CR tested 16 echinacea products and 13 turmeric products. Noting that CR’s scientists “selected the testing methods and thresholds used in [the] evaluations based on their expert judgment,” CR concluded that six echinacea products and one turmeric product exceeded CR’s lead limits, one echinacea and one turmeric product exceeded the aerobic bacteria limits set by CR, and three echinacea products contained low or undetectable levels of phenols.
Crucially, the report noted that none of the products tested exceeded the lead standards set by U.S. Pharmacopeia (USP)—rather, “seven had lead levels that exceeded CR’s stricter threshold,” a threshold which was not made clear within the report. James E. Rogers, Ph.D., Director of Food Safety Research and Testing at CR, said in the report that “No amount of lead is acceptable,” but went on to add that “products we tested were able to keep lead levels under our threshold,” without noting what amount of lead, actually, is acceptable.
With regards to the aerobic bacteria, the report notes that “none of the products we tested contained E. coli or salmonella, [but] some significantly exceeded the USP standards for aerobic bacteria. Higher aerobic bacteria levels don’t necessarily make a supplement unsafe to take, but they can indicate that products were manufactured or processed in unsanitary conditions.”
For the key active compounds—specifically, in echinacea, the phenols—the report found that one product contained less than 20% of the phenol count listed on its label, and two others didn’t contain any detectable amount of a key phenol associated with the species listed on the label, suggesting either that “the listed species wasn’t present or that low-quality echinacea was used.”
AHPA issued a statementnoting that “supplement companies are obligated to comply with FDA’s stringent labeling rules to ensure that what’s on the label is in the bottle, but are not required to meet arbitrary expectations for what CR thinks should be in the bottle.” According to the statement, “AHPA has found that CR relied on arbitrary or internal standards for its analysis, apparently in order to support its preconceived view of herbal supplements, expressed by repeating in today’s article the false myth of ‘lack of regulation’ of dietary supplements… CR claims its review ‘identified concerns with more than a third’ of the tested products. For all but one specific product, however, the ‘concerns’ identified are related to factors on which CR assigned analytical targets that ignore federal labeling regulations and quality standards developed by AHPA and other authoritative organizations.”
Related: Dietary Supplements Regulatory Summit: Industry/FDA Unite; Discuss Future of DSHEA
With regards to the products apparently missing key constituents, the statement says: “CR also challenges two other products for which its analysis found no detectable amount of a specific constituent associated with the echinacea species listed on the products’ labels, though neither of these products actually declared the presence of this constituent…The reductionist focus by CR on one specific compound ignores that herbs are complex mixtures of numerous natural constituents and are often valued for more than a single such compound.”When it comes to aerobic bacteria, AHPA notes in the statement that “AHPA president Michael McGuffin was interviewed for this article and pointed out to the CR writer that the AHPA standard is the same as that established in NSF/ANSI 173, the American National Standards Institute’s approved standard for dietary supplements. It is unfortunate that CR chose to ignore AHPA’s input on this detail.”
Related: AHPA Analyzes FDA Recall Data
CRN, likewise,denounced the report as “the kind of snake oil the magazine so hypocritically rails against… a thinly veiled and poorly researched assault on the dietary supplement industry with ill-informed opinion posing as fact.” Plus, CRN notes, CR did all of this and still managed to ignore the biggest problem in the supplement industry: “adulterated products masquerading as dietary supplements marketed by rogue actors.”Steve Mister, President and CEO at CRN, said in the release: “If Consumer Reports’ intention is to expose threats and warn consumers, then the publication utterly failed. Today, consumers are actually at risk from adulterated products, and while this threat exists only at the fringes of the industry, it is one that can and must be eradicated. There is no better time than now to improve the industry and increase consumer safety. For once, we must establish a clear picture of the dietary supplement marketplace for the government agencies who regulate the industry and one common sense way to achieve that is by creating a mandatory product listing.”
The statement notes that for the past 25 years, the industry has been regulated by DSHEA, and that the industry has advocated for and helped to enact additional measures to further regulate the dietary supplement industry.
Related: DSHEA at 25: Time for Celebration and Discussion
“Legitimate, science-based testing standards are widely accepted and used by our industry—and others—to ensure safe and quality products come to market,” added Andrea Wong, Ph.D., SVP of Scientific & Regulatory Affairs at CRN. “Well-respected, independent certification bodies routinely evaluate both manufacturing practices and the contents of finished products to provide consumers with added assurance. The industry’s vast adherence to these standards is one of the many factors that has contributed to dietary supplements’ wide margin of safety. As a scientist, I am disappointed that a consumer publication would disregard these best practices that responsible companies take seriously and essentially establish its own arbitrary standards that are neither grounded in science nor relevant to consumer safety.”Mister concluded with some facts: “First, there will always be low levels of lead found in products naturally sourced from plants grown in soil—whether it’s an herbal extract or the produce found at a farmer’s market—and the law permits these levels because they are not unsafe. Second, opening up a dialogue with your doctor is one of the best ways to ensure proper selection and safe use of dietary supplements. And third, 77% of Americans take dietary supplements each year, including popular products like the multivitamin, vitamin D, calcium, omega-3 fatty acids, and probiotics, and when taken responsibly, they can play a valuable role in helping Americans live healthy lifestyles.”
