There is very little regulation as to what goes into a supplement and even less on labeling quantities per ingredient.
Below I have quoted directly from the www.transparentlabs.com website regarding the dangers of labeling. I have also added articles published by CNN on a study on Melatonin and discussions of Extract ratios from www.akarali.com. You should read these.
The following is from Transparent Labs
“Why Supplements with Proprietary Blends Are Ripping You Off“
Dietary supplements, notably multivitamins, protein powders, pre-workout drinks, probiotics, and herbal extracts, collectively comprise one of the world’s most prolific industries. In fact, gross supplement sales in the United States alone reached an astonishing $42.6 billion in 2018, and that number is projected to grow at least 5-fold by 2026.
While high-quality dietary supplements are undoubtedly useful for a range of health and performance purposes, there is no shortage of products that are loaded with proprietary blends and questionable ingredients.
But what is a proprietary blend? Why should you avoid supplements with proprietary blends? Read on to learn all about this deceptive marketing tactic.
What is a Proprietary Blend?
In short, a proprietary blend is a mixture of ingredients in undisclosed doses. These “prop blends” typically feature 10 or more ingredients with no specifics about the actual dose of the individual ingredients. Hence, they are “proprietary” (read: secret).
However, a proprietary blend in a dietary supplement must list one quantity – the total amount of the entire blend. For example, many pre-workout powders contain proprietary blends under the guise of a clever name on the ingredient panel, such as “Concentrated Energy-Enhancing Blend” or “Mental Performance Augmentor,” followed by a single dose for the many ingredients that comprise that particular blend.
But that’s all the information you get, so it’s impossible to say how much of each individual ingredient is in the blend.
About the only thing you can ascertain regarding individual ingredients is their relative amounts in the proprietary blend since the ingredients are to be listed in descending order (i.e. the first ingredient is the most abundant).
Though, this still doesn’t tell you much about the exact doses…
Let’s take a hypothetical supplement that contains a proprietary blend of 15 different ingredients and a cumulative dose of 7,000 mg. The first ingredient in the proprietary blend could be 6,999 mg while the remaining 14 ingredients are merely “sprinkled in” at negligible doses. This is often referred to as “label dressing” since virtually all of the ingredients are dosed so low as to be useless.
There’s a saying that “the dose makes the poison,” and the same can be said for efficacy: the dose makes the medicine.
Sure, a proprietary blend might contain ingredients that are generally effective, but if the dose is way below the threshold for performance/health benefits, it won’t matter. 100 mg of creatine monohydrate – the most proven supplement ingredient known to man – is not going to do anything for athletic performance, but 2,000+ mg will.
WHY DO SUPPLEMENT COMPANIES USE PROPRIETARY BLENDS?
Aside from the obvious (it saves money), the only advantage of proprietary blends is that they hide the precise formula from competitor brands, making it much like a form of intellectual property. This prevents other companies from stealing your formula, but this also means consumers are left in the dark about ingredient doses, which can make or break results.
At the end of the day, consumers deserve to know exactly what they’re getting when they purchase a supplement. This is why you will never find proprietary blends in Transparent Labs supplements. We proudly specify the precise amounts of every single ingredient on all of our supplement labels, even the inactive ingredients like flavoring.
Understanding Supplement Label Claims
When shopping for a dietary supplement, it’s imperative that you don’t just read the label claims and assume that the ingredients will benefit you in some capacity.
Just browse through your local supplement shop or pharmacy and you’ll see endless aisles of supplements with flashy, attractive labels that say things like “Build 1000% more muscle!” and “Burn 5x more stubborn body fat!”
If it’s not obvious, statements like that are baseless and misleading, especially once you look at the actual ingredients.
So, how do supplement companies get away with such egregious marketing tactics?
THE TRUTH ABOUT SUPPLEMENT REGULATION
For better or for worse, there is no governing body that oversees how dietary supplements are made, what they contain, or if they are even effective. The Food and Drug Administration (FDA) may step in from time to time if there are multiple reports about safety concerns over certain supplements/ingredients, but beyond that, it’s essentially a free for all.
