And so Elysium is currently running a human trial to suss out the effect of NR in older adults. Not that the company is waiting for those results. It’s already touting NR’s benefits for DNA repair and energy, which is perfectly legal under the Food and Drug Administration’s (loose, sketchy) rules about dietary supplements. You can say almost anything you want as long as the claims aren’t about specific diseases.
As others have pointed out, Elysium’s supplements business is a savvy way of sidestepping the FDA’s more onerous regulations around drugs. The agency doesn’t even consider aging a disease. Why make a costly, time-consuming bet on FDA approval when you can start selling supplements for $50 a month right away?
But another company, ChromaDex, actually is interested in getting FDA approval for NR right now. It wouldn’t be an anti-aging drug—again, aging isn’t a disease—but would instead get approved to treat a rare, genetic disease in kids called Cockayne syndrome … which, yes, has symptoms that look a lot like premature aging. The disease is rare enough that ChromaDex is hoping for an orphan drug designation, a fast track to approval for medicines aimed at diseases that affect very few people.
The point? While ChromaDex is waiting for that approval, it makes and sells raw NR to several companies, who repackage the supplement and sell it under their own brands—including, yes, Elysium. “We’re an ingredient technology company,” says ChromaDex CEO Frank Jaksch. ChromaDex holds patents for making NR, and it wants the ingredient to be as widely used as possible—be it in prescription drugs or dietary supplements. Elysium has attracted press because of its scientific stars, but ChromaDex is quietly blurring the boundary between drug and supplement.
The NAD Story
Scientists didn’t think much of nicotinamide riboside—a trace molecule in milk—until they realized the human body converted it to another molecule: nicotinamide adenine dinucleotide. NAD is vital to how cells use energy, a key player in metabolism. “I’m always reluctant to say there’s going to be a miracle molecule that is the next great thing,” says Christopher Martens, an aging researcher at the University of Colorado Boulder, “but NAD seems to be very important.”
Dozens of studies have sketched out a promising story: Levels of NAD decline with age. Boosting it seems to rejuvenate cells in mice. But does taking NR boost NAD levels enough to slow aging in humans? Nobody knows.
Nevertheless, the mouse studies created demand for stable molecules that turned into NAD in the body. In 2011, ChromaDex licensed a patent for synthesizing NR in a lab—far cheaper than trying to purify it from milk. They named the product Niagen. You can buy it from several different consumer brands online, including Elysium.
To boost future demand, ChromaDex has set up 70 research agreements with universities or research institutes to study nicotinamide riboside, putting up money and supplying scientists with the compound. Martens, the UC Boulder researcher, had been working with a different NAD precursor in mice when he found out about ChromaDex’s NR. He reached out to the company, and they are now collaborating on a human trial that looks at NR’s effect in healthy, older adults. That’s independent of Elysium’s trial.
Meanwhile, hopes of turning NR into a drug for Cockayne syndrome rest on another research collaboration, this time with the National Institutes of Health. Vilhelm Bohr’s lab at the NIH studies aging by looking at genetic diseases like Cockayne. He too realized the importance of NAD and got in touch with ChromaDex. In mice genetically altered to have Cockayne syndrome, NR has looked promising, he says. The group is now collecting data to submit an Investigational New Drug application to the FDA, which would allow the investigators to conduct a clinical trial for the disorder.
If the trial is approved, if the drug works, and if the drug is approved—which would take years—NR could be sold as a prescription drug for Cockayne syndrome and an off-the-shelf dietary supplement.
Drugs v. Supplements
Weird as that might seem, it wouldn’t be the first time. In the mid 2000s, the pharmaceutical giant GlaxoSmithKline began selling Lovaza, an extract from readily available fish oil, as an FDA-approved drug for high blood triglyceride levels. Sales of the drug hit $1.1 billion a year before generic versions of the compound came along. And of course doctors have long given out prescriptions of high doses of vitamins and minerals.
But what makes NR different is that lots of factories can pump out vitamins, minerals, and fish oil. Only ChromaDex has the patents for making NR in the US.
