The American Botanical Council’s Mark Blumenthal has called for more self-regulating from industry and regulating from FDA to combat adulteration, as the ABC-AHP-NCNPR Botanical Adulterants Program lines up black cohosh and pomegranate extracts as the next topics in its series.
Blumenthal, ABC’s founder & executive director, was talking to NutraIngredients-USA about the ABC-AHP-NCNPR Botanical Adulterants Program, a collaboration of ABC, the American Herbal Pharmacopoeia, and the National Center for Natural Products Research at the University of Mississippi.
The collaboration is supported by over 90 companies, independent laboratories, schools and institutes of natural medicine, media, law firms, and trade associations.
So far, the collaboration has published in-depth reviews on the issue of adulteration in grapefruit seed extracts (HerbalGram, 2012, 94:62-66), bilberry (HerbalGram, 2012, 96:64-73), skullcap (HerbalGram, 2012, 93:34-41), and a historical overview of the adulteration dilemma (HerbalGram, 2011, 92:42-57).
Blumenthal said that, on topics like grapefruit seed extract and bilberry, FDA should be taking an active role. “The agency is uniquely empowered to help remedy the problem,” he said.
A spokesperson from FDA told NutraIngredients-USA today that it is aware of concerns expressed related to the use of grapefruit seed extract which may have had antimicrobial ingredients added to it.
"It is the responsibility of the manufacturer to ensure that their product is safe, properly labeled, and in compliance with all applicable laws and regulations. If FDA encounters a product that is not in compliance with FDA regulations, the Agency will take appropriate action to protect the public health," said the Agency spokesperson.
In terms of self-regulation, Blumenthal estimates that about 20% of the industry is involved in trade associations (NPA, CRN, AHPA, UNPA, and CHPA). “So about 20% of the industry is subject to self-regulatory requirements,” he said. That leaves about 80% of the industry not playing by the same rules, he observed.
“People recognize adulteration is a problem, and the remedy is to increase the amount of information out there, and reduce ignorance,” said Blumenthal.
The collaboration’s next topic will be black cohosh, the subject of a recent peer-reviewed paper of a new method based on specific markers in the DNA, which can ‘consistently’ distinguish black cohosh (Actaea racemosa) from closely related species that may be accidental or deliberate adulterants in herbal dietary supplements.
New York-based scientists subsequently applied their DNA test to 36 dietary supplements, and found that nine contained three Asian Actaea species (A. cimicifuga, A. dahurica, and A. simplex).
The concern for black cohosh, said Blumenthal, is the possible liver toxicity of Asian Actaea species. There have been case reports from some countries about liver toxicity, but these do not prove causation, he said.
“Several companies have contacted me and asked if I think they should look into their sourcing procedures,” said Blumenthal. “Based on that quote, and the way it was worded, I said yes. It suggests that the companies may not have had adequate specification for what they called black cohosh.”
Blumenthal noted that there is no evidence of any chemical toxicity for true American black cohosh, and that the toxicity reported is possibly associated with adulteration.
Information is available, but not yet published in peer-reviewed journals, that products associated with liver toxicity contained Chinese Actaea. However, this is not sufficient evidence to indict Chinese Actaea, but it is important information, he said.
“This should be a concern to people in the industry,” said Blumenthal. “Chinese Actaea is being labeled as ‘black cohosh’, and this is potentially a serious issue.”
Ellagic acid and pomegranate
After black cohosh will be ellagic acid in pomegranate. Blumenthal noted that there are some products in the market place claiming 40-70% ellagic acid, and asked why the products were making such claims.
Ellagic acid is present in pomegranate fruit at a level of about 3%, and on extraction some ellagitannins would hydrolyze to ellagic acid, giving an extract containing possibly 5%.
In order to get an extract containing 40% ellagic acid, you’d need a 8:1 extract, said Blumenthal, but analysis of the other compounds in the pomegranate extract are not in the same ratio, which begs the question, “is ellagic acid being added?”
Ellagic acid is also found in berries, but obtaining it from these sources is pricey, and “doesn’t make sense economically”, he said. Wood pulp is also a source of naturally-occurring ellagic acid. The other possibility is chemically synthesized ellagic acid.
“Presumably, with many of the other compounds not found in high concentrations, exogenous ellagic acid is being added.
“Other evidence is the pricing of these extracts is so low,” he added. “The economics show that some of these extracts are being sold at prices that make it very suspect.”
“There is no public health implication of such practice,” said Blumenthal, “because ellagic acid is safe, and there is no evidence of adverse events. It seems to be strictly an economic issue.”