As the lab turns: History as a cautionary tale

Welcome to season 1, episode 2 of, “As the lab turns, with Elan Sudberg.” Thank you for returning for more of my take on current events challenging our industry and potential solutions from my perspective. In the last episode, I discussed the poisonous complacent shoulder shrug, an existential threat to our livelihoods, the flawed history of marketing quality and how we need to make third-party lab testing sexy again. In this episode, I plan to narrow my focus and cover the dangers of the “blind authority fallacy,” and even though I hated history in grade school, it does and will repeat itself.

I really hope you enjoy this column.

Remember that one time, back in 2015, when a guy named New York Attorney General Eric T. Schneiderman who knew a lot about a lot, but not a lot about botanical identity testing, “asked” major retailers to halt sales of certain herbal supplements after DNA tests he commissioned by an expert in dinosaur DNA failed to detect plant materials listed? I do, and so should you.

Bombshell news report based on misinformation, fearmongering

It was a brisk early February morning. Suddenly, out of nowhere—unprovoked and unwarranted—a bombshell news report cast doubt on the supplement industry’s credibility. And nevermore was the industry the same.

Related:As the lab turns, with Elan Sudberg

It was The New York Times, the country’s most emulated newspaper, happy to disclose that Schneiderman had sent cease-and-desist letters to major retailers, demanding they remove certain store-brand botanical dietary supplement products from their New York stores.

His attack on our industry using misinformation, fearmongering and abuse of power changed the way we regulate our industry (#qualityautonomy) and was the first time a state law-enforcement agency took direct action against major supplement retailers for alleged fraud— ignorance of technical realities be damned. While such new legal action was specific to New York, it had far-reaching impact. Several of the biggest retailers’ credibility was impugned.

Rather than fight the inappropriate new testing requirements demanded by a non-regulatory individual, the biggest retailers, who were all already beyond compliant with cGMPs (current good manufacturing practices), added this unvalidated and expensive test to their existing world-class repertoire of testing methods. One respected, major brand CEO was vocal about the matter and spoke with, to, and for the industry about how ridiculous this all was. Unfortunately, his outspoken position coupled with increased costs and slumping sales from the NYAG’s PR hit cost him his job. And all of this was based upon misrepresentations.

A “new-to-the-scene” testing technology was mandated alongside a “comply or cease-and-desist” policy, and abruptly we found ourselves reporting to a new grand master. While FDA had been regulating our industry, suddenly a soon-to-be-disgraced and former attorney general Eric Schneiderman was now calling the shots on botanical identity testing, and the industry could do virtually nothing about it.

Complexities of plants and faulty science

The science he mandated was mostly known and used in research—but had never been validated or proven fit for purpose for the medicinal plant industry, nor had it been deployed on such a scale. There was no method transparency and no willingness from Schneiderman to engage when engaged. Naturally, some of us questioned the science, loudly. We were instantly branded as luddites, but when we looked deeper, we discovered the scientists behind the failing analysis were busy publishing over 100 peer-reviewed scientific papers on reptiles, which is truly extraordinary. But where was the expertise on plant identification?

Knowing how I love to weaponize logical fallacies against their creators, you might be wondering, “Why is the fact that the scientists were ‘herpetologist DNA people’ relevant and not a straw man logical fallacy?” First, great job detecting a logical fallacy. Second, plants are genetically promiscuous, making their identity by DNA more complicated than those simple lizards. Lizards and all animals tend to stick to the rivers and the lakes where they are accustomed. Plants, on the other hand, don’t see anything wrong with a little “inter-genus bump and grind.” Eventually, a peach and ginkgo may figure out—in the field when no botanists are looking—how to create an entirely new plant.

In addition to the complexity of identifying plants with DNA, our further investigations revealed the products surveyed in Schneiderman’s investigation were not plants but rather extracts of plants. This is an important distinction because plant extracts have little or no DNA residuals. It’s no wonder the results were, “DNA tests fail to detect plant materials listed on majority of products tested.”

Still, the industry was forced to fully adopt this new way of existence or else risk not being able to make our livings. The path of least resistance for all major retailers was to just roll with it and add this mostly unnecessary additional DNA analysis to their already world-class repertoire of testing methods. This was done in an effort to be obedient to Schneiderman’s GMPs.

