No change for ginkgo monograph, says AHPA

The supplier, Ethical Naturals, issued two releases stating the May edition of the United States Pharmacopoeia (USP)'s National Formulary contained updated versions of the monograph to bring it into line with the stricter European version.

It said the new monograph includes detection of compounds such as bilobalides and tightens the ratios for other components so that products that bear the USP seal will have to be closer in composition to the ginkgo leaf.

Monographs old and new Ethical Naturals president Cal Bewicke said the monograph would make it more difficult for companies to manipulate the 24 percent flavonol glycosides; six percent terpene lactones ratio (24:6 standard) by introducing cut-price adulterants like rutin that can mimic those in the ginkgo leaf.

This is a widely known of and widespread industry practice that has more efficacy than safety effects but is something reputed suppliers have been trying to stamp out for decades.

"This new work by USP closes the door for unprincipled parties to influence tests by adding cheap substitutions that mimic compounds during testing," said Bewicke.

"USP 2008 appeals to us because it sets the quality bar higher for this important product."

A tightening of the standard may assist this end but AHPA said no such changes had been made in the latest monograph revision, despite Ethical Natural's statement.

Technical changes The Maryland-based AHPA's chief science officer, Steven Dentali, told NutraIngredients-USA.com that while a USP spokesperson had confirmed "minor changes" to the monograph last year, " the assertion that USP made major changes in their ginkgo monograph this year to more closely match the European one was incorrect.

These good standards were already in place."

"I looked up the monograph currently in force (USP 30-NF 25) and there are only a few minor technical changes to the monograph compared to the year before," Dentali said.

"The basic standards for chemical composition have not changed."

He said he saw no changes in the powdered ginkgo extract monograph from the earlier edition and noted that testing of bilobalide "has been in force for at least a year."

Larry Kolb, president of Montana-based supplier, TSI Health Sciences, said while ginkgo adulteration was widespread, the USP monograph shouldn't be blamed and perceived gaps between the quality it assures

and that of its European counterpart, were exaggerated.

He noted rutin adulteration was not a safety issue, but one of economics and efficacy, as it was an approved dietary supplement ingredient.

"It's like spiking guarana with caffeine - there are no safety issues but the customer is being deceived and that is wrong."

Back to source Regardless of when or how many changes have been made to the monograph, the issue of quality in the ginkgo biloba supply chain and that of many other botanicals is at issue.

Dentali said that while USP standards were important, a more holistic approach was required if quality in the supply chain was to be guaranteed.

"Ethical Naturals should be congratulated for offering USP quality material to their customers," he said.

"Pharmacopeial standards are important quality standards that more of the industry should be aware of it they aren't already.

They have legal standing and are valuable tools for quality assurance but are not the be-all and end-all.

They don't replace an intimate knowledge of the supply chain and I think a lot of suppliers forget that."