A proprietary blend is a unique combination of ingredients used in a product, where the specific amounts of each ingredient are not disclosed to the public. They’re commonly found throughout the food and dietary supplement space. While some of these blends are relatively innocuous, others are dangerous. What specific factors make proprietary blends dangerous in some industries (or product types) and not others?
Proprietary Blend Background and Legality
Proprietary Blends in Dietary Supplements: Are They Legal?
The Dietary Supplement Health Education Act of 1994 (DSHEA) created the dietary supplements category. It allows dietary supplement manufacturers to use proprietary blends in the United States (read more about DSHEA and its implications here).
There are still restrictions on how these blends can be marketed. Plus, certain products have unique requirements. For example, some U.S. states have regulated products like kratom above and beyond the DSHEA standards.
Generally, though, the manufacturer just has to provide a list of all ingredients contained in the product and the total weight of the blend. According to advocates for allowing proprietary blends, the practice protects companies from having to disclose their trade secret formulas with the patent office, which other companies could then appropriate.
Even though foods and dietary supplement may in some cases legally contain proprietary blends or undisclosed amounts of certain ingredients, there are numerous proprietary blend products that are sold illegally, unsafely, and unethically.
This is the fourth and final part of Harmful Headlines, a series exploring why the media, politicians, and individuals commonly misunderstand substances like tianeptine and plants like kratom.
In the previous installments, we covered what Za Za Red Pills are and how calling them gas station heroin causes harm, how tianeptine and kratom differ, and how conflating 7-hydroxymitragynine with kratom is akin to conflating products like Pegasus Red with tianeptine.
“Coca-Cola Does It, So It’s Fine for Other Companies to Do It, Too”
The Top Tree team recently researched dietary supplement products containing tianeptine to help consumers understand the differences between tianeptine and kratom. One odd thing our team took note of is that most tianeptine products on the market don’t display the amounts of the active ingredients they contain.
The products we came across in local smoke shops all contained a proprietary blend of various psychoactive ingredients. These blends include undisclosed amounts of tianeptine mixed with other substances, such as phenibut, kana, or kava (also listed as Piper methysticum or yagona). The product labels show the total weight of the blend, but not the weight of each individual substance.
We aren’t all that surprised by the lack of transparency in the tianeptine market. What we do find surprising, however, is how retailers and consumers don’t seem to think that the use of proprietary blends for these products is an issue.
We heard one retailer on a podcast rationalize the lack of transparency by pointing out the fact that food and drink companies use proprietary blends all the time.
Is that a sufficient excuse? The claim that other brands are using proprietary blends is true. Popular brands from Coca-Cola to Ben & Jerry’s hide their product formulations like your prepper uncle hides stacks of cash behind his house’s drywall. Unfortunately, this rationalization is missing a really important point. It all comes down to which ingredient weights are proprietary and which ingredient weights are displayed on the label.
Transparency in Ingredient Disclosure: A Closer Look
Sure, Coca-Cola may not tell you which natural flavors they use or how much caramel coloring is in each can. Nevertheless, they do tell you how much caffeine is in each serving. Bacardí may not tell you which strains of yeast they use to make the rum for their signature drinks. Yet they certainly list the alcohol concentration on each rum bottle’s label.
While it may be okay to conceal the amounts of inactive ingredients in a product, concealing the amounts of active ingredients is an entirely different story. Though concealment of ingredient weights is legal for certain products, it isn’t always safe.
Using a Proprietary Blend to Keep the Amounts of Psychoactive Ingredients Secret is Dangerous
When you use a psychoactive product, it’s important to know the approximate amount of each active ingredient in it. If you don’t have this knowledge before consuming the product, you could be seriously injured. This is true regardless of how commonplace or high quality the product you are consuming is.
A prominent example of the potential harms of undisclosed product ingredients occurred when Panera started selling Charged Lemonade in 2022 and multiple people died after drinking it.
The lemonade contained a large amount of caffeine, but the caffeine content wasn’t an issue in and of itself. It likely contained as much caffeine as one or two energy drinks. The issue was that when Panera started selling the drink, they failed to clearly display the caffeine content to customers. One woman who consumed the lemonade had a heart condition and was sensitive to caffeine. She went into cardiac arrest and died a few hours after drinking it.
Kratom Products Should Always Have the Weights of Active Ingredients Listed
If it’s essential for kratom companies and dietary supplement manufacturers to list the amounts of active ingredients on their product labels, why don’t all companies do so?
