It’s Now Herbal Products’ Turn to (Unfairly) Wear the Scarlet Letter

11/8/13

A recent research article, “DNA barcoding detects contamination and substitution in North American herbal products,” has generated a considerable amount of attention toward its findings. Having read, reread and read again the entire article, I humbly accept any offerings of gratitude for saving you time, as these two sentences summarize the entire article:

A recent study using an emerging novel technology (DNA barcoding) found a questionably alarming conclusion about the prevalence of contamination in supplements. Industry leader responses are unanimous that significant flaws may exist in the methodology, findings, and hype produced.

That said, a little information can be a dangerous thing. I suggest you read the whole thing. (Here’s the link: http://www.biomedcentral.com/1741-7015/11/222.) It should be noted that serious consideration should always be taken when evaluating a method and, ultimately, if its results fit the purpose.

Unfortunately, the study was quickly picked up and summarized by The New York Times, where it gained momentum and is causing most of its potential damage. Since only 44 products from 12 companies were analyzed, I find it an anemic perspective on the industry’s overall quality. The sample size is a major flaw since it’s hardly a representative sampling.

Its claims like “59 percent of the products tested contained DNA barcodes from plant species not listed on the labels” that gets me excited. I can go online and find 44 bad products from one vendor or 12 vendors (as they did). I can also go online and find thousands of good products. Too bad they missed all the good products in this market. Too bad they missed ~70 percent of our customers… Too bad the study does a good job in questioning the effectiveness of the products tested ultimately lowering consumer confidence. As if to rub it in, the authors then suggest we embrace a novel testing methodology when its limitations are clearly not yet understood.

From a lab perspective I am shocked at this alleged failure rate of ~60 percent. We saw this failure rate a decade ago before cGMPs. At Alkemists we see thousands of test samples each month—our failure rate is barely half that high. Since we do a great deal of “is it or is it not St. John’s wort?” type of tests, we occasionally notice that materials labeled as raw plants are in fact plant extracts with substrate. The last time I checked, DNA barcoding requires genetic information and hence does not work for plant extracts. Our experience is that a great proportion of the botanical products in this industry are plant extract-based. This could be one reason why the methodology produced such poor findings.

What’s peculiar, and scratching at conspiracy theory, is that to the best of my knowledge, there have been no reports of any fatalities from the dietary supplement that this study examined. Still, the “Herbiphobic” effect will resonate for many moons. Meanwhile Johnson & Johnson was fined billions of dollars for misrepresenting one or more of its FDA-approved drugs, possibly with fatalities involved. The media will soon forget how dangerous a newly FDA-approved pharmaceutical is, half of which might be recalled permanently or for relabeling.

All that said, the dietary supplement industry is sick. It has a cold. We at Alkemists are committed, along many other key players (both large and small), to improving the situation. That is what’s important: within a few years, thanks to the FDA’s increasing efforts to enforce 21 CFR Part 111 and with labs like ours, we will cure this sickness and be the model of a healthy industry.

I hope when that day arrives, the media will find that news newsworthy.

 

Categories: Analytical Testing, Botanical Identification, Product Verification/Validation, Regulations