The American Herbal Products Association (AHPA), Silver Spring, MD, has challenged the findings of a recent review from ConsumerLab.com, White Plains, NY, which questioned the quality of valerian supplements.

The ConsumerLab.com analysis stated that “only 22%” of valerian products tested passed the company’s “tests for quality.”

AHPA’s review calls into question some of ConsumerLab’s procedures and suggests that most of the tested products meet standards established by the European Pharmacopoeia and the Food and Drug Administration.

Tested valerian products selected for the recent ConsumerLab.com (CL) review include some that specify the level of valerenic acids and others that list only the amount of valerian root. In the latter case, CL states that a product passed if the amount of total valerenic acids detected was at least 0.17% of the amount of valerian root in the product. Although CL does not provide a reference for this 0.17% standard, this is the minimum amount established by the European Pharmacopoeia (EP) for whole, dried valerian root. But the EP level for valerenic acid from dried valerian root in cut form is 0.10%, reflecting changes that may occur during processing.

“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,” stated Steven Dentali, PhD, chief science officer of AHPA. “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 manufactur of its valerian products.”

CL identifies four products that had acceptable levels of valerenic acids by its selective criteria, and classes five others as “not approved” for failure to contain valerenic acid at the amount claimed by the company or calculated at 0.17%, the EP-established level for whole, dried valerian root. But one of the unapproved products is made with fresh valerian root, and three others are made with dried valerian root in forms (capsule or liquid) that indicate the use of a cut or powdered form of dried valerian, rather than the whole dried root.

“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,” said Dr. Dentali.

A seventh product can be calculated as containing 85 or 90% of CL’s hypothetical level of valerenic acids or the claimed amount, respectively. “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,” said Dr. 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.”

CL relies on valerenic acids as the sole indicator of valerian quality, implying that the level of valerenic acids is the only factor that can be used to determine whether a valerian product has any benefit.

But one of the products that was “not approved” by CL’s tests to measure valerenic acids has been the subject of a successful clinical trial involving subjects with poor sleep experience. CL’s chemical analytical approach thus ignores the fact that this product has been shown in a double-blind, placebo-controlled study to provide significant sleep benefits, even with just a single dose.

“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,” noted Dr. Dentali. “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.”

Two valerian products were confirmed by CL to contain the claimed or expected amount of valerenic acids but are nonetheless classed as “not approved” due to the presence of lead at levels above 0.5 micrograms per maximum daily serving (mcg/day), and specifically at amounts of 1.15 and 3.5 mcg/day. CL’s limit of 0.5 mcg/day is the level above which products sold in the state of California are required to bear warning labels.

But this California standard is inconsistent with other established limits on lead. For example, Health Canada allows up to 20 mcg/day of lead in natural health products (the Canadian equivalent of dietary supplements in the U.S.). And while FDA has not established a regulatory limit for lead or other heavy metals in supplement products, FDA’s Principal Deputy Commissioner Joshua Sharfstein, MD, referenced 6 mcg/day as “FDA’s tolerable daily intake” in testimony before Congress earlier this year.

“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.”