Empowered By Evidence (EBE), a global nonprofit group that supports evidence-based natural health product development, and the American Botanical Council (ABC), a nonprofit research and education organization that promotes science-based herbal medicine, have collaborated on the announcement.
A lengthy article in ABC’s HerbalGram Spring 2023 journal outlines the initiative.
Sorting through the smoke and mirrors of marketing
Many generic herbal dietary supplements use terms like “science-based,” “clinically proven” and others on labels. In many cases, what’s being cited is generic science backing for a broad herbal category such as berberine or black cohosh.
However, the HerbalGram article makes the case that most of this scientific evidence should be regarded as product-specific. The variability in product specifications means that while a given product might contain some of the stated botanical on the label, it might not have enough of the bioactivity to be able to claim the same health effects demonstrated by the research done on that botanical.
Indeed, this variability has been the bane of botanical ingredient research for decades and has been the reason many experts cite for a number of failures over the years. Observers say it has only been in the past decade or so that researchers at universities and medical schools have started to get the message that the research material must be well characterized in terms of purity and potency for their studies to have valid outcomes.
The HerbalGram article notes several examples of this variability. A study published in 2021 compared a ginkgo product manufactured by German firm Schwabe (one of the pioneers of scientifically substantiated herbal health products) and other ginkgo products on the market. The Schwabe product was consistent over a number of tested batches, while the others demonstrated significant variability, even if they had ostensibly been manufactured in compliance with local pharmacopeial standards.
In another case, a 2019 study compared 11 turmeric formulations on the market. The curcuminoids within turmeric are notoriously difficult molecules for the body to absorb, and the study found bioavailability differences among the products of as much as two orders of magnitude.
Science backing demonstrated to be product-specific
This all points to the issue that studies in the botanical space, just as they are for pharmaceuticals, should be regarded as product-specific. Generic drugs must by law be identical to the branded pharmaceutical, so the same scientific evidence of efficacy applies automatically to both.
But there are no regulatory parameters for, say, the specifications of a turmeric-based dietary supplement, other than to stipulate that the products must be manufactured in compliance with good manufacturing practices (GMP) rules.
How then is a clinician or a consumer to know which product marketers are blowing smoke and who is citing legitimate research for their botanical products? Enter the new listing by EBE of verified ingredients and finished products.
ABC helped pioneer link between science and ingredient specifications
Over the years ABC has popularized botanical research under its “HerbClip” offerings. To date more than 9,000 such bulletins have been made public, and ABC founder and executive director Mark Blumenthal said the product name and manufacturer associated with the research is included whenever that information is available.
Blumenthal said detailed information on the ingredient also is included when available, such as the strength of the extract and to what compound or compounds it has been standardized.
“Since its founding in 1988, ABC has strived to clarify to phytomedicinal research scientists, health professionals, industry members and consumers that the growing body of clinical trial research studies on herbs and phytomedicines is not generic, but almost always, it is based on specific proprietary formulations,” Blumenthal said. “Consequently, as a science organization, ABC has consistently identified the actual commercial botanical ingredient or specific commercial finished consumer health product used in any research study that ABC summarizes and on which it reports.”
“Making science-based natural health product choices is very challenging,” says Nigel Pollard, chair of the board of directors of EBE. “Independent advice, education, and an authoritative voice, like that provided by ABC, is essential. Mark Blumenthal and the team at ABC have inspired many improvements in the evidence base for natural health products. Up until now, it has been difficult to find the exact products that can deliver results shown in specific clinical trials.”
Rigorous accreditation
Pollard said over the past several years EBE has developed an accreditation process overseen by expert academics to vet the science behind ingredients and to verify that the finished products using those ingredients match the specifications of what was studied.
The database now includes five ingredients whose science backing has been vetted and whose finished product forms have been verified. It comes as no surprise that all of those are manufactured by two old-line European herbal product manufacturers: four by Swiss firm Max Zeller Söhne AG and one by German company Dr. Willmar Schwabe GmbH & Co. KG. Those five ingredients are sold in 32 finished product forms in 39 countries.
A sixth ingredient, manufactured by US-based firm Verdure Sciences, has received provisional approval, as the verification step for finished products featuring that ingredient has yet to be completed.
The accreditation process is rigorous. According to EBE, the other nine submissions by ingredient manufacturers in the first phase of program failed, mostly because of an inability to demonstrate batch-for-batch consistency and equivalency to what has been studied. The names of companies whose submissions are judged to be deficient are kept strictly confidential, the group says.
Answering the question of which products really work
It has often been said that it’s difficult for consumers—and for many health care professionals for that matter—to tell a carefully made dietary supplement from one of lesser quality, other than some vague generalizations based on price or where the product was purchased. This new accreditation answers that question, at least for the listed products, said Stefan Gafner, Ph.D., ABC’s chief science officer.
“We often get asked by consumers and health care professionals how to find good quality products among the many different brands in the dietary supplement aisle or online,” Gafner said.
“But so far, we didn’t really have a good answer on how to easily determine the quality of a product. Our primary criterion, especially when we are communicating with health professionals, is to suggest that people utilize clinically tested products, when available. The new database will be an excellent resource to help find those products and will hopefully incentivize more companies to invest in clinical research and get their products listed,” he added.