Why research and clinical studies are key to systematic changes in the herbal supplement industryWhy research and clinical studies are key to systematic changes in the herbal supplement industry
February 1, 2022
Sponsored by Karallief
The Council for Responsible Nutrition (CRN) revealed in its 2021 Consumer Survey on Dietary Supplements that 80% of Americans are using dietary supplements for natural health care.1 This statistic speaks volumes in support for the nutraceutical industry, but formulators and manufacturers should never forget how easily sales can come to a crashing halt following a publication releasing data suggesting potential harm from a natural supplement.2 A negative report about even a single ingredient can cause a catastrophic decline in revenue and loss of trust with the consumers. This can have a cascading negative impact on other product lines as well, so it becomes a big issue especially for larger established companies with multiple product lines.
However, the exact opposite can occur when structure/functions and safety claims are scientifically supported by clinical studies, such as what’s currently occurring with the coronavirus pandemic and the increased uptake of immune-supporting supplements like vitamins D, C and zinc.1,3
With a direct correlation between clinical research and sales, along with consumers and companies like Amazon demanding data to show the safety and efficacy of nutraceutical products, you’d assume more formulators and manufacturers would invest time and financial resources to conduct clinical studies on their products. Unfortunately, this testing isn’t occurring nearly enough, especially within the herbal supplement sector.
The Herbal Supplement Industry Needs to Change
A majority of herbal ingredient suppliers do not perform clinical trials on their formulas due to cost and timing constraints. So instead, they only support their structure/function claims on the rationale that herbal extracts have successfully been used for centuries. You can quickly spot these companies when reading about their products, because all you see are blanket statements that the herbs in their formula are “traditionally used for…”. While these traditional use statements may be true, to solely rely on them as the only source for substantiation is irresponsible, as they do not provide any type of safety and efficacy support for the specific product they are selling.
There are also ingredient suppliers and manufacturers who attempt to leverage research conducted by other companies selling similar herbal formulas as support for their own products. This not only discourages innovation and high-quality testing in the industry but is also detrimental to the consumer who purchases this product, because what they end up taking may be a less effective, inferior and potentially unsafe version of what was properly tested.
In order to establish credibility for herbal use in the supplement industry, traditional usage claims must be complemented by rigorous clinical studies on the actual herbal product being formulated and sold. The catalyst for change must begin with formulators. It’s imperative that they choose to only work with ingredient partners who develop and clinically test their herbal ingredients.
The Importance of Documented Proof and Manufacturing
Another key component to creating premium herbal products is to have the same company who designed and tested the formula play a role in manufacturing them. This puts a safeguard in place to ensure that the final deliverable is safe and efficacious. There are a handful of reputable herbal companies that follow this trifecta approach, and it’s evident in the product documentation they provide with their ingredient formulas to clients.
The following detailed testing and documentation should be standard protocol in the herbal extract sector of what’s provided to finished product manufacturers/brands:
Safety and efficacy data on the herbal formula that’s been created, including human clinical studies
HPTLC fingerprinting analysis, which authenticates which specific herb species were used. Some herbs may have more than 100 species and using the wrong species could be dangerous.
Verification that the herbal extracts used are standardized to the claimed percentage of the active compound since the active compound is what gives the benefit.
Real-time and accelerated stability testing data to determine the shelf-life of the product.
Third-party lab reports to check for the content of impurities, such as heavy metals and microbials.
Third-party certifications such as GMP, ISO 22000, Non-GMO, Kosher, Halal and Vegan.
Transparency and the Future
One company that has become an industry leader and is paving the way for other herbal ingredient suppliers to follow is Karallief. Karallief has always put science first, and they adhere to every one of the strict protocols mentioned in this article.
Karallief’s diverse team of experts consists of MDs, Naturopathic doctors, R&D industry leaders and herbal scientists. The company also holds an exclusive partnership with a world-renowned herbal extract manufacturer and high-end research facility, bringing a combined 23+ years of experience and 25 international patents amongst their combined groups.
Karallief has successfully united the powerful forces of nature, science and innovation, and this is evident in their clinically tested herbal formulas like Easy Climb joint support, KaraLiv liver support and KaraHeart heart support.
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