What’s to stop customers from just buying the cheaper supplement version? You can thank health insurance. If your copay is cheaper that the store price of the supplement, your choice is easy—even if the cost to the insurance company and the overall health care system is higher. So splitting the market for NR into supplements for healthy people and drugs for the sick means more ways to make money. That’s two separate markets for a single product.
But that’s … screwed up, right? Misaligned incentives here? “I’m not going to disagree,” says Steve Mister, president and CEO of the Council for Responsible Nutrition, a dietary supplement trade association. But it is perfectly legal. Companies can continue to sell NR or fish oil as dietary supplements—again, as long as the supplement bottle doesn’t make claims about specific diseases.
Getting the FDA to approve a drug for a disease is hard—but once you’ve done it, that same barrier keeps out competition. The opposite is true with dietary supplements: fewer regulations, lower barriers to entry, and a lot more competition. So you find a way to differentiate yourself.
Elysium is differentiating itself with Nobel prize winners and with savvy branding. The company buys NR and pterostilbene—a natural compound similar to resveratrol found in red wine—from ChromaDex and repackages both as Basis, a daily dose of pills. Lots of other companies also buy from ChromaDex and package NR in their own bottles.
But Basis by Elysium just looks different. The other companies use cheap-looking plastic bottle. Elysium’s pills come in a minimalist white jar, more reminiscent of expensive Japanese face cream than multivitamins. And you can’t buy it in a drug store. “There’s a quite a bit of fragmentation in this market and lack of leadership,” says Elysium CEO and co-founder Eric Marcotulli. “There needs to be a brand and company where people say, ‘I believe what this brand is saying. I can trust that.’”
To make Elysium that brand, the cofounders went around recruiting a scientific advisory stacked with heavyweights. The list is headlined by six Nobel Prize Winners, but includes more than a dozen other scientists from Harvard, Yale, Stanford, and the Mayo Clinic. When I asked Meir Stampfer—a professor at Harvard Medical School and head of the famous long-running Nurses’ Health Study—how he got involved, he told me he had originally gotten a call from Marcotulli but was busy and not interested. Then he got a call from Eric Kandel, a Nobel-prize winning neuroscientist who had signed on as scientific advisor to Elysium. “He’s one of my heroes. When I was in college I was thinking if I should go to graduate school and study with him,” says Stampfer. “He basically reassured me indeed they really wanted to do solid work and it wasn’t, you know, a fly-by-night operation. So I said, ‘OK, I’m in.’”
Another member of the board, David Moore, now a metabolism researcher at Baylor, told me he was recruited by Jack Szostak, another one of Elysium’s Nobel prize winners. Moore’s and Szostak’s labs were next to each other at Harvard, and Szostak knew his former colleague was interested in natural products. “I don’t have much to say because I haven’t been in much direct contact with them,” Moore said when I called. “I’ve emailed back and forth but nothing substantive.” (tampfer says he has been more closely involved; he’s given feedback into the design of Elysium’s human trial.)
Despite Elysium’s pledged allegiance to scientific rigor, it is still selling a supplement unproven in humans—an expensive one, at that. Guarente told me he thought the nonhuman evidence was convincing, and he wanted to put the information out to let the customer decide. “You don’t have to start now. If you want to wait, wait,” he says. “We’re taking it.”
Elysium does have serious scientists who have put their names to the product. And I caught my self feeling that Elysium’s pills, packaged in a sleek jar and backed by so many experts, seemed more legitimate than the bottles of NR online. But then why should I? It’s all the exact same NR made by ChromaDex. Branding is a powerful thing.
Bohr, the NIH scientist studying NR for Cockayne Syndrome, told me he was uneasy with the supplements push. “I think it’s a very promising thing, but dietary supplements are not controlled,” he says. “They don’t have to go through FDA. They don’t have to do through through real interrogation.”
If NR truly does end up reversing the signs of aging in humans, the FDA will decide how to regulate it—as a supplement or as a drug. Or as both, which companies looking to maximize payments from customers and insurance companies might prefer.