimer that FDA has not evaluated the claim. Congress defined the term dietary supplement in DSHEA. A dietary supplement is a product taken by mouth that contains a dietary ingredient intended to supplement the diet. The dietary ingredients in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of foods, not drugs, and requires that every supplement be labeled a dietary supplement. FDA does not require notification by manufacturers of structure/function claims on conventional foods, and there is no requirement for a disclaimer.

These types of claims describe how a nutrient affects normal structure and/or function, or how a nutrient maintains structure and/or function. Calcium builds strong bones or antioxidants maintain cell integrity are examples of structure/function claims. Be aware that formulating for structure/function claims in conventional foods may trigger content-claim regulations, and its a fine line for FDA interpretation between structure/function and disease claims.

Whether a companys health claims are authorized, approved, qualified or limited, it is important to have a strategy for formulating foods that meet current and future wellness trends. The market continues to grow, but companies can only sustain that growth through the development of innovative products with wellness benefits that reflect good science and technology, comply with regulations, are benchmarked against the competition, and meet consumers needs.

Philip Katz is a senior vice president at Shuster Laboratories, Canton, MA, a Specialized Technology Resources (STR) company. Shuster is an independent provider of quality-assurance testing, product development and supply-chain support services for a cross section of consumer product industries, including food and foodservice. Katz can be reached at [email protected].

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