and other regulatory agencies have taken considerable action to control and regulate probiotic health claims. In Steele’s opinion, the level of science being required to support certain claims is approaching “pharma” level documentation. She expressed concern that not all manufacturers will have the funding or resources needed to provide such support, resulting in consolidation and even elimination of some competitors. While probiotics that successfully pass regulatory scrutiny will likely instill consumer confidence and acceptance of probiotic products and thereby increase their market share, those that fail regulatory scrutiny could have the opposite effect.

Because of the changing regulatory pressures, major players such as Danone are softening their claim language. Previously, Danone’s claims on its probiotic products were focused on structure-function claims. Now the claims are focused on nutrition or general function, and some products make no claims at all. Interestingly, Steele noted, despite the increasing regulatory pressure and changes in claim language, the probiotic market continues to show remarkable growth. Whether that growth is sustainable is difficult to predict.

In addition to regulatory restraints, other key market constraints include the presence of substitutes (e.g., other functional ingredients for gut and immune health such as vitamin C); lack of awareness of the word “probiotic,” especially in the United States; and challenges with product stability (i.e., probiotics are sensitive to many food and beverage applications). Key market drivers include growing benefit substantiation (i.e., clinical documentation on an expanding list of conditions); health care provider endorsements; increasing awareness as a result of companies such as Danone and Yakult promoting digestive health; a trend toward self-care; and the perceived immediate impact of probiotic products (e.g., feeling the benefit of taking Activia after only 2 weeks of regular consumption).

Positioning of Probiotics: Types of Claims

In the United States, there are three general categories of probiotic claims: (1) content claims, (2) structure-function claims, and (3) health claims. Examples of content claims are “contains L[actobacillus] acidophilus bifidobacteria,” “contains live and active bacteria,” and “probiotic.” These require the least amount of documentation. Examples of structure-function claims are “supports good digestion,” “promotes a healthy digestive and immune function,” and “helps naturally regulate your digestive system.” Structure-function claims require more documentation than content claims and, according to Steele, resonate very well with consumers. Examples of health claims are “reduces the risk of cancer,” “reduces IBS [irritable bowel syndrome],” and “reduces incidence and severity of chronic constipation.” These require the greatest amount of documentation. Probi-

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