Evaluating the Safety and Regulations of Probiotics Added to Food

Not all bacteria are harmful to the body. Certain bacteria, termed probiotics[1], may work with the body and have a positive influence – potential effects include maintaining optimal intestinal flora, lower colonic pH, improve digestion and support of the immune system. There is no one definition of probiotics, but the Food and Agriculture Organization (FAO) of the World Health Organization (WHO) has defined probiotics as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. The nature of the host and the level of benefit impacts how a probiotic is regulated in the U.S.: a probiotic added to food is a food ingredient and is therefore categorized as a food; a probiotic for animal use is a direct-fed microbial and is therefore a feed ingredient, while a probiotic administered to treat, prevent, cure or mitigate disease, or to competitively inhibit another organism would be regulated as a drug. Essentially, the intended use of the probiotic and the associated claims will drive how the probiotic is regulated.

In the U.S., there is no legal definition of the term “probiotic” and so there is no regulatory framework that companies can utilize specifically for probiotic ingredients or claims. However, basic tenants for food and dietary supplements address certain core issues: an ingredient, whether for food or for dietary supplements, must provide the intended function throughout the proposed shelf life of the product. For probiotic ingredients this means that the microorganism must be viable for the shelf life of the final product. The shelf-life studies must be conducted under conditions that mimic storage and retail conditions, such as whether the probiotic is to be refrigerated, stored at room temperature, or away from sunlight. In addition to viability, the probiotic must have been shown to be able to perform its intended effect. To meet U.S. regulations, a probiotic to be added to food must be approved as a food additive through a food additive petition (FAP) or must be determined to be generally recognized as safe (GRAS). Although a probiotic is intended to confer a health benefit to the host, the FDA (for a food additive) or a GRAS panel of experts should only evaluate the safety of the intended use (typically thought of as the amount of ingredient consumed on a daily basis); benefits are not evaluated within a GRAS or FAP. The general aspects of safety for a food ingredient also apply to a probiotic (e.g., manufacturing process controls, specifications, stability) and extend to aspects specific for a microorganism, which include taxonomy, pathogenicity, potential toxin production and the potential for the probiotic to become antibiotic resistant.

The historical stance of the U.S. Center of Veterinary Medicine (CVM) that evaluates the safety of food and drugs for animals was that use of the term “probiotic” on the label of a product automatically made the product a drug. However, in the last couple of years the term “probiotic” has h