support an adequate regulatory framework for food and dietary supplements, according to Roller.

Under FDA regulations implementing the food provisions of the FD&C Act, FDA has recognized that there are different categories of “food”: conventional foods and beverages, chewing gum, food ingredients and components, dietary supplements, food for special dietary use (FSDU), and medical food. Roller referred to Levy’s discussion of the challenges that the dietary supplement category creates for probiotic-containing food. She emphasized that further development of FDA policies concerning foods for special dietary use and medical foods is needed and could represent an important but yet “untapped opportunity” for probiotics, in her opinion. FSDU is an old category that was used more often in the past, before the Nutritional Labeling and Education Act of 1990. This category includes foods used for disease-related purposes, specifically for “supplying dietary needs which exist by reason of a physical, physiological, pathological or other condition, including … the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight.” Roller suggested that probiotics used to equilibrate the microbiome after antibiotic therapy might be considered FSDU. Medical foods are foods that are to be consumed under a physician’s supervision. Lofenalac, an infant formula made for infants with phenylketonuria (PKU), is a classic example of a medical food. In Roller’s opinion, between these two food categories, FDA has a “huge amount of discretion.”

Changing the Legal Framework

To strengthen the legal framework in the ways that are necessary, Roller urged that the outdated and dualistic “food versus drug” conceptual framework be reconsidered, in view of the distinctions between the cause-and-effect relationships that explain the mechanisms by which pharmaceuticals commonly deliver benefits and those that characterize the mechanisms by which food and dietary patterns deliver benefits. She urged that environmental health and ecological models of causation be given careful consideration in the development of regulatory policies governing food marketing claims for food and dietary supplement products.

In the specific context of claims characterizing the benefits of prebiotic and probiotic components of food and dietary supplement products, Roller outlined several types of claims that she believes would hold promise for product marketing purposes. These include (1) content claims that communicate information about how much of a given prebiotic or probiotic is present in a food, (2) dietary contribution claims that communicate information about the contribution that is made to overall dietary intake of certain prebiotics or probiotics from consumption of particular products



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