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Probiotics are defined by the Food and Agriculture Organization of the World Health Organization as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host (1). The term probiotic can be subcategorized to include probiotic drugs, probiotic foods (e.g., foods, food ingredients, and dietary supplements), direct-fed microbials (probiotics for animal use), and designer probiotics (genetically modified probiotics) (2). In the United States, probiotic products are marketed to a generally healthy population as foods or dietary supplements (3).
If a probiotic is intended for use as a dietary supplement, it is placed under the umbrella of “foods,” and as such is regulated by FDA’s Center for Food Safety and Applied Nutrition (15). A dietary supplement is defined by the Dietary Supplement Health and Education Act (DSHEA) of 1994 as a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. Supplements must contain >1 of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical (excluding tobacco); an amino acid; a dietary substance for use by persons to supplement the diet by increasing the total dietary intake; a concentrate, metabolite, constituent, extract; or combination of any of the above (16).
In contrast to drugs, dietary supplements do not need FDA approval before being marketed. However, manufacturers need to notify FDA before marketing a product. According to DSHEA, the manufacturer is responsible for determining that the dietary supplements that it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading; the manufacturers need not provide FDA with evidence that substantiates the safety or purported benefits of their products, either before or after marketing. If a dietary supplement contains a new dietary ingredient that was not sold before October 15, 1994, then the manufacturer is required to notify FDA and demonstrate to FDA before marketing why the ingredient is reasonably expected to be safe for use in a dietary supplement. On June 22, 2007, FDA announced a final rule establishing Current Good Manufacturing Practice requirements for dietary supplements. To ensure the identity, purity, quality, strength, and composition of dietary supplements, those who manufacture, package, or hold dietary supplements must follow these regulations (17). Also, since implementation of the Dietary Supplement and Nonprescription Drug Consumer Protection Act in 2006, manufacturers and distributors of dietary supplements have been required to record and forward to FDA any directly received reports of serious adverse events associated with use of their products. MedWatch Form 3500A (www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082728.pdf) must be completed by the manufacturer or distributor and submitted to FDA. FDA encourages voluntary reporting of adverse events by healthcare professionals, consumers, or patients on MedWatch Form 3500 (www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf) (18).
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Claims for Dietary Supplements
The law allows that in addition to nutrient content claims, manufacturers of dietary supplements may make structure/function or health claims for their products. For a structure/function claim, FDA requires that manufacturers’ substantiation is accepted by experts in the field and that the claim is truthful and not misleading. The data substantiating structure/function claims need not be publicly available and need not be disclosed. In general, the level of substantiation and the quality of evidence needed to make a structure/function claim are less than that needed to make a health claim. When a structure/function claim is made, the manufacturer must state in a disclaimer that FDA has not evaluated the claim and that the product is not intended to “diagnose, treat, cure, or prevent any disease”; such a claim can legally be made only with regard to a drug (19,20).
