The American Herbal Products Association (AHPA), Silver Spring, MD, has revised its analysis of a recent product review from ConsumerLab.com (CL), White Plains, NY, based on a response from CL.

ConsumerLab.com announced on November 10 that “only 22%” of valerian products tested had passed the company’s “tests for quality.” AHPA then issued an analysis of this study on November 23 and called into question some of CL’s procedures and conclusions. CL released a response the following day in which it branded AHPA’s statement as “false” and took issue with three of the points made in AHPA’s analysis.

AHPA’s revised statement takes into account the issues raised in CL’s November 24 response and reaffirms AHPA’s view that CL’s reliance on arbitrary criteria for measuring valerian products misrepresents the quality of some tested products.

“AHPA makes no defense of products that fail to meet claims that appear on their labels,” stated Michael McGuffin, AHPA’s president. “But herbal products that comply with all laws do not need to meet standards that are assigned by some third party and that go beyond the promises made to consumers on product labels.”

Valerenic acids levels depends on ingredient form

Some of the products selected by CL specify the level of valerenic acids while others list only the amount of valerian root. In the latter case, CL states that a product was 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, it matches the European Pharmacopoeia (EP) for whole, dried or fragmented underground parts of Valeriana officinalis (i.e., the rhizomes, roots, and stolons; hereinafter “root”) for sesquiterpenic acids calculated as the sum of valerenic and acetoxyvalerenic acids. The EP standard for valerian root in cut form, however, is 0.10% sesquiterpenic acids.

“ConsumerLab appears to have arbitrarily chosen to apply the 0.17% standard to finished products made from any form of valerian root in their attempt to determine product quality,” stated Steven Dentali, PhD, AHPA’s chief science officer. “This is a misapplication of this EP standard for products made with cut or fresh valerian root, since that 0.17% standard is for dried, whole valerian root,” he added. “In addition, unless a company claims to comply with the EP or another compendial measure, it may use other quality standards in the sourcing and manufacture of its valerian products.”

Authoritative references vary in qualifying valerian root ingredients

One other such compendial standard is the United States Pharmacopoeia-National Formulary (USP-NF), which is published by the U.S. Pharmacopoeia (USP). According to USP, its standards are “recognized and used in more than 130 countries around the globe.”

The current edition of the USP-NF includes monographs for unprocessed dried valerian root and powdered valerian root. The USP-NF describes whole valerian root as containing not less than 0.05% valerenic acid, and powdered valerian root as containing not less than 0.04% of this same single compound.

Questions on analytical methods used

CL identifies their initial assay method as an HPLC method “developed by the Institute for Nutraceutical Advancement’s (INA) Method Validation Program to specifically test for the presence for these substances.” CL also states that a “similar” method was used to re-test products that did not pass the first assay but provides no additional information to identify this second method.

The INA method quantifies four compounds: valerenic acid, acetoxyvalerenic acid, hydroxyvalerenic acid, and valerenal. CL’s second “similar” method counts at least three of these. It is not clear how CL uses this information to approve or not approve products if they relied on the EP standard for whole, dried valerian root for all tested products, since, as CL pointed out in their November 24 response, the EP levels are sums of only two of these compounds.

Re-analysis of data

CL identifies four products that had acceptable levels of valerenic acids by its criteria, and classes five others as “not approved.” CL claims that three of these did not contain the amount of valerenic acids identified on product labels, and AHPA notes that such products would be mislabeled if CL’s analysis is correct.

But two of the “not approved” products do not make any claims as to the amount of valerenic acids in their products. CL nonetheless holds these to its own standard, which assumes that the level of valerenic acids in finished products should be 0.17% of the declared quantity of valerian root. This approach apparently applies the EP standard for whole, dried valerian root, irrespective of the form of the root used in each product. One of these “not approved” products is made with fresh valerian root.

“Any assumption that the levels of valerenic acids set by the USP or the EP for dried valerian ingredients should apply to a product made with fresh valerian root completely ignores the fact that neither organization has established a fresh root standard,” observed Dr. Dentali.

