Aspergillus Niger Safety

Fermentation is a process where a microorganism is utilized as a factory to produce certain nutrients or other biologically useful substances for humans. The culture, environment, and feed can encourage production of various products including enzymes and organic acids that are commonly used in foods and supplements. Some molds are benign; think of Saccharomyces boulardii (related to the yeasts in bread or beer) or blue cheese. 

While Aspergillus niger is a black mold, it is not the black mold that contaminates homes. As with the enzymes produced by A. niger, inhalation of mold or enzymes is not healthy for the lungs, and precautions are taken during production. In addition, A. niger is considered GRAS (generally regarded as safe) by the FDA and has been used for a century to produce citric acid and enzymes. Enzymes produced by A. niger do not contain significant amounts of the culture after isolation and purification to USP monograph standards of purity. Just as milk does not contain a cow, enzymes produced by A. niger do not inherently contain black mold. 

The U.S EPA has reported: 

“Exposure to Aspergillus must be nearly universal but disease is rare. The physiological condition of the exposed individual thus appears to be of paramount importance. Patients exhibiting aspergillosis are generally immunocompromised, and thus susceptible to otherwise common and usually harmless microorganisms. Factors that may lead to immunosuppression include an underlying debilitating disease (e.g., chronic granulomatous diseases of childhood), chemotherapy, and the use of supraphysiological doses of adrenal corticosteroids (Bennett, 1980)…A. niger is not a significant human pathogen. Throughout years of use and widespread exposure to A. niger in the environment, there are only several reports of aspergillosis with A. niger, and in Nigeria, one report of a number of cases of otomycosis. There have been only several reports of allergic reactions, which are not uncommon for aspergilli in general, and not unique to A. niger. A. niger is capable of producing several mycotoxins. However, mycotoxin production appears to be controlled by the conditions of fermentation.”  

EPA’s Final risk assessment for Aspergillus niger https://www.epa.gov/sites/production/files/2015-09/documents/fra006.pdf

https://pubmed.ncbi.nlm.nih.gov/12172605/

Limits on Oral Potassium in tablets and capsules

The U.S. Food and Nutrition Board (FNB) has established an Adequate Intake (AI) of 4.7 grams/day of potassium in a healthy adult. A tolerable upper limit (UL) was not established for potassium since there was no evidence of adverse effects from a high level of potassium from foods consumed by healthy adults.

Potassium is a food substance and is affirmed as generally recognized as safe (GRAS) by the U.S. FDA (21 CFR 184.1622) (FDA, 2012a). In October 2000, food containing at least 350 mg potassium and 140 mg or less of sodium was approved by the FDA to have the following health claim on product labeling: "Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke." (FDA, 2012b; NMCD, 2012).

Some experts suggest that a single dose of potassium should be limited to 500 mg, while a total of 1,500 mg daily is considered safe for general supplementation. This is well within the AI level.

The 99 mg. limit on potassium tablets and capsules is based on a remote risk of a pill damaging the intestinal wall if it releases its content slowly. That risk does not apply to liquid forms, or to powders that are mixed with liquids. While higher amounts are allowable, a long warning is required on all potassium products intended for oral ingestion providing 100 mg or more of the mineral in a capsule or coated tablet form: http://law.justia.com/cfr/title21/21-4.0.1.1.2.7.1.7.html

Canola Oil was developed without GMO biotechnology

The rape plant (Brassica napus) is related to mustard, turnip, cabbage, radish, and horseradish plants. Its oil has been used for centuries as a cooking oil in Europe and Asia (India and the Far East).

Both rapeseed oil and mustard seed oil contain relatively high levels of a fatty acid called erucic acid. As with some other oils, when heated to high temperatures unrefined rapeseed oil can release fumes which have been theorized to be associated with an increased lung cancer risk. These fumes have been blamed on its high erucic acid content; perhaps undeservedly since refined rapeseed oil did not seem to share this characteristic and since mustard seed oil is still a staple cooking oil in South and East Asia.

In any case, rapeseed oil was not sold as a food in the United States for many years, and this is why a low-erucic acid version was developed by traditional cross-breeding of varieties that had lower than usual levels. Originally developed in Canada in 1974, it was dubbed “Canola” oil to distinguish it from traditional rapeseed oil; the name implies its Canadian origin. This oil is often sold in Europe under its more commonly known “rapeseed” rather than the “Canola” name, even if the low erucic acid type is used.

Canola (low erucic acid rapeseed) oil received GRAS status in 1985, allowing it to be sold as a food or food additive in the United States.

These dates are long before the first commercial GMO crops were approved by the U.S. government in the mid-1990s. Since Canola’s breeding history actually goes back decades before that, it clearly was originally developed without the use of genetic engineering (GE, or biotechnology). Today, most of the canola grown in North America is GMO (from GE seeds); though there are still some Identity Preserved (IP) canola crops, from which is produced non-GMO canola oil.

The history of the use of rapeseed oil in food in the US is well summarized in the preamble of the final rule which affirmed the GRAS status of low erucic acid rapeseed (LEAR) oil (Federal Register, 1985: 21 CFR 184.1555 (c)(4)).

REFERENCES:

http://www.ers.usda.gov/topics/crops/soybeans-oil-crops/canola.aspx#crophistory

http://www.hort.purdue.edu/newcrop/afcm/canola.html

http://www.snopes.com/medical/toxins/canola.asp