Hence, the supplement industry operates on a bona fide honor system, leaving consumers with the predicament of “taking a company’s word it.” This is actually what spawned Transparent Labs, as we grew tired of the industry’s trend towards proprietary blends and coyness.
In 2015, the New York state attorney general issued multiple cease-and-desist letters to major retailers after testing their leading herbal supplements and finding that virtually all of them had unrecognizable chemicals and/or contaminants.
In fact, nearly half of the 120 DNA samples from one of the herbal supplement lines had no plant DNA at all. In other words, it was an herbal extract supplement with no herbs!
So, what did these products actually have in them?
Sadly, cheap fillers.
Many of the products that were tested contained little more than powdered houseplants and powdered wheat. What’s most concerning is that a good chunk of these supplements claimed to be gluten-free/wheat-free.
Not only is this highway robbery, but a blatant disregard for the health of consumers who can have potentially fatal allergic responses to wheat/gluten. It’s a miracle someone didn’t get violently ill from taking one of these supplements.
It’s disconcerting that the supplement industry is rife with products that contain little more than inert fillers, and in some cases, harmful contaminants like mercury, arsenic, and lead.
Nevertheless, if a supplement or vitamin has an attractive eye-catching label, it will sell.
“Potentially dangerous doses of melatonin and CBD found in gummies sold for sleep“
Testing of over two dozen melatonin “gummies” sold as sleep aids found some had potentially dangerous amounts of the hormone that helps regulate sleep, according to a new study.
“One product contained 347% more melatonin than what was actual listed on the label of the gummies,” said study coauthor Dr.Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in Somerville, Massachusetts.
A jar of gummies might also contain ingredients you didn’t count on, Cohen said: “One of the products that listed melatonin contained no melatonin at all. It was just cannabidiol, or CBD.”
According to the US Food and Drug Administration, “it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” Yet several of the tested products containing CBD in the study openly advertised the addition of that compound to their melatonin product, Cohen said.
“Four of the tested products contained levels of CBD that were between 4% and 18% higher than on the label,” Cohen said.
The use of CBD in over-the-counter aids is particularly concerning because parents might purchase gummy products to give to their children to help them sleep, said Dr. Cora Collette Breuner, a professor of pediatrics at Seattle Children’s Hospital at the University of Washington.
“There’s no data that supports the use of CBD in children,” said Breuner, who was not involved in the study. “It’s currently only recommended for a very specific use in children over 1 with intractable seizure disorders.”
Aside from CBD, consuming a gummy that unknowingly contains extremely high levels of melatonin — well over the daily 0.5 to 1 milligram per night that has been shown to induce sleep in kids — is also dangerous, said Breuner, who serves on the integrative medicine committee of the American Academy of Pediatrics, which is currently writing new guidelines on supplements in children.
Side effects of melatonin use in children can include drowsiness, headaches, agitation, and increased bed-wetting or urination in the evening. There is also the potential for harmful interactions with medications and allergic reactions to the melatonin, according to the National Center for Complementary and Integrative Health, a department of the National Institutes of Health.
The agency also warns supplements could affect hormonal development, “including puberty, menstrual cycles, and overproduction of the hormone prolactin,” which causes breast and milk development in women.
Carefully chosen from government database
In the study, published Tuesday in the journal JAMA, researchers sent 25 products labeled as melatonin gummies to an outside lab that tested for levels of melatonin and other substances.
However, the research team didn’t pick products “willy-nilly” off the internet, Cohen said. The scientists carefully chose the first 25 gummy melatonin products displayed on the National Institutes of Health database, which the public can check to see labels of dietary supplements sold in the United States.
“We choose gummies over other products because we thought parents would chose edibles to give to their children,” Cohen said. “”We also wanted to take a closer look at those products after last year’s report that poison centers have had over a quarter million calls about pediatric ingestion, thousands of hospitalizations, ICU visits, even some deaths.”
A 2022 report by the US Centers of Disease Control and Prevention found calls to poison control about melatonin ingestion by children rose 530% between 2012 to 2021. The largest spike in calls — 38% — occurred between 2019 and 2020, the report said.
Most of the calls were about children younger than 5 years old who had accidentally eaten gummies caregivers had not properly locked away.
