above ingredients. The only appropriate category for probiotics is “dietary substance for use by man to supplement the diet by increasing the total dietary intake.” The draft guidance suggests that this definition is limited to substances previously in the diet, suggesting that an entirely new bacterium must enter the food supply as a food other than a dietary supplement.

Pre-Market Notification for New Dietary Ingredients: Implications for Probiotics

The FD&C Act requires pre-market notification to FDA describing the safety of a dietary supplement containing “new dietary ingredients.” New dietary ingredients are defined as dietary ingredients not marketed in the United States prior to October 15, 1994. However, there is an exemption from the notification requirement for a dietary supplement containing only dietary ingredients that have been present in the food supply “as an article used for food in a form in which the food has not been chemically altered.” When it passed the DSHEA, Congress included a “legislative agreement” describing what “chemically altered” does not mean. It does not include minor loss of volatile components, dehydration, lyophilization, milling, tincture or solution in water, slurry, powder, or solid in suspension. Yet even with this list, there are uncertainties. For example, what does “tincture or solution in water” mean? Levy commented that everyone would probably agree that making an extract by soaking leaves in hot water would not be “chemically altered.” More complicated extractions, such as the use of organic solvents and chromatography, make more significant changes in the chemical composition of the extract, changes that may be described as chemically altered.

The issue of whether or not something is chemically altered is especially challenging for live microbial organisms used in food production because chemical characterization is usually not used to describe the difference between microorganisms. For example, when a strain of a Lactobacillus species that has been used to ferment cheese is selected to produce a variant having properties that optimize its use in an industrial fermentation for the production of a dietary supplement, is the selected strain chemically altered relative to the strain that was in the original dairy product?

The FDA Food Safety Modernization Act (FSMA) of 201111 required FDA to publish guidance on new dietary ingredients to help industry and other stakeholders understand when new dietary ingredients (NDIs) require pre-market notifications and what those notifications should include (see Box 6-1). FDA published a draft guidance in July 2011, with a comment

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11 FDA Food Safety Modernization Act of 2011, Public Law 111-353, 111th Cong. (Jan. 4, 2011).



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