New Rules on Food Health Claims

The retail highway to health is increasingly crowded with science-backed and government-allowed health claims. But then, what’s in a claim?

By Kantha Shelke and Rakesh Amin

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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.


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
      "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
      "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
      "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
  • 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.


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 Authors

Kantha Shelke is a principal at Corvus Blue LLC, a Chicago firm that specializes in competitive intelligence and expert witness services. Contact her at 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.

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