As the lab turns, with Elan SudbergAs the lab turns, with Elan Sudberg
In this column, Elan Sudberg of Alkemist Labs discusses restrictions on the marketing of dietary supplements, the stream of misinformation plaguing industry and the need to be an activist.
December 15, 2022
Welcome to season 1, episode 1 of, “As the lab turns, with Elan Sudberg.” Thank you for taking the time to read my take on current events affecting our industry and their potential solutions from my perspective. In this episode, I plan to discuss 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. I really hope you enjoy it.
The truth is I identify as a marketing guy with a chemistry degree and have always found it frustrating for you (since I don’t sell a product to consumers) that we, the dietary supplement industry, can rarely say our products work. Ours is a “supplemental to good nutrition and exercise” industry, and if those two aren't a “consumer’s thing,” there’s always the allopathic medicine industry path consisting of needles, pills and scalpels. Before these times, medicine was an evolving mixture of many maturing, scientific-light disciplines. At some point, if we go way back in time, it was just us and the plants and fungus among us. Through the marvels of zoopharmacology, where we watched what the beasts of the field did, used and ate, we learned what plants and fungi use for stomach issues or skin infections or to get drunk and relax, or get high and “meet God.”
For most of the botanicals and fungi we trade in our industry, we have hundreds or even thousands of years of real-use safety data. Yet we are forced into a pharma model as if we were selling drugs. We can proudly share how we source materials and by which amazing farm and how it was grown or made. But without spending a small fortune on clinical trials, we can't claim elderberry improves your immune system and vitamin D helps fight Covid, even when we know they do.
When these restrictions started in October 1962, President John F. Kennedy had just signed into law the Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act (FDCA). They established the scientific safeguards used today (about 60 years ago) by FDA to ensure consumers will not be the victims of unsafe and ineffective medications. The impetus for this important bill was a drug called thalidomide that had made it through a rigorous (for the time) FDA approval process. It was designed as a sedative, but shortly after, with contemporary scientific consensus, it was marketed as a morning sickness remedy for pregnant women due to its antiemetic effects. The issue was the manufacturer failed to analyze for any potentially dangerous teratogenic effects, and babies were born with severe abnormalities and the drug was pulled from the market.
Early results of these amendments were successful in keeping the public safer, which we should all truly appreciate. However, they also prevented the modern dietary supplement industry from stating our products treat, cure or prevent disease. Even though we are not drugs, we got lumped into a drug law but can't use the same marketing claims of drugs.
Fiction: ‘We are not regulated’
Many wonderfully natural gifts from the land are available, some with thousands of years of safety studies (not in the sense that we use the term “studies” today based upon the pharma model, but used repeatedly safely and effectively). While we can prepare and market these natural products, we still can't say they do anything other than support the structure or function of some aspect of a body’s systems. As if the masking of our efficacy isn't enough, there's a constant stream of misinformation that our industry has been plagued with since the dawn of allopathic medicine. The fiction that irks me the most because I live and breathe FDA cGMPs (current good manufacturing practices) is “we are not regulated” (insert dramatic sigh noises and eye rolls), as if the only form of regulation is that used by pharma. Most recently and what I also find exasperating, FDA produced a “helpful” guidance document for educators on how to talk with teenagers about dietary supplements, where a video about snake oil appears only a few pages in, and there were 15 mentions of “benefit” versus 65 mentions of “risk.”
Unfortunately, we in the dietary supplement industry have been browbeaten relentlessly on credibility, efficacy and risk, yet the global dietary supplement market continues to grow. The industry’s role in fostering consumer health has become pronounced, especially in the last two years where the global population is still challenged with a new enemy whose assets can't just be frozen or bombed into oblivion or a shot be taken for it to go away.
Sadly, the prize for the biggest existential threat to our industry is a newly passed bill in California, “CA AB 2098,” where “it shall constitute unprofessional conduct for a physician and surgeon to disseminate misinformation or disinformation related to Covid-19, including false or misleading information regarding the nature and risks of the virus, its prevention and treatment; and the development, safety and effectiveness of Covid-19 vaccines.” That sounds almost reasonable considering the pickle the unhealthy and delicate global population is in, but you must read more because the devil is in the details. In this bill, “misinformation” means information that is contradicted by “contemporary scientific consensus,” contrary to the standard of care.
Take a moment and see if you can think of anything else that has historically been considered contradicting of contemporary scientific consensus. Here is a strong hint, the entire dietary supplement industry!
