RAY A. MATULKA
Burdock Group,
859 Outer Road, Orlando, FL 32814, USA

Abstract

Probiotics have been consumed for centuries as part of food with known beneficial effects on the body. Today, more people are turning to natural products to maintain health, as well as potentially prevent diseases or their symptoms. Recent scientific studies find benefits on unlikely organ systems, and so companies are utilizing this information to better explain the specific benefits of probiotics. However, companies may make claims that push the probiotic product from a food or supplement category into a drug category. What types of claims can be made for probiotics consumed as food, and what types of statements will make the same product a drug? What types of clinical trials would be perceived as drug trials? This article will discuss different claims that can be made for probiotics in the United States, as well as in other countries, focusing on the differentiation of probiotics regulated as food or as drugs.

The term “beneficial bacteria” seems contradictory in today’s germophobic culture, with sanitizing hand cleansers now being found in public places, but in reality, not all bacteria are harmful to the body. In fact, many studies have found that bacteria in the intestinal tract play a significant role in human physiology. Human biota are involved in the development of a healthy immune system, prevention of infection from pathogenic or opportunistic bacteria, and help in the development and maintenance of intestinal barrier function (1). Certain bacteria, termed probiotics, work with the body and have a positive influence – potential effects include maintaining optimal intestinal flora, lower colonic pH and improve digestion. Although use of bacteria in food with the potential for a beneficial effect has a history dating back centuries (typically from the consumption of fermented foods), the term “probiotic” was first used in 1965 by Lilly and Stillwell to describe substances secreted by one bacteria that stimulate growth of another (2). There is no singular definition of probiotics, but the Food and Agriculture Organization (FAO) of the World Health Organization (WHO) ...