title: Health claim regulation of probiotics in the USA and the EU: is there a middle way?
abstract: In both the USA and Europe, supermarkets and pharmacies are brimming with probiotics - products containing live micro-organisms claiming they improve health. The availability of these products corresponds to a growing consumer demand for foods that improve or maintain health and wellness. The most persuasive include claims that consumption may confer health benefits. While some of these claims may have merit, others have not been substantiated. For a number of products, claims are based on insufficient research, underpowered studies, or mixed research results, yet individual consumers find that the product is of benefit to them. In attempting to regulate health claims, as distinct from safety, government entities may take positions which represent opposite ends of a philosophical spectrum. On one end of the spectrum they may take a limited approach to regulation relying primarily on the marketplace that respects individual autonomy and assumes a sophisticated consumer and honest sellers; alternatively they may choose substantial regulation based on a belief that consumers need protection from profit-seeking manufacturers. The USA and the European Union have taken two different approaches on this regulatory spectrum.
authors.affiliation: Francis King Carey School of Law, University of Maryland, 500 West Baltimore Street, Baltimore, MD 21201, USA. dhoffmann@law.umaryland.edu
authors.forename: D E
authors.initials: DE
authors.lastname: Hoffmann
mesh_terms: D017277:Drug Approval / Q000379:methods*; D005062:European Union; D006801:Humans; D019936:Probiotics / Q000494:pharmacology* / Q000592:standards*; D014481:United States