FDA demands proof of botanical claims

In June, the agency sent letters to Fresh Samantha Inc., U.S. Mills Inc., and Hansen Beverage Co. telling them to bring their products in line with existing law or risk regulatory action. Products cited included Fresh Samantha Super Juice with Echinacea, Healthy Start Immune Juice with Echinacea, New Morning Organic Ginkgo, and Organic Ginseng Crunch breakfast cereals. Letters to other companies were planned, FDA said. Improprieties cited in the letters included unauthorized content claims and falsely labeling some products as dietary supplements. Because no standards have been established, FDA also warned against making claims that the products provide a certain percentage of the recommended daily intakes for the botanicals or making claims only suitable for drugs. These claims require premarket submission of data proving they are safe and effective. FDA said beverage companies must submit scientific proof that all ingredients, including botanicals, are generally recognized as safe. The agency merely wants companies to share the information they have, said a spokesperson.