ConsumerLab.com, White Plains, NY, responded to comments recently made by the American Herbal Products Association (AHPA) regarding ConsumerLab.com’s report on the quality of valerian herbal supplements. That review found that only 22% of the supplements selected for testing passed quality criteria.

“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.com’s findings and conclusions,” said Tod Cooperman, MD, president of ConsumerLab.com. “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.”

Under the current GMPs, identity testing is mandatory for all dietary ingredients. To date, however, AHPA nor any other trade group has set a minimum standard for identity for valerian using chemical testing, ConsumerLab.com said.

AHPA questioned the minimum criteria used by ConsumerLab.com for evaluating the chemical content of valerian supplements. AHPA’s chief science officer, Steven Dentali, PhD, claimed that had ConsumerLab.com set expected valerian root products to contain 0.10% valerenic acids (based on the European Pharmacopoeia (EP) minimum for dried valerian in cut root form) instead of 0.17% used by ConsumerLab.com (based on EP minimum for whole dried valerian root), two additional products would have passed testing.

However, Dr. Dentali failed to note that the criteria used by ConsumerLab.com represents the total valerenic acids as the sum of three compounds, as explained in the publicly available “How Products Were Evaluated” section of the report. The 0.10% requirement suggested by Dr. Dentali is based on the sum of only two compounds. Contrary to APHA’s press release, 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.

Dr. Dentali of AHPA claimed that another product that failed ConsumerLab.com testing was the subject of a successful clinical trial and that “CL’s analytical approach thus ignores the fact that this product has been shown … to provide sleep benefits.” However, the description of the clinically tested product is inconsistent with the product tested by ConsumerLab.com and the study did not chemically characterize the product in the trial, making comparison to any current product impossible. ConsumerLab.com also noted that the clinical study that AHPA referenced was not independently conducted, but was funded by the product’s manufacturer and co-authored by one of its employees.

ConsumerLab.com’s use of the California Prop 65 limit for lead contamination (0.5 mcg/day per supplement) was also criticized by AHPA. Although AHPA acknowledged that products exceeding this limit are legally required to have a warning label and the offending products did not, AHPA’s president, Michael McGuffin, claimed that the California reference was “arbitrary” and that “these products do not represent adulteration under federal law.”

ConsumerLab.com defended its choice of the California limit, noting that it was not arbitrary but the only limit in the U.S. as the FDA has failed to set a limit on lead in dietary supplements (although the FDA limit for candy is just 0.1 mcg per gram), and that consumers should avoid products that unnecessarily increase their exposure to lead. AHPA has provided guidance that would permit an arbitrary 10 mcg/day per supplement with an unspecified lower limit for children and women who may be pregnant. ConsumerLab.com has actively disagreed with such a permissive limit, noting that over 90% of the supplements it has tested to date meet the more stringent limit and that the many people who take multiple supplements daily risk exposure to toxic amounts of lead if products fell just below AHPA’s lenient limit.