Hyped Supplement Tests Reveal Questionable Methods and MotivationsApril 23, 2013
Dr. Oz needs to dig a little deeper into this organization.
Here are a few things we said about ConsumerLab in an earlier report:
One of the most prominent [supplement] testing laboratories does not appear to us to be either independent or impartial.
ConsumerLab.com says its stated mission is “To identify the best quality health and nutritional products through independent testing.” Unfortunately, their claim to independence does not appear to us to be valid.
ConsumerLab.com (CL) approaches dietary supplement makers and asks them to enroll in its “voluntary” testing program—for a fee. CL doesn’t publicly disclose its fee schedule, but we know that one company was charged over $4,000 to test a single product. Companies that pay the fee are guaranteed that if one of their products passes the testing under their Voluntary Certification Program, it gets listed on the site and may carry the CL Seal of Approval—and if it fails the testing, the product will never be identified publicly because the results are “proprietary to the manufacturer”!
However, companies that do not agree to pay for the voluntary certification program risk having their products tested anyway through the firm’s “product review program.” If they fail the test, those failures will be publicized on ConsumerLab.com’s website and in the media, with complete details for sale in CL’s Product Review Technical Reports.
This arrangement strikes us as nothing short of scandalous. It sounds like, “Pay up, and you won’t have to worry about the results. Don’t pay up, and you may be exposed to bad publicity.” What kind of game is this?
You might guess from the name “ConsumerLab” that the company was an actual testing facility. But CL actually farms out its product testing. Although the company admits it’s a “third party group” certifying the quality of dietary supplements, CL does not identify the laboratories it uses. Does the company do an annual audit of the labs it uses to make sure they are following Good Laboratory Practices and otherwise operating up to standard? We don’t know, and they’re not saying. Despite all this, CL is often quoted by mainstream media as being experts on supplement safety and testing.
In its latest report, CL tested forty-two of the leading multivitamin/multimineral products sold in the US and Canada (including three multis intended for pets). They “failed” sixteen products—some for the most specious of reasons.
For example, CL tested how long it took for a product to disintegrate in water, claiming that it is indicative of whether it can be absorbed in the body fast enough. Products taking longer than thirty minutes to dissolve received a failing grade. The stomach, of course, does not digest in water—and the process takes a lot longer than thirty minutes.
The FDA has established what are called Current Good Manufacturing Practices (cGMPs). The cGMPs require companies to set specifications for all aspects of its products, including disintegration. One supplement company, NOW Foods, established its own disintegration time of sixty minutes for relevant products, and this met with FDA’s approval. CL’s thirty minute disintegration time isn’t an arbitrary number, however: it’s based on a drug standard. This is absolutely not appropriate for supplements, because supplements are digested as foods.
CL also warned against products for exceeding the upper limits (UL) for nutrients set by the Institute of Medicine, whom we have taken to task for their disastrously low recommendation for vitamin D dosages. As Dr. Robert Verkerk, scientific and executive director for ANH-Europe, points out in the journal Toxicology, ULs are intrinsically flawed, as they focus on a single, most sensitive adverse effect on the most vulnerable sub-population. “Paradoxically,” he writes, “dosages that induce risks in sensitive populations commonly overlap with those which induce benefits in the majority.” The result is dietary supplement dosages that are so weak as to be ineffectual in the majority of the population.
One of the ULs that CL tests for is niacin. As Verkerk notes, “Given that ULs for niacin have been set at 10 and 35mg/d by the Scientific Committee on Food / European Food Safety Authority (EU) and the Institute of Medicine (USA), respectively, it is noteworthy that most of the benefits, such as blood lipid management, occur substantially above these dosages.” Further, he notes that different levels may be reached depending on the form of niacin.
CL “failed” one product for not meeting what CL claimed was the folic acid level claimed on the label, even though the product actually contained not folic acid but natural folates. The method for testing for natural folates (which is the method recommended by the Association of Analytical Communities) is very different from the folic acid test (which is the US Pharmacopeial Convention method). After contacting CL, they claimed to have tested the product using both methods. We’ll just have to take their word on that.
CL also singles out companies that were just within the UL for certain nutrients. If they are within range, why even mention these companies at all?
The simple “approve” or “fail” method for grading multivitamins can itself be misleading. Some supplements may “fail” on very debatable grounds, such as UL or some technicality, while others might have far more serious problems. Lumping them together appears to serve no purpose other than to encourage more companies to buy CL “services.”
As usual, CL’s report does not discuss the methodology they used—how many times they tested a product, what lab was used, etc. Laboratories can be very unreliable, and repeat testing may be necessary. How can they expect anyone to take them seriously while withholding this information?
On a recent TV show, Dr. Mehmet Oz discussed the report—and frankly hyped it—while at the same time giving viewers further misleading information. For example, Dr. Oz claims that FDA doesn’t monitor supplements as they do drugs. That is simply not true. Both have Adverse Event Reporting systems. Both have to follow cGMPs—whether the product is pure, lives up to the information on its label, etc.—which is what CL is essentially testing for.
The show implied that many supplements are contaminated with heavy metals such as lead, with serious health effects. In reality, only one product had any lead contamination at all, at levels that weren’t very high—and it should have been mentioned that it was one of the products marketed for pets.
Dr. Oz claimed that “many” products failed in the aforementioned disintegration test, when in fact only two of them did, and as we have pointed out above, it isn’t the right test.
Supplement safety is an important topic. We don’t have all the answers on this complicated subject, although there is evidence that supplements are the safest part of the food chain. One of the problems is that the highest quality supplements, with the most carefully sourced ingredients and the most checking, often cost more, and many consumers simply cannot afford the extra cost.
We urge consumers to educate themselves as much as possible in order to make an informed choice and we hope to provide more information for you on this important subject in the future. In the meantime, check out our guidelines for making sure your nutritional supplements are of the highest quality.