Many depressed individuals may be laying hopes on St. John's wort products too weak to help them
In the face of corporate bottom-line decisions and a paucity of research grade (double-standardized high hyperforin/hypericin) raw material, many St. John's Wort manufacturers are reportedly turning to a less active species of the plant. AKA fraud.
An analysis of St. John's wort commissioned by The LA Times examining if retail St. Johns wort products were as potent as they claimed, bought in six Los Angeles-area stores, and labeled as "standardized" or having "certified potency," "high potency" or "guaranteed potency," seven of the 10 products contained between 75% and 135% of the labeled hypericin level, and three contained no more than about half the labeled potency.
And price had no baring. Two of the three lowest-scoring brands cost less than the average price of 18 cents per pill. Two of the three highest-scoring brands also cost somewhat less than the average. The most expensive brand was among the highest in potency, but the second-most expensive brand was among the least potent. The method used in the tests was a spectrophotometric test--a measurement of color in a solution--called DAC-91. The method used by The Times is "the accepted industry standard for testing," said Roy Upton, an herbalist and editor of the American Herbal Pharmacopoeia. It was adopted several years ago by the German government for St. John's wort testing, though methods continue to evolve.
Jarrow Formulas, for example, resulted in hypericin readings that are 20% below those found by the method the company's extract supplier uses, "which accounts for the difference between our label claim and the results obtained." Officials at Enzymatic Therapy and Nature's Resource made a similar argument. Just how closely herbal supplements should adhere to their labeled potency is a matter of some debate, said the Times article. FDA regulations state that the concentration of labeled ingredients in dietary supplements, including herbal medications, must equal 100% of the amount claimed on the package throughout the product's shelf life. In reality, though, holding herbal products to that standard can be difficult because the chemical composition of a plant varies from crop to crop, and analytical techniques for measuring key compounds can yield somewhat different results, an FDA official said.
So some experts argue that herbal products containing 80% to 120% of the labeled potency are close enough. "That might be reasonable," said Sally Guthrie, a University of Michigan clinical pharmacist. Others narrow the margin to 90% to 110%. "At this point, 90% of label claim is what I would specify" as a minimum, said V. Srini Srinivasan, a senior scientist at the U.S. Pharmacopeia. But Mark Blumenthal, director of the American Botanical Council, an independent scientific and policy group, disagrees, arguing that a product really should have 100% of what its label claims. "If they say they have 0.3% hypericin at 300 milligrams, they should have that," he said. "As a consumer, I want to know that I'm getting what I pay for."
One of the lowest-scoring products sampled, with about 20% of the labeled potency, was from Sundown Herbals, a division of Rexall, the nation's No. 1 distributor of dietary supplements. Informed of the results, Deborah Shur Trinker, Sundown's vice president of regulatory affairs, said they were "false" and "misleading." Tinker, in a letter to The Times, argued that the tests involved too few pills for the findings to be significant. Trinker also argued that chemical ingredients specific to Sundown's brand might interfere with the analysis, giving an artificially low reading. Finally, she stated that an independent lab hired by Sundown had found the product to be 100% potent.
However, The Times arranged for a
second lab to analyze the capsules. That lab's findings were
consistent with The Times' original results.
Adding to the quality control issue, U.S. herbal distributors tend to copy one another's products. These copycat supplements are a concern because they may not in fact be identical to the original formulations tested in research studies, says Mark Blumenthal, director of the American Botanical Council, an independent scientific and policy group, which receives some funding from the herb industry. "Is it possible that some of the herbal supplements out there are not wearing any clothes?" he said. "Are they just making claims . . . after borrowing somebody else's research conducted on a different commercial product that may or may not be similar?" Given the absence of direct government oversight, the herb industry is taking steps to improve standards and police itself. Industrial Laboratories, a Denver-based testing firm, has formed the Institute for Nutraceutical Advancement, an industry-funded group to validate methods of analyzing botanical products.
If the basic findings are representative of the hundreds of St. John's wort supplements now on the U.S. market, it would suggest that Americans are spending millions of dollars on products that do not live up to their claims. Moreover, a significant number of depressed people may be laying hopes on products too weak to help them even when taken at the recommended dosages, medical researchers say. "How is it possible to appropriately regulate a treatment regimen if you can't even be sure of the dosage?" said Dr. Norman Rosenthal, a research psychiatrist at the National Institute of Mental Health and a strong believer in St. John's wort's mood-elevating properties. "You're using this [product] for important reasons and you want to know you're getting what you're supposed to be getting," he said after reviewing results. "It's quite important that there should be truth in advertising."products.