Editorial: Product Quality Makes Headlines - Again

By Len Monheit

Over the past week or so, the vulnerable side of the industry has quite predictably been presented yet again as quality concerns make mainstream media headlines. And even as this is happening, the same types of disclosures are occurring between those ‘in the know’, on trade show floors, and the quality topic has even made its way into the outcome of the NIHState of the Science Panel on Multivitamin/Mineral Use for Chronic Disease Prevention, held this week in Bethesda, Maryland.

Let’s recap.

Earlier this week, the following headline appeared on Medical News Today:

“Black Cohosh Supplements With No Black Cohosh”. (http://www.medicalnewstoday.com/medicalnews.php?newsid=43217) The title speaks for itself, and instead of wondering what new media attack we were now facing, much of the industry probably grudgingly nodded its head and said, “yes, that’s probably true- doesn’t surprise me” – and went on about their day. This particular study, scheduled for publication in the Journal of Agricultural & Food Chemistry, reports that a number (3 of 11) of black cohosh supplements the researchers tested that are sold in the United States, did not contain black cohosh and instead contained a related Asian species of the plant that does not have the same chemical compounds or uses as the native North American plant. One product contained, according to the researchers, both black cohosh, as well as the adulterant. The article on Medical News Today does however point out that this product adulteration is a violation of good manufacturing practices and is therefore illegal, making it technically another enforcement issue, rather than one of under-regulation, but many readers won’t read that fine print. Instead, they’ll see more quality concerns related to supplements, have less faith in the marketplace, suspect that regulations are inadequate, call for more regulation, or stop buying supplements altogether. Of concern too is the fact that practitioners and science oriented individuals as influencers, will be less inclined to use their ‘influence’ on industry’s behalf when quality concerns about supplements keep appearing in scientific literature.

While coverage on Medical News today at least acknowledges the practices as illegal, other pickup and inferences are now and in the future, will not be so kind. The reverberation of words such as “you cannot assume that what’s on the label is in the bottle” only get ramped up in volume and actually renew support for the similar statements “you can’t be sure…” which actually came also out of the NIH scientific advisory panel, even though the panel was speaking about multivitamins rather than herbs.

On a very similar note, last week at SupplySide, several conversations I was involved in turned to supplement quality. One such dialogue led to an examination of product alleged to be “pygeum” dry powder extract. Figure 1 is the TLC fingerprint for this particular sample of “pygeum” dry powder extract being offered to US and Canadian manufacturers. The first column is beta-sitosterol reference standard; the second column is ursolic acid reference standard. The third column is the “pygeum” sample with a single band at beta-sitosterol. Columns 4 and 5 are two different lots of EUROMED’s pygeum extract, with multi bands on the TLC.

Figure 1 - TLC
[Figure 1]

Figure 2 represents the Certificate of Analysis with conclusions that the material is not “pygeum”, although the material met the specification of 13% minimum total sterols (17% versus 13%). It took a more detailed analysis to conclude that this material is not pygeum africanum extract, merely powder with sitosterols added, offered to the marketplace at a seriously discounted price. As it turns out, real pygeum extracts also come with a CITES certificate. Pygeum dry powder extract can only have a maximum of about 5% total sterols once a carrier is added, while pygeum extract with 13% sterols is a soft (paste) extract and is put into soft gels.

Figure 2 - CofA
[Figure 2]

While some manufacturers realize that you get what you pay for, others continue to accept at face value, inferior (or adulterated or misrepresented) materials. Some might do so out of ignorance, others knowingly anticipating an easy way to increase margins or gain a competitive finished product price position. Whatever the case, these practices seriously hurt all those interested in developing and sustaining this industry well into the future.

While we’re sometimes very quick to market our products to new audiences, and correct misconceptions in the media, we sometimes forget our own backyard. If we don’t mind our own backyard, we might find ourselves evicted, without a backyard to mind.

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