The report published earlier this month found seven of nine valerian supplement products purchased in US retail stores contained too little of active valerian compounds or were contaminated with lead.
AHPA chief science officer Steve Dentali, PhD, said ConsumerLab was universally applying a European Pharmacopoeia (EP)-established valerenic acids level of 0.17% to all products tested, when that level was only intended for certain types of source valerian material.
He said the EP highlighted that level was only relevant for extracts derived from whole, dried valerian root, whereas valerenic acid levels of 0.10% were relevant for extracts sourced from dried valerian root in cut form. The Food and Drug Administration had established similar levels.
“ConsumerLab arbitrarily chose to apply the 0.17% standard to all forms of valerian root in their attempt to determine the quality of these products,” Dentali said in a statement.
“This is clearly not correct for products made with cut or fresh valerian root. In addition, unless a company claims that its product complies with the EP or any other compendial standard, it may use other appropriate quality standards in the sourcing and manufacture of its valerian products.”
“Taking into account the actual forms of valerian in the tested products, a re-analysis of ConsumerLab’s data indicates that six – not four – of the tested products contain levels of valerenic acids claimed, expected from the EP standard for dried and cut valerian root, or likely to be found in fresh root.”
He added: “ConsumerLab has not provided information to indicate whether their analytical methods have been validated for each specific product matrix, or had otherwise been proven to be scientifically valid across the range of tested products,” commented Dentali. “Absent this information, it is impossible to know whether the test results for this product are within the limits of accuracy for CL’s analytical methods.”
ConsumerLab president Tod Cooperman said AHPA’s assertions were inaccurate and his firm was in the process of publishing a retort as NutraIngredients-USA.com went to press.
Efficacy
Dentali noted that at any rate, valerenic acid was not the only measure of product efficacy. One of the products in ConsumerLab’s report that failed to deliver on valerenic acid content had clinical data backing its sleep-promoting effects, highlighting an issue that runs through nutrition science about how whole plant extracts deliver benefits versus specific extracts.
“While valerenic acids are useful markers for identifying a valerian ingredient, there is no scientific consensus that these are the sole or even primary constituents that contribute to valerian’s therapeutic value,” Dentali said.
“It is at best an oversimplification to try to ‘test in the quality’ of a valerian product simply by measuring valerenic acids, and this narrow approach has in at least one case ignored a product’s proven efficacy.”
Lead contamination
In a situation echoed this year in the omega-3 sector over PCB contamination, AHPA said the lead thresholds (between 1.15 and 3.5 mcg/day), related to those established by California’s Proposition 65 and which were below federal levels established by Health Canada (20mcg/day).
The FDA has no set level but Principal Deputy Commissioner Joshua Sharfstein, MD, referenced 6mcg/day as “FDA’s tolerable daily intake” in testimony before Congress earlier this year, AHPA said.
“ConsumerLab has again chosen an arbitrary reference to determine whether products meet its self-assigned quality standards,” stated Michael McGuffin, AHPA’s president. “While AHPA has been active in providing information to assist companies to comply with the California law, the lead levels in these products do not represent adulteration under federal law.”
US valerian supplement sales were worth $68m in 2009 according to Nutrition Business Journal, a 10 percent rise on 2008.