Medicinal Mushrooms Archives

The law requires manufacturers of supplements to indicate the quantities of active ingredients in a product. However, most supplements contain “other ingredients” known as excipients. Excipients are considered necessary for production but of negligible effect to your health, or inactive. You can see a list of excipients on the “supplemental facts” panel of a product, and they may include fillers and flow agents.

Although manufacturers consider fillers and flow-agents as inactive, research shows the opposite. Some could affect your health negatively. Here’s more on why manufacturers use fillers and flow agents in supplements, and their safety.

What are fillers and flow agents?

Fillers and flow agents are vehicles, or mediums, for the main components in a supplement. They enhance workability, taste, looks, and stability of a product. Excipients, including fillers and flow agents, can perform other functions such as coloring, binding, coating, and preserving.

Ironically, these qualities do not enhance the effectiveness of the final product. However, many manufacturers portray fillers and flow agents as necessary ingredients.

Manufacturers add fillers and flow agents to increase the bulk, reduce production costs, and stretch the product’s shelf life. These objectives have nothing to do with your health.

Digging deeper into fillers and flow agents

The primary function of fillers, as the name suggests, is to add bulk to the product. Naturally-occurring bioactive supplement ingredients are hard to cultivate, extract and process. Take, for instance, Chaga mushroom supplements. It is a well-known fact that you cannot cultivate medicinally viable Chaga mushroom; it must be of wild provenance. Few supplement manufacturers go the extra mile to source for wild Chaga. Fewer are transparent about their product specs. Since wild Chaga is scarce, manufacturers use fillers to give their products a fuller look whilst having as little active ingredients as possible.

Flow agents, on the other hand, are meant to make the manufacturing process seamless. They reduce caking and other processing hurdles. Agents such as Magnesium Stearate and Silicon dioxide have been hailed for making the products flow seamlessly during manufacturing. But, there are questions about their necessity.

Modern extraction methods (such as dual-extraction) incur significantly less caking since extracts have less moisture. Supplements manufactured using such processes are also richer because the extract contains both the water-soluble and non-water-soluble compounds. However, they tend to be slightly more expensive because dual extraction requires extra investment by the manufacturer.

It is easy to see that fillers and flow agents only help the manufacturer get a better profit. But, their effect goes beyond the manufacturer’s balance sheet. Some can affect your health.

Common fillers and flow agents and how they affect your health

Although manufacturers consider fillers and flow agents as inactive substances, it is hard to believe that they have zero effect on your health. Questions over the safety of some of the most popular fillers and flow agents are hard to ignore.

Here’s a look at what you should consider as you scroll the supplemental facts panel of your bottle.

Starch is the most common filler used in supplements, and it’s considered safe. In most cases, supplement manufacturers use plant-extracted starch which is also regarded as suitable for vegans. However, many manufacturers use GMO-sourced starch. It makes more economic sense and is easier to access. There’s much controversy about the effect of GMO products on human health. Although the jury is still out there regarding GMO products, you may want to avoid consuming them in your supplement.

Magnesium Stearate is a flow agent used to prevent clumping of a supplement’s ingredients in the manufacturing process. It is made from a combination of Magnesium and Stearic acid. Although it’s an efficient flow enhancer, there’s much controversy over how it can affect human health. A study released in the 1990s found that it suppresses the immune system in rats; suggesting that the same could also happen in humans. But more recent studies have disputed this claim.

Silicon dioxide is yet another common anti-caking agent. It draws moisture from the ingredients without interfering with the composition of the ingredients. It is also thought not to interfere with your health. But studies suggest that micro granules of Silicon dioxide can sneak past the brain-blood barrier and affect your health.

Choosing a supplement

Studies are yet to prove that fillers and flow agents are harmful. However, this is an area of controversy which you are better off on the safer side.

Scrutinize the supplemental facts panel on the supplement’s label, and choose products that have no filler and flow agents. Manufacturers who go the extra mile to source natural ingredients, and use top-notch processes, do not need to add fillers and flow agents. Their products are purer and healthier. Although they may cost slightly more, you have the guarantee of a richer and more effective supplement. Most importantly, there’s a lower chance of affecting your health negatively.

Whether it’s to boost your immunity, lower the risk of health problems, or to address a particular condition, dietary supplements are a big hit in America. They come in various forms and contain different nutrients which have proven health benefits. But, dietary supplements also contain traces of heavy metals. One study which examined 121 natural health products found that many products exceeded the safe daily consumption limits for Mercury, Cadmium, Lead, and Arsenic.

In the modern industrialized world, heavy metal contamination in food, water, and dietary herbal supplements is a reality we cannot escape. We must cope with it. However, you can avoid products with unsafe levels of heavy metal content. In this article, we shall look at the risks of heavy metal poisoning and what you can do to keep it safe.

The risk of heavy metal poisoning in dietary supplements.

