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We Effing Told You So
By Elan Sudberg
Early in my career, I attended a few seminars with the great executive coach Marshal Goldsmith. Among many things, he preached to us future leaders the social importance NOT to always prove we are right (leaving a tiny room for proving we were right sometimes). And so, I am cashing in a credit to prove we were right.
When (now former) New York State Attorney General Eric Schneiderman sent Cease and Desist letters to Target, GNC, Walgreens, and Walmart on February 3rd, 2015, he accused them of selling fraudulent and potentially dangerous herbal extract supplements and demanded they be removed from shelves in that state.
He said his legal actions were based upon testing that was definitive, supported by more than 70 studies proving the test method’s ability to identify the thing being tested. The New York Times, which has never made a secret of its disapproval of the dietary supplements industry, went on to print five additional articles and two editorials on dietary supplements over the next two weeks, including a call for Congress to take action to regulate supplements like drugs. According to my journalism-trained colleagues, the timing and content suggested close coordination between the NY AG and the Times reporter.
A “new-to-the-scene” testing technology was mandated alongside a “comply or cease-and-desist” policy, and abruptly we as an industry found ourselves reporting to a new grand master. While the FDA had been regulating our industry for decades, suddenly a soon-to-be-disgraced-and-former Attorney General was now calling the shots on botanical identity testing, and the industry could do nothing about it.
All of this uproar was based upon a testing method that those of us who actually are experts in botanical identity testing strongly believed was neither scientifically valid nor fit for purpose, the two cardinal rules upon which accurate testing is founded. When we requested validation data from the labs pioneering this new tech we were stuck behind a proprietary wall of deceit. DNA barcode testing has a place in the pantheon of testing methods when performed by trained experts who understand the kinds of substances they are working with and have appropriate reference standards. However, DNA testing just can’t give accurate results on extracts because the commercial extraction process pulls out the actives, and does not contain any plant tissue, which is where DNA would be found.
There was even a misconception, based on some quotes and articles by me in industry trade publications , that I’m a hater of the new kid on the testing block. A far more accurate statement would be that I hate when techniques are misused, and the user doesn’t prioritize fit for purpose testing in their quality control. The material point we all should be making is that there is no silver bullet testing technique that trumps all other techniques in this industry.
Now, as the veil of deceit is lifted and the editor of BMC Medicine has announced the retraction of the 2013 paper that used DNA testing to allege widespread failings of herbal products, we as an industry are left frustrated and curious.
I am angry it took so long to vindicate the ex-CEO of GNC, Michael Archbold, who fell on his sword for this debacle. I am angry that time-tested and FDA-approved botanical identity techniques were shrugged off. I am angry that so many smart industry people failed to question rapid deployment of experimental technology in the misguided rush to match the obviously inappropriate DNA testing employed in the now-retracted paper.
Under severe pressure from our loyal clients, who were mandated to deploy this new and untested technology, we tried very hard to make this DNA testing work for botanicals. Alkemist Labs lost nearly a million dollars on “equipment and team” trying to make unvalidated technology viable, in an effort to support worried clients. I am fortunate that I don’t answer to a board of directors, who likely would have invited me to resign.
While this event did ultimately reaffirm that HPTLC is a perfect technology to deploy on plant and fungi identification to combat adulteration, I hope the industry learned that accepting a questionable proposition solely based on the authority making the claim is dangerous.