Fillers and Flow Agents in Supplements: What are they, and are they safe to consume?

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.

Heavy Metal Poisoning in Dietary Supplements: What You Must Know.

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

Why avoid proprietary blends when buying supplements?

Why avoid proprietary blends when buying supplements?

Have you ever seen the words “proprietary blend” on a supplement and wondered what does that mean? Or maybe like many people, you’ve seen it and thought that it’s probably a fancy way of saying that the product is high-quality and exclusive. If that’s you, you are dead wrong! Read on and find out what it means when a supplement is labeled “proprietary blend” and why you should avoid it.

What are proprietary blends?

There are many supplements in the market labeled as “proprietary blends.” In others, the label could read proprietary “mix,” “matrix,” “formula,” or “complex.” They all refer to products that have a particular combination of ingredients. But the product owners don’t reveal how much of each component the product contains. Thus, the “proprietary” label. 

  • Why do supplement  Manufacturers don’t have to list the specific masses of each component? 
  • Many uninformed consumers wrongly associate the term “proprietary blends” with high-quality or exclusive products. But in many cases, it’s a marketing hype to drive up revenues.
  • Since no one knows how much of each ingredient is in the blend (apart from the manufacturer), it’s easy to disguise a low-quality product using the “proprietary blend” mask. 

 

Proprietary blends provide manufacturers with leeway to sell you a mystery supplement. 

Most manufacturers claim their reason for producing proprietary blends is to maintain their trade secrets. They don’t want competitors to duplicate their products. But there’s more to it than what they say. Supplement manufacturers are increasingly embracing the “proprietary blends” label because: 

FDA rules only require manufacturers to indicate the total weight of the product and use fanciful terms like “proprietary blend traces of the effective ingredients, and a big part is just non-dietary fillers. But the point is, you never really know.

 

Should you take proprietary blends?

The simple answer to this is a straight NO! But here are the reasons you should avoid proprietary. 

Their effectiveness is unproven: Proprietary blends often have an asterisk next to any claim. The asterisk means that the claims are not validated by experts. Instead, you will see a celebrity endorsing the product. Don’t fall for such tricks. Use products that have clinical evidence to support their claims. 

No one can tell how they work: Since no one knows the exact weight of each component, it’s impossible to establish the mechanism of action. Many proprietary blends only have traces of the effective ingredients, and a large part is non-dietary fillers. Thus, they are classified as non-herbal supplements. 

You could be going around in circles: Consuming a supplement whose effectiveness is not proven and the mechanism of action not established takes you around in circles. There’s no real outcome – you will not inch closer your health goals. 

It’s hard to trust a secretive manufacturer: It’s hard to trust a supplement manufacturer who cannot tell you the details about their product. Could it be that the celebrity endorsement is just a gimmick to get you to buy lots of fillers at a premium price?

Your health and wellness are vital. Don’t fall for unproven proprietary blend supplements that are, at best, mysterious formulas. Use only brands that give details about the ingredients. It could cost you slightly more, but it’s worth it. 

Chaga and Lion’s Mane Mushroom Buying Guide

chaga-and-lionsmane-buying-guide

Chaga and Lion’s Mane Mushroom Buying Guide

Thousands of branded products made from various fungal stages – the fruiting body, mycelium, sclerotium, and spores – are sold worldwide. Mushroom extracts often originate either from the whole fruiting bodies (a reproductive structure), mycelium (an underground network of branching filaments) or their blend. Vegetative mycelium can also form a dense mass (sclerotium) which is considered a means for many fungi to survive environmental extremes and provide nutritional sources to produce fruiting bodies under favorable conditions. Medicinal mushroom extracts are designed to offer high-quality and concentrated products containing all healthy components present in them.

 

Why Finest Formula Products?

 
We offer our customers medicinal mushroom extracts that match the potency and quality of preparations utilized in traditional Chinese medicine, as well as the extracts used in scientific research. Hot water and alcohol extracts are the only kind of medicinal mushroom supplements ever used in traditional herbal practice or scientifically validated. In contrast, other market alternatives – mushroom and/or mycelium tinctures preserved in alcohol (“cold water extracts”) or non-extracted mycelium powder (mycelium grown on sterilized rice) or fruiting bodies powders – have not been scientifically proven or used in traditional practices. In addition, they contain very low levels of the key bioactive ingredients that can define a mushroom as “medicinal” compared to multistep hot water or alcohol  extracts.

Hot water and alcohol extracts guarantee at least one bioactive ingredient (preferably beta-glucans) that should be listed on the Supplement Facts label. Most mushroom extracts are either hot water extracts only and contain no triterpenes, or they are dual extracts performed in one step (hot water and ethanol extractions combined). One-step combined extraction results in an impure, low potency dual extract that also has a low content of the bioactive compounds compared to high-quality and more efficient multistep extraction procedure, where hot water and ethanol extractions are performed separately.

 

Premium Quality Chaga Extract

 
Chaga cannot yet be cultivated to medicinally viable standards, so it must be of wild provenance. We use only the purest quality Chaga from the northern most latitudes in the world when manufacturing our Chaga extract. The Chaga sclerotia are sustainably harvested, tested for environmental pollutants to ensure safety and dried before entering the extraction phase. Chaga contains a wide array of bioactive compounds, which are either soluble in alcohol (sterols) or water (beta-glucans). Therefore, the sclerotia are extracted in two separate extraction procedures – via pressurized hot water and then via organic ethanol extraction, which are repeated multiple times until the fungal material has yielded everything of medicinal value. It is subsequently spray-freeze-dried to create the fine-grain powder, which is 100% free from ethanol/alcohol. Both extracts are then combined and concentrated at a 35:1 ratio. The final product is filler- and additive-free.

supplement_facts_chagaConsidering Chaga, a thorough and pure, multistep extraction of high-quality wild sclerotia should yield a product that is rich in many bioactives naturally present in the highest quantities, such as beta-glucans, triterpenes, polyphenols and betulinic acid. It is therefore important for us to deliver the highest quality certified Chaga product which retains its medicinal value.

Our Chaga product offers the most benefit to your health. We use the source material of the highest quality, the extraction process is thorough and precise resulting in the most potent, effective and valuable for money supplement. Analysis for specific beta-glucans reflects the Chaga product’s potency, and the percentage of triterpenes indicates that a dual extraction has taken place and that many important sterols and triterpenoids are present in the final product. The higher percentages of the main bioactive compounds will indicate that a multistep extraction process has been performed and that the product is of high quality, efficient and filler- and additive-free. Take a look at the authorized Supplement Facts label for this product.

 

Premium Quality Lion’s Mane Extract

 
 Our Lion’s Mane product is a concentrated extract produced to the highest quality specifications currently available. It is a multistep dual extract of organically grown Hericium erinaceus 50 % fruiting body and 50 % mycelium (cultivated in liquid).  Such “full-spectrum” extract provides a wider array of nutritional components originating from both the fruiting body and the mycelium. The highest quality source material is ensured by cultivating the fruiting bodies indoors on hardwood logs and liquid fermentation of the mycelium. The fruiting bodies and the mycelium are extracted separately via a multistep process to guarantee the maximum medicinal potency of the product. Alcohol-based extraction has proven to be the most effective way to harness the broadest spectrum of constituents, especially the nerve growth factor (NGF)-stimulating terpenes and polyphenols – the hericenones and erinacines. The two extracts are then combined and vacuum-dried over the course of many days. The final product is pure Lion’s Mane extract that has been tested for the presence of immune-enhancing beta-glucans, terpenes and polyphenols. It is important to keep in mind that beta-glucans are a very important component of medicinal mushrooms, but they alone do not have any regenerative effect on the nervous system. The unique health benefits attributed to Lion’s Mane extract are immune health support and “neural nourishment” – enhancement of cognitive functions such as memory and concentration and promotion of the normal function of neurons.

Finest Formula Lion’s Mane delivers a supreme quality and potency product representing a rich source of the nerve-regenerating compounds that this fungus has to offer. See the product’s Supplement Facts label for the detailed list of bioactive compounds.

 

 

 

 

 

 

Value For Money

 
 The value (read “therapeutic potency”) and the cost of the product depend on the amount of bioactive ingredients you get for the money spent. The overwhelming majority of extracts on the market do not specify the exact amount of the most valuable bioactives. The presence of starch, dextrin or maltodextrin, common additives in a mushroom product, can artificially increase the overall percentage of polysaccharides and give a false-positive value for the medicinal beta-glucans. Product labels should therefore clearly inform the consumer on what is in the product. Authentic, high-quality extracts are always accompanied by valid certificates of analysis (COA).

We are committed to help our customers to select the most effective and health beneficial mushroom supplements. Our mushroom  supplements are 100% PURE only use extracts from the fruiting body or in combination with the mycelium cultivated in liquid  (Lion’s Mane) and do not include any substrate matter or fillers in its formulation.

 

Consumer Beware!

 
Carefully read the Supplement Facts label – it should be detailed enough and show % of bioactive compounds.

Look for mushroom extracts that primarily contain the fruiting body, not just the mycelium in grain.
Avoid products that lack specification about the parts of the fungi used in the extraction.
Is beta-glucan content (percentage) listed on the Supplement Facts label?
Are there other bioactive compounds (triterpenes, polyphenols) present in the product?
Is the product tested for heavy metal, fillers- and additive-free?
Ask for a valid certificate of analysis COA with corespondeting Lot # of your product.

COA should reveal lab results from cGMP manufacturing company and 3rd party FDA acredited labaratories.