Health Claims, Healthy Trends: Navigating the Legal Thicket

My banana proclaims: “Superfood for your heart.”

“HeartWise™. Proven to help reduce cholesterol,” touts my orange juice.

“Helps remove cholesterol,” claims my oatmeal.

My simple breakfast illustrates how prevalent health claims have become. The over-50 crowd now makes up nearly one-third of our population. With increasing life expectancy, aging baby boomers and an overall aging of the population, consumer interest in prevention and treatment of chronic disease is at an all-time high—and rising.

While interest in health claims climbs, the law does not make it easy. Health claims for food fall into a legal thicket. A map to this thicket is vital to avoid regulatory briars.

The law traditionally barred all health claims on food. Congress began to change that with passage of the Nutritional Labeling and Education Act (NLEA) in 1990. But each change—rather than removing the underlying strictness—pasted exceptions onto old law. These exceptions include three types of accepted health claims: pre-approved health claims, claims based on authoritative statements, and qualified claims.

Pre-approved health claims are expressly authorized by FDA rule. Rule promulgation is painfully slow but, once approved, these claims may be used by anyone without further FDA approval or notification. The key to using pre-approved claims is following the detailed requirements of the corresponding rule.

Claims based on authoritative statements of a scientific body of the U.S. government are the simplest and quickest to attain, but little used. These claims do not require FDA approval, only notification. If FDA does not object within 120 days, the claim may be used. For example, potential claims could arise from the authoritative advice in the 2005 Dietary Guidelines for Americans about how good dietary habits can promote health and reduce risk for major chronic diseases.

Qualified claims require a quality and strength of scientific evidence that falls below the requirements for an unqualified health claim. Qualification language is designed to assure that the claim is accurate and not misleading; for example, “Supportive but not conclusive research shows....” Qualified claims require FDA approval.

Additionally, ameliorating the strictness of the law are two categories of health-related claims that are not regulated as health claims: General well-being claims describe the benefits of consuming a nutrient or dietary ingredient. A key to this exception is that general wellbeing claims do not mention a disease or disease-related condition; for example, “A diet rich in fruits and vegetables is good for your health.”

Structure/function claims describe the effect that a substance has on the structure and/or function of the body, but do not refer to a disease; for example, “Calcium builds strong bones.” These claims may also characterize the means by which a nutrient or dietary ingredient acts to maintain structure or function; for example, “Antioxidants maintain cell integrity.”

The opportunities to make health claims are far greater than ever before. But do not forget: The area remains a legal thicket. Become fully informed about applicable laws before marketing foods with health claims.

Neal D. Fortin is an attorney concentrating in food and drug law. He is also a professor of food and drug law at Michigan State University. For more information, visit his websites: www.fortinlaw.com or www.foodlaw.org.