Fact: My argument against California’s bill—that it’s a slippery slope and has the danger to set a precedent for future attacks on freedom of speech and restrictions on our beloved industry—is itself a slippery slope. Here’s another fact. My highest grade in college was an A- in a course called Logic and Critical Thinking, and I love to weaponize logical fallacies, sometimes on myself.
Incidentally, there is an underestimated culprit behind most atrocities of our time here on earth. We can blame it for aiding and abetting racism, climate change denial, misogyny, antisemitism, and just about anywhere inequality and its brother injustice show their ugly heads. I call it “the poisonous shoulder shrug.” It’s an extremely contagious and virulent attitude that if something doesn’t directly affect you, you don’t need to care. But as history shows us, even small doses can be poisonous and lead to demise. If we offer this same shoulder shrug to CA AB 2098 and future bills just like it, we just might lose the rest of our freedom. A doctor friend of mine, out of concern for my health, told me it's not healthy to be outraged by everything. I agree, but I feel it’s more dangerous to stay silent and complacent on the aforementioned threat as history has shown and is showing us right now as we continue to lose our body autonomy in the name of a population of unhealthy and or delicate people. Mandates for drugs? How about mandates for health? Yeah, I said it. Covid should never have been deemed the “pandemic of the unvaccinated” as some of my close industry colleagues passed around early in the pandemic. Rather, it should be dubbed the pandemic of the unhealthy and or delicate... Fight me.
Activism & fighting the ‘shoulder shrug’
Good news! There are solutions to what I have shared above. It’s called activism. We must not only be our own advocates and activists, but advocates and activists for issues that may seem ancillary to our own lives. As a white male CEO in a growing industry, I don't know what it feels like to worry about a gender-based pay gap. However, I care and work hard to identify that gap in my own organization and quickly correct it. As an inhabitant of Earth, I may not see the ocean overwhelm my front yard anytime soon, but I care enough to be investigating solar panels for both home and the lab. There are incremental things we can all do to drive change, and the shoulder shrug isn't one of them. When bills show up that are an attack on our freedom, even if you aren't against the specific narrative, you must care about the slippery slope we are on toward medical tyranny, where it may soon become more illegal to market an herb for immune health.
History is one of the best teachers. However, times are changing—and what once worked to market our products to consumers must now be rethought. We have a flawed history of marketing quality in our industry. We basically don't do it. We talk a lot about how we grow our raw ingredients and how great the farms are. We carefully allude to distant and almost unrelated clinical studies with mostly unremarkable results. Sometimes, we lean on celebrity endorsements, or worse, low prices. Rarely do we share actual proof of our quality. On average, most brands have some meaningless logo of a microscope, or the words “lab tested,” but sadly there is nothing beyond that. Where is the independent data showing the consumer that what's on the label is in the capsule? They are seeking reassurance and confidence that the fruits of our labor will help treat, cure or prevent disease, even though we can't say those words. At least show them proof that the ingredients are what they are paying for.
Transparency is the vehicle by which trust is communicated, a phrase coined by my friend Scott Steinford which I have taken to heart. A few weeks ago, I was visiting one of the world's largest dietary supplement brands. It sells in the billions of dollars a year. In awe of its spectacular lab and facilities, I asked these loaded questions: “How much do you spend on quality?” Knowing that’s a tough question to answer since so much goes into quality, I accepted the answer of, “millions.” My follow-up question was, “What are you doing to share that with the consumer?” The brand stumbled a bit and agreed it can be doing more. I have run through this exercise with much smaller companies, and while their ratio of quality spend versus annual revenue is way more dangerous than the big organizations considering their financial fragility, small brands have the nimbleness to deploy this underutilized value proposition more quickly.
In an industry where our value propositions are endangered, the mainstream media rhetoric is we are unregulated, and bills like CA AB 2098 are primed and ready to cull the rest, it is absolutely critical that we as an industry share proof of our quality with the consumers. Let’s share our spending, communicate lab results, and disclose where and how our products are tested from batch to batch because we all know it’s best to be testing that way. If we make this information accessible to the consumer, then when it's time for them to make a purchase, at least they trust the product is safe and effective to treat, cure or prevent disease, even if you can't say those words. Lastly, if you test by input (calculator instead of lab), I triple dog dare you (yeah, triple...) to share that with the consumers. See what happens.
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. Élan holds a degree in chemistry from California State University Long Beach, and he is on the American Herbal Products Association (AHPA) board of trustees.
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