to FDA to examine the differences between the organism as it appears in that yogurt product and the organism as it appears in a supplement? Levy responded that the answer lies in intended use or effect. If the intended effect of the organism in the original product was the same, then yes, that is a valid approach.

There was a question about a hypothetical probiotic product designed to be administered to cesarean section (C-section) babies in an effort to establish a microbiota that is similar to that developed by a vaginally delivered baby. Would such a product be considered by FDA to be a food or a drug? Levy replied that it is unclear what that type of product would be considered. He would encourage discussion with “representatives from both sides of the agency.”

Another participant asked under what circumstances a probiotic is considered a new dietary ingredient as opposed to a food additive. Levy described that type of categorization as “a gray area” because it often depends on how the food is intended to be marketed. He also pointed out that each category has its own safety evaluation paradigm. “However it is represented,” he said, “you have to meet the requirements of that particular paradigm.”

Finally, when asked whether any probiotics or prebiotics are being self-determined as generally recognized as safe (GRAS) food ingredients, Levy replied, “It would not surprise me if a lot of people are doing GRAS self-determinations.” However, because GRAS self-determination does not require FDA notification, FDA does not have a complete list of such determinations although there are procedures that allow voluntary notification of FDA. GRAS determinations, however, are limited to ingredients in conventional foods, not dietary supplements. Mary Ellen Sanders added that she knew of about six GRAS notices for probiotics posted on the FDA website.


The U.S. regulatory landscape for foods is governed not just by FDA, but also by the Federal Trade Commission (FTC). Michelle Rusk explained how the two agencies share authority on marketing claims not just for foods, but also for supplements, drugs, and other health and medical products. Specifically, through a long-standing liaison agreement, FDA has primary authority for claims appearing on labeling or product packaging, while FTC has primary authority for claims appearing in advertising (with the exception of prescription drugs, over which FDA has authority on both labeling or packaging and advertising). By “advertising,” Rusk was refer-


12 This section summarizes the presentation of Michelle Rusk.

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