Back to being called a luddite. While this drama was happening, I was continuously invited to speak on stage to our industry and help explain what to do when old and new technologies collide. I chose the path of orthogonality where not one technology could—nor should—rule them all. There was and is room for DNA technology to serve the dietary supplement industry, but it should not be used alone without the use of other testing methods. That is because DNA technology doesn’t collect data on plant parts and quality, only identity.

That’s when it happened. During an event that I participated in, another presenter promoting this new technology, who is now all but forgotten, called me a “Model T” (circa 1908) in comparison to a “Tesla.” A Model T! Never had I been attacked like that by an industry colleague or even co-presenter. "Trust the science,” and “don’t fear new tech.” That’s what the presenter expertly ordered the crowd while noticeably staring directly at me.

Figuratively standing there holding the test tube racks were time-tested and FDA-approved botanical identity techniques: HPTLC (high-performance thin-layer chromatography), microscopy and macroscopy. While the technologies had been globally accepted and relied upon for decades as accurate and fit for purpose, our new master discarded them, and they were temporarily abandoned by industry to make room for the shiny new thing we had to use. When we brought up legacy identity techniques, we were accused of going against a new scientific consensus, which was that only DNA testing should be used to identify plant material. Gaslight much?

In summary, Schneiderman conjured up a problem so it would look like he had a solution.

A newish technology was rapidly mandated, which had not been validated, transparent or proven effective. Time-tested and FDA-approved botanical identity techniques—acceptable for decades—were momentarily relegated as irrelevant. To add insult to injury, the problem still exists in that DNA tests fail to detect plant materials in botanical extracts. Fortunately, no industry was harmed (long term) in the hijacking of our “quality autonomy.” Alkemist Labs, however, did spend and lose nearly a million dollars on “equipment and team” trying to comply with these mandates of new unvalidated testing technology to support the requests of worried clients.

However, as it turns out, the leading researcher’s data was later revealed as fraudulent at best, making the entire event based on lies. For our part, our company subsequently returned all the equipment and, in our only time in history, laid off the small team we hired for that failed technology. “Trust the science?” How about, “Challenge the science.” Never stop challenging the science!

Lessons for supplement industry

At any moment, FDA—our grand master who for all intents and purposes mostly works well with our industry—might at any time be overshadowed by a new and self-appointed master who shows up and changes how the dietary supplement industry is regulated. The series of events in 2015 set the precedent for other government authorities to, potentially, become the pawns of politicians and at times the media.

The “blind authority fallacy”—in which a proposition is true solely based on the authority making the claim—is one of the most dangerous fallacies, as it can change the trajectory of our lives without our consent. It is often the case that those who blindly follow an authority ignore any evidence that is contrary to the authority’s actions no matter how strong. 

Such authority could be anyone or anything, including parents, a coach, a boss, a military leader, a document, or a god. Couple that with another logical fallacy, “group think,” where the desire for consensus overrides the wisdom to consider alternatives. In so doing, we risk losing the ability and the power to challenge or change policy or actions that would render us helpless kittens on the teat of more false narratives. In short, we lose our bearings, common sense and better judgment. Having lost these critical guides, we surrender our fundamental freedoms, and the power to regain them.

In many ways, Schneiderman’s herbal supplements investigation was a classic case in the inability of critical thinking and facts to overcome fearmongering and headlines, at least in the short term. As an industry, we must do a better job when it’s time to rally together to fight against the narrative that we are not a regulated industry, and that our products do little to support human health. We must also do a better job making sure outsiders with no direct experience in supplements cannot so easily bully our industry for a few years and then disappear as if they never existed, while the damage they caused remains.

Élan M. Sudberg is CEO of Alkemist Labs, a passionately committed contract testing laboratory specializing in plant and fungal identity, potency and purity testing for the food, beverage, nutraceutical and psychedelic industries. His favorite part of his job is catching cheaters, and he is known for pushing the industry to continually raise the bar on quality and transparency. Sudberg holds a degree in chemistry from California State University Long Beach, and he is on the American Herbal Products Association (AHPA) board of trustees.