For kratom in particular, the legal requirements for product labels haven’t always been clear. The U.S. Food and Drug Administration has not yet announced which regulatory category kratom falls into. (Regardless, under DSHEA, kratom intended for consumption should be labeled as a dietary supplement/food if no drug claims are made.) Only a handful of U.S. states have created regulations for kratom products. Not all of them explicitly require companies to include the amounts of active ingredients on product labels.
Legal requirements aside, there are ethical reasons that manufacturers should test kratom products and list active ingredients on the label.
Not Just the Leaf: Listing Mitragynine and Other Alkaloids
Kratom products are made from the leaves of kratom trees. In addition to the cellulose, lignin, chlorophyll, proteins, and other compounds that make up leaves of all kinds, kratom leaves contain a range of psychoactive alkaloids. The most abundant alkaloid in dried kratom leaves is typically mitragynine. The most potent alkaloid that researchers have identified is called 7-hydroxymitragynine.
The amount of each alkaloid isn’t the same in every batch of kratom. Many factors can influence how much of each alkaloid ends up in a gram of dried kratom leaf. These include the tree’s genetic makeup, the soil the tree is growing in, the maturity of the leaf when it is picked, the season it is picked in, the way the leaf is processed and dried… As is the case with many natural products, the list is a long one.
Consequently, some kratom leaf products can have higher concentrations of active ingredients than others. So one gram from Batch A won’t have the exact same concentration of alkaloids as one gram from Batch B. Accordingly, many kratom laws specify that companies must list the amount of mitragynine and 7-hydroxymitragynine on the label.
These state laws apply to all products derived from kratom leaves, not just powder or crushed leaf. It is similarly important for kratom extract product labels to clearly display the weights of active components. These products are highly concentrated, so it’s essential to ensure consumers are fully informed about their strength before they consume them.
The Cost of Transparency: Why a Company Would Neglect to List the Amounts of Active Compounds
Aside from wanting to keep their formulation secret, why would a company leave active ingredient weights off of the label? One prominent reason is that transparency cuts into a company’s bottom line.
To know the amount of active alkaloids in a batch of kratom leaf, a company would have to send a sample to a laboratory for testing. Depending on the lab, accurate kratom lab testing costs around $100-$200 for a full alkaloid panel. A company that manufactures numerous types of kratom products can therefore wrack up big testing bills each month.
Plus, a company would have to create new labels every time they produced a new batch of kratom. Top Tree Herbs does this with every new batch of tea. Unlike Coca Cola and Ben & Jerry’s, we can’t use the same exact packaging for each lot of a particular product. We have to print our kratom tea boxes and capsule pouches in small quantities, which makes production more expensive.
Some businesses may also want to hide the fact that their products generally have low concentrations of active alkaloids or high amounts of heavy metals and other contaminants. Not every business is willing to cut into their profits to increase their transparency.
Instructions for Suggested Use on Proprietary Blends Isn’t Sufficient
Some companies may argue that it is okay to use a proprietary blend and keep their active ingredient amounts a secret if they display a serving size and tell consumers how to use the product. However, while it’s great (and often legally required) for product labels to have recommended instructions for use, this isn’t enough.
Not everyone has a good experience by following a package’s instructions for suggested use. Some people are sensitive to substances like kratom or cannabis due to distinctive genetics or health conditions. Some people who have a lot of experience with a particular substance can consume much more of it than an inexperienced consumer can.
Here’s a quick example. A 100mg mitragynine extract shot may suggest that a consumer drink half of the bottle up to twice daily. But what if a person knows they can’t have more than 25mg of mitragynine at a time without feeling uncomfortable?
They may choose not to follow the package instructions, and instead drink just 1/4 of the bottle at a time. If, however, the label of the extract shot had instructions for suggested use but did not say how much mitragynine was in it, that person could easily consume too much of the extract and have an adverse experience.
Be Cautious with Proprietary Blends: Don’t Support Brands That Don’t Care About Your Safety
As a final note, we urge you to stay away from brands that fail to display the amount of each active ingredient they contain. Education is key to having a good experience with any psychoactive plant or other substance. Certain brands that make proprietary blends seem to care more about their profit margin than their customers’ safety, and you deserve better.
We won’t tell consumers which types of products they should or should not consume. We just encourage you to get your products from a source that meets minimum expectations for quality and transparency.
Lastly, we recommend getting involved in advocacy efforts to improve regulation of kratom and other substances. Better regulations can help keep unsafe products off the market and preserve access to beneficial substances like kratom.