We should not tolerate dietary supplements that contain traces of heavy metals over the limits. However, the reality is, heavy metals are present in natural plant products. The study which examined 121 natural health products found that many contained traces of heavy metals. But this is not strange. Science shows that heavy metals are a part of the natural ecosystem. They are a part of the earth’s crust and are found in soil in nearly all geographical locations. Therefore, it is not strange to find traces of arsenic, cadmium, lead, and mercury in plants and natural plant products. It is highly unlikely for living organisms, including plant-based supplements and human beings, to not be without some level of heavy metals within their systems. In fact, science shows that humans require various levels of different metals like Calcium, Chromium, and Iron, for the proper functioning of the body.

The presence of heavy metals in our systems is not dangerous per se. However, excessive levels of heavy metals, brought about by consuming products that don’t adhere to the acceptable standards, poses a risk of Heavy Metal Toxicity.

What makes toxic levels of heavy metals in dietary supplements particularly risky?

Many consumers may think that they can fall back to the FDA. After all, the FDA checks whether drugs are safe to consume and which ones are not. But Congress defines dietary supplements pretty much like food. Thus, manufacturers of supplements have no obligation to provide proof of quality before availing a product for sale. The best that the FDA can do, according to the Dietary Supplement and Health Education Act 1994, is to check if a product is safe after it has been on the shelves.
The rules also stipulate that you don’t need a doctor’s prescription to purchase a supplement. Thus, without educative articles like this one, many consumers would be intoxicating themselves with heavy metals in a quest for the health-giving components of supplements.

Most dietary supplements contain only traces of heavy metals. However, the health-giving components in supplements are also available in small quantities. Therefore, the positive impacts of a dietary supplement only occur when you take the supplement consistently over a prolonged period. Ironically, this cumulative effect also happens with the toxic heavy metals creating a health risk.
When heavy metals accumulate in your body, it can be detrimental to your health. Scientists attribute many chronic health problems, such as brain damage, and organ failure, to the accumulation of heavy metals in our bodies.

What can you do?

The government, FDA, and your doctor may not provide much help to protect you from dietary supplements with excessive levels of heavy metals. But you can do something about it. Here is more on what you can do
Know the acceptable limits.
Acceptable level of toxins is not the kind of information that to always have with you. But it does pay to keep in mind where you can retrieve it. For example, the American Herbal Products Association prepared California Proposition 65, which recommends daily limits for heavy metal consumption. Some of the recommended limits are:

0.5 µg of Lead/day
4.1 µg of Arsenic/day
10 µg of Cadmium/day

But these figures wouldn’t make any sense if you cannot figure out the heavy metal content in your daily dose of the supplement.

Learn how to calculate your intake.

Here’s a simplified way to tell whether your supplement is within or exceeds the acceptable daily limit.
For example, the Certificate of Analysis of ashwagandha capsules shows that it contains Lead at 0.0392ppm. Each capsule weighs contains 450mg of powder. Therefore, at a daily dose of two capsules per day, you would be taking 900mg of powder per day (0.9g). This quantity of supplement contains.

In the math od toxic analysis, 1ppm translates to 1 mg toxic element per 1g product.

0.0392 ppm is equivalent to 0.0392 µg lead per 1g of ashwagandha = 0.0392 µg lead

Simplified Calculation:

0.0392 µg lead x 0.45g (one capsule) = 0.0176 µg lead per capsule or 0.0352 µg lead per serving.

0.0176 µg of lead will be ingested for every capsule of ashwagandha per capsule or 0.0352 µg lead per serving of 900mg/day

These levels are exceptionally low and below CA PROP 65 limits.

How do you determine if a PROP 65 warning label is needed?

Commonly known as a ‘Prop 65 warning’, it must be applied to any product containing a listed chemical, unless the level of exposure is below the regulatory safe harbor level. Firstly, check whether the chemical is listed and, if it is, whether the level in the product exceeds the safe harbor level. If it is not listed, or the level is below the safe harbor level, no ‘Prop 65 warning’ is required.

Be a vigilant buyer.

Since existing regulation is insufficient, you should be extra vigilant about the products you buy. Checking out the Certificates of Analysis is great, but some unscrupulous manufacturers use fake certificates. Also, some manufacturers use outdated methods that give inaccurate results.

The reliability of the verifying agent and the accuracy of the testing methods are vital.
You should purchase supplements from manufacturers who use multiple highly-regarded laboratories to verify their products. You should be confident about the autonomy of the laboratory, and its standards. You should verify the product’s accuracy before purchasing.

Resources:

https://oehha.ca.gov/proposition-65/proposition-65-list

http://www.imjournal.com/resources/web_pdfs/0607_liva.pdf

https://www.finestformula.com/lab-test/lions-mane/007002lm820-1/

http://www.ahpa.org/Portals/0/PDFs/Policies/AHPA_Guidance_Policies.pdf

https://www.sgs.com/en/news/2018/01/understanding-california-proposition-65-commonly-asked-questions