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/

Agave Nectar Dangers; facts and myths

The people claiming that fructose is worse than sucrose are ignorant and plain wrong. HFCS is typically 42% fructose, mostly glucose; some is 55% fructose.

Is blood sugar no longer an important issue? Diabetes statistics would seem to insist that it is still relevant. In that regard alone, fructose (with a Glycemic Index rating of 20, versus 100 for 100% sucrose white sugar) is far better than sucrose in terms of not provoking high blood sugar and the resulting insulin reactions.

And the repetition that agave nectar production is analogous to HFCS production is mind numbingly simplistic and misleading. In terms of agave production, taking inulin that's made of chains of fructose, adding non-GMO "plant enzymes" to free the fructose, then heating and filtering is not really that unnatural a process; in fact, in some ways quite similar to human digestion. HFCS production involves converting 100% sucrose corn syrup into fructose and then adding pure corn syrup to achieve the 42% or 55% fructose syrup (the rest of the 100% in each form is pure corn syrup as sucrose). There is no corn used to make agave nectar, and sugars are not converted into other forms or blended.

Studies showing that getting 25% of daily calories, around 500 calories, solely from fructose is related to obesity begs the question of why getting nearly all of our carbs from a single sugar, rather than from a mix of sugars along with fiber and starches, is anything other than a fast food worst case scenario. This is not relevant to those taking a little agave nectar in place of other sweeteners. Trying to frighten people who now won't even take a piece of whole fruit or a couple of calories worth of fructose in a chewable or liquid dietary supplement (this is actually happening!) is in my opinion both cynical and misleading. That is not honest nutrition. Common sense should be more common.

Vegetarian Dietary Supplements

Vegetarian Dietary Supplements By Neil E. Levin, CCN, DANLA 

Most dietary supplement manufacturers use the term “vegetarian” to include “vegan” and one even recently began adding the word “vegan” to their product labels to assure users that they are offering products without any animal-derived ingredients. 

However, some products are always animal-derived. These include: Fish Oil, Gelatin, Chondroitin sulfate, Vitamin D3, Hydroxyapatite calcium, collagen, Chitosan fiber, Celadrin oils, Pancreatin, Pepsin, Trypsin, Chymotrypsin, ImmunoLin® immunoglobulin complex, Bovine or Shark Cartilage, Sea Cucumber, Sea Mussel, Liver products that contain actual liver tissue, IGF-1 deer velvet and glandular substances. Other products are sourced from milk or dairy products: Whey proteins, Casein, Colostrum, and MicroLactin™. 

Probiotics are typically made by growing bacterial cultures on dairy products. Some strains are weaned off of the dairy and are harvested with only traces of dairy protein (casein) remaining. The growers will not certify these probiotics as non-dairy, dairy free or vegetarian, but tell us that most manufacturers do label their probiotics with these claims. 

 Yet another class of products is considered non-vegan because of the honeybee source: Bee Pollen (collected by, but not made by, bees), Honey, and Royal Jelly. This is an interesting distinction because bees also are essential for pollination and increasing the yields of many fruits, vegetables and nuts eaten by vegans. 

 Some dietary supplements may come from either animal or vegetarian sources. One example is Glucosamine, a structural component of the joints normally extracted from clam shells. While most glucosamine products are from shellfish, there is a vegetarian version that can be combined with MSM to provide the sulfur needed for the body to turn glucosamine hydrochloride into glucosamine sulfate. This vegetarian form is obtained by fermentation. Still, the vast majority of glucosamine supplements on the market use the shellfish-derived form, including the supplement called NAG (N-acetyl glucosamine) that is used for GI health and as an “essential sugar”. 

HA (Hyaluronic acid), used to aid the moisture-holding, cushioning ability of the joints, is often extracted from poultry. There is a vegetarian form, produced by fermentation. 

The digestive enzymes amylase, lipase and protease are found in the animal product called Pancreatin. But there are also plant-derived enzymes. These plant enzymes include amylase, lipase and protease, but they work in a much wider pH range over a longer period of time than Pancreatin enzymes, which work only in the alkaline pH of the intestine. Beginning digestion of fats and carbohydrates in the stomach can improve even good digestion. 

Look for vegetable-derived excipients such as magnesium stearate, stearic acid, rice flour, maltodextrin, etc. The stearates can also be sourced from beef fat, so it pays to check! 

Gelatin has long been the substance that capsules are made from. Originally, all capsules were gelatin caps. Two-piece capsules are normally derived from beef and pork gelatin, whereas the gelatin in softgel capsules is normally exclusively derived from beef gelatin. More recently, Vcaps have become a preferred form. In the past ten years or so there have also been Vcaps® as a vegetarian alternative, made from vegetable cellulose. A newer version, called NP Caps or Vcaps®, is made from non-GMO corn polysaccharides. Some considerations in the choice of which type of capsule to use revolve around the technical differences in filling and storing gelatin versus Vcaps. These differences include different moisture barrier characteristics, different transparency of the capsule, different speeds at which these capsules can be filled on our production line, whether only vegetarian materials are used in the formula, etc. There is a way to fill two-piece vegetarian capsules with liquids, but the resulting product has an air bubble in the capsule and is typically a much lower dose and much more expensive than softgels made from gelatin. So this form has not been fast to catch on. 

One softgel that is available in a vegetarian capsule is Vegetarian E-400. But this form is not yet widely used for other supplements. Most vitamin E softgel caps are primarily made from beef gelatin. There is often hidden gelatin (often from fish) in beta-carotene, lutein, and other oil-based ingredients. Companies should scrupulously ensure that they use only non-gelatin bases for ingredients in their vegetarian/vegan products. It is unknown how aware vegetarian shoppers are of this hidden, tricky issue. Often, these problems apply to carotene or lutein in multiple vitamin formulas, which could get mislabeled as “vegetarian” if a manufacturer does not take the care to pay attention to these important ingredient details. 

Other common names for animal-derived ingredients include Porcine (from pork/pigs), Bovine (beef/cows), and Ovine (lamb/sheep). Consumers can contact the vitamin companies directly to ask about their vegetarian products. Knowledgeable health food store personnel, especially certified nutritionists or vitamin specialists familiar with their inventory, can be very helpful. Often an employee at a store who is a vegetarian will be familiar with the products from that perspective. And please be aware that the availability of vegetarian options is always increasing! 

In many cases, there is no functional difference between differently sourced ingredients; for example, glucosamine or HA. It is only when the actual form of the active constituent is physically/chemically different that a difference in the actions and efficacy of a substance is likely. There may be some differences in efficacy between plant and animal sourced ingredients, as we have seen with plant enzymes having a wider range of action than the same types of animal enzymes. 

Fish oil is far more effective than flax oil in terms of providing the maximum EPA and DHA per serving. Flax oil contains ALA, which is poorly converted into EPA and DHA (5-10% and 2-5%, respectively). 

One good example is melatonin, usually sold as a synthesized ‘nature-identical’ molecule. It can also be extracted from the pineal gland, but considerations of Mad Cow Disease and animal ingredient issues have pretty much sunk that source, which was the original form available. While glandulars may have other, subtle effects on the body, the actual melatonin produced either way is the exact same molecule with identical actions. 

Phosphatidyl Serine (PS) is normally produced from lecithin, with additional sources more rarely available (bovine, egg). Most of the research is on the soy-derived source, so its efficacy should not be in question. In the human body PS is synthesized from phosphatidylcholine; a similar process is used commercially to produce PS.