Belvedere Environmentals, LLC tests SuperMannan capsules (containing the two deactivated yeast ingredients and canberry powder) for safety and purity. Independent labs do the testing on each lot of SuperMannanan to provide independent results.

 

Belvedere Environmentals follows the rules for testing of dietary supplements as codified in the Food and Drug Administration’s cGMPs (current Good Manufacturing Practices),  21CFR Part 111.

 

All raw materials used in Belvedere Environmentals, LLC products conform to CA Prop 65 for heavy metals. Furthermore, Belvedere Environmentals follows dietary supplement industry best practices to ensure microbial safety. We employ the latest generation safety testing with the MEM Elution Test, which provides assurance of biological safety, but does not require the use of laboratory animals.

 

SuperMannan capsules pass the following tests…always!

 

Safety Test:  MEM Elution Test for cytotoxicity

 

The MEM Elution Test (ISO) is a qualitative cytotoxicity assay, in which a sample of the test material is exposed to a healthy culture of tissue culture cells for one to two days to examine its effect on those cells. The MEM Elution test is stringent: it is extremely sensitive to substances harmful to animal cells. The MEM Elution Test provides a 0 to 4 cytotoxicity value. A score of 0 is given if the test cells are completely unchanged after 24 hours; a score of 4 is given if the test cells are completely deactivated This rigorous testing also employs positive and negative controls that are tested simultaneously and under the same conditions as the test article: (1) positive control, or material of known toxicity, which have a score of 4, and (2) negative control, or materials known to be harmless, which have a score of 0. Safety is determined by a MEM Elution Test score of 2 or less. SuperMannan ingredients must pass the MEM elution test with a score of 2 or less.

 

Heavy Metal Tests:

Belvedere Environmentals, LLC, uses the California Prop 65 requirements.

-Arsenic: 10 ug/day (0.01 mg/day)

-Cadmium: 4.1 ug/day (0.0041 mg/day)

-Lead: 0.5 ug/day (0.0005 mg/day)

-Mercury (NSF/ANSI limits):  20 ug/day (0.02 mg/d)

 

Microbial Tests

Belvedere Environmentals, LLC, uses the NSF/ANSI 173 standards for dietary supplements. The NSF/ANSI 173 limits for the standard microbial test performed on a dietary supplement ingredient are:

Aerobic bacteria            1 x 10⁴ CFU/g

Yeast and mold             1 x 10³ CFU/g

E. coli                          <1 x 10² CFU/g

Salmonella                   <1 x 10² CFU/g

 

Belvedere Environmental, LLC also has published a case series report, (Brown, Katz, McCulloch, “Yeast mannan oligosaccharide dietary supplement in the treatment of chronically  acute urinary tract infections: a case series”, UroToday International 5(5) Oct 2012), which shows the efficacy of using SuperMannan.