ties to convey the health benefits of food products, particularly when the benefits are attributable to components that are not currently recognized to be essential nutrients and/or when the component plays a role in preventing, mitigating, or treating disease. Under the FD&C Act legal framework, marketing claims that represent a product to have disease prevention, mitigation, or treatment-related benefits are prohibited unless the product is an FDA-approved drug and is marketed in compliance with the terms of the FDA approval. Roller pointed out, however, that the regulatory framework FDA has developed for conventional pharmaceutical products is not designed to accommodate foods that can play a useful role in disease prevention, mitigation, or treatment. The obstacles associated with the outdated paradigm are not limited to the FD&C Act framework. The old paradigm has been influential in shaping the legal standards that govern the regulation of food marketing claims under the FTC Act, the federal Lanham Act, other federal statutes administered by the U.S. Department of Agriculture’s Food Safety and Inspection Service, and food and drug laws and consumer protection statutes that have been adopted by the 50 states.

Roller called attention to the fact that many state laws allow consumers to sue companies for money damages and injunctive relief when consumers have been misled by the marketing claims companies use to promote their products. In the current legal environment, Roller noted that health benefit claims for food and dietary supplement products are commonly targeted in consumer class action lawsuits filed under state laws. Roller explained that consumer class action lawsuits of this kind are commonly filed in the wake of FDA warning letters and FTC consent orders challenging food marketing claims based on the outdated paradigm. As a result, inadequate federal policies can have a cascading effect under state law, which has costly liability implications for and may deter companies from communicating accurate scientific information about the health benefits of food and dietary supplements, including prebiotics and probiotics. Roller observed that these trends also have the potential to deter industry investment in products that she believes could hold “huge promise for public health.”

Roller suggested that it will be necessary to confront the limitations of the FD&C Act “drug” definition as it is applied to food and dietary supplement products to provide sufficient flexibility to allow accurate, substantiated information to be conveyed about the health benefits of these products in commercial contexts, consistent with First Amendment requirements and sound science. Back in 1938, Roller said, the old paradigm probably made sense from a scientific standpoint. At that time, there was little scientific evidence to establish that disease prevention, mitigation, and treatment claims could rightly characterize the benefits of food products. Since that time, science has marched on, and the old “drug” definition and the scientific paradigm upon which it is based no longer



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