For another product that made no quantitative claim for valerenic acid, CL measured 0.04% valerenic acid and 0.10% total valerenic acids, resulting in a “not approved” classification. The manufacturer of this product has communicated to AHPA that its product is made with dried, cut valerian root in a manner that intentionally includes a broad spectrum of the naturally-occurring compounds found in valerian root. The company notes that its product contains exactly the amount of valerenic acid prescribed by the USP for dried valerian root powder, but believes this to be of lesser importance than its intention to produce a broad spectrum extract. The company states that its product meets its internal quality specifications for this broad spectrum extract.

Valerenic acids not a ‘magic bullet’

According to AHPA, CL apparently 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 is a clinically tested valerian-hops combination. CL seemingly ignores the fact that this product has been shown in a double-blind placebo controlled study to provide significant sleep benefits with a single dose.

“While valerenic acids are useful markers for identifying a valerian ingredient, you can’t ‘test in the quality’ of a valerian product simply by measuring these compounds,” noted Dr. Dentali. “This narrow approach has in at least one case caused ConsumerLab to classify a product with proven efficacy as ‘not approved.'”

In CL’s November 24 response to AHPA’s analysis, Dr. Tod Cooperman, CL’s president, accurately noted that this clinical study “was not independently conducted, but was funded by the product’s manufacturer and co-authored by one of its employees.”

“I am confused by Dr. Cooperman’s comment, which seems to imply that he thinks it is a bad thing for companies to conduct clinical trials on their products,” stated Mr. McGuffin. “Drug trials are routinely paid for by the developing drug company and conducted by scientists employed by that company. There should be nothing suspect when an herbal company does the same,” he added.

CL also stated that the description of the clinically tested product “is inconsistent with the product tested” by CL, so that any comparison is “impossible.” This statement ignores, however, that the company has publicly announced the positive results of its clinical study for this specific marketed product.

Lead levels under FDA threshold

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 the Food and Drug Administration (FDA) has not issued a regulation to provide quantitative limits for lead or other heavy metals in supplement products (or in most conventional foods), FDA’s Principal Deputy Commissioner Joshua Sharfstein, MD, referenced 6 mcg/day as “FDA’s tolerable daily intake” for lead in testimony before Congress earlier this year, referring to the agency’s long-established provisional total tolerable intake (PTTI) of lead in the most sensitive population of children under 7.

“ConsumerLab has again chosen an arbitrary reference to determine whether products meet its self-assigned quality standards,” stated Mr. McGuffin. “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.”

In its November 24 statement, CL states that the California limit is “the only limit in the U.S.” except for FDA’s limit for candy. But this ignores the fact that FDA considers its PTTI levels to represent the agency’s current thinking on lead limits, and that FDA in fact used the 6 mcg/day level to set its lead limit for candy (and to be most precise, for candy “likely to be consumed frequently by small children”) at 0.1 ppm. It is also important to note that the only enforcement action taken to date by FDA against a supplement due to the presence of lead was for a product that contained 12 mcg/day at its maximum dosage.

Still unanswered

In its November 24 response CL addressed three of the issues raised by AHPA’s initial analysis of its valerian product review, but ignored others. The response also raised some new questions. The following issues are as yet not addressed, according to AHPA:

What is the reference for CL’s selection of its 0.17% standard? Is it the EP standard for whole, dried valerian root?

Why should products made with cut or powdered valerian root contain 0.17% valerenic acids instead of the 0.10% EP standard for cut valerian root or the USP standard for dried valerian root powder of 0.04% for just valerenic acid?

Why should products made from fresh valerian root contain 0.17% valerenic acids, as the EP standard does not apply to fresh valerian root?

Why shouldn’t an herb company conduct and pay for clinical trials for its products? If they should not, then who should conduct and pay for such studies?

Has any company that participates in CL’s Voluntary Certification Program ever requested or permitted CL to post the results of a product that failed its tests?