AHPA guidelines strive to set reasonable levels for botanical 'contaminants'

How much is a safe or reasonable level of microorganisms, mycotoxins or heavy metals in an herb or botanical product?

Suppliers and end-product manufacturers now have established guidelines to refer to in a new document released by the American Herbal Products Association. The guidelines are the result of several years of work by the trade association, although its president, Michael McGuffin, concedes, "several years is probably an understatement."

"I'm probably exaggerating down when I say it's taken several years, because it's painful to remember just how much work it was!" McGuffin said. "It really was a very thorough process we went through, looking at parties around the world to see what has been established elsewhere."

These guidelines are not needed because there is a widespread problem with "contamination," McGuffin explained. Rather, the problem comes from companies that establish unreasonably low levels for nonpathogenic plate counts.

"Planet earth contains microbes, mycotoxins and heavy metals — they've been here long before we were here, and they will be here long after we are gone," McGuffin said. "The problem is a misguided belief that the same numbers that apply to vitamins and minerals should apply to botanicals, and that simply doesn't make any sense. It shows a lack of understanding about natural microbial levels in a plant versus a mineral."

To call these three groups "contaminants" is also misleading, although it's tough to find an umbrella catch term that covers all of them," McGuffin said. "A contaminant suggests something that shouldn't be there. What we are really talking about is a cleanliness standard. Obviously, toxic pathogens such as salmonella, e-coli and certain aflotoxins, that's another matter. For those, there are no acceptable levels. But for the rest, you find microbes, mycotoxins and heavy metals at your neighbourhood salad bar."

By making the guidelines free on its website, AHPA hopes they become broadly observed in the industry and help inform the Food and Drug Administration, as the new GMP guidelines come into effect.

"Because FDA has not established guidelines like these, we hope that if a company establishes specifications for a microbe or mycotoxin — and the FDA comes back and questions them — the company can explain that they are conforming to an industry standard," McGuffin said. "We are not suggesting that a company should establish specifications for every one of the 'contaminants' we have listed. But if you do need to establish a specification, this gives you a guideline to do so."

How did AHPA develop its guidelines? The association looked at guidelines from the following parties:

Microbials and mycotoxins: World Health Organization; U.S. Pharmacopoeia; NSF/ANSE; European Pharmacopoeia; and the European Herbal Infusions Association.

Heavy metals: NSF/ANSE; ANWHO; Health Canada NHD; European Commission; European Food Safety Authority; FDA and EPA limits for standard drinking water; California's Prop 5 on heavy metals; and data identified by the FDA but never adopted as policy, called Provisional Tolerable Intake.

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