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)
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 firstname.lastname@example.org 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.