“Gummies are enticing to young children, who see them as candy,” Cohen said. “We wondered if there was something going on with the products that might be contributing to the calls to the poison control centers.”
The new study found 88% of the gummies were inaccurately labeled, and only three contained a quantity of melatonin that was within 10% of what was listed on the label, said Cohen, who has studied invalid labeling of supplements for years.
Gummies sold as sleep aids had much higher levels of melatonin than stated on the label, as well as CBD, according to the study.Grace Cary/Moment RF/Getty Images
“The regulatory framework for supplements is broken,” he said, “The manufacturers are not complying with the law, and the FDA is not enforcing the law. So what that means is that we have a lot of poor-quality products out there.”
A spokesperson for the FDA told CNN the agency would review the findings of the study, adding that the FDA generally doesn’t comment on specific studies, but “evaluates them as part of the body of evidence to further our understanding about a particular issue.”
“It’s important to underscore that under current law, the FDA does not have the authority to approve dietary supplements before they are marketed, and firms have the primary responsibility to make sure their products are not adulterated or misbranded before they are distributed,” the spokesperson said via email.
Steve Mister, president and CEO of the Council for Responsible Nutrition, a trade association for the dietary supplement industry, released a statement saying that manufacturers may add additional melatonin to be sure the product remains at the levels on the label as degradation naturally occurs over time.
“While there may be some variability in overages as companies adhere to the FDA’s requirements regarding shelf life and potency, it does not mean there is a risk in taking these products as intended,” Mister said.
Melatonin is a hormone
People often view melatonin as an herbal supplement or vitamin, experts say. Instead, melatonin is a hormonethat is made by the pineal gland, located deep within the brain, and released into the bloodstream to regulate the body’s sleep cycles.
Studies have found that while using melatonin can be helpful in inducing sleep if used correctly — taking a small amount at least two hours before bed — but the actual benefit is small, Breuner said.
In six randomized controlled trials on melatonin treatment in the pediatric population, she said, melatonin decreased the time it took to fall asleep, ranging from 11 minutesto 51 minutes.
“However, these were very small studies with widely variable results,” Breuner said. “So I say to the parents, ‘You’re really looking at as little as 11 minutes in decreasing the amount of time it takes your child to fall asleep.’”
Anyone considering melatonin should be sure that the bottle has the stamp of the United States Pharmacopeia (USP), which manufacturers hire to test and verify products.
“If it has a USP stamp on the label, you can be sure the product is accurately labeled,” Cohen said. “However, that doesn’t mean melatonin products are going to work or they’re agood idea to take.
“That’s not what the USP is about,” he said. “But at least the verification of the label should eliminate the problems we’re seeing here in our study.”
Extract ratios and standardized extracts are both terms used to describe the concentration of active compounds in a herbal supplement. However, there are key differences between the two.
Extract ratios are simply a way of expressing the ratio of the raw herb to the final extract. For example, a 10:1 extract means that 10 grams of raw herb were used to produce 1 gram of extract.
Standardized extracts, on the other hand, are extracts that have been guaranteed to contain a specific amount of active compounds. This is typically done using a laboratory test.
You, the consumer, want to know what percentage and/or volume of the active ingredient is in each supplement to know if you are ingesting the proper amount required to give you the specific results you are looking for. Look for the standardized extract information to review the specific amount of active compounds.
The following is from Akarali.com
The difference between extract ratios and standardized extracts
When extraction ratios are used to define the Tongkat Ali extract, it suggests X amount of raw Tongkat Ali material was used to produce Y amount of extract.
This gives the consumer the impression that more bioactive compounds are present in an extract if the extract ratio of X:Y were high.
For an example a consumer may think a 100:1 extract A is more potent that a 10:1 extract B because for a 100 mg supplement the product A may be more concentrated than B.
The same can be said for 200:1 Tongkat Ali extract. Many believe 200:1 Tongkat Ali extract is stronger than 100:1 extract, but this is not the case as when high amounts of raw material is used, it may also represent poor and inefficient extraction to achieve the same standardized active compounds by other extraction ratios.
In other words for every 1 kg of extract A, it is the perception that 100 kg ‘dry herb equivalent’ raw material was used for extraction compared to extract B which utilized 10 kg.
However, this is misleading and incorrect.
For example
100 mg 100:1 Tongkat Ali extract containing 1% Eurycomanone
100 mg 10:1 Tongkat Ali extract containing 1% Eurycomanone
In this example both the extracts are standardized to 1% Eurycomanone. The extract with a higher extraction ratio 100:1 did not have 10X more Eurycomanone, in other words 10% Eurycomanone.
It also gives the impression that if we consume the Tongkat Ali raw roots (dry herb equivalent), we will get the same benefit as the extract. This too is not true as the whole purpose of extraction is to extract the bioactive compounds that would otherwise be locked in the dry herb and not be bioavailable.
If one relies on Tongkat Ali extract ratio, they could risk being underdosed as they might be tempted to reduce the dose if they find the extract is a product of higher extract ratios.
When the consumer no longer experiences the benefits of the Tongkat Ali extract, they may get mis-jaded and conclude that the Tongkat Ali supplement is ineffective.
Comparison of extracts based on extract ratio and standardization
To ensure that one is getting the best benefits from Tongkat Ali extract, standardizing the level of eurycomanone, eurypeptides, saponin and total protein is key to deliver a holistic 360 health benefits.
The standardization ensures that the right amount of bioactive compounds are present in the extract to ensure you are getting optimal benefits.
Most of the Tongkat Ali studies on the health benefits are based on standardized extract, and Malaysia is the country that produces quality Tongkat Ali extracts as reported by The New World Report, Reuters and ABC News.
Clinical urologist Dr. Ismail said “For it to work on humans, Tongkat Ali extracts that are clinically validated by qualified human clinical tests perform optimally to deliver the expected health benefits”
Head scientist Dr. Annie George from Biotropics added that Tongkat Ali extract ratio is not the determinant for potency nor efficacy, thus consumers should not fall into the trap believing 200:1 Tongkat Ali extract is the best extract.
To illustrate this, we secured several Tongkat Ali extracts in the market defined by extract ratios, of 200:1, 100:1 and comparing it with standardized extract.
Testing for the standardized markers of Eurycomanone, Glycosaponin, Protein and Polysaccharide twenty-three samples were analysed at the in-house chemistry laboratories in Malaysia.
The compilation of the analysis is shown below:
Table 1: Tongkat Ali extract from various suppliers (undisclosed) with bioactive compounds as tested in a Chemistry laboratory
Source
Sample Label
Eurycomanone (%w/w)
Total Protein (%)
Total Polysaccarides (%)
Glycosaponin (%)
Malaysia
Standardised Tongkat Ali water extract according to Malaysian Standards MS2409:2011
0.8-1.5
≥22
≥30
≥40
Indonesia
XX One Hundred
0.53
25.37
46.66
30.6
TA 10:1
0.15
0.80
81.20
7.50
TA 20:1
0.20
0.60
83.00
19.4
TA 50:1
0.51
6.92
69.20
28.3
Malaysia
Tongkat Ali Powder Extracts (100:1)
1.23
26.7
31.30
52.5
Japan
Tongkat Ali 100 fold Concentrated
0.80
21.55
N/A
N/A
China 1
200:1
0.05
0.10
80.80
3.70
100:1
0.06
0.10
81.00
3.80
200:1 (Source 2)
0.25
6.20
58.50
44.70
Note: The names of the supplier for the extracts above is undisclosed.
Based on the Table above, it is apparent that the extracts based on extract ratio do not represent a more potent version of the standardized extract if one were to use eg. Eurycomanone as the indicator.
The ones described based on the higher than 1.5% Eurycomanone content {China (1) and (2)} has not been clinically validated for safety or toxicology. Furthermore, the extract with high content of Eurycomanone is possibly produced by organic solvent extraction which is not the method used in traditional preparation for which safety and efficacy is available.
The standardized Tongkat Ali aqueous extract standardized according to Malaysian Standards (MS) 2401:2011 is the only extract with extensive clinical studies demonstrating safety and efficacy.
Parting Thoughts
Consumers should be careful when buying 200:1 Tongkat Ali extract as it may not be the most potent, or strongest Tongkat Ali. The extraction ratio provides a false impression as it is not used as an efficacy measure to deliver the intended benefits.
