ConsumerLab, AHPA Disagree on Valerian Report

WHITE PLAINS, N.Y.ConsumerLab.com (CL) released a report earlier this month on the quality of valerian herbal supplements, which stated only 22 percent of the supplements selected for testing passed its quality criteria. In response, the American Herbal Products Association (AHPA) questioned some of CL procedures and suggested most of the tested products meet standards established by the European Pharmacopoeia (EP) and FDA. ConsumerLab.com retorted AHPA used false comments" in its rebuttal.

In an apparent attempt to defend the reputation of products that have failed to meet our quality criteria, the AHPA trade group has overlooked key facts that clearly support ConsumerLab.coms findings and conclusions," said Tod Cooperman, M.D., president of CL. AHPA is misleading the public with false information. We encourage AHPA to instead, use its resources to improve the quality of valerian supplements in the marketplace, as there are products containing little of their listed ingredients."

Tested valerian products selected for the 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 stated a product passed if the amount of total valerenic acids detected was at least 0.17 percent of the amount of valerian root in the product. This 0.17-percent standard is the minimum amount established by the EP for whole, dried valerian root. However, the AHPA noted the EP level for valerenic acid from dried valerian root in cut form is 0.10 percent, reflecting changes that may occur during processing.

CL identified 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-percent. AHPA said one of the unapproved products is made with fresh valerian root, and three others made are 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.

"ConsumerLab arbitrarily chose to apply the 0.17-percent standard to all forms of valerian root in their attempt to determine the quality of these products," stated Steven Dentali, Ph.D., chief science officer of the AHPA. "This is clearly not correct for products made with cut or fresh valerian root," he added. "In addition, unless a company claims 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."

In a re-analysis of data, Dentali said CLs data indicated that sixnot fourof 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 a seventh product can be calculated as containing 85 or 90 percent of CL's 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," Dentali said. 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 responded by saying Dentali failed to note the criteria used by CL represents the total valerenic acids as the sum of three compounds, whereas it said the 0.10-percent requirement suggested by Dentali is based on the sum of two compounds. Further, CL said calculating results based on these two compounds and using the lower minimum, the failed products still would not pass testing. For AHPA to assert that inadequate products are of acceptable quality is a great disservice to consumers," added Dr. Cooperman. CL added that under the current GMPs, identity testing is mandatory for all dietary ingredients and to date, AHPA nor any other trade group has set a minimum standard for identity for valerian using chemical testing.

The AHPA further questioned CL reliability on valerenic acids as the sole indicator of valerian quality. The organization said this implied the level of valerenic acids is the only factor that can be used to determine whether a valerian product has any benefit. AHPA said 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.

"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 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."

CL answered by saying the study did not chemically characterize the product in the trial, making comparison to any current product impossible, and that the description of the clinically tested product was inconsistent with the product tested by CL. CL also noted the clinical study AHPA referenced was not independently conducted, but was funded by the products manufacturer and co-authored by one of its employees.

 CL also reported two valerian products contained 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. However, AHPA said this California standard is inconsistent with other established limits on lead. For example, it said Health Canada allows up to 20 mcg/day of lead in natural health products. While FDA has not established a regulatory limit for lead or other heavy metals in supplement products, FDA's Principal Deputy Commissioner Joshua Sharfstein, M.D. 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."

CL defended its choice of the California limit, noting that it was not arbitrary, but the only limit in the United States as the FDA has failed to set a limit on lead in dietary supplements (although the FDA limit for candy is 0.1 mcg per gram).