US Food and Drug Administration regulations governing label claims for food products, including probiotics

NutrIQ LLC, Alexandria, Virginia 22303, USA.
Clinical Infectious Diseases (Impact Factor: 8.89). 03/2008; 46 Suppl 2:S119-21; discussion S144-51. DOI: 10.1086/523328
Source: PubMed


The US Congress has granted the Food and Drug Administration the authority to permit manufacturers to use claims in food labels that fit into the following broad categories: health claims, structure/function claims, nutrient content claims, and dietary guidance messages. This article outlines the scope and evolution of these claims and how they are used in the marketing of probiotics. Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial microorganisms found in the human gut.

17 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Although there exists some evidence of the safety and efficacy of probiotics for treatment of disease, many of the clinical trials have lacked methodological quality, particularly with regard to protocol design, selection of population, and product characterization. Depending on the regulatory route, data need to be collected carefully to satisfy regulatory requirements in the United States and elsewhere. This article discusses how the regulations for probiotics affect clinical research. It also describes clinical trial design and issues that affect the design of trials for probiotics conducted to improve the scientific evidence for these products.
    Clinical Infectious Diseases 03/2008; 46 Suppl 2(s2):S101-3; discussion S144-51. DOI:10.1086/523332 · 8.89 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Available reports on adherence to recommended guidelines for labeling of probiotic products are based on assessment of these products in developed countries. In the Arabian Gulf region, there is a paucity of data on the characterization of probiotic products and an absence of local guidelines for their labeling. This study, carried out in the United Arab Emirates (UAE), represents the first evaluation of probiotic products available in the Arabian Peninsula. Probiotic products were purchased over the counter from a variety of sources, including pharmacies, healthfood stores, and supermarkets across the UAE. All identified products were listed and information regarding type of product preparation and labeling information were recorded. A total of 37 probiotic products, 15 dairy-based and 22 non-dairy-based were identified. The dairy products comprised of 12 yogurts, two fermented milk products and one powdered baby formula. The majority of non-dairy products were in capsule form (n = 16). While all the non-dairy products gave information about the strain of probiotic microorganism and number present at time of manufacture, this information was provided for only one dairy-based product. Strains of Lactobacillus acidophilus were the most common probiotic organisms identified. However, one probiotic product listed Enterococcus faecalis (750 million viable bacteria per capsule) as a component. With the exception of one non-dairy-based product, all health-related claims were structure/function statements, according to the US Food and Drug Administration nomenclature. These findings indicate that a wide variety of probiotic products are available in the Arabian Gulf. Development of guidelines for labeling of these probiotic products and use of structure/function statements and health claims should be addressed.
    Food & Nutrition Research 02/2009; 53. DOI:10.3402/fnr.v53i0.1842 · 1.79 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Depending on intended use of a probiotic (drug vs. dietary supplement), regulatory requirements differ greatly. For dietary supplements, premarketing demonstration of safety and efficacy and approval by the Food and Drug Administration are not required; only premarket notification is required. Saccharomyces boulardii is a probiotic regulated as a dietary supplement intended for use by the general healthy population, not as a drug to prevent, treat, or mitigate disease. However, since recent increases in incidence and severity of Clostridium difficile infection, probiotics have been used to treat recurrent and/or refractory disease in hospitalized patients. Saccharomyces fungemia secondary to use of the probiotic has been described for patients who are critically ill, are receiving nutrition enterally, or have a central venous catheter. Before use of a probiotic is considered for hospitalized patients, careful assessment of risk versus benefit must be made. To ensure patient safety, probiotics should be properly handled during administration.
    Emerging Infectious Diseases 11/2010; 16(11):1661-5. DOI:10.3201/eid1611.100574 · 6.75 Impact Factor
Show more