Health claims can be intimidating to achieve on packaging. However, the FDA has clearly outlined health claims around soluble fiber and coronary heart disease in 21 CFR 101.81 and 21 CFR 101.77. With Americans lacking in fiber consumption (they eat, on average, less than half the daily requirement), formulating with soluble fiber to achieve a link to a reduced risk heart disease claim is feasible.
When exploring the use of health claims, you should always work closely with your legal counsel and regulatory advisors. However, this information should give you a head start when developing around a heart health claim.
Potential Claim Example:
- Soluble fiber from foods such as oats, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of my product supplies 1 gram of the 3 grams of soluble fiber from oats necessary per day to have this effect.
- Diets low in saturated fat and cholesterol that include 3 grams of soluble fiber per day from oats may reduce the risk of heart disease. One serving of my product provides 1 gram of this soluble fiber.
- Implied health claim using symbols or images.
Diets with 3 g or more of beta-glucan soluble fiber from whole oats or barley, or 7 g or more of soluble fiber (EU) from psyllium seed husk (EU) have been associated with a reduced risk of coronary heart disease.
Sources of approved soluble fiber ingredients are detailed in 21 CFR 101.81, and you can work with your vendor to find a source which meets the requirements.
- Whole Grain Oats (EU); oat bran, rolled oats (oatmeal), whole oat flour and oatrim.
- Whole grain barley and dry milled barley; barley bran, barley flakes, barley grits, pearl barley, barley flour, barley meal, and sieved barley, and barley betafiber.
- Husks of the seed of Plantago ovata (P. indica, or P. psyllium)
- Note: Per CFR 21 101.17 you may require a label statement such as: ‘‘NOTICE: This food should be eaten with at least a full glass of liquid. Eating this product without enough liquid may cause choking. Do not eat this product if you have difficulty in swallowing.’’
Total Formula Requirements:
To move toward a coronary heart disease claim, your product must meet general guidelines for health claims under 21 CFR 101.14. In addition, foods must qualify for low fat, low saturated fat and low cholesterol defined in 21 CFR 101.62, as well as contain a minimum fiber content of either beta-glucan or phyllium as outlined in 21 CFR 101.81.
Additional Formula considerations:
A quick formula calculation exercise will help you identify potential usage levels before you ever make a prototype. For example, calculate how much ingredient will need to be incorporated to achieve a minimum 0.75 grams of beta-glucan. Adjust the formula so the nutrition profile meets the minimum requirements.
Often the limiting factor for soluble fiber will be taste and texture changes. However, several ingredients have been developed with high levels of beta-glucan from oat or barley sources, which will have less of an impact on sensory characteristics.
Bakery: Fiber should be added in the dough stage, not the sponge stage, to minimize interaction with yeast. As you increase soluble fiber, you will need to adjust the water in the formula to accommodate the extra fiber and adjust the baking profile accordingly.
Beverages: The fiber supplementation of choice has been resistant starches (colorless, flavorless, and easy to use). Using oat, barley or psyllium in beverages will increase viscosity. However, this increased thickness may provide a satisfying base for breakfast or meal replacement smoothies.
Meat: These fibers are allowed as a binder in many products. Per the USDA FSIS, psyllium husk can be used up to 0.1% of total product weight and oat fiber up to 3.5% of the product formulation. A study in 2011 indicated that beta-glucan may enable a reduction in sodium or phosphates and still achieve product structure in processed chicken. If incorporated into a meal product, the soluble fiber content of meat may enable a health claim for the full meal if the rest of the guidelines are met.
Dairy: Naturally high in protein, adding beta-glucan to dairy products will enable a powerful protein and fiber formula. To achieve a claim, be conscious of the sat fat and total fat of the finished product. The USDA ARS reported in March 2013 that a usage level of 0.3% refined beta-glucan, (yielding 0.75g/ 8 oz serving) could be added into a low fat yogurt mix without sensory or performance changes.
In reviewing calculations for your formulation, be sure to note that costs of materials increase as more concentrated forms of fiber are added, and this may impact your finished product costs. Look at other fiber options if cost becomes a substantial issue in commercializing a product.
No matter your product, make sure you collect data following the appointed AOAC methods (beta-glucan: method 992.28 and psyllium husk: modified method 991.43) to establish that your final product meets the requirements. Work with your legal and regulatory contacts to ensure they have the data repeated as needed.
Here are some ingredients to get you started:
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