63 Food and Drug Law Journal 537-578 (2008).
As scientific understanding of human physiological processes has increased, so has the recognition that diet and health are closely related. The American population is constantly hearing media reports of scientific studies linking particular foods or food ingredients to various health effects. Such heightened consumer awareness of the correlation between food and wellbeing has not gone unnoticed by the food industry. Many foods are now being marketed as having health benefits beyond basic nutritional value. These "functional foods" claim a wide array of health benefits. Companies, however, may be too quick in their marketing, placing wellness claims on their labeling that science cannot confidently support. Despite government oversight of the food industry, unsupported claims may be rampant among functional foods because when subject to regulation as "conventional foods," these products have little check on claim validity for the most common wellness claim — the structure/function claim. Though the Federal Food, Drug, and Cosmetic Act requires labeling to be "truthful and not misleading," this standard is undefined and thus unenforceable for food labeling structure/function claims.
This paper fills the hole in the regulatory scheme by establishing the extent of scientific substantiation necessary for these claims to be "not misleading." The development of the regulatory framework specifically focuses on yogurts, since this functional food's enormous popularity can be attributed in large part to the marketing of digestive and immunological benefits of the probiotics in these yogurts. Applying the framework to a claim on one of the probiotic yogurts emphasizes the importance of the framework's establishment since the analysis suggests that the claim may indeed be misleading in violation of the law.