Probiotics in the United States

Abstract

Probiotics are live microbial products that have a defined health benefit. Scientific research has established that there are validated indications for the use of some probiotics available in the United States; however, in many cases, they are often used for conditions for which no benefit has been established. This article will review the uses of probiotics in the United States, as well as the current state of regulatory issues surrounding probiotics. Although the use and scientific understanding of probiotics are rapidly increasing, it is evident that there is a need to clarify the regulatory issues, which, at present, are unclear and subject to misinterpretation. In addition to efficacy, safety issues must be considered in determining when and how probiotics are to be used.

Probiotic Supplements and Food Products: A Comparative Approach

“…Suitable labeling and health claims are also the main requirement to provide a well-versed choice for the consumers [60,61]. Therefore, the subsequent information must be exhibited on the label: a. Genus, species and strain which should pursue the standard international categorization; b.…”

Probiotic Food Products Classes, Types, and Processing

“…A structure/function claim is defined as "a statement of nutritional support that affects the structure or functioning of the human body, or characterizes the mechanism to maintain such structure or function. For example 'supports the immune system' [23,24]. No therapeutic claim or disease-prevention is known to have been approved by the United States, EU, or Canada [23].…”

“…For example 'supports the immune system' [23,24]. No therapeutic claim or disease-prevention is known to have been approved by the United States, EU, or Canada [23].…”

“…The amount and quality of the data to be supplied depend on the claim that is sought. The HC/NHPD regulations concerning probiotic bacteria have requirements related to toxicity and safety [23,31]. It is suggested to use a multidisciplinary approach to assess the pathological, genetic, toxicological, immunological, gastroenterological, and microbiological safety aspects of probiotic strains.…”

“…In addition to the general labeling requirements under the food laws of each country, necessary information should also be stated on the label [23,39]. Even though, that currently in most countries, only general health claims are labeled on foods containing probiotics, it is also recommended that specific health claims be allowed relating to the use of probiotics, where sufficient scientific evidence is available [22,25].…”