Attorney Amy Pauli and colleagues at Crowell and Mooring recently published on FDA regulations relating to labeling and promotion of food and beverages with specific reference to health claims.  The FDA shares responsibility with the Federal Trade Commission for promotional statements included on labels and advertisements.  Claims that will be disallowed include statements that are in violation of regulations are unsubstantiated or misleading.

All health-related claims must be substantiated with acceptable scientific studies.

The FDA defines a health claim as an implied or expressed statement that relates a product to a disease or a health-related condition.  In contrast a nutrient content claim is an expressed or implied statement that relates specifically to the level of the designated nutrient in the product.

An example of a possible claim would be that eggs containing choline and DHA “to promote fetal and neonatal neurodevelopment”. This would be allowed based on numerous published studies in peer-reviewed journals.  Nutritional claims are based on the Dietary Guidelines that are in turn derived from clinical